Updated: January 18, 2025
United States – 448
World Wide – 1,033
There are clinical trials going on all over the world in the area of obesity and cancer. Here are the current clinical trials going on in the US and worldwide (below). These studies are listed in more details with contact information on the clinicaltrials.gov website. This table represents search for the keywords CANCER AND OBESITY.
United States
| NCT Number | Study Title | Study URL | Acronym | Brief Summary | Study Results | Conditions | Interventions | Primary Outcome Measures | Secondary Outcome Measures | Other Outcome Measures | Sponsor | Collaborators | Sex | Age | Phases | Enrollment | Funder Type | Study Type | Study Design | Other IDs | Start Date | Primary Completion Date | Completion Date | First Posted | Results First Posted | Last Update Posted | Locations | Study Documents |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06751589 | A Study of a Weight Loss Intervention in People With Endometrial Cancer | https://clinicaltrials.gov/study/NCT06751589 | The researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. The researchers will also look at participants’ experience with the study drug, the safety of taking the study drug while receiving chemotherapy, and changes in weight, body fat composition, and blood pressure of participants. | NO | Endometrial Cancer | DRUG: Tirzepatide | percentage of patients that complete treatment, measured by the percentage of patients that complete at least 70% of weekly doses, specifically 17 out of 24 weekly doses., 1 year | frequency of gastrointestinal adverse events, as graded by CTCAE 5.0 that are attributable to the study treatment (tirzepatide) and occur during the on-treatment period from baseline initiation of the intervention to the end of study, up to 24 2weeks | Memorial Sloan Kettering Cancer Center | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 36 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 24-331 | 2024-12-19 | 2026-12 | 2026-12 | 2024-12-30 | 2025-01-06 | Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen, Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Commack, Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States | |||||
| NCT06740162 | Physical Activity and Community EmPOWERment Project | https://clinicaltrials.gov/study/NCT06740162 | PACE | Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer’s Disease (AD)/age-related dementias (ARD). Participants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Participants also include 16 exercise professionals. Procedures (methods): Each cohort will include 20 triads who are randomly assigned to the PACE program or the waitlist control group. | NO | Intellectual Disability|Neurodevelopmental Disorders|Autism Spectrum Disorder|Down Syndrome|Fragile X Syndrome|Cri-du-Chat Syndrome|De Lange Syndrome|Mental Retardation, X-Linked|Prader-Willi Syndrome|Rubinstein-Taybi Syndrome|Trisomy 13 Syndrome|WAGR Syndrome|Williams Syndrome | BEHAVIORAL: PACE Program | Number of Steps Per Day as Measured by the ActiGraph GT9X Link, The Actigraph GT9X Links measures daily step counts. Step counts less than 2500 are classified as basal, step counts between 2500 to 4999 are classified as limited, step counts between 5000 to 7499 are classified as low, step counts between 7500-9999 are classified as somewhat active, step counts between 10000 to 12499 are classified as active, and step counts over 12500 are classified as very active., Baseline, post-intervention (16 weeks)|Minutes of Moderate-to-Vigorous Activity Per Day as Measured by the ActiGraph GT9X Link, The Actigraph GT9X Links measures activity counts each minute of wear time. Each activity count over 3,941 equals 1 minute of moderate-vigorous physical activity. A total of 150 or more weekly MVPA minutes meets Physical Activity guideline recommendations., Baseline, post-intervention (16 weeks) | Body Composition from Baseline as Measured by percentage of total body mass, Body composition will be assessed using the Bod Pod at University of North Carolina and the DXA at University of Arkansas. The Bod Pod is an air displacement plethysmograph that uses whole-body densitometry to determine fat, lean, and total body mass. Total body mass \>30%for men/40% for women=risky, 21- 30%for men/31-40%for women=extra fat, 13-20%for men/23-30% for women=acceptable, 9-12% for men/19 -22% for women=excellent health ), 5-8 % for men/15-18 %for women= ultra lean, and \<5 percent and \<15%=risky low body fat. The Dual-Energy X-Ray Absorptiometry (DXA) scan measures body fat percentage. Optimal body fat percentages for adults age 20-29 are 16-24%for females/7-17 % for males; age 30-39 are 17-25% for females/12-21% for males, age 40-49 are 19-28% for females/14-23% for males, ages 50-59 are 22-31% for females/16-24% for males, age 60+ are 22-33% for females/17-25% for males. Numbers that are higher than optimal=overweight and lower than optimal=underweight., Baseline, post-intervention (16 weeks), Follow-up (74 weeks)|Wellbeing from Baseline as Measured by the World Health Organization Quality of Life Assessment and Disabilities Module, Adults with intellectual disability (ID) will complete the World Health Organization Quality of Life Assessment and World Health Organization Disabilities Module measures of quality of life. The WHOQoL-BREF and WHO Disabilities module is an abbreviated 39-item version of the original WHOQOL tool that has been used in adults with ID. The domain scores will be used to measure the general quality of life (Overall, Health, Physical, Psychological, Social, Environment, and Disabilities Module). Scores Range from 0-100 with higher scores indicating better quality of life., Baseline, post-intervention (16 weeks)|Daily Living Skills from Baseline as Measured by the Waisman Activities of Daily Living Scale, Activities of daily living will be measured using caregiver-report using the Waisman Activities of Daily Living (W-ADL). The 17-item W-ADL measures the level of independence in performing typical daily activities for adolescents and adults. The W-ADL has demonstrated high internal consistency (Cronbach alphas= .88-.94) and reliability over time (Kappas= .92-.93) in adults with intellectual disability. Performance is rated on a 3-point scale (0 means the participant does not do the activity at all, 1 means the participant does the activity with help, and 2 means the participant does the activity independently). The scoring range is 0 to 34 with higher scores signifying greater independence in daily living activities., Baseline, post-intervention (16 weeks)|Mental and Cognitive Functioning from Baseline as Measured by the NIH-Toolbox Cognitive Battery, Mental and cognitive functioning will be measured using the NIH-Toolbox Cognitive Battery (NIHTB-CB), which has been validated in individuals with intellectual disability and adults across the spectrum of Alzheimer's disease and age-related cognitive decline. The NIHTB-CB is an iPad-based assessment of memory, executive function, and crystallized intelligence. The Fluid Cognition Composite includes fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. The Crystallized Cognition Composite Score includes the Picture Vocabulary and Reading Tests. The composite scores are derived by averaging the standard scores of each of the measures. Higher scores indicate higher levels of functioning - a score at/near 100 indicates ability that is average compared with others nationally, 115 suggests above-average, 130 suggests superior ability, 85 suggests significantly below-average, and a score of below suggests very low., Baseline, post-intervention (16 weeks)|Psychological Well-Being, and Social Relationships from Baseline as Measured by the NIH Toolbox Emotion Battery, Social belonging will be assessed through questionnaires using the NIH Toolbox Emotion battery including the Psychological Well-Being, Social Relationships domains with adults with intellectual disability. The NIH-Toolbox Emotion Battery has been validated in adults with and without neurological disorders. The Psychological Well-Being Domain is derived from a weighted average of T-scores for Positive Affect, General Life Satisfaction, and Meaning \& Purpose. Higher scores indicate more self-reported psychological well-being. Scores below 40 suggest low levels of psychological well-being, and scores above 60 suggest high levels of psychological well-being. The Social Satisfaction summary score is derived from Friendship, Loneliness, Emotional Support, Instrumental Support, and Perceived Rejection. Higher scores indicate higher social satisfaction. Scores below 40 suggest low levels of social satisfaction, and scores above 60 suggest high levels of social satisfaction., Baseline, post-intervention (16 weeks)|Stress and Self-Efficacy, and Negative Affect from Baseline as Measured by the NIH Toolbox Emotion Battery, Social belonging will be assessed through questionnaires using the NIH Toolbox Emotion battery including the Stress and Self-Efficacy, and Negative Affect domains. Stress and Self-Efficacy focus on individual perceptions about the nature of their events and their relationship to the perceived coping resources. On Perceived Stress, higher scores are indicative of more perceived stress. Scores at or below 40 suggest low perceived stress and scores at or above 60 suggest high perceived stress. On Self-efficacy, higher scores are indicative of more general self-efficacy. Scores at or below 40 suggest low self-efficacy levels and scores at or above 60 suggest high self-efficacy levels. Negative Affect summary score is derived from the Anger-Affect, Anger-Hostility, Sadness, Fear-Affect, and Perceived Stress Domains. Higher scores are indicative of more negative affect. Scores at or below 40 suggest low levels, and scores at or above 60 suggest high levels of negative affect., Baseline, post-intervention (16 weeks)|Grip Strength from Baseline as Measured by the Hand Dynamometer, Grip strength will be assessed by a 1-rep max strength assessment. Participants will be asked to squeeze the hand dynamometer as hard as they can for 3 seconds. Grip strength is measured with a standard score metric (normative mean = 100, Standard Deviation = 15). It compares the performance of the test-taker to those in the entire NIH Toolbox nationally representative normative sample. Higher standard scores indicate better performance., Baseline, post-intervention (16 weeks)|Ability to Maintain Balance from Baseline as Measured by the 4-Stage Balance Test, Balance will be measured by the 4-Stage Balance Test. The test consists of four standing positions that are progressively harder to maintain. Each position is held for a maximum of 10 seconds. This is scored by number of seconds, with 10 being the maximum score indicating static balance., Baseline, post-intervention (16 weeks)|Functional Lower Extremity Strength and Endurance from Baseline as Measured by the 30-Second Chair Stand, Functional strength will be measured by the 30-second chair stand. This test consists of participants getting up from a chair without using their arms. They get up and sit down repeatedly for 30 seconds. Their score is the number of times they can get up from the chair. The higher the score indicates greater leg strength and endurance., Baseline, post-intervention (16 weeks)|Mobility from Baseline as Measured by the Timed Up & Go (TUG), Mobility will be assessed through the Timed Up \& Go (TUG) assessment. This test consists of participants getting up from a chair, walking 10 feet across the room around a cone, and sitting back down. This is scored in seconds. A time of ≥12 seconds to complete the TUG is at risk for falling., Baseline, post-intervention (16 weeks)|Endurance from Baseline as Measured by the 2-Minute Walk Endurance Test, This test consists of participants walking as fast as they can for two-minutes up and down the hallway of the assessment spaces. The participant's raw score is the distance walked in two minutes, reported in feet (and fractions thereof). This score is then converted to the NIH Toolbox normative scores. Higher scores are indicative of better endurance. Scores at or below 30 are suggestive of motor dysfunction., Baseline, post-intervention (16 weeks) | University of North Carolina, Chapel Hill | National Institute on Aging (NIA) | ALL | ADULT, OLDER_ADULT | NA | 376 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 24-0921|5R01AG076678-02 | 2025-01-10 | 2027-12 | 2028-06 | 2024-12-18 | 2025-01-15 | University of Arkansas, Fayetteville, Arkansas, 72701, United States|University of North Carolina, Chapel Hill, North Carolina, 27517, United States | |||
| NCT06705504 | A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib | https://clinicaltrials.gov/study/NCT06705504 | This study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (aBC/mBC) treated with ribociclib or alpelisib between the period of 01 January 2018 and 30 September 2021. Patients who were receiving active treatment for malignancies other than BC or participating in a clinical trial were excluded. This study was conducted retrospectively with secondary use of data. | NO | Hormone Receptor Positive HER-2 Negative Breast Cancer | Real-world Progression-free Survival (rwPFS), rwPFS was defined as the time from the index date to the date of the first documented progression or death due to any cause. If a patient did not have an event, rwPFS was censored at the date of the last adequate tumor assessment. The index date was defined as the date of the first treatment with ribociclib or alpelisib., Up to 51 months | Age, Baseline|Number of Patients by Age Group, Age groups: * Younger than 65 years * 65 years or older, Baseline|Gender, Baseline|Number of Patients Categorized by Year of Index Date, The index date was defined as the date of the first treatment with ribociclib or alpelisib., Baseline|Number of Patients With a History of Breast Cancer, Baseline|Number of Patients by Comorbidity, Comorbidities included: * Diabetes mellitus * Cardiovascular disease * Cerebrovascular disease * Chronic obstructive pulmonary disease (COPD) * Dementia * Depression * Heart Failure * Hypertension * Hypothyroidism * Ischemic heart disease * Liver disease * Myocardial infarction * Osteoporosis * Peripheral vascular disease * Renal Disease * Rheumatological disease * Ulcer disease * Other, Baseline|Body Mass Index (BMI), Baseline|Number of Patients per BMI Category, BMI Categories: * Underweight: below 18.5 kilograms per meter squared (kg/m\^2) * Healthy/normal weight: 18.5 to 24.9 kg/m\^2 * Pre-obesity: 25 to 29.9 kg/m\^2 * Obesity: 30 kg/m\^2 and higher, Baseline|Number of Patients by Menopausal Status, Menopausal status: * Pre- or peri-menopausal * Post-menopausal, Baseline|Number of patients per Charlson Comorbidity Index (CCI) Score Category, CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2)., Baseline|Number of Patients Categorized by Duration of Disease Recurrence, Disease recurrence categories: * 12 months or less * More than 12 months, Baseline|Number of Patients by Smoking Status, Smoking status: * Current smoker * Former smoker * Never smoked, Baseline|Number of Patients Categorized by Primary Tumor Type, Tumor types: * Invasive ductal * Lobular carcinoma * Other, Baseline|Number of Patients Categorized by Disease Site, Disease site categories: * Non-visceral * Visceral * Multiple, Baseline|Number of Patients With Primary Metastatic Disease, Baseline|Number of Patients Categorized by Number of Metastatic Sites, Categories for number of metastatic sites: 0, 1, 2, 3, 4 or more., Baseline|Number of Patients Categorized by Type of Metastases, Metastases: * Local/breast metastases * Bone metastases * Lung metastases * Liver metastases * Central nervous system metastases * Lymph node metastases * Other metastases, Baseline|Number of Patients Categorized by Time From Diagnosis to Metastasis, Categories: * 24 months or less * More than 24 months * Metastatic BC at diagnosis, Baseline|Number of Patients With Asymptomatic Disease, Baseline|Number of Patients Categorized by Tumor Grade, Tumor Grades: * Grade 1 * Grade 2 * Grade 3, Baseline|Number of Patients Categorized by Stage of Cancer, Cancer Stages: I, IIA, IIB, IIIA, IIIB, IIIC, and IV., Baseline|Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Score, ECOG performance score describes a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores ranged from a lower value of 0 (fully active, able to carry out all pre-disease performance without restriction) up to 4 (completely disabled; cannot carry out any selfcare; totally confined to bed or chair)., Baseline|Number of Patients Categorized by Previous Types of Treatment, Treatment categories: * Chemotherapy * Surgery * Radiotherapy * Adjuvant endocrine therapy * Everolimus treatment, Baseline|Number of Patients Categorized by the Number of Prior Lines of Endocrine Therapy (ET), Categories for number of lines of ET: 0, 1, 2, and 3 or more., Baseline|Number of Patients Resistant to ET, Baseline|Number of Patients Sensitive to Hormonal Therapy, Baseline|Number of Patients Categorized by Line of Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment Received, CDK4/6i lines of treatment: * Adjuvant * 1st metastatic line * 2nd metastatic line * 3rd metastatic line or later, Baseline|Number of Patients Categorized by the Number of Previous Lines of Treatment, Categories for number of lines of treatment: 0, 1, 2, and 3 or more., Baseline|Baseline Neutrophil-to-lymphocyte Ratio (NLr), Baseline|Baseline Platelet-to-lymphocyte Ratio (PLr), Baseline|Baseline Lymphocytes-to-monocytes Ratio (LMr), Baseline | Novartis | ALL | ADULT, OLDER_ADULT | 435 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | CLEE011A3002 | 2021-06-11 | 2023-11-30 | 2023-11-30 | 2024-11-26 | 2024-11-26 | Novartis, East Hanover, New Jersey, 07936, United States | |||||||
| NCT06644573 | Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia | https://clinicaltrials.gov/study/NCT06644573 | PSHW | This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes. | NO | Chronic Insomnia|Sleep Deprivation|REM Behavior Disorder|REM Sleep Behavior Disorder|REM Sleep Measurement|Insomnia|Insomnia Related to Specified Disorder|Insomnia Due to Other Mental Disorder|Insomnia Comorbid to Psychiatric Disorder|Insomnia Due to Anxiety and Fear|Insomnia Related to Another Mental Condition|Insomnia Disorders|Idiopathic Hypersomnia|Sleep Disorders, Circadian Rhythm|Post Trauma Nightmares|PTSD – Post Traumatic Stress Disorder|Sleep Quality|Anesthesia|Anxiety|Depression|Mental Health|Alzheimer Disease or Associated Disorder|Parkinsons|Circadian Rhythm|Circadian Dysregulation|PTSD|Post-Traumatic|Post-Traumatic Stress Disorder Complex|Military Combat Stress Reaction|Sleep|Military Activity|Veterans|Shift Work Sleep Disorder|Menopause Related Conditions|Pain|Cancer Pain|Athletes | PROCEDURE: PROSOMNIA Sleep Therapy™ (PSTx)|PROCEDURE: Anesthesia-Induced Sleep Therapy|DRUG: Diprivan (propofol), Astra-Zeneca|DEVICE: Continuous EEG Monitoring | Reduction in Homeostatic Sleep Pressure, Evaluate the effectiveness of PROSOMNIA Sleep Therapy in reducing homeostatic sleep pressure, as measured by EEG recordings, blood serum uric acid levels and subjective self-reports., 60-120 minutes|Change in Sleep Onset Latency, Measure the time it takes for patients to fall asleep (sleep onset latency) following PROSOMNIA Sleep Therapy, using polysomnography (PSG)., 30 days|Change in REM Sleep Duration, Measure the improvement in the duration of REM sleep using EEG and polysomnography (PSG) before, during and after PROSOMNIA Sleep Therapy., 30 days|Change in Overall Sleep Health, The PROSOMNIA Sleep Quiz (PSQ) is a comprehensive tool used to assess sleep health, specifically for identifying chronic insomnia, REM sleep deprivation, or both. The scale measures sleep quality, quantity, and overall health factors contributing to sleep disorders. The PSQ consists of 18 questions, each scoring various sleep and health-related conditions. Quiz Scoring System: Minimum Score: 0 points Maximum Score: 55 points Higher Scores Indicate: Poorer sleep health and worse outcomes., 30 days | Changes in Blood Serum Uric Acid Levels, Measure changes in blood serum uric acid levels, reflecting adenosine release into the bloodstream, after PROSOMNIA Sleep Therapy sessions., 60-120 minutes|Improvement in Patient-Reported Mood, The Mood Quality Assessment is used to evaluate the impact of PROSOMNIA Sleep Therapy on patient-reported mood following treatment. This assessment utilizes a 5-point scale: Minimum Value: 1 (Happy) Maximum Value: 5 (Bad) Higher scores indicate worse mood outcomes, reflecting increased mood disturbances or negative emotional states. The assessment is conducted at baseline and post-treatment to gauge changes in mood and emotional well-being, providing insights into the therapy’s effect on overall mood regulation and mental health., 30 days | Adverse Event Reporting, Record any adverse events associated with PROSOMNIA Sleep Therapy, categorized by severity and likelihood of relation to the intervention., 6 months|PROSOMNIA Sleep Virtual Consultation Note, The data collected during the PROSOMNIA Sleep Virtual Consultation Note will establish baseline characteristics, identify risks and create a Personalized PROSOMNIA Sleep Therapy Plan. This plan will integrate specific interventions to address risk factors and enhance treatment effectiveness. Continuous monitoring and periodic reassessment will be conducted to identify any emerging patterns, modify interventions as needed, and ensure long-term improvements in sleep health and overall well-being., 30 days | Nyree Penn | Masimo Corporation|PROSOMNIA Sleep Health & Wellness | ALL | ADULT, OLDER_ADULT | PHASE1 | 100 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | PROSOMNIAsleep | 2024-11-01 | 2025-05-01 | 2025-05-01 | 2024-10-16 | 2024-11-01 | PROSOMNIA Sleep Health and Wellness, Aventura, Florida, 33180, United States | ||
| NCT06644560 | A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients | https://clinicaltrials.gov/study/NCT06644560 | The purpose of this study is to assess the feasibility of a prehab intervention among American Indian (AI) patients diagnosed with obesity-related cancer and measure inflammatory biomarkers to evaluate the preliminary impact of the trial intervention. The central hypothesis is that this community-informed prehab intervention will demonstrate feasibility, patient acceptability, and modulation of host and tumor-microenvironment inflammatory biomarkers. Aim 1: Implement the prehab translational clinical trial for AI patients with obesity-related solid tumor cancer scheduled for surgery. Aim 2 Measure host and tumor-microenvironment (TME) biomarkers using paired serum and tissue samples to compare baseline and post-intervention levels of expression. Serum markers include CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin. Tissue markers include Ki67, insulin receptor, TNFa, NFKB, NOS2, and cleaved caspase 3. Aim 3: (optional exploratory aim): Assess differential expression of inflammatory genes in the TME using tumor tissue samples to compare baseline and post-intervention levels of expression. This will be done with a panel that analyzes inflammatory genes only. | NO | Cancer|Obesity | BEHAVIORAL: Prehabilitation Intervention | Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements, Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via patient enrollment and retention. Patient retention will be estimated as the proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements, with an exact 95% binomial confidence interval., Baseline and post-intervention (an average of 5 weeks)|Adherence to study protocol: compliance with intervention foods (walnuts), Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with intervention foods (walnuts). Compliance with intervention foods (walnuts) will be estimated as the number of daily packets eaten/number distributed, with an exact 95% binomial confidence interval., 3 weeks during participant’s preoperative window|Adherence to study protocol: compliance with exercise recommendations, Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with exercise recommendations. Compliance with exercise recommendations will be estimated as the increase in daily steps (as measured by pedometers) post- versus pre-intervention using a 95% confidence interval., 3 weeks during participant’s preoperative window|Assessing patient acceptability via exit interviews to solicit patient experience and feedback, Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via exit interviews. The exit interviews will provide qualitative data for assessment. The interview transcriptions will be coded and themed. Themes will be vetted with SCAHC staff to ensure shared understanding of concepts and accurate representation of community perspective., 3 weeks during participant’s post-intervention assessment|Comparison of pre/post-intervention 6 Minute Walk Test Scores to assess lifestyle behavioral change, Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the 6 Minute Walk Test scores. The score of the 6MWT is the distance a patient walks in 6 minutes. Pre/post intervention performance changes on the 6MWT will be estimated using 95% confidence intervals, with transformation as needed to induce normality., Baseline and post-intervention assessment (an average of 3 weeks)|Comparison of pre/post-intervention sit-to-stand test scores to assess lifestyle behavioral change, Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the sit-to-stand test scores. The sit-to-stand test score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Pre/post intervention performance changes on the sit-to-stand test will be estimated using 95% confidence intervals, with transformation as needed to induce normality., Baseline and post-intervention assessment (an average of 3 weeks)|Comparison of pre/post-intervention patient responses to the Dietary Screener Questionnaire, Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing pre/post- intervention responses to the Dietary Screener Questionnaire. The Dietary Screener Questionnaire has 30 questions. There is a scoring algorithm that converts the responses to estimates of dietary intake of fruits and vegetables, dairy, added sugar, whole grain, fiber, and calcium. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality., Baseline and post-intervention assessment (an average of 3 weeks)|Comparison of pre/post-intervention patient responses to the Arizona Activity Questionnaire, Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing Arizona Activity Questionnaire. The Arizona Activity Questionnaire has 14 sections with 77 line items. There is a formula that converts the responses to estimates of total energy expenditure and physical activity energy expenditure. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality., Baseline and post-intervention assessment (an average of 3 weeks)|Assessing biosample collection rates: percentage of patients completing blood and tissue sample collection, Primary endpoint: determining feasibility of the prehabilitation intervention by assessing percentage of patients who complete blood and tissue sample collections. Biosample collection rates (plasma and tissue) will be estimated as the proportion of patients who provide biospecimens at the pre- and post-intervention visits, with exact 95% binomial confidence intervals., Baseline and post-intervention assessment (an average of 3 weeks) | Assess stability of anthropometric measures: blood pressure, Blood pressure is measured in units of millimeters of mercury (mmHg). Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality., Baseline and post-intervention assessment (an average of 3 weeks)|Assess stability of anthropometric measures: weight, Weight will be measured in kilograms. Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality., Baseline and post-intervention assessment (an average of 3 weeks)|Assess stability of anthropometric measures: waist circumference, Waist circumference will be measured in centimeters. Pre/post intervention changes will be estimated using 95% confidence intervals, with transformation as needed to induce normality., Baseline and post-intervention assessment (an average of 3 weeks)|Assess changes between pre and post intervention levels of serum biomarkers., Serum biomarkers \[including CRP, IL-6, IL-10, TNFa, IGF-1, VEGF, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and prealbumin\] will be quantified with ELISA. Changes in serum biomarker levels will be estimated using 95% confidence intervals., Baseline and post-intervention assessment (an average of 3 weeks)|Assess changes between pre and post intervention levels of tissue biomarkers., Tissue biomarkers \[including Ki67, insulin receptor, TNFa, NFKB, NOS2, cleaved caspase 3\] will be quantified with ELISA. Changes in tissue biomarker levels will be estimated using 95% confidence intervals., Baseline and post-intervention assessment (an average of 3 weeks) | Assess differential expression of inflammatory genes in the tumor microenvironment, For patients who agree to the optional exploratory aim, the existing diagnostic biopsy tissue and surgical specimen tissue can be additionally analyzed for gene expression data. Genes related to inflammation would be measured and no other genes would be studied., Baseline and post-intervention (an average of 3 weeks) | University of Arizona | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | STUDY00004848|K08CA276137 | 2025-01-15 | 2027-03-31 | 2028-06-30 | 2024-10-16 | 2024-12-20 | University of Arizona Cancer Center, Tucson, Arizona, 85724, United States | |||
| NCT06609057 | Cooking for Your Health in Southern New Mexico: an 8-week, Bilingual (English and Spanish) Nutritional Intervention in Adults Living in Doña Ana and Otero Counties | https://clinicaltrials.gov/study/NCT06609057 | This clinical trial evaluates a nutritional intervention called Cooking for Your Health in Southern New Mexico for improving diet quality and knowledge related to nutrition and cancer prevention among individuals living in the Southern region of New Mexico. New Mexico border communities have high rates of cancer and obesity, both exacerbated by poor diet quality. Traditional Mexican diets are high in fruit, vegetables, and fiber, but are intensive to prepare and not practical for many families living in New Mexico now. Vegetable oils, such as canola, safflower, and sunflower oils, are commonly used in cooking within the regional New Mexican community because they are inexpensive and readily available; however, they may not be as healthy as other options. Interventions focused on teaching proper cooking techniques and raising awareness about nutritious foods have shown positive behavior changes, including greater preference for healthier foods, increased confidence in food preparation and cooking a balanced meal, and higher vegetable variety and availability in the home. This study may help identify effective and culturally relevant real-world strategies to improve knowledge, skills, behaviors, and access to resources to improve nutrient intake, with the long-term goal of decreasing cancer risk and chronic disease risk in southern New Mexican communities. | NO | Dietary Carcinogenesis|Nutrition, Healthy | OTHER: Nutritional Intervention|OTHER: Questionnaire Administration|OTHER: Survey Administration|OTHER: Discussion | Accrual rate, The intervention will be considered feasible if accrual goals are met within 6 months of trial activation. Will be summarized using descriptive statistics., Within 6 months of trial activation|Engagement, The intervention will be considered feasible if \>= 70% of participants attend \>= 70% of sessions. Will be summarized using descriptive statistics., Up to 8 weeks|Retention, The intervention will be considered feasible if \>= 70% of participants complete the week 8 food frequency questionnaire. Will be summarized using descriptive statistics., At week 8|Acceptability, The intervention will be considered feasible if \>= 70% or more of participants state that the program and study processes were acceptable, appropriate, and feasible. Acceptability will assess: intervention pre-work and in-class work activities, as well as specific data collection methods. Will be summarized using descriptive statistics., Up to 8 weeks | Fred Hutchinson Cancer Center | National Cancer Institute (NCI)|New Mexico State University | ALL | ADULT, OLDER_ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | RG1124544|NCI-2024-06525|20558|U54CA132381 | 2025-01-09 | 2025-06-30 | 2025-06-30 | 2024-09-23 | 2024-12-10 | New Mexico State University, Las Cruces, New Mexico, 88003, United States | |||||
| NCT06570642 | eMOTION: Examining Affective Mechanisms in Physical Activity Engagement | https://clinicaltrials.gov/study/NCT06570642 | This early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese. | NO | Physical Inactivity|Overweight or Obesity|Cancer | BEHAVIORAL: Physical Activity Goals mHealth Intervention|BEHAVIORAL: TYPE/CONTEXT enhancement|BEHAVIORAL: SAVOR enhancement | Physical Activity: Step Count, Daily steps will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis., Daily total for weeks 2-9 and weeks 12-19|Physical Activity: Minutes, Daily minutes of light, moderate, and vigorous physical activity will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis., Daily total for weeks 2-9 and weeks 12-19 | Affective Response, Event-contingent ecological momentary assessment (EMA) check-ins sent to the smartwatch during physical activity measure affective response. Event-contingent EMA are triggered when Fitbit sensors detect physical activity via moving average heart rate. A ≥30-minute buffer separates the first and second EMA during a single physical activity bout. A maximum of two event-contingent EMA will be sent within any given 60-minute period. Participants are asked to safely pause their activity to answer seven items about their affective response using a 5-point bipolar Likert Scale. Five items (Energetic-Fatigued, Happy-Discouraged, Relaxed-Tense, Excited-Bored, Satisfied-Frustrated) are drawn from Russell’s Circumplex Model of Affect; one (Good-Bad) represents core affective valence; and one (Proud-Embarrassed) represents self-conscious emotion., Max 2 per 60-min physical activity period|Affectively-Charged Motivations, Affectively-charged motivations for physical activity are measured during the morning goal session via REDCap. A text message alerts participants to complete the morning goal session on their smartphone. A single item from the Attraction-Antipathy subscale of the AFFEXX measures affectively-charged motivation by asking, “How do you feel about doing physical activity today?”. Participants select a response using a Visual Analogue Scale ranging from 0 (Dread) to 100 (Excited)., Once daily for weeks 2-9 and weeks 12-19|Anticipated Affect, Anticipated affect is measured during the morning goal session via REDCap. A text message alerts participants to complete the morning goal session on their smartphone. A single item asks, “How do you expect to feel during physical activity today?”. Participants select a response using a Visual Analogue Scale ranging from 0 (Miserable) to 100 (Thrilled)., Once daily for weeks 2-9 and weeks 12-19 | University of Southern California | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 280 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | UP-22-00332|R01CA272933 | 2024-08-14 | 2026-05 | 2027-06 | 2024-08-26 | 2024-08-26 | University of Southern California, Los Angeles, California, 90032, United States | ||||
| NCT06517212 | Tirzepatide Weight Loss for MRD+ Early Breast Cancer | https://clinicaltrials.gov/study/NCT06517212 | TRIM-EBC | This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease. | NO | Breast Cancer|Breast Neoplasms|Breast Cancers | DRUG: Tirzepatide | ctDNA efficacy, Clearance of the presence of plasma ctDNA within two years of documented ctDNA positivity at time of study entry., 2 years|distant disease-free survival efficacy, Percentage of patients alive and free of distant metastatic disease at 2 years following detection of ctDNA at the time of study entry., 2 years | ctDNA kinetic changes using Haystack MRD, Differences in ctDNA kinetics between patients who clear ctDNA versus patients who do not clear ctDNA while on tirzepatide using the Haystack MRD assay., 2 years|Number of patients with Treatment-Related Adverse Events (Safety and Tolerability), Number of patients with treatment related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., 2 years|weight loss, Percentage of weight loss observed on tirzepatide associated with clearance or persistence of ctDNA in patients receiving standard adjuvant endocrine therapy., 2 years | time to recurrence, Breast cancer distant disease-free survival, defined as the time from beginning tirzepatide therapy to the time of distant disease recurrence or death, over five years in ctDNA-positive patients who clear ctDNA versus patients who do not clear ctDNA while on tirzepatide., 5 years|exploratory molecular changes via Next Generation Sequencing (NGS), Flow Cytometry, and Reverse Phase Protein Array (RPPA), Exploratory analysis of metabolic, hormonal and immune cell changes associated with weight loss on tirzepatide in early breast cancer patients. Exploratory analyses may include NGS, Flow Cytometry, and RPPA., 5 years | Baylor Research Institute | ALL | ADULT, OLDER_ADULT | PHASE2 | 48 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 024-273 | 2024-11-26 | 2029-08-31 | 2030-12-31 | 2024-07-24 | 2024-11-27 | Baylor University Medical Center, Baylor Charles A Sammons Cancer Center, Dallas, Texas, 75246, United States | |||
| NCT06518837 | Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer | https://clinicaltrials.gov/study/NCT06518837 | FITWISE | This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA). | NO | Hormone Receptor-Positive Breast Cancer|HER2-Negative Breast Cancer | DRUG: Tirzepatide | Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction), To determine the effectiveness of tirzepatide in facilitating a 5% or more weight loss in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer., Through study completion, total of two years. | Safety and Tolerability of Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Incidence of Adverse Events Using CTCAE v5.0), This outcome assesses the safety and tolerability of tirzepatide for weight loss in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to monitor and document the incidence of adverse events (AEs) associated with tirzepatide use, utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This assessment will help determine the risk profile of tirzepatide and ensure that the benefits of weight loss outweigh potential adverse effects in this patient population., Adverse events will be monitored through study completion for two years.|Feasibility of Tirzepatide for Weight Loss Intervention during Adjuvant Treatment for HR+/Her2- Breast Cancer (Assessed by Discontinuation Rates and Completion of Treatment Course)., This outcome measures the feasibility of using tirzepatide for weight loss intervention in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to assess the intervention’s practicality by evaluating discontinuation rates and the completion of the treatment course. High completion rates and low discontinuation rates will indicate that tirzepatide is a feasible weight loss intervention in this patient population., Feasibility will be evaluated through study completion for two years.|Clinical Efficacy of Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by 3-Year Invasive Disease-Free Survival and 3-Year Distant Relapse-Free Survival), This outcome measures the clinical efficacy of tirzepatide in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to determine the 3-year invasive disease-free survival (IDFS) and the 3-year distant relapse-free survival (DRFS) rates. These metrics will help evaluate whether weight loss using tirzepatide contributes to preventing cancer recurrence and metastasis in this patient population., Patients will be monitored for recurrence through study completion and an additional year, for total three years.|Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, as measured by Waist/Hip Ratio (WHR), and waist circumference., This outcome measures the impact of tirzepatide on obesity-related metrics in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in Body Mass Index (BMI), body fat distribution as measured by Waist/Hip Ratio (WHR), and waist circumference. These assessments will help determine the effectiveness of tirzepatide in improving body fat distribution and reducing obesity in this patient population. Weight and height will be combined to report BMI in kg/m\^2 and waist circumference reported in inches., Obesity measurements will be evaluated through study completion for two years.|Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Weight and height will be combined to report BMI in kg/m^2., This outcome measures the impact of tirzepatide on obesity-related metrics in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in Body Mass Index (BMI), body fat distribution These assessments will help determine the effectiveness of tirzepatide in improving body fat distribution and reducing obesity in this patient population. Weight and height will be combined to report BMI in kg/m\^2., Obesity measurements will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Blood Pressure Changes unit of Measure: Millimeters of mercury (mm Hg)., This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, blood pressure (mm Hg),assessment of blood pressure changes unit of measure: millimeters of mercury (mm Hg)These assessments will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of fasting insulin changes, unit of Measure: Milli-international units per liter (mIU/L), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, Assessment of Fasting Insulin changes, unit of measure: milli-international units per liter (mIU/L)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Fasting Blood Glucose Changes, Unit of Measure: Millimoles per liter (mmol/L), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of fasting blood glucose changes unit of measure: millimoles per liter (mmol/L). This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of HgbA1c Changes, Unit of Measure: Millimoles per mole (mmol/mol), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-assessment of HgbA1c Changes unit of measure: millimoles per mole (mmol/mol). This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Cholesterol (Total, LDL, HDL) Changes Unit of Measure: Milligrams per deciliter (mg/dl), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of cholesterol (Total, LDL, HDL) changes unit of measure: milligrams per deciliter (mg/dl)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Triglyceride Changes Unit of Measure: Millimoles per liter (mmol/L), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of triglyceride changes unit of measure: millimoles per liter (mmol/L)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of IGF1 Changes, Unit of Measure: Nanograms per milliliter (ng/ml), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of IGF1 changes unit of measure: nanograms per milliliter (ng/ml)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Assessment of Estrogen Changes, Unit of Measure: Picograms per milliliter (pg/ml), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of estrogen changes unit of measure: Picograms per milliliter (pg/ml)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Testosterone Changes, Unit of Measure: Nanograms per deciliter (ng/dL), This outcome measures the impact of tirzepatide on obesity-related metabolic markers in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to evaluate changes in various metabolic markers, assessment of testosterone changes unit of measure: nanograms per deciliter (ng/dL)This assessment will help determine the effectiveness of tirzepatide in improving metabolic health and reducing obesity-related risks in this participant population., Metabolic markers will be evaluated through study completion for two years.|Monitoring Circulating Tumor DNA (ctDNA) Levels Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer (Detection and Changes in ctDNA Levels during Treatment)., This outcome measures the effect of tirzepatide on circulating tumor DNA (ctDNA) levels, which potentially serve as an early indicator of cancer recurrence in participants undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to detect ctDNA and monitor changes in its levels throughout the treatment duration. Assessing ctDNA levels can provide insights into the molecular response to obesity treatment using tirzepatide., ctDNA levels will be monitored through study completion for two years. | Rutgers, The State University of New Jersey | Ludwig Institute for Cancer Research | ALL | ADULT, OLDER_ADULT | PHASE2 | 40 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 042403 | 2024-10-30 | 2027-09-30 | 2027-09-30 | 2024-07-24 | 2024-12-02 | Trinitas Comprehensive Cancer Center, Elizabeth, New Jersey, 07202, United States|RWJ Barnabas Health – Robert Wood Johnson University Hospital, Hamilton, Hamilton, New Jersey, 08690, United States|RWJBarnabas Health – Cooperman Barnabas, Livingston, Livingston, New Jersey, 07039, United States|RWJBarnabas Health – Monmouth Medical Center, Long Branch, New Jersey, 07740, United States|Rutgers Cancer Institute, New Brunswick, New Jersey, 08901, United States|RWJBarnabas Health – Newark Beth Israel Medical Center, Newark, New Jersey, 07112, United States|RWJ Barnabas Health – Robert Wood Johnson University Hospital, Somerset, Somerville, New Jersey, 08876, United States | |||
| NCT06504914 | Preparing FIM-BCS – A Lifestyle Modification for African-American Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT06504914 | FIM-BCS | Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention – grocery delivery, cooking classes, and nutrition education – for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control. | NO | Hypertension|Obesity|Nutrition, Healthy | BEHAVIORAL: Assigned Interventions | Number of participants who complete the 12 week intervention, Completion will be measured by class attendance, [Time Frame: Up to 12 weeks] | University of Illinois at Chicago | FEMALE | ADULT, OLDER_ADULT | NA | 24 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2022-0966 | 2024-02-05 | 2024-11 | 2025-01 | 2024-07-17 | 2024-07-17 | University of Illinois Chicago, Chicago, Illinois, 60612, United States | |||||
| NCT06496295 | The Use of a Novel Vaginal Speculum for Cervical Cancer Screening in Sunrise Community Health Patients | https://clinicaltrials.gov/study/NCT06496295 | The specific aim of this research is to determine if the Bouquet Speculum TM , compared to the existing 2-bladed vaginal speculum, provides better visualization of the cervix, is easier for the provider to use and is more comfortable for the patient. Additionally, the clinician’s experience with vaginal speculum exams and the patient’s last vaginal speculum exam, parity and self-reported weight classification will be surveyed to see what effect, if any, it has on visualization of the cervix, ease-of use, and comfort level for the patient. The objective of this project is to investigate the use of a novel, FDA-cleared, 5-petaled vaginal speculum in cervical cancer screening (Pap test and/or HPV probe) on 200 patients from Sunrise Community Health Clinics in the Denver-Metro area. | NO | Cervical Cancer Screening | DEVICE: Vaginal Speculum Exam | Evaluating the use of the Bouquet Speculum for cervical visibility, ease-of-use, and comfort level, 200 women will be selected from the Sunrise Clinics in the Denver-Metro area. The clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1. visualization of the cervix 2. ease-of-use 3. experience with speculum exams. The patient will be consented and de-identified and assigned a number to their survey of four questions: 1. comfort level 2. last vaginal speculum exam 3. self-reported description of weight (underweight, normal, overweight, obese) 4. parity (number of births). The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans. Regulation Number: 884.4520, 3 months | Rocky Vista University, LLC | FEMALE | ADULT, OLDER_ADULT | 200 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IRB #2023-266 | 2024-11-14 | 2025-03-14 | 2025-05-30 | 2024-07-11 | 2024-12-16 | Rocky Vista University, Englewood, Colorado, 80112, United States | |||||||
| NCT06485089 | Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers | https://clinicaltrials.gov/study/NCT06485089 | Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss. | NO | Obesity|Breast Cancer Risk | DRUG: tirzepatide | Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months, Accrual defined as signed consent and ompleting baseline proceedures, 12 months|Completion rate of 70% or more, Completion of procedures for biomarker assessment after 3-6 months of tirzeptide, 6 months | Change in mammographic fibroglandular volume, as measured by Volpara software baseline and 6 months, 6 months|Change in benign breast tissue proliferation, Difference in baseline and off study Ki-67 in women with baseline Ki-67 of 1 % or higher, 3-6 months|Change in benign breast tissue estrogen response and ELF5 gene expression, Difference in baseline and off study mRNA, 3-6 months|Assessment of GIP-R expression in breast tissue, GIP- R mRNA and protein, 3-6 months|Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho, change in blood levels with assays primarily by ELISA, 3-6 months | University of Kansas Medical Center | FEMALE | ADULT | 20 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | STUDY00160627 | 2024-09-14 | 2025-07 | 2025-12 | 2024-07-03 | 2024-12-18 | University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|University of Kansas Medical Center Breast Cancer Prevention Center, Westwood, Kansas, 66208, United States | ||||||
| NCT06463249 | Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions | https://clinicaltrials.gov/study/NCT06463249 | Helpline | The objective of the HELPLINE Weight Loss Program is to determine the comparative effectiveness of two active multi-component, augmented interventions for cancer survivors with overweight or obesity who do not achieve early weight loss goal in the initial intervention period (termed, early non-responders). The core study design is randomized controlled trial with adaptive intervention. 1. CORE Helpline in all participants (first 2 months) 2. Extended Helpline in early responders (additional 6 months) 3. Enhanced Helpline in early non-responders (additional 6 months) 4. Intensive Helpline in early non-responders (additional 6 months) | NO | Weight Loss | BEHAVIORAL: CORE Helpline|BEHAVIORAL: Extended Helpline|BEHAVIORAL: Enhanced Helpline|BEHAVIORAL: Intensive Helpline | Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms, Weight change for Enhanced Helpline and Intensive Helpline in early non-responders, 8 months | Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms, Weight change for Enhanced Helpline and Intensive Helpline in early non-responders, 12 months | Weight (pounds) change from baseline to 2 months in all participants, Weight change for CORE Helpline over the first 2 months in all participants, 2 months|Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs, Weight change for each program over 12 months, 12 months | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Cigarette Restitution Fund | ALL | ADULT, OLDER_ADULT | NA | 200 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT | IRB00403808 | 2024-06-17 | 2026-12 | 2027-12 | 2024-06-17 | 2024-07-18 | Johns Hopkins ProHealth, Baltimore, Maryland, 21207, United States | ||
| NCT06413888 | Nasogastric Decompression Following Pancreaticoduodenectomy | https://clinicaltrials.gov/study/NCT06413888 | whipple | Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period. | NO | Pancreatic Head Neoplasm|Delayed Gastric Emptying|Post Operative Ileus|Whipple Procedure | PROCEDURE: pancreaticoduodenectomy | to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications, Severity of post operative complications was graded according to the Clavien-Dindo classification system adopted for pancreaic surgery, which relies on the type of treatment used for each complication with scores range from 1-4, and any complication graded \>2 considered a major complication., 30-days postoperatively | Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy, Patient will be considered to undergo nasogastric decompression with nasogastric tube if he/she demonstrated clinical evidence of postoperative ileus and delayed gastric emptying as defined according to the consensus definition proposed by the international study group of pancreatic surgery (ISGPS), the severity of which was classified into 3 grades (A,B, and C) based on clinical course and postoperative management such as the need nausea and vomiting and inability to tolerate solid oral intake by the end of the first postoperative week., 30- days postoperatively|identify factors that necessitated its use in the immediate postoperative period, To identify preoperative factors such as obesity with BMI 30 or more, Preoperative uncontrolled diabtes, older age (over 70), gender (male/female), histroy of gastric outlet obstruction, primary diagnosis (malignant disease vs benign). Intra-operative factor such such as the length of the procedure, blood loss, any concurrent procedure such as extensive lysis of adhesions, colon resection; and postoperative factors including postoperative blood counts, phosphorus and magnesium levels, blood sugar level, and postoperative complications. These factors will be assessed using logistic regression analysis to predict the necessity of nasogastric decompression in the postoperative period following the whipple procedure., 30 days postoperatively | Baylor College of Medicine | ALL | ADULT, OLDER_ADULT | NA | 230 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | H-43383 | 2018-06-01 | 2023-05-31 | 2023-12-31 | 2024-05-14 | 2024-05-14 | Baylor college of medicine, Houston, Texas, 77030, United States | ||||
| NCT06399276 | 4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity | https://clinicaltrials.gov/study/NCT06399276 | This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase. | NO | Breast Cancer | BEHAVIORAL: Weight Loss | Body Weight, Measured using digital scale accurate to =/-0.1 kg, in the morning in a fasted state, 3 months|Adherence to 4:3 Intermittent Fasting Dietary Paradigm as Measured by Food Records, Dietary energy intake assessed using written food records for 7 consecutive days, 3 months|Physical Activity, Moderate to Vigorous Physical Activity (MVPA) (min/wk) measured with the activPALv4 activity monitor for 7 consecutive days., 3 months | Rate of Enrollment, Number of participants enrolled per month during the recruitment phase., at recruitment|Percent of Participants Completing Outcome Measures, Retention of participants in the 3-month intervention assessed by percent of enrolled participants that complete outcome measures., 3 months | University of Colorado, Denver | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 36 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 23-1546.cc|R01CA258766 | 2024-05-28 | 2026-06 | 2027-06 | 2024-05-03 | 2024-11-22 | Anschutz Health and Wellness, Aurora, Colorado, 80045, United States|University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States | ||||
| NCT06323421 | Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer | https://clinicaltrials.gov/study/NCT06323421 | MindCRC | Many neighborhoods in Chicago experience daily exposure to stressors including economic inopportunity and violent crime in public spaces. There is mounting evidence that chronic psychosocial stress can facilitate carcinogenesis by modulating the gut microbiome and immune system. The proposed research aims to study the practice of mindfulness to mitigate CPS and reduce colorectal cancer risk factors among Black American women at elevated risk. | NO | Mindfulness|Colon Cancer|Females | BEHAVIORAL: Mindfulness | Feasibility measures, easible if ≥ 30% of those approached enroll at a minimum rate of 1-3 women/week for each wave and ≥ 80% of women enrolled are retained with complete data collection at both assessment time-point, Monitored across the duration of study and 8-week intervention|Acceptability, The intervention will be deemed acceptable if women attend ≥ 80% of the Mindfulness group sessions, engage with ≥ 80% of the asynchronous Mindfulness content and score ≥ 16 on the acceptability survey., Week 4 and post-intervention at week 9 | Body mass index, weight in kg divided by height in meters squared, Baseline and post-intervention at week 9|Stress measure, Hair cortisol concentration, Baseline and post-intervention at week 9|Fasting glucose, Measured in serum, Baseline and post-intervention at week 9|Gut microbiota composition, 16S rRNA amplicon sequencing from stool, Baseline and post-intervention at week 9|Gut inflammation, Fecal calprotectin, Baseline and post-intervention at week 9|Adiposity, % body fat and visceral body fat area from whole body DEXA, Baseline and post-intervention at week 9|Epinephrine, From serum measured via mass spectrometry, Baseline and post-intervention at week 9|Norepinephrine, From serum measured via mass spectrometry, Baseline and post-intervention at week 9|Cortisol, From serum measured via mass spectrometry, Baseline and post-intervention at week 9|Resting heart rate, Measured with an electronic monitor, Baseline and post-intervention at week 9|Blood lipids, From serum – total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, Baseline and post-intervention at week 9|Fasting insulin, From serum, Baseline and post-intervention at week 9|Hemoglobin A1c, From whole blood, Baseline and post-intervention at week 9|Systemic inflammation, C-reactive protein measured in serum, Baseline and post-intervention at week 9 | University of Illinois at Chicago | FEMALE | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | STUDY2023-1359 | 2024-07-15 | 2025-08-15 | 2025-08-31 | 2024-03-21 | 2024-08-21 | University of Illinois Chicago, Chicago, Illinois, 60612, United States | ||||
| NCT06318507 | The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy | https://clinicaltrials.gov/study/NCT06318507 | IMPACT | This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not. | NO | Breast Neoplasms | COMBINATION_PRODUCT: Fecal microbial diversity | Pathologic Complete Response (pCR), Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis, Week 24 | Pennington Biomedical Research Center | FEMALE | ADULT, OLDER_ADULT | 25 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PBRC 2023-014 | 2024-03-11 | 2024-12-31 | 2025-12-31 | 2024-03-19 | 2024-03-19 | Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States | ||||||
| NCT06315296 | An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer | https://clinicaltrials.gov/study/NCT06315296 | This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and improving survival outcomes after stereotactic radiosurgery in patients with breast or lung cancer that has spread to the brain (brain metastases). Lung cancer and breast cancer are the two most frequent causes of brain metastases. The diagnosis of brain metastases is associated with poorer survival and tumor-induced and treatment-related side effects. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. Patients who receive stereotactic radiosurgery for brain metastases may experience less neurocognitive side effects than with other types of brain radiation, but may still be at risk for their brain metastases growing, spreading, or getting worse. Patients with obesity and diabetes have been shown to have worse survival and increased radiation-related side effects. Evidence demonstrates that simply changing meal timing can have a positive impact on multiple health outcomes. Time-restricted eating, or prolonged nighttime fasting, has been proven to have positive effects on heart disease risk reduction, weight control management and chemotherapy side effect reduction. Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain metastases from breast or lung cancer. | NO | Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Breast Carcinoma|Metastatic Lung Carcinoma|Metastatic Malignant Neoplasm in the Brain|Stage IV Lung Cancer AJCC v8 | BEHAVIORAL: Behavioral Dietary Intervention|OTHER: Text Message-Based Navigation Intervention|OTHER: Internet-Based Intervention|BEHAVIORAL: Dietary Counseling and Surveillance|RADIATION: Stereotactic Radiosurgery|PROCEDURE: Biospecimen Collection|PROCEDURE: Magnetic Resonance Imaging|OTHER: Neurocognitive Assessment|OTHER: Questionnaire Administration|OTHER: Interview|OTHER: Internet-Based Intervention|RADIATION: Stereotactic Radiosurgery|OTHER: Text Message-Based Navigation Intervention|PROCEDURE: Biospecimen Collection|PROCEDURE: Magnetic Resonance Imaging|OTHER: Neurocognitive Assessment|OTHER: Questionnaire Administration|OTHER: Interview | Accrual rate, Feasibility will be defined as 70% of eligible patients reached consent and enroll. Accrual rate will be summarized using percentage and 95% exact confidence intervals., Up to 5 years|Attrition rate, Feasibility will be defined as 70% of enrolled participants complete post-intervention follow-up. Attrition rate will be summarized using percentage and 95% exact confidence intervals., Up to 6 months post intervention|Time-restricted eating (TRE) compliance rate, Feasibility will be defined as 70% of participants are compliant with 70% of the intervention days with suggested TRE. TRE compliance rate will be summarized using percentage and 95% exact confidence intervals., Up to 6 months post intervention|Incidence of adverse effects (AEs), AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events., Up to 6 months post intervention|Patient satisfaction, Acceptability will be measured through a validated treatment satisfaction measure and patient interview data. Acceptability will be established by a group median score ≥ 28 on the Coping Strategies Questionnaire-837. Patient satisfaction will be summarized using percentage and 95% exact confidence intervals., Up to 6 months post intervention | Neurocognitive function decline, Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject., At baseline|Neurocognitive function decline, Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject., at the end of the 30-day intervention|Neurocognitive function decline, Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject., at 3 month follow up|Neurocognitive function decline, Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject., at 6 month follow up|Intracranial progression free survival (PFS), Intracranial PFS of brain metastases will be detected by magnetic resonance imaging. Intracranial PFS between the two treatment groups will be compared using a two-sided log-rank test with the significance level of 0.05., Time between SRS to progression of brain metastases, assesed up to 6 months post intervention | Thomas Jefferson University | ALL | ADULT, OLDER_ADULT | NA | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | iRISID-2023-1985 | 2023-12-13 | 2028-06-30 | 2028-12 | 2024-03-18 | 2024-03-18 | Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States | |||||
| NCT06299891 | Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity | https://clinicaltrials.gov/study/NCT06299891 | Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for “common” obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness. Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 12-28-year-old individuals with HO. | NO | Hypothalamic Obesity|Hypothalamic Tumor|Craniopharyngioma | DRUG: Phentermine / Topiramate Extended Release Oral Capsule [Qsymia]|OTHER: Placebo | Treatment-emergent adverse events, Incidence of treatment-emergent adverse events including any during withdrawal in study drug vs. placebo., From baseline to completion of week 28 | Maximum tolerated dose, Maximum tolerated dose achieved by the end of the study in study drug vs. placebo., Week 0 to 28|% change in BMI, % change in BMI in response to study drug vs. placebo., Week 0 to 28|Proportion of individuals who experience 5% decrease in BMI, Proportion of individuals who experience 5% decrease in BMI in response to study drug vs. placebo., Week 0 to 28|Proportion of individuals who experience 2.5% decrease in BMI, Proportion of individuals who experience 2.5% decrease in BMI in response to study drug vs. placebo, Week 0 to 28|Change in body fat mass, Change in body fat mass via DXA in response to study drug vs. placebo., Week 0 to 28|Change in visceral fat mass, Change of visceral fat mass in response to study drug vs. placebo via DXA., Week 0 to 28|Change in hunger, Daily assessment of hunger by questionnaire scores will be recorded prior to the patient’s first meal of the day., Week 0 to 28|Change in energy intake, Patient’s dietary intake via the Automated Self-Administered 24-Hour Dietary Recall., Week 0 to 28 | Seattle Children’s Hospital | Children’s Hospital of Philadelphia | ALL | CHILD, ADULT | PHASE2 | 24 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | PhT_HypOb_Protocol_Clean_07-05 | 2024-08-01 | 2026-05-31 | 2026-05-31 | 2024-03-08 | 2024-07-22 | The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Seattle Children’s, Seattle, Washington, 98101, United States | ||||
| NCT06298149 | Reach Through Equitable Implementation of Turtle Island Tales | https://clinicaltrials.gov/study/NCT06298149 | Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts. | NO | Obesity, Childhood|Obesity|Cancer | BEHAVIORAL: Turtle Island Tales | 20-item Family Nutrition and Physical Activity Survey, Pre- and post-evaluation of effectiveness in behavioral outcomes including family-level questions targeting diet, physical activity, screen time, and sleep. The total score is used as the summary score, with a higher score indicating a more positive family home environment relative to health behaviors., one year | Food insecurity screener, United States Department of Agriculture Household Food Insecurity 2-item screener: 1) “We worried whether our food would run out before we got money to buy more” and 2) “The food we bought just didn’t last and we didn’t have money to get more.” An affirmative response (“Often True” or “Sometimes True”) on either item is considered positive for food insecurity., one year|Mental Health screening, Two items from the validated Short Form-12 survey: 1) In the last month, how often have you felt that you were unable to control the important things in your life? and 2) In the last month, how often have you felt confident about your ability to handle your personal problems? Scores are summed, with a higher score being associated with more positive mental health status., one year | Montana State University | National Institutes of Health (NIH)|University of Utah|National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 200 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 2023-650-EXEMPT|1U54CA280812-01 | 2023-11-01 | 2028-04-30 | 2028-04-30 | 2024-03-07 | 2024-03-07 | Montana State University, Bozeman, Montana, 59717, United States | ||||
| NCT06237179 | Behavioral Exercise Training to Reduce Cardiovascular Disease Risk | https://clinicaltrials.gov/study/NCT06237179 | EXTRA-PC | To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks. | NO | Prostate Cancer|Supportive Care | BEHAVIORAL: Exercise Training Intervention|BEHAVIORAL: Healthy Living Education | Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks, Exercise capacity will be measured by the maximal volume of oxygen utilization (VO2 peak) during a supine graded cardiopulmonary exercise test done in conjunction with cardiac magnetic resonance (exeCMR+CPET). VO2 will be measured in both relative (ml/kg/minute) and absolute (L/minute) terms., Baseline, 12 weeks, and 24 weeks|Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks, The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m)., Baseline, 12 weeks, and 24 weeks | Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls., By measuring resting and exercise -associated left ventricular (LV) end-diastolic (EDV) and end-systolic volumes (ESV) we will calculate stroke volume (SV) in milliliters/beat (ml). SV = EDV – ESV, Baseline, 12 weeks|Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls., By measuring resting and exercise-associated stroke volumes (SV) as a proportion of end-diastolic volumes (EDV) we will calculate left ventricular ejection fraction (%). LVEF = SV/EDV, Baseline, 12 weeks|Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls., By measuring resting and exercise-associated stroke volume (SV) and the heart rate (HR) in conjunction with image acquisition we will calculate cardiac output in liters per minute (L/min). CO = SV x HR, Baseline, 12 weeks|Arterial-venous oxygen (a-vO2) difference as a musculoskeletal determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls., From the exercise tests we will calculate a-vO2 difference using the FICK equation. The difference in oxygen saturation between the venous circulation and the arterial circulation will be reported in milliliters (ml) and also expressed as ml/100ml of blood (%) a-vO2 = VO2 / CO, Baseline, 12 weeks|Change in lean body mass, We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for lean body mass. Lean body mass will be reported as kilograms (kg), Baseline, 12 weeks|Change in fat mass, We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for fat mass as well as distribution patterns of adiposity, e.g., visceral adipose tissue. Fat mass and visceral fat mass will be reported in kilograms (kg) and body fat percentage will be reported as fat mass / body mass (%), Baseline, 12 weeks|Neighborhood Environment & Walkability Survey (NEWS-A), NEWS-A is a validated self-reported survey used to assess factors that are correlates or determinants of participants ability to engage in physical activity in their neighborhoods. For example, higher walkability is determined by availability of sidewalks and access to nearby facilities., Baseline, 12 weeks, 24 weeks|Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ), GLTEQ is a self-report survey to determine the level typical activity a participant engages in each week. Higher scores on the index indicate more activity., Baseline, 12 weeks, 24 weeks|Change in physical activity assessed with Accelerometry, The ActivPAL and Actigraph accelerometers provide an objective assessment of sedentary sitting time and increasing intensities of physical activity in minutes per week, Baseline, 12 weeks, 24 weeks|Change in self-efficacy to navigate barriers to engaging in exercise, A self report of self-efficacy to engage in exercise or physical activity under different challenging conditions such as when experiencing fatigue. Higher scores indicate increased confidence to navigate barriers., Baseline, 12 weeks, 24 weeks|Change in self-efficacy to walk for increasing periods of time., A self report of self-efficacy to engage in walking for an increasing period of time. Higher scores indicate increased confidence to walk for a longer periods of time without resting., Baseline, 12 weeks, 24 weeks|Change in Functional Assessment of Cancer Therapy – Prostate (FACT-P) scores, FACT-P is a validated self report measures of different domains of quality of life that are important for men who have been diagnosed with prostate cancer. Subscale scores can be assessed to gauge functional wellbeing, physical wellbeing, social wellbeing and emotional wellbeing as well as prostate specific wellbeing. Higher scores indicate a higher quality of life on overall and sub scales., Baseline, 12 weeks, 24 weeks|Change in health-related quality of life (SF-36) scores, SF-36 (RAND) is a validated self report measure of different domains of health-related quality of life that are important for adults. Higher scores indicate a higher health-related quality of life ., Baseline, 12 weeks, 24 weeks|Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) – Fatigue scores, PROMIS – Fatigue is a validated self-report measure of fatigue among patients diagnosed with cancer and higher scores indicate a lower level of fatigue., Baseline, 12 weeks, 24 weeks|Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) – Physical Functioning scores, PROMIS – Physical Functioning is a validated self-report measure of physical functioning among patients diagnosed with cancer and higher scores indicate a better function., Baseline, 12 weeks, 24 weeks|Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) – Sleep Disturbance scores, PROMIS – Sleep Disturbance is a validated self-report measure of sleep disturbance among patients diagnosed with cancer and higher scores indicate less sleep disruption., Baseline, 12 weeks, 24 weeks|Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) – Depression scores, PROMIS – Depression is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms., Baseline, 12 weeks, 24 weeks|Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) – Anxiety scores, PROMIS – Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms., Baseline, 12 weeks, 24 weeks|Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) – Emotional Distress scores, PROMIS – Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms., Baseline, 12 weeks, 24 weeks|Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) scale, FACUT-F is a validated self-report measure of fatigue among patients undergoing treatment for a chronic illness and higher scores indicate less fatigue., Baseline, 12 weeks, 24 weeks|Change in perceived stress as measured with Cohen’s perceived stress scale (PSS), PSS is a validated self-report measure of perceived stress and higher scores indicate more perceived stress., Baseline, 12 weeks, 24 weeks|Change in physical function assessed with the Short Physical Performance Battery (SPPB), SPPB is a validated objective assessment of 3 domains of physical function that includes gait speed, grip strength and time taken to stand from a chair 5 times. Each down is scored on a scale of 0-4 with a total score summed from each domain. A higher score is indicative of better functioning., Baseline, 12 weeks, 24 weeks | Virginia Commonwealth University | National Heart, Lung, and Blood Institute (NHLBI) | MALE | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | MCC-23-20934|HM20028583|1K01HL161419-01A1 | 2024-02-21 | 2028-01-31 | 2028-01-31 | 2024-02-01 | 2024-02-23 | Richmond Veterans Affairs Medical Center, Richmond, Virginia, 23249, United States|Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, 23298, United States | |||
| NCT06195306 | Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction | https://clinicaltrials.gov/study/NCT06195306 | This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk. | NO | Breast Atypical Hyperplasia|Breast Carcinoma|Breast Ductal Carcinoma In Situ|Breast Lobular Carcinoma In Situ | PROCEDURE: Biospecimen Collection|PROCEDURE: Mammography|DRUG: Omega-3-Acid Ethyl Esters|OTHER: Questionnaire Administration|PROCEDURE: Random Periareolar Fine-Needle Aspiration|DRUG: Tamoxifen | Change in serum adiponectin, An analysis for difference between the two arms will be conducted to document a beneficial effect of addition of high dose omega-3 fatty acids to low dose tamoxifen. Paired and unpaired t-tests will be used., From baseline up to end of treatment (6 months) | Change in insulin resistance, Evaluated using Homeostatic Model Assessment of Insulin Resistance, as calculated using fasting glucose and fasting insulin. Paired and unpaired t-tests will be used. Spearman correlation between change in biomarkers will be estimated and compared across the study arms using Fisher’s Z-transformed values., From baseline up to end of treatment (6 months)|Change in insulin sensitivity, Evaluated using Homeostatic Model Assessment of Insulin Sensitivity. Paired and unpaired t-tests will be used. Spearman correlation between change in biomarkers will be estimated and compared across the study arms using Fisher’s Z-transformed values., From baseline up to end of treatment (6 months)|Change in insulin secretory function, Evaluated using Homeostatic Model Assessment of Beta Cell Function. Paired and unpaired t-tests will be used. Spearman correlation between change in biomarkers will be estimated and compared across the study arms using Fisher’s Z-transformed values., From baseline up to end of treatment (6 months)|Estrogen response gene index (ERGI), The estrogen response gene index reflects change in gene expression over time. The genes assayed for this index are: ESR1 (codes for estrogen receptor alpha), ESR2 (codes for estrogen receptor beta), GREB1 (codes for growth regulation by estrogen in breast cancer 1), PGR (codes for progesterone receptor) and TFF1 (also known as pS2, which codes for trefoil factor 1). The log2-transformed values of the ratio of relative abundance (6-month value: baseline value) for GREB1, PGR, TFF1, and the ratio of ESR1:ESR2 are averaged to produce the ERGI. Paired and unpaired t-tests will be used. Spearman correlation between change in biomarkers will be estimated and compared across the study arms using Fisher’s Z-transformed values., From baseline up to end of treatment (6 months) | Effect of change in red blood cell omega-3:omega-6 fatty acid ratio on within arm change in blood adiponectin, Up to 6 months|Effect of change in red blood cell omega-3:omega-6 fatty acid ratio on within arm change in tissue ERGI, Up to 6 months|Effect of baseline bioavailable estradiol on within arm change in blood adiponectin, Up to 6 months|Effect of baseline and 6-month bioavailable estradiol on within arm change in tissue ERGI, Up to 6 months|Effect of 6-month tamoxifen active metabolites on change in ERGI, Up to 6 months|Effect of eicosapentaenoic acid/docosahexaenoic acid dietary intake on red blood cell omega-3:omega-6 fatty acid ratio change, Up to 6 months|Serum triglycerides, Will evaluate within arm effects of low dose tamoxifen +/- high dose omega-3 fatty acids on this exploratory outcome., Up to 6 months|Adiponectin:leptin ratio, Will evaluate within arm effects of low dose tamoxifen +/- high dose omega-3 fatty acids on this exploratory outcome., Up to 6 months|Anterior gradient protein 2 homolog messenger ribonucleic acid, Will evaluate within arm effects of low dose tamoxifen +/- high dose omega-3 fatty acids on this exploratory outcome., Up to 6 months|Forkhead box A1 protein, Will evaluate within arm effects of low dose tamoxifen +/- high dose omega-3 fatty acids on this exploratory outcome., Up to 6 months|Anterior gradient protein 2 homolog protein, Will evaluate within arm effects of low dose tamoxifen +/- high dose omega-3 fatty acids on this exploratory outcome., Up to 6 months|Ki-67, Will evaluate within arm effects of low dose tamoxifen +/- high dose omega-3 fatty acids on this exploratory outcome., Up to 6 months | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 66 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | NCI-2023-10830|NCI-2023-10830|UMI23-14-02|UMI23-14-02|P30CA046592|UG1CA242632 | 2024-06-16 | 2027-01-01 | 2027-01-01 | 2024-01-08 | 2024-01-08 | University of Kansas Cancer Center, Kansas City, Kansas, 66160, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States | ||||
| NCT06191666 | BfedBwell Proof-of-Concept Pilot | https://clinicaltrials.gov/study/NCT06191666 | This single-arm proof-of-concept pilot will assess the feasibility and acceptability of integrating a survivorship nutrition intervention (BfedBwell) into an existing clinical exercise oncology program (BfitBwell). | NO | Cancer Survivorship|Obesity|Overweight | BEHAVIORAL: Group-based education and discussion|BEHAVIORAL: Individual 1:1 counseling|BEHAVIORAL: Group based behavioral skills development and cooking demonstrations|BEHAVIORAL: BfitBwell | Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention, Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll., 12 weeks|Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention, Adherence will be assessed as \[# sessions attended/# sessions provided\], 12 weeks|Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention, Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]., 12 weeks|Determine the research protocol retention feasibility of the BfedBwell nutrition intervention, Retention will be assessed as \[# of participants who complete the 12-week intervention/# of participants enrolled\]., 12 weeks|Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM), Upon completion of the intervention, program delivery staff will be asked to complete the Feasibility of Intervention Measure (FIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention feasibility., 12 weeks|Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM), Upon completion of the intervention, program delivery staff will be asked to complete the Acceptability of Intervention Measure (AIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention acceptability., 12 weeks|Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM), Upon completion of the intervention, program delivery staff will be asked to complete the Intervention Appropriateness Measure (IAM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention appropriateness., 12 weeks|Determine the intervention acceptability by participants using the Net Promoter Score (NPS), Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). Respondents are grouped as follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) are unhappy customers who can impede growth with negative word-of-mouth. The final NPS score is calculated as % promoters – % detractors. NPS scores range from -100 to +100, with scores \>0 indicating good acceptability., 12 weeks|Determine the intervention acceptability by participants and program providers during qualitative interviews, 1:1 interviews will be conducted with all program delivery staff and BfedBwell survivorship nutrition intervention participants after the 12-week intervention to assess acceptability of intervention and provide feedback for continued refinement., 12 weeks | Assess preliminary efficacy for increased adherence to lifestyle recommendations, Determine the change in adherence to cancer survivorship guidelines as measured by World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) scoring criteria. Scores range from 0 to 7 points. A higher score reflects greater adherence to the recommendations., 12 weeks|Assess preliminary efficacy for weight loss, Determine the change in weight as measured by digital scale. A lower weight indicates an improvement., 12 weeks|Assess preliminary efficacy for improvement in body composition, Determine the change in body composition as measured by dual x-ray absorptiometry (DXA). A lower body fat percentage indicates an improvement., 12 weeks|Measure the change in systolic blood pressure to determine improved cardiometabolic health, Systolic blood pressure will be measured at specific time points during the trial. A lower systolic blood pressure indicates an improvement., 12 weeks|Measure the change in diastolic blood pressure to determine improved cardiometabolic health, Diastolic blood pressure will be measured at specific time points during the trial. A lower diastolic blood pressure indicates an improvement., 12 weeks|Measure changes in total cholesterol to determine improved cardiometabolic health, Total cholesterol will be measured at specific time points during the trial. A lower total cholesterol indicates an improvement., 12 weeks|Measure changes in LDL cholesterol to determine improved cardiometabolic health, LDL cholesterol will be measured at specific time points during the trial. A lower LDL cholesterol indicates an improvement., 12 weeks|Measure changes in HDL cholesterol to determine improved cardiometabolic health, HDL cholesterol will be measured at specific time points during the trial. A higher HDL cholesterol indicates an improvement., 12 weeks|Measure changes in triglycerides to determine improved cardiometabolic health, Triglycerides will be measured at specific time points during the trial. Lower triglycerides indicate an improvement., 12 weeks|Measure changes in glucose to determine improved cardiometabolic health, Glucose levels will be measured at specific time points during the trial. Lower glucose levels indicate an improvement., 12 weeks|Measure changes in insulin to determine improved cardiometabolic health, Insulin levels will be measured at specific time points during the trial. Lower insulin levels indicate an improvement., 12 weeks|Intervention safety determined by number of adverse events, Overall rates of study-related mild, moderate, severe, and serious adverse events (AEs) will be tracked by study staff., 12 weeks | University of Colorado, Denver | ALL | ADULT, OLDER_ADULT | NA | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 23-1501.cc | 2024-02-05 | 2025-01 | 2026-01 | 2024-01-05 | 2024-07-22 | University of Colorado Cancer Center, Aurora, Colorado, 80045, United States | |||||
| NCT06184256 | BfedBwell Optimization Pilot | https://clinicaltrials.gov/study/NCT06184256 | Using the Multiphase Optimization Strategy (MOST) framework, an engineering-based approach to efficiently and systematically develop, optimize, and evaluate behavioral interventions, this study will test three components: (1) 1:1 counseling with a registered dietitian, (2) behavioral skills development, and (3) group support for delivery alongside a core nutrition curriculum within a clinical exercise oncology program. | NO | Survivorship|Cancer | BEHAVIORAL: BfedBwell – Core Curriculum|BEHAVIORAL: BfedBwell – 1:1 Counseling|BEHAVIORAL: BfedBwell – Behavioral Skills|BEHAVIORAL: BfedBwell – Group Support|BEHAVIORAL: Program delivery | Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention, Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll., 24 weeks|Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention, Adherence will be assessed as \[# sessions attended/# sessions provided\] for each BfedBwell component., 24 weeks|Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention, Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]., 24 weeks|Determine the research protocol retention feasibility of the BfedBwell nutrition intervention, Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants randomized\]., 24 weeks|Determine the intervention acceptability by participants during focus groups, Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention., 24 weeks|Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM), Upon completion of the intervention, program delivery staff will be asked to complete the Feasibility of Intervention Measure (FIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention feasibility., 12 and 24 weeks|Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM), Upon completion of the intervention, program delivery staff will be asked to complete the Acceptability of Intervention Measure (AIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention acceptability., 12 and 24 weeks|Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM), Upon completion of the intervention, program delivery staff will be asked to complete the Intervention Appropriateness Measure (IAM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention appropriateness., 12 and 24 weeks|Determine the intervention acceptability by participants using the Net Promoter Score (NPS), Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). Respondents are grouped as follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) are unhappy customers who can impede growth with negative word-of-mouth. The final NPS score is calculated as % promoters – % detractors. NPS scores range from -100 to +100, with scores \&amp;gt;0 indicating good acceptability., 12 and 24 weeks | Identify a set of components that demonstrate patterns of efficacy for increased adherence to lifestyle recommendations, Determine the change in adherence to cancer survivorship guidelines as measured by World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) scoring criteria. Scores range from 0 to 7 points. A higher score reflects greater adherence to the recommendations., 12 and 24 weeks|Identify a set of components that demonstrate patterns of efficacy for weight loss, Determine the change in weight as measured by digital scale. A lower weight indicates an improvement., 12 and 24 weeks|Identify a set of components that demonstrate patterns of efficacy for improvement in body composition, Determine the change in body composition as measured by dual x-ray absorptiometry (DXA). A lower body fat percentage indicates an improvement., 12 and 24 weeks|Measure the change in systolic blood pressure to determine improved cardiometabolic health, Systolic blood pressure will be measured at specific time points during the trial. A lower systolic blood pressure indicates an improvement., 12 and 24 weeks|Measure the change in diastolic blood pressure to determine improved cardiometabolic health, Diastolic blood pressure will be measured at specific time points during the trial. A lower diastolic blood pressure indicates an improvement., 12 and 24 weeks|Measure changes in total cholesterol to determine improved cardiometabolic health, Total cholesterol will be measured at specific time points during the trial. A lower total cholesterol indicates an improvement., 12 and 24 weeks|Measure changes in LDL cholesterol to determine improved cardiometabolic health, LDL cholesterol will be measured at specific time points during the trial. A lower LDL cholesterol indicates an improvement., 12 and 24 weeks|Measure changes in HDL cholesterol to determine improved cardiometabolic health, HDL cholesterol will be measured at specific time points during the trial. A higher HDL cholesterol indicates an improvement., 12 and 24 weeks|Measure changes in triglycerides to determine improved cardiometabolic health, Triglycerides will be measured at specific time points during the trial. Lower triglycerides indicate an improvement., 12 and 24 weeks|Measure changes in glucose to determine improved cardiometabolic health, Glucose levels will be measured at specific time points during the trial. Lower glucose levels indicate an improvement., 12 and 24 weeks|Measure changes in insulin to determine improved cardiometabolic health, Insulin levels will be measured at specific time points during the trial. Lower insulin levels indicate an improvement., 12 and 24 weeks|Intervention safety determined by number of adverse events, Overall rates of study-related mild, moderate, severe, and serious adverse events (AEs) will be tracked by study staff., 12 and 24 weeks | University of Colorado, Denver | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 94 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 23-2151.cc|1K99CA287061-01 | 2024-10-01 | 2026-07 | 2028-02 | 2023-12-28 | 2025-01-10 | University of Colorado Cancer Center, Aurora, Colorado, 80045, United States | ||||
| NCT06171945 | Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors | https://clinicaltrials.gov/study/NCT06171945 | AYAConnect | The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program. | NO | Cancer|Physical Activity|Cancer Survivorship|Mental Health|Obesity | BEHAVIORAL: AYA Connect intervention|BEHAVIORAL: Positive Psychology (PP) intervention|BEHAVIORAL: Positive Psychology Plus (PP+) intervention | Feasibility of interventions as measured by accrual rate, Feasibility of interventions as measured by accrual rate will be calculated as the number of adolescent and young adult cancer (AYA) survivors who agreed to participate divided by the number of months of recruitment, at 3 months|Feasibility of interventions as measured by participation rate, Feasibility of interventions as measured by participation rate will be calculated as the number of participants who agreed to participate divided by the number of eligible AYA survivors., at 3 months|Feasibility of interventions as measured by retention rate, Feasibility of interventions as measured by retention rate will be calculated as the number of AYA survivor participants who completed 3-month measures divided by the number who participated., At 3 months | Retention rate at 6 months, Retention rate at 6 months, calculated by the number of participants who completed all study measures at the 6-month time point divided by the number who participated., At 6 months|Acceptability of Young Adult Cancers (AYAs) Connect, Acceptability of the interventions will be measured by ratings of program acceptability and satisfaction. Participants will provide ratings on the helpfulness and difficulty of the program’s behavioral goals (e.g., diet and physical activity goals) using an 8-point scale (1 = Not satisfied/Very difficult to 8 = Very satisfied/very easy). Additional questions will ask participants about the helpfulness of intervention features (e.g., lessons, feedback messages) for reaching their weight goals (1 = Not at all helpful to 4 = Extremely helpful). Higher scores indicate greater acceptability., At 3 and 6 month|Adherence to dietary tracking, Number of days red foods (high-calorie, high-fat foods) are tracked, as measured by the food log data in the AYA Connect app. Participants will be asked to log their red foods in the app daily., Up to 6 month|Adherence to physical activity monitoring, Number of days physical activity is tracked, as measured by activity tracker, Up to 6 month|Adherence to self-weighing, Number of days weighed, as measured by smart scale, Up to 6 month|Change in weight, Change in weight, as measured by smart scale, from baseline to 3 and 6 months., Up to 6 month|Change in energy intake, Change in energy intake (kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate energy intake., from the baseline to 3 and 6 month|Change in saturated fat intake, Change in saturated fat intake (% kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24 The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate saturated fat intake., from the baseline to 3 and 6 month|Change in fruit and vegetable consumption, Change in fruit and vegetable consumption (cups), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate average fruit and vegetable consumption., from the baseline to 3 and 6 month|Change in fiber consumption, Change in fiber consumption (g), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate fiber consumption., from the baseline to 3 and 6 month|Change in Healthy Eating Index score, Change in Healthy Eating Index (HEI) score, measured using the HEI and the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate HEI. HEI scores range from 0 to 100, with higher scores indicating greater adherence to the Dietary Guidelines for Americans., from the baseline to 3 and 6 month|Change in weekly minutes of moderate-to-vigorous activity, Changes in weekly minutes of moderate-to-vigorous activity, computed from the participant’s activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times., From baseline to 3 and 6 months|Change in steps per day, Changes in daily steps, were computed from the participant’s activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times., From baseline to 3 and 6 months|Change in self-reported physical activity, Change in self-reported physical activity, measured using the Paffenbarger Activity Scale (PAQ). The PAQ provides an estimate of minutes per week of moderate-to-vigorous intensity, and calories/week of light (5 kcal/min), medium (7.5 kcal/min), and high (10 kcal/min) intensity activities. PAQ changes have been predictive of weight change., From baseline to 3 and 6 months|Change in frailty index, Change in frailty index, measured using the FRAIL Questionnaire. The FRAIL Questionnaire assesses: 1) self-reported fatigue (1 item from Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health), 2) weight loss, 3) comorbidities (11 items from UNC Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Global Health), and 5) ability to overcome resistance (1 item from Medical Outcomes Study 36-Item Short Form). Positive responses for these components are summed to create the FRAIL index (range 0-5). A value \> 3 is considered frail, and a value of 2 is considered prefrail., From baseline to 3 and 6 months|Change in health-related quality of life, Change in health-related quality of life, measured using the Medical Outcomes Study 36-Item Short Form (SF-36) survey. This survey includes 36 items with eight subscales (physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions). Responses are coded on a scale of 0 to 100, where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score., From baseline to 3 and 6 months|Change in depressive symptoms, Change in depressive symptoms, measured by the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a self-report depression scale including 20 items that relate to depressive feelings and behaviors during the past week. Response options range from 0 (rarely or none of the time) to 3 (most or almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms., From baseline to 3 and 6 months|Change in anxiety symptoms, Change in anxiety symptoms, as measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). Possible scores range from 0 to 21, with higher scores reflecting greater symptom severity; cut-points of 5, 10, and 15 correspond to mild, moderate, and severe levels of anxiety., From baseline to 3 and 6 months|Change in perceived stress, Change in perceived stress, measured by the 10-item Perceived Stress Scale (PSS-10). PSS-10 measures overall perceived stress during the past month. Factor analysis supports a two-factor correlated model with perceived self-efficacy and perceived helplessness subscales., From baseline to 3 and 6 months|Change in positive and negative affect, Change in positive and negative affect, measured using the Positive and Negative Affect Schedule (PANAS). PANAS is a 20-item scale divided into two subscales to measure positive and negative affect. Each item is rated on a five-point Likert scale from 1 (very slightly or not at all) to 5 (extremely) and are summed to yield scores for each subscale., From baseline to 3 and 6 months | UNC Lineberger Comprehensive Cancer Center | ALL | ADULT | NA | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | LCCC2133 | 2024-03-01 | 2025-03-20 | 2025-03-20 | 2023-12-15 | 2024-11-01 | Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27599, United States | ||||
| NCT06125964 | eMOTION Formative Study | https://clinicaltrials.gov/study/NCT06125964 | The eMOTION Study is a two-part ORBIT model phase 1 trial. The first part, called the Formative Study, will assess acceptability and feasibility of a novel physical activity intervention in adults at increased risk for cancer due to overweight or obesity. | NO | Physical Inactivity|Overweight or Obesity|Cancer | BEHAVIORAL: Intensity-Based Goals|BEHAVIORAL: Affect-Based Goals|BEHAVIORAL: TYPE/CONTEXT Enhancement|BEHAVIORAL: SAVOR Enhancement | Safety Benchmark: Percentage of participants experiencing an adverse event, An adverse event is that which is unexpected, related or possibly related to the study procedures, and serious (adversely affecting the balance of risks and benefits to participation, including incidents that require hospitalization, specialist treatment, or medical intervention). This refers to any adverse event that can be reasonably determined (at least in part) to be due to the study procedures and not due to a participant’s underlying medical conditions or risk factor profile alone. This is assessed by official University of Southern California Institutional Review Board reporting procedures. The study’s official “go/no-go” criterion is that less than 1% of participants experience an adverse event during the study., Event onset reported as from first day of run-in period (i.e., day 1) to one week post-data collection (week 4)|Efficacy Benchmark: Percentage of participants with increased physical activity enjoyment, During the exit interview, participants compare their experience with physical activity before and after participation in the eMOTION Study and are asked if they personally feel as if the degree of enjoyment they feel while engaging in physical activity changed or stayed the same. The percentage of participants responding affirmatively will be calculated. The “go/no-go criterion” is that ≥51% of participants in the affect-based conditions report a perceived increase in enjoyment of physical activity., Reported at 3 weeks (i.e., post-study)|Accessibility/Usability Benchmark: System Usability Scale score (0 to 100) for Daily Goal Sessions & Fitbit, In the Post-Study Questionnaire, participants will rate the usability of the eMOTION Study’s daily goal sessions and Fitbit Versa protocol via the System Usability Scale (SUS). The SUS has 10 items, and participants indicate their degree of agreement with each statement on a 5-point Likert scale ranging from “strongly disagree” (1) to “strongly agree” (5). The SUS is then scored by summing across items (all items are first rescored to a 0 to 4 scale, and even items are reverse-scored before summing) and then multiplying the sum by 2.5. The study’s go/no-go criterion is that both the daily goal sessions and Fitbit protocols receive at least an average score (≥68) on the SUS., Reported at 3 weeks (i.e., post-study)|Equity Benchmark: Accessibility (SUS score) approximately equal between sub-groups, Equity is defined as SUS scores for daily goal sessions and Fitbit protocol (i.e., accessibility) that are approximately equal between sex, race, ethnicity, age, BMI, income, and able-bodied groups. While this cannot be tested statistically due to a lack of power in the Formative Study to compare groups of subjects, the investigators will compare average scores to ensure that the intervention yields similar effects regardless of sex, race, ethnicity, age, BMI, income, and able-bodied. The go/no-go criterion is that SUS scores will be approximately equal between groups., Reported at 3 weeks (i.e., post-study) | Accessibility Benchmark: Percentage of participants rating Fitbit interface as accessible, The degree of accessibility of the Fitbit interface for the study will also be assessed in the exit interview. Specifically, participants are asked a series of questions about whether they were able to read, understand, and select answers for Fitbit watch face surveys and use the exercise settings. The go/no-go criterion is that at least 51% of participants respond affirmatively for each facet., Reported at 3 weeks (i.e., post-study)|Sustainability/Feasibility Benchmark: Event-Contingent Fitbit surveys correctly triggered, Event-contingent surveys are triggered when Fitbit sensors detect physical activity via moving average heart rate max. Using Fitabase data exports, the investigators will determine the percentage of correctly triggered surveys. The go/no-go criterion is that the auto-detection algorithm for physical activity correctly triggers event-contingent surveys 51% of the time., From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)|Sustainability/Feasibility Benchmark: Fitbit device malfunctions, Another go/no-go criterion for the sustainability/feasibility of the study’s Fitbit component will assess (via participant tracking) whether fewer than 25% of participants need to be mailed a new Fitbit device due to device issues over the course of the study., From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)|Satisfaction Benchmark: Participants reporting dissatisfaction with Fitbit, During the post-study questionnaire, participants will complete the validated Delighted-Terrible Scale. Directions specify that they will be asked “about specific elements of the Fitbit smartwatch features.” Response options are feeling delighted (7), pleased (6), mostly satisfied (5), mixed- about equally satisfied and dissatisfied (4), mostly dissatisfied (3), unhappy (2), terrible (1) — OR — neutral- neither satisfied nor dissatisfied (a), or never thought about it (b). Fitbit items ask how they felt about the exercise settings on the smartwatch; how they felt about notifications they received to complete smartwatch surveys; and how they felt about the frequency and length of these surveys. The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with any of the Fitbit items., Reported at 3 weeks (i.e., post-study)|Accessibility Benchmark: Percentage of participants rating smartphone interface as accessible, The degree of accessibility of the smartphone interface for the study will also be assessed in the exit interview. Specifically, participants are asked two questions about whether they were able to read and understand questions for daily goal sessions on their smartphone. Go/no-go criteria will be that at least 51% of participants answer affirmatively for both questions., Reported at 3 weeks (i.e., post-study)|Sustainability/Feasibility Benchmark: Repeated syncing reminders, Participants are asked to keep the Fitbit app on their smartphone open in order to allow study data from the app to sync with Fitabase servers. Researchers will check Fitabase servers multiple times per day to ensure adequate syncing, and if a participant's device has not been synced for a few days, they receive a text asking them to open and sync the app. Go/no-go criteria for this benchmark are that \<25% of participants need to be sent more than one reminder to open their Fitbit app and sync their study data, as recorded by researchers in participant tracking forms., From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)|Satisfaction Benchmark: Participants reporting dissatisfaction with smartphone components, During the post-study questionnaire, participants will complete the validated Delighted-Terrible Scale. Directions specify that they will be asked about their experiences using their smartphone for the eMOTION Study. Response options are feeling delighted (7), pleased (6), mostly satisfied (5), mixed- about equally satisfied and dissatisfied (4), mostly dissatisfied (3), unhappy (2), terrible (1) -- OR -- neutral- neither satisfied nor dissatisfied (a), or never thought about it (b). Smartphone items ask how they felt about completing the daily goal sessions on their smartphone and Fitbit smartphone app. The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with any of the smartphone items., Reported at 3 weeks (i.e., post-study)|Accessibility Benchmark: Physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only) appropriately consider participant constraints, Participants are asked to indicate whether they have any constraints limiting their engagement in specific physical activity types or contexts as part of the baseline questionnaire. They also rate the relative importance of each of the psychological needs to them personally at baseline. For participants who are placed in the affect-based goals + TYPE/CONTEXT or affect-based goals + TYPE/CONTEXT + SAVOR groups, an algorithm produces physical activity recommendations based on their psychological needs that also considers their reported constraints. During the exit interview, participants in this group are asked whether they were able to follow the physical activity recommendations. The go/no-go criterion is that the number of constraints reported at baseline is not associated with participants' reported ability to follow activity recommendations., Assessed on date of baseline questionnaire completion and at 3 weeks (i.e., post-study)|Satisfaction Benchmark: Participants reporting dissatisfaction with physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only), During the post-study questionnaire, participants who received recommendations for the specific types or contexts of physical activity to do (i.e., were in the affect-based goals + TYPE/CONTEXT or affect-based goals + TYPE/CONTEXT + SAVOR groups) will complete the validated Delighted-Terrible Scale. They are asked how they felt about the physical activity recommendations they received. Response options are feeling delighted (7), pleased (6), mostly satisfied (5), mixed- about equally satisfied and dissatisfied (4), mostly dissatisfied (3), unhappy (2), terrible (1) -- OR -- neutral- neither satisfied nor dissatisfied (a), or never thought about it (b). The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with physical activity recommendations., Reported at 3 weeks (i.e., post-study)|Accessibility Benchmark: Participants report being able to understand and follow savoring prompts (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups), During the exit interview, participants in the affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups will be asked whether they were generally able to understand and follow the savoring questions they received. The go/no-go criterion is that ≥51% of participants in this group reported being able to understand and follow the savoring questions., Reported at 3 weeks (i.e., post-study)|Satisfaction Benchmark: Participants reporting dissatisfaction with savoring questions (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups), During the post-study questionnaire, participants in the affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups will complete the validated Delighted-Terrible Scale. They are asked how they felt about the savoring questions they received. Response options are feeling delighted (7), pleased (6), mostly satisfied (5), mixed- about equally satisfied and dissatisfied (4), mostly dissatisfied (3), unhappy (2), terrible (1) -- OR -- neutral- neither satisfied nor dissatisfied (a), or never thought about it (b). The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with savoring questions., Reported at 3 weeks (i.e., post-study) | University of Southern California | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 37 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | UP-22-00332-formative|R01CA272933 | 2023-10-06 | 2024-05-12 | 2024-06-03 | 2023-11-13 | 2024-08-23 | University of Southern California, Los Angeles, California, 90032, United States | ||||
| NCT06124391 | Novel Subtypes of Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT06124391 | To classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes. | NO | Polycystic Ovary Syndrome | OTHER: Long-term follow-up | Persistence of PCOS Diagnosis, Determining if patients still meet the Rotterdam criteria for a PCOS diagnosis at the follow-up. The hyperandrogenic, ovulatory, and polycystic ovarian conditions at the follow-up time will be assessed., At the 6.5-year follow-up visit.|Changes in PCOS Subtype, Tracking if patients have transitioned between different PCOS subtypes at the follow-up., At the 6.5-year follow-up visit.|Body Mass Index, Patients’ weight (in kilograms) and height (in meters) will be collected and combined to report BMI in kg/m\^2, At the 6.5-year follow-up visit.|Non-Alcoholic Fatty Liver Disease (NAFLD), NAFLD will be assessed using abdominal ultrasound., At the 6.5-year follow-up visit.|Hypertension, Blood pressure will be assessed, and we will determine if a patient has hypertension, defined as systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg., At the 6.5-year follow-up visit.|Type 2 Diabetes Mellitus (T2DM), Fasting glucose will be assessed, and we will determine if a patient has T2DM, defined as fasting glucose ≥ 7.0 mmol/l., At the 6.5-year follow-up visit.|Dyslipidemia, Defined as the presence of any of the following abnormalities: * Total cholesterol ≥ 5.2 mmol/l * Triglycerides (TG) ≥ 1.7 mmol/l * High-density lipoprotein (HDL) \< 1.0 mmol/l * Low-density lipoprotein (LDL) ≥ 3.35 mmol/l, At the 6.5-year follow-up visit.|Total live birth rate, Live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation., From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.|Clinical pregnancy rate, Clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac., From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.|Pregnancy loss rate, Pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy., From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.|Maternal and neonatal complications, Any maternal and neonatal complications, including gestational diabetes, preeclampsia, etc., will be collected., From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years. | Shandong University | FEMALE | ADULT | 50000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PCOS-Subtypes | 2021-01-01 | 2025-12-30 | 2025-12-30 | 2023-11-09 | 2023-11-30 | Penn State College of Medicine, Hershey, Pennsylvania, 17033, United States|Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil|Chengdu Jinjiang Maternity and Child Health Hospital, Chengdu, China|Guangdong Second Provincial General Hospital, Guangzhou, China|Shandong University, Jinan, 250012, China|Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China|Tianjin Medical University General Hospital, Tianjin, China|General Hospital of Ningxia Medical University, Yinchuan, China|National University Hospital, National University of Singapore, Singapore, Singapore|Karolinska Institutet, Solna, 17165, Sweden|Hacettepe University School of Medicine Hacettepe, Ankara, Turkey | |||||||
| NCT06123286 | Tart Cherry and Omega-3’s for Aromatase Inhibitor Musculoskeletal Symptoms | https://clinicaltrials.gov/study/NCT06123286 | Both Tart Cherry and Omega 3 FAs have better side effect profiles compared to other commonly used medications for AIMSS, such as nonsteroidal anti-inflammatories, steroids, and serotonin norepinephrine reuptake inhibitors. Additionally, in our clinics we often find that patients tend to be more receptive to taking a supplement as opposed to an additional medication. Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues like insomnia. There is preliminary evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately14. Although to our knowledge, no human studies have tested this hypothesis. This study has been designed to test the hypothesis that Tart Cherry and fish oil when given in combination over a 12-week period could produce beneficial changes in joint function when compared to Tart Cherry or fish oil in isolation in an obese breast cancer population experiencing AIMSS. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition. | NO | Breast Cancer|Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)|Joint Pain | DRUG: Tart Cherry|DRUG: Omega 3 FA (Fish Oil) | The primary objective is to assess changes in joint function between groups., Changes in joint symptoms will be assessed via the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC Pain score ranges from 0% to 100% with higher scores indicating greater difficulty with activities of daily living., 6 Months | To assess changes in nociplastic pain between groups., Changes in nociplastic pain will be measured by composite score on Symptom Severity Scale. The Symptom Severity Scale ranges from 0-12 with higher scores equating to increased nociplastic pain., 6 Months|To assess changes in nociplastic pain between groups., Changes in nociplastic pain will be measured by composite score on Widespread Pain Index. The Widespread Pain Index score ranges from 0-19 with higher scores equating to increased nociplastic pain., 6 Months|To assess changes in functional performance between groups., Functional Performance will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer 3D Function Profile. The PROMIS Cancer 3D Function Profile has 3 subgroups including Physical Function, Fatigue and Social Participation. The Physical Function score ranges from 5-30 with higher scores equating to better function. The Fatigue score ranges from 3-15 with higher scores equating to less fatigue. The Social Participation score ranges from 3-15 with higher scores equating to worse social participation., 6 Months|To assess changes in quality of life between groups., Quality of Life will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) PROMIS-29+2. The PROMIS-29+2 has 8 subgroups including physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, pain interference and cognitive function. All subgroups are scored from 4-20 except for cognitive function which is scored from 2-10., 6 Months|To assess changes in cognition between groups., Cognition will be measured by changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function 8a Short Form. The PROMIS Cognitive Function Short Form 8a score ranges from 8 to 40 with higher scores indicating better cognitive function., 6 Months | Philip Chang | The Cherry Marketing Institute | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IIT2022-08-CHANG-TaCO3AIMSS | 2025-01 | 2027-01 | 2027-01 | 2023-11-08 | 2024-12-13 | Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|CS Cancer at the Hunt Cancer Center, Torrance, California, 90505, United States | ||||
| NCT06117241 | Reducing Metabolic Dysregulation in Dyads | https://clinicaltrials.gov/study/NCT06117241 | REMEDY | This study is a 6-month randomized controlled trail of diet modification designed to reduce chronic inflammation and reverse metabolic dysfunction among obese individuals with one or more polyps found at a colonoscopy screening. We also will recruit an at least overweight partner, who lives in the same household. To be eligible, participants will be apparently disease-free, obese AAs or EAs who have self-identified a partner who is at least 9 years, with whom they live and who also is at least overweight. Each index participant will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have undergone a colonoscopy screening and found to have ≥1 polyp(s); 4) Be free of co-morbid conditions or other factors that would limit participation in this trial; 5) Have a BMI ≥30kg/m2; 6) Be willing to commit to investing the time and effort required to participate in this trial (i.e., willing to complete all assessments and provide biological samples as specified in the consent); and 7) Have no recent antibiotic use. Their partner needs to: 1) Be at least 9 years old; 2) Live in the same household and consumes meals together; 3) Be at least overweight; 4) Agree to all study procedures, including provision of biological samples, body measurements, and self-reported dietary and other assessments; and 5) Have no recent antibiotic use. | NO | Colorectal Cancer|Inflammation|Nutrition Related Cancer | BEHAVIORAL: IMAGINE HEALTHY | Blood, Tumor Necrosis Factor alpha (TNFα), Interleukin 6 (IL-6), and C-Reactive Protein (CRP), Baseline, 3-month, 6-month|Stool, Determine race-specific microbiome signatures associated with anti-inflammatory dietary input and reversal of metabolic dysfunction, Baseline, 3-month, 6-month | University of South Carolina | ALL | CHILD, ADULT | NA | 180 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | Pro00120270 | 2023-10-17 | 2025-04 | 2027-07 | 2023-11-03 | 2023-11-03 | University of South Carolina, Columbia, South Carolina, 29208, United States | |||||
| NCT06106477 | Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer | https://clinicaltrials.gov/study/NCT06106477 | This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET). | NO | Breast Cancer | BEHAVIORAL: Intermittent Fasting | Subject adherence to the intermittent fasting schedule., This measure is the number of subjects who adhere to at least 80% of the intermittent fasting schedule (i.e., follow the schedule on average for at least eight out of 10 days) throughout the six-month intervention period., Six months | Medical College of Wisconsin | ALL | ADULT, OLDER_ADULT | NA | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | PRO00049422 | 2024-07-24 | 2027-07-15 | 2027-07-15 | 2023-10-30 | 2024-08-02 | Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States | ||||||
| NCT06059651 | The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology | https://clinicaltrials.gov/study/NCT06059651 | This study aims to determine the relationship between lipid kinetics changes and blood immunosuppressive cells by metabolic surgery in two patient cohorts. | NO | Obesity | PROCEDURE: Metabolic & Bariatric Surgery | Change in insulin-inhibited adipose tissue lipolysis, Baseline, week 52|Change in the number of circulating myeloid-derived suppressor cells, Baseline, week 52 | Pennington Biomedical Research Center | FEMALE | ADULT | 20 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PBRC 2023-026 | 2024-01-01 | 2024-12-31 | 2025-12-31 | 2023-09-28 | 2024-01-26 | Pennington Biomedical Resarch Center, Baton Rouge, Louisiana, 70808, United States | |||||||
| NCT06049420 | Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients | https://clinicaltrials.gov/study/NCT06049420 | Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings. | NO | Obesity|Hyperlipidemias|Polycystic Ovary Syndrome|Hypertension|Coronary Heart Disease|Heart Failure|Depression, Anxiety|Type II Diabetes|Metabolic Syndrome | BEHAVIORAL: Lifestyle counseling and coaching | Demand, initial demand for the program, 1 month|Attrition rate, Drop out rate after opting in to the intervention, 4 months|physical activity, minutes of moderate to vigorous physical activity, 4 months | Blood pressure, Systolic and diastolic blood pressure (mmHg), 4 Months|Blood glucose, mg/dL, 4 Months|blood lipids, triglycerides (mg/dL), 4 Months|Glycosylated hemoglobin, A1C (percent of hemoglobin that is glycosylated), 4 Months|BMI, weight and height will be combined to report BMI in kg/m\^2, 4 Months|total cholesterol, Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol., 4 Months|Self-efficacy, Exercise Self Efficacy scale – ranges from 0 (low self efficacy) to 10 (high self efficacy) These data measure individual’s confidence in his or her capacity to execute behaviors necessary to maintain an active lifestyle., 4 Months | West Virginia School of Osteopathic Medicine | ALL | ADULT | NA | 95 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | R010422CP | 2024-04 | 2025-09 | 2025-09 | 2023-09-22 | 2023-10-19 | West Virginia School of Osteopathic Medicine, Lewisburg, West Virginia, 24901, United States | |||||
| NCT06030427 | Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors | https://clinicaltrials.gov/study/NCT06030427 | This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Obesity has been linked to increased risk for certain kinds of cancer and is the second highest modifiable risk factor for cancer. It is also well documented that having a cancer diagnosis and treatment is a stressful experience. It is hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the virtual positive health habits group focused on weight management can improve wellbeing and distress. Virtual care options continue to extend the reach of medical providers to cancer survivors, particularly those in the rural setting. A virtual behavioral weight management program with an integrated mindfulness component may improve mood, coping strategies, stress management, and weight loss among community practice and rural obese cancer survivors. | NO | Hematopoietic and Lymphoid System Neoplasm|Malignant Solid Neoplasm|Obesity-Related Malignant Neoplasm | BEHAVIORAL: Behavioral Dietary Intervention|OTHER: Educational Intervention|OTHER: Health Promotion and Education|OTHER: Internet-Based Intervention|OTHER: Interview|OTHER: Medical Device Usage and Evaluation|BEHAVIORAL: Mindfulness Relaxation|OTHER: Physical Performance Testing|OTHER: Questionnaire Administration | General anxiety disorder-7 (GAD-7), Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety)., Baseline; 12 weeks|Patient Health Questionnaire (PHQ)-8, Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression)., Baseline; 12 weeks|Feasibility of virtual mindfulness and weight management program, Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12., 12 weeks | Body weight, Assessed by change in body weight, Baseline; 12 weeks|Body composition parameter, Will be assessed in a fasted state or 3 hour post meal by subjects standing on a scale without socks or shoes., Baseline; 12 weeks|Daily activity levels – heart rate, Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire), Baseline; 12 weeks|Daily activity levels – activity, Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity., Baseline; 12 weeks | Mayo Clinic | ALL | ADULT, OLDER_ADULT | NA | 19 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 23-004890|NCI-2023-06407|23-004890 | 2023-09-08 | 2024-01-02 | 2024-01-02 | 2023-09-11 | 2024-12-02 | Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, 54601, United States | |||||
| NCT06029517 | A Sugar-Sweetened Beverage Reduction Intervention for Native American Men | https://clinicaltrials.gov/study/NCT06029517 | This clinical trial develops and tests a culturally-appropriate educational program (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with Native American athletics communities. Sugary drinks are drinks like pop, soda, and juice. Increased sugar consumption may lead to an increased risk of chronic diseases, including obesity, diabetes, some types of obesity-related cancers, coronary heart disease, hypertension, and dental decay. A culturally sensitive program may help reduce sugar-sweetened beverage consumption in Native American men | NO | Cardiovascular Disorder|Coronary Artery Disease|Diabetes Mellitus|Obesity-Related Malignant Neoplasm | OTHER: Education Intervention|OTHER: Interview|PROCEDURE: Discussion | Change in SSB intake for men affiliated with Native American athletic communities, Will conduct half hour classes with the Native American community members on how to improve wellness and drink less sugary drinks, up to 6 months | Sugar sweetened beverage intake, change in consumption of sugar sweetened beverages, Baseline to 6 months|Change in body weight, baseline to 6 months | Roswell Park Cancer Institute | National Institute of Nursing Research (NINR) | MALE | ADULT, OLDER_ADULT | NA | 100 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | I 810620|R56NR019498 | 2022-07-20 | 2024-12-20 | 2024-12-20 | 2023-09-08 | 2024-08-09 | Roswell Park Comprehensive Cancer Center, Buffalo, New York, 14263, United States | ||||
| NCT06022887 | Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer | https://clinicaltrials.gov/study/NCT06022887 | MBSR&TRE | The goal of this clinical trial is to evaluate the feasibility of remote time-restricted eating (TRE) and mindfulness-based stress reduction (MBSR) interventions and the preliminary effect on EOCRC-related markers. The main question\[s\] it aims to answer are: * Is it feasible and acceptable to conduct 8-week remote interventions of TRE, MBSR, and combined TRE+MBSR among young adults with excess adiposity and moderate-to-severe perceived stress? * Will participants in the combined group lose more body weight and reduce their stress levels than those in the remaining groups? * Will participants in the combined group experience better body composition changes and improve their cardiometabolic health compared to those in the remaining groups? * Will participants in the combined group exhibit changes in the microbiome compared to those in the remaining groups? Participants will: * Complete 8 weeks of a TRE intervention * Complete 8 weeks of a remote MBSR intervention Researchers will compare 1. TRE alone; 2. MBSR alone; 3. TRE + MBSR; and 4. Control to see if the study is feasible and acceptable; to see if individuals lose body weight; to see if individual stress levels reduce; to see changes in the microbiome. | NO | Obesity|Colorectal Cancer|Microbial Colonization|Time Restricted Feeding|Stress, Psychological | BEHAVIORAL: TRE|BEHAVIORAL: MBSR | Feasibility of the study, the number of people interested in the study, those who pass phone and in-person screenings, and those who decline enrollment and their reasons. Once enrolled, we will closely monitor attendance, data completeness, session attendance, asynchronous intervention usage, and loss to follow-up/withdrawal. To monitor participant progress, we will update the CONSORT participant flow diagram every week. Participants who withdraw voluntarily will be asked for their reasons., Baseline; through study completion, an average of 9 weeks|Acceptability of the study, Participants will complete the acceptability of intervention measure (scores range from 4-20 points with higher scores reflecting higher acceptability)., Week 4 of the intervention; through study completion, an average of 9 weeks | Hair cortisol, Objective stress markers will be measured via hair cortisol, Baseline; through study completion, an average of 9 weeks|Serum adrenocorticotropic hormone (ACTH), Objective stress markers will be measured via serum ACTH., Baseline; through study completion, an average of 9 weeks|Serum cortisol, Objective stress markers will be measured via serum cortisol., Baseline; through study completion, an average of 9 weeks|Serum norepinephrine, Objective stress markers will be measured via serum norepinephrine, Baseline; through study completion, an average of 9 weeks|Perceived Stress Scale., The Perceived Stress Scale queries participants’ perceptions of feeling stress during the last month. Responses were on a 5-point scale from “never” to “very often.” Scores will be summed to indicate current stress levels, with higher scores suggesting greater perceived stress (≥ 14 indicates moderate to high perceived stress)., Screening; through study completion, an average of 9 weeks|Body fat mass, Body fat mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan., Baseline; through study completion, an average of 9 weeks|Body lean mass, Body lean mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan., Baseline; through study completion, an average of 9 weeks|Body bone density, Body bone density will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan., Baseline; through study completion, an average of 9 weeks|Triglycerides, Will be measured from plasma by a commercial lab., Baseline; through study completion, an average of 9 weeks|High sensitivity C-reactive protein., Will be measured from plasma by a commercial lab., Baseline; through study completion, an average of 9 weeks|homeostasis model assessment-insulin resistance (HOMA-IR), calculated from fasting glucose and insulin using a standard formula., Baseline; through study completion, an average of 9 weeks|Microbial Deoxyribonucleic acid (DNA) isolation: 16S on V4 region, performed on stool using Microbial DNA isolation, Baseline; through study completion, an average of 9 weeks | Lisa Tussing-Humphreys | University of Illinois at Chicago | ALL | ADULT | NA | 43 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | STUDY2023-0498 | 2023-10-18 | 2024-07-24 | 2024-07-24 | 2023-09-05 | 2024-08-21 | Applied Health Sciences Building – University of Illinois at Chicago, Chicago, Illinois, 60612, United States | |||
| NCT06011499 | Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors | https://clinicaltrials.gov/study/NCT06011499 | iLIVE | This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can lead to a decrease in quality of life and an increased risk of recurrent falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT. | NO | Prostate Carcinoma | OTHER: Internet-Based Exercise Intervention|OTHER: Internet-Based Diet Intervention|OTHER: Education Intervention | Change in overweight/obesity, Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Overweight is defined as body mass index \> 25 kg/m\^2 and a 5% loss will be viewed as a successful outcome., At baseline, 3 months, 6 months and 12 months|Change in sarcopenia, Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of \< 10.75 kg/m\^2 (moderate sarcopenia)., At baseline and 6 months|Change in slowness, Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed \< 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence., At baseline, 3 months and 6 months|Change in weakness, Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time \> 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for “weakness.”, At baseline, 3 months, and 6 months|Change in inactivity, Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use \< 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit., At baseline, 3 months, 6 months, and 12 months|Change in frailty, Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of \< 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years., At baseline, 3 months, 6 months, and 12 months | Change in health behaviors, Dietary intake measured using a 2-day diet recalls of 1-weekday and 1 weekend day will be collected by a registered dietitian via telephone and entered into the National Cancer Institute-developed Automated Self-Administered 24-hour. Physical activity measured using CHAMPS as described above. We will also assess free-living physical activity over 7-days using Fitbits., At baseline, 3 months, 6 months, and 12 months|Change in physical functioning, Measured by Timed Up and Go using a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. SF-36 Physical Function measured using a 10-item physical function subscale of the SF-36., At baseline, 3 months, 6 months, 12 months|Change in quality of life, Measured by European Quality of Life-5D with 1 question in 5 separate domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will also be used to calculate Quality of Life Adjusted Years for cost-effectiveness analysis. Healthcare utilization measured using a brief questionnaire that assesses physician and emergency room visits, hospitalizations, etc., At baseline, 3 months, 6 months, and 12 months | OHSU Knight Cancer Institute | National Cancer Institute (NCI)|Oregon Health and Science University|University of Alabama at Birmingham | ALL | CHILD, ADULT, OLDER_ADULT | NA | 250 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | STUDY00025281|NCI-2023-03141|STUDY00025281|R01CA275055 | 2024-04-02 | 2027-09-30 | 2027-12-31 | 2023-08-25 | 2024-10-22 | University of Alabama, Birmingham, Alabama, 35294, United States|OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States | |||
| NCT05963971 | A Bilingual Virtually-based Intervention (PEDALL) for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors | https://clinicaltrials.gov/study/NCT05963971 | PEDALL | The purpose of this study is determine the effectiveness of a six-month virtually-delivered dietary education intervention (PEDALL) on the prevention of overweight and obesity (OW/OB) during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). | NO | Acute Lymphoblastic Leukemia|Obesity | BEHAVIORAL: PEDALL|OTHER: Standard of care | To prevent the development of OW/OB during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL., Number of participants with overweight or obesity as assessed by body mass index (BMI) for age z-scores \>1 will change from baseline following 6 month virtual diet education intervention. BMI z-score will be evaluated at the end of 6-month intervention in the maintenance phase of ALL therapy. BMI z-scores will be classified by comparing age, sex, height and weight to CDC growth charts. OW is defined as BMI z-score ≥ +1.04 , and OB is defined as BMI z-score ≥ +1.645 . For participants ≥20 years of age, adult classifications will be used to determine weight status as recommended by the CDC and include BMI \< 19 underweight; BMI 19-\<25 healthy weight; BMI ≥ 25 - \<30 overweight; BMI ≥ 30 obese., 3.5 years | The effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors., The proportion of OW/OB based on BMI (measured in kilograms per meters squared) at the end of treatment (EOT) for ALL and at one-year post-EOT for ALL will be analyzed as the exploratory outcomes measure of interest. The change in outcome at EOT to 1-year post EOT using a similar analytical approach to the Primary Objective will be analyzed also., 4 years|The modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL intervention, The modifying effect of GPS score will be calculated based on an algorithm optimized for trans-ethnic application both as a continuous variable and a dichotomized variable (\ | Columbia University | United States Department of Defense | ALL | CHILD, ADULT | NA | 376 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | AAAU5938|W81XWH2210452 | 2024-03-19 | 2026-12-23 | 2027-06-23 | 2023-07-27 | 2024-08-09 | Columbia University Medical Center, New York, New York, 10032, United States | |||
| NCT05950282 | Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis | https://clinicaltrials.gov/study/NCT05950282 | The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions. | NO | Insulin Resistance|Polycystic Ovary Syndrome|Hyperinsulinism|Obesity|Metabolic Syndrome | Assessment of Fasting Insulin levels and HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) scores among different groups stratified by age, sex, race/ethnicity, BMI, and PCOS (Polycystic Ovary Syndrome) diagnosis., The primary objective is to investigate the association between these measures and the specified demographic and clinical factors, providing insights into the variations and potential disparities in insulin resistance across different subgroups., 3 years | Identify any significant interactions or relationships between the primary outcomes (Fasting Insulin and HOMA-IR) and the demographic and clinical factors, including age, sex, race/ethnicity, BMI, and PCOS diagnosis., The secondary outcome measure will provide a comprehensive understanding of how various factors may influence insulin resistance and contribute to its heterogeneity in different populations., 3 years | Lilli Health | ALL | ADULT, OLDER_ADULT | 500 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2023-0060 | 2024-02-01 | 2026-10 | 2026-12 | 2023-07-18 | 2024-09-19 | Lilli Health, Houston, Texas, 77554, United States | |||||||
| NCT05930483 | Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT05930483 | This clinical trial evaluates a remotely delivered, culturally tailored weight loss interventions in Latina breast cancer (BC) survivors. Cancer is the leading cause of death among Latinos, and among Latinas, BC is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer BC outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina BC survivors. The development of an adaptive program that provides survivors the support they need, as opposed to what is typically available, is essential to reducing persistent inequities in cancer survivorship. | NO | Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8 | BEHAVIORAL: Behavioral Dietary Intervention|BEHAVIORAL: Behavioral Intervention|PROCEDURE: Biospecimen Collection|OTHER: Dietary Intervention|OTHER: Educational Intervention|OTHER: Exercise Intervention|OTHER: Health Promotion and Education|OTHER: Internet-Based Intervention|OTHER: Interview|BEHAVIORAL: Lifestyle Counseling|OTHER: Medical Device Usage and Evaluation|OTHER: Medical Device Usage and Evaluation|OTHER: Nutritional Intervention|OTHER: Questionnaire Administration|BEHAVIORAL: Telephone-Based Intervention | Body weight (kg) percent change, Will be assessed by the percent of weight loss at month 12 and compared across the four embedded adaptive intervention (EAI) groups using the doubly robust estimator model., Up to 12 months | Body weight (kg) percent change as moderated by baseline characteristics, Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics., Up to 12 months | Fred Hutchinson Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 620 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION | RG1123416|NCI-2023-03748|0020054|R01CA270441 | 2025-01-09 | 2028-03-01 | 2028-03-01 | 2023-07-05 | 2024-12-10 | Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States | ||||
| NCT05903131 | A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia | https://clinicaltrials.gov/study/NCT05903131 | Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in increasing rates of AEH in this age group. Hysterectomy with removal of the fallopian tubes and ovaries is 100% effective in preventing endometrial cancer, but this approach results in infertility. Fertility-sparing treatments exist, such as treatment with oral or intrauterine progestin, but these treatments do not work uniformly and do not combat the underlying cause of endometrial cancer, which is obesity and metabolic syndrome. Additionally, up to 41% of women on progestin eventually experience relapse of AEH or endometrial cancer. Third, many patients have insulin resistance that may worsen with progestin therapy. Thus, to improve treatment of AEH and grade 1 endometrial cancer, prevent and reverse endometrial cancer, and allow women to preserve their fertility, the investigators must integrate an effective weight loss strategy to be given with progestin treatment. It is the hypothesis that premenopausal women with AEH desire uterine preservation will be more likely to have atypia-free uterine preservation at one year if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care. | NO | Endometrial Hyperplasia|Grade 1 Endometrial Cancer | BEHAVIORAL: Telemedicine behavioral weight intervention|DRUG: Progestin|BEHAVIORAL: Enhanced usual care|DRUG: Levonorgestrel-releasing IUD. | Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy, At 1 year | Time to resolution of atypical endometrial hyperplasia (AEH), Defined as the period of time in months/days from the first biopsy to show AEH or grade 1 endometrial cancer to the first biopsy that shows no evidence of hyperplasia or malignancy, Through completion of follow-up (estimated to be 2 years)|Time to resolution of endometrial cancer, Through completion of follow-up (estimated to be 2 years)|Atypia-free survival, -Defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of atypical endometrial hyperplasia (AEH) recurrence. AEH-free or the patients with lost to follow-up will be censored at the last follow-up., Through completion of follow-up (estimated to be 2 years)|Endometrial cancer progression-free survival (EC-PFS), EC-PFS is defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of recurrence of EC. Endometrial cancer-free patients or the patients with lost to follow-up will be censored at the last follow-up., Through completion of follow-up (estimated to be 2 years)|Change in weight, Through completion of follow-up (estimated to be 2 years)|Change in Cancer Worry Impact Events Scale (CWIES), The CWIES is a 15-item self-report measure evaluating stress reactions and traumatic experiences, specifically inquiring about cancer worry-specific distress. Range of values for each individual item will be a Likert Scale from 0-5. 0=not at all and 5=often. The higher the score, the more cancer-worry specific distress the participant has., At enrollment, 6 months, 12 months, end of intervention, and 24 months (estimated to be 2 years) | Washington University School of Medicine | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 96 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT | 202307204|P50CA265793 | 2024-10-24 | 2028-10-31 | 2029-10-31 | 2023-06-15 | 2024-12-20 | Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|University of New Mexico, Albuquerque, New Mexico, 87106, United States|University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States | ||||
| NCT05903521 | BAriatric Surgery Induced Chromosomal Change | https://clinicaltrials.gov/study/NCT05903521 | BASICC | The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity. | NO | Obesity, Morbid | Telomere length, Difference in terms of telomere length between patients with obesity class II or more (Body Mass Index \[BMI\] ≥ 35kg/m2) and patients after metabolic and bariatric surgery., 1 day | Metabolic disease remission (hypertension and type 2 diabetes remission versus no remission), Evaluate if remission of metabolic disease (no remission versus remission) has an impact of metabolic disease remission on telomere length after bariatric and metabolic surgery, 1 day|Excessive weight loss (Weight loss [kg] / excess body weight [kg]) x 100 = Percent of excess body weight loss), Evaluate if the amount of excessive weight loss has an impact on telomere length after bariatric and metabolic, 1 day|Lifestyle (Simple Lifestyle Indicator Questionnaire), Evaluate if lifestyle (Simple Lifestyle Indicator Questionnaire) has an impact of lifestyle on telomere length after bariatric and metabolic, 1 day|Oxidative stress (Interleukin-1β, Interleukin-6, TNF-α), Evaluate if oxidative stress level (Interleukin-1β, Interleukin-6, TNF-α) has an impact on telomere length after bariatric and metabolic, 1 day | The Cleveland Clinic | ALL | ADULT, OLDER_ADULT | 126 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 23-488 | 2023-06-12 | 2023-10 | 2023-12 | 2023-06-15 | 2023-09-15 | Cleveland Clinic Florida, Weston, Florida, 33331, United States | ||||||
| NCT05889780 | Screening for and Responding to Food Insecurity Among Infusion Patients | https://clinicaltrials.gov/study/NCT05889780 | Food insecurity impacts 1 in 8 people in the United States and 1 in 4 people receiving cancer treatment. Food insecurity is associated with poor dietary quality, adverse health conditions (e.g., Type 2 diabetes, overweight and obesity, hypertension), and worse cancer treatment outcomes. To effectively address food insecurity among people with cancer, screening and effective response programs are needed. The Food to Overcome Disparities (FOOD) program screens breast cancer patients for food insecurity and refers people who screen positive to 11 clinic pantries across New York City. In addition to clinic referrals, researchers have found the addition of monthly grocery vouchers or home grocery delivery to be even more effective at improving treatment completion rates than pantry access alone. Another innovative food security strategy, nutritious no-prep, ready-to-eat meals may also be helpful for patients given that no-prep meals reduce the time and physical demand of food preparation. Nutritious no-prep, ready-to-eat meals have been positively associated with improvements in healthy eating index (HEI) scores, fewer instances of hypoglycemia, and improved quality of life among people with food insecurity that have diabetes, but has yet to be tested among patients with cancer. People receiving cancer treatment, such as infusion services, often report fatigue and other barriers to food preparation, which make no-prep, ready-to-eat meals another potential solution to cancer-specific challenges to healthy eating. In the present study the investigators will test which evidence-based strategies are most effective and well-liked by patients and will inform the development of a comprehensive food security response program at the Harold C. Simmons Comprehensive Cancer Center. | NO | Cancer|Diet, Healthy|Nutrition, Healthy | OTHER: Food pantry referrals|OTHER: No-prep, ready-to-eat meals|OTHER: Vouchers | Food security, 6-item United States Department of Agriculture Food Security Screener (USDA); questionnaire; raw score 0-1-High or marginal food security, 2-4-Low food security, 5-6-Very low food security., 3-months | Patient satisfaction, Satisfaction with clinical experience and interventions; two-items from the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey will be used to measure patient satisfaction with the clinical experience – items 21 \& 22 on Overall Rating of Hospital (Q21) and Willingness to Recommend Hospital (Q22) – minimum = 0 (poorer quality care), maximum = 4 (higher quality care)., 3-months|Patient wellbeing, The World Health Organisation-Five Well-Being Index (WHO-5), 5-items with 5 response options each, 0 to 25, 0 respresents worst possible quality of life and 25 represents best possible quality of life., 3-months | Diet quality, Abbreviated Diet History Questionnaire III (DHQ-III) is a food frequency questionnaire (FFQ) that will be used to calculate a Healthy Eating Index score with a minimum value of 0 indicating poor dietary quality and a maximum value of 100 indicating high dietary quality., 3-months | University of Texas Southwestern Medical Center | ALL | ADULT, OLDER_ADULT | NA | 45 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT | 48557 | 2024-01-08 | 2024-09-06 | 2024-09-06 | 2023-06-05 | 2024-12-09 | UT Southwestern Medical Center, Dallas, Texas, 75390, United States | ||||
| NCT05874726 | Biological Sample Repository for Gastrointestinal Disorders | https://clinicaltrials.gov/study/NCT05874726 | The goal of this observational study has the purpose of collecting biological samples from obese patients undergoing evaluation for weight loss by means of medical or endoscopic therapies; and of post bariatric surgery patients presenting with short- and long-term surgical complications. The aim is to enhance the overall understanding of the mechanisms leading to obesity, weight loss, failure to lose weight, and weight regain following treatment. Additional goals are to determine the efficacy of endoscopic and surgical procedures, to identify potential therapeutic targets and disease biomarkers that predict response to therapy. | NO | Obesity|Obesity, Morbid|Obesity, Primary|Gastro-Intestinal Disorder|Overweight and Obesity|Overweight|Overweight or Obesity|Diabetes Type 2|Diabetes Mellitus|Diabetes Mellitus, Type 2|Hypertension|Hyperlipidemias|Sleep Apnea|GERD|Gastroesophageal Reflux|Musculoskeletal Pain Disorder|Cancer | DIAGNOSTIC_TEST: Blood Collection|DIAGNOSTIC_TEST: Urine Collection|DIAGNOSTIC_TEST: Tissue Sample Collection | Serum sample repository, Blood (10 ml) will be collected from the enrolled subjects, serum will be extracted and stored at -80 degrees for up to 10 years., Change from Baseline to 10 years.|Urine sample repository, Urine (5 ml) will be collected via free catch method and stored at -80 degrees C for up to 10 years., Change from Baseline to 10 years.|Tissue sample repository, Tissue samples (gastric, duodenum, jejunum and ileum – number of biopsies will be 3-4 from each site, ranging in size from 4-7mm) will be collected during a scheduled endoscopic examination. Biopsy tissue will be collected with a large capacity biopsy forceps and deposited into a conical vial containing a freshly prepared balanced salt solution including a HEPES buffer at the bedside, using 5mL of buffered salt solution per 5-10 mm3 of tissue biopsy, at 4 degrees C. Tissue will be stored at -80⁰C until they are “used up” or for up to 10 years from collection., Change from Baseline to 10 years. | Pichamol Jirapinyo, MD, MPH | Tufts University|Boston Children’s Hospital|Mayo Clinic | ALL | ADULT, OLDER_ADULT | 500 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2022P003060 | 2023-07-19 | 2028-07 | 2029-04 | 2023-05-25 | 2024-08-06 | Brigham and Women’s Hospital, Boston, Massachusetts, 02115, United States | ||||||
| NCT05869604 | Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors | https://clinicaltrials.gov/study/NCT05869604 | HEALTHY-AYA | There are close to 700,000 survivors of adolescent and young adult (AYA) cancer (aged 15 to 39 at diagnosis) in the US. Survivorship for AYAs is often complicated by long-term and late-effects. Cardiovascular disease (CVD), in particular, is a leading cause of death for cancer survivors and is a growing public health concern for survivors diagnosed as AYAs. Risk of CVD may be associated with treatment exposures and may be potentiated by weight gain and poor health behaviors. Healthy eating and physical activity are key behaviors for weight loss and maintenance and may be protective against CVD risk, yet few AYA cancer survivors adhere to guidelines for healthy eating or activity. AYA survivors’ abilities to engage in health behaviors (i.e., healthy eating, physical activity) necessary to manage weight may also be challenged by persistent cancer-related symptoms (i.e., pain, fatigue, psychological distress). Thus, weight gain is common. Using input from AYA cancer survivors, the investigators have adapted a behavioral weight and symptom management protocol for AYA cancer survivors with obesity to create an intervention that is responsive to AYAs’ unique needs. A pilot randomized controlled trial will be conducted to examine intervention feasibility and acceptability and to examine patterns of change in outcomes including weight, body mass index, symptoms (e.g., pain, fatigue, distress) as well as other CVD risk factors, including blood pressure, cholesterol (total, HDL, LDL), HbA1c, and atherosclerotic cardiovascular disease (ASCVD) risk score. | NO | Cancer|Cardiovascular Diseases|Weight Management|Pain|Fatigue|Distress, Emotional|Physical Inactivity | BEHAVIORAL: HEALTHY AYA|OTHER: Education Control | Feasibility of study recruitment, Number of participants recruited over the course of 12 months., 12 months|Session attendance, Treatment feasibility will be assessed by measuring the session attendance rate for each participant., Following completion of the intervention (up to 3 months)|Participant attrition, Participant attrition will be assessed by measuring the number of participants who drop out of the study, Following completion of the intervention (up to 3 months)|Intervention acceptability: Treatment Acceptability Questionnaire, The Treatment Acceptability Questionnaire is a six-item scale assessing participants’ views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 “very unacceptable” to 7 “very acceptable”)., Following completion of the intervention (up to 3 months)|Intervention satisfaction: SSTS-R, Intervention satisfaction will be assessed using the SSTS-R, a 13-item measure with the first 12-items on a five-point scale ranging from 1 “strongly disagree” to 5 “strongly disagree.” The 13th item asks, “How much did the program help with the specific concern that led you to participate?” with 5 answer choices ranging from “made things a lot better” to made things a lot worse.”, Following completion of the intervention (up to 3 months)|Open-Ended Questions About the Program, Intervention will be evaluated using 3 open-ended questions, including the following: “1) What was the most helpful part of the program?,” “2) What was the least helpful part of the program?”, and “3) What suggestions do you have for us to help improve the program?”, Following completion of the intervention (up to 3 months) | Change in diet and eating behavior: Three factor eating questionnaire, Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating., Baseline, follow-up assessment (up to 3 months)|Change in weight, Participants will be weighed at each assessment., Baseline, follow-up assessment (up to 3 months)|Change in diet: Dietary screener questionnaire, The Dietary Screener Questionnaire is a 25-item measure asking participants to rate on the frequency of eating/drinking certain foods in the last week., Baseline, follow-up assessment (up to 3 months)|Change in Physical Activity: Stanford L-Cat, The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active., Baseline, follow-up assessment (up to 3 months)|Change in Pain: Brief Pain Inventory (BPI), The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents “no pain” and 10 represents “pain as bad as you can imagine.” Participants also rate their level of interference from pain., Baseline, follow-up assessment (up to 3 months)|Change in Fatigue: PROMIS Fatigue Scale, The Promis Fatigue Scale is a 8-item self-report measure of fatigue in the last week. Participants are asked to respond to items (e.g., “I felt fatigued”, “I have troubled starting things because I am tired”) using scales ranging from 1 to 5., Baseline, follow-up assessment (up to 3 months)|Change in Depressive Symptoms: PROMIS Depression Short Form, Depressive Symptoms will be assessed using the PROMIS Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., “I felt sad,” “I felt helpless”) using a five-point scale ranging from 1 “never” to 5 “always.”, Baseline, follow-up assessment (up to 3 months)|Change in Anxiety: PROMIS Anxiety Short Form, Symptoms of Anxiety will be assessed using the PROMIS Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., “I felt nervous,” “I felt tense”) using a five-point scale ranging from 1 “never” to 5 “always”., Baseline, follow-up assessment (up to 3 months) | Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale, The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 “not at all confident” to 10 “totally confident.”, Baseline, follow-up assessment (up to 3 months)|Change in Self-Efficacy for weight management: Weight efficacy Lifestyle questionnaire- short form, The Weight Efficacy Lifestyle Questionnaire is an 8-item measure of eating self-efficacy. Participants are asked to provide information about how certain they are that they can resist overeating in difficult situation (e.g., over the weekend, when tired, etc.). Response choices range from 0= “not at all confident” to 10= “very confident.”, Baseline, follow-up assessment (up to 3 months)|Change in blood pressure (systolic and dyastolic), Both systolic and dyastolic blood pressure will be assessed at the baseline and follow-up assessment., Baseline, follow-up assessment (up to 3 months)|Change in total cholesterol, Cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment., Baseline, follow-up assessment (up to 3 months)|Change in LDL, LDL will be assessed through peripheral blood at the baseline and follow-up assessment, Baseline, follow-up assessment (up to 3 months)|Change in HDL, HDL will be assessed through peripheral blood at the baseline and follow-up assessments., Baseline, follow-up assessment (up to 3 months)|Change in Triglycerides, Triglycerides will be assessed through peripheral blood at the baseline and follow-up assessments., Baseline, follow-up assessment (up to 3 months)|Concentration of HbA1c, HbA1c will be assessed through peripheral blood at the baseline and follow-up assessments., Baseline, follow-up assessment (up to 3 months)|Change in Atherosclerotic Cardiovascular Disease (ASCVD) risk, The 10 year risk for ASCVD is calculated using a patient’s age, sex, race, systolic blood pressure, diastolic blood pressure, total cholesterol, HDL, LDL, history of diabetes, smoking status, whether or not they’re on hypertension treatment, and whether or not they’re on statin., Baseline, follow-up assessment (up to 3 months) | Duke University | ALL | ADULT | NA | 36 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | Pro00110049 | 2023-12-01 | 2025-01-31 | 2025-03-31 | 2023-05-22 | 2024-11-15 | Duke University, Durham, North Carolina, 27705, United States | |||
| NCT05848856 | The RISC Registry–Risk Informed Screening Registry | https://clinicaltrials.gov/study/NCT05848856 | RISC | Chronic diseases such as heart disease, cancer, and diabetes are the leading causes of death and disability in the United States. Six in ten adults have one chronic disease; 4 in 10 have two or more. These are also leading drivers of the nation’s $4.1 trillion in annual health care costs. Cardiovascular disease is the number one cause of death for men and women, cancer is the second largest, with breast cancer being the second largest cause of death in women. Diabetes is the 8th highest cause of death for both men and women. Routine screening, a focus on prevention, early detection, and patient engagement with proposed care plans, effective surveillance and follow up are some of the most effective ways to reduce the burden of chronic diseases across an individual’s lifetime and at the population level. Estimating dollar costs associated with non-compliance with screening and health management recommendations is complex and variable depending on the specific context, disease, and condition. But there is much evidence to indicate that a significant amount of these annual costs can be mitigated if compliance with health management recommendations increases, and health problems are prevented or detected early. Access to screening and noncompliance with health management recommendations impact the entire population, but more disparities exist in racial and ethnic minorities and in the historically underserved for cancer, obesity, diabetes and cardiovascular disease. The overall cost of these disparities in the U.S. has been estimated at around 1.24 trillion U.S. Dollars. The RISC Registry seeks to pursue the intersection of breast cancer, metabolic, and cardiovascular risk in women and study the application of individualized multi-condition risk assessments, risk-informed or personalized screening, prevention and follow up care approaches in a broad cross section of patients. It pursues the hypothesis that these approaches accompanied by population appropriate methods of clinician and patient engagement may increase understanding and compliance with breast cancer, obesity, and metabolic/cardiovascular/cardiometabolic risk screening, surveillance and follow up recommendations by empowering women to make healthier choices. In doing so, these methods may identify ways to address disparities in screening and patient care and ultimately promote early detection or even reversal of adverse health conditions, improve overall personal health, and reduce overall health care costs. The primary focus is cancer, cardiovascular and metabolic health screening with a focus on utilization of Precision Screening. (Precision Screening attempts to separate those who will benefit from screening from those that may not, through use of information on disease risk.) The study will start by focusing on women and risk for these diseases and health conditions. | NO | Breast Cancer Risk|Cardiovascular Disease Risk|Cardiometabolic Risk|Diabetes | BEHAVIORAL: Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up | Disease risks and issues identified during multi-condition risk assessment, Types of disease risks or issues identified by implementing a multi-condition risk assessment in a single patient., Within 3 months|Objective health measures within different population subgroups–blood pressure, Changes in an individual’s blood pressure (both systolic and diastolic) tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups. Could include data gathered from connected health devices used as part of the care plan and follow up., Within 6 months|Objective health measures within different population subgroups–BMI, Changes in an individual’s BMI using combined height and weight measures, tracked over time, associated with different cardiovascular and breast cancer risk assessments, recommended care plans and patient engagement techniques, by different population subgroups., Within 6 months|Objective health measures within different population subgroups–HDL levels, Changes (increase or decrease) in an individual’s HDL tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups., Within 6 months|Objective health measures within different population subgroups– abnormal germline genetic test results, Prevalence of abnormal germline genetic test results for cardiovascular and breast cancer disease risk, by different population sub groups, Within 6 months|Number of subjects with newly diagnosed early stage cardiometabolic conditions and breast cancer, Early detection as measured by stage/extent of disease, linked to different risk assessments, care plans and patient engagement techniques, within different population subgroups., Within 6 months|Cancer health outcomes–imaging follow up, Short term cancer health outcomes using RECIST (Response Evaluation Criteria in Solid Tumors) to analyse how well treatment has worked as measured or detected by imaging results, Within 1 year|Short and Long term cancer health outcomes–biospecimen tests, Short–within one year and longer term –within 5 years–cancer health outcomes using survival measure scales including Progression Free Survival (PFS) correlated with biospecimen tests that detect presence of disease., Within 1 year|Short and Long term cancer health outcomes–biospecimen tests, Short–within one year and longer term –within 5 years–cancer health outcomes using survival measure scales including Event Free Survival (EFS–complications and events the treatment was supposed to prevent) correlated with biospecimen tests that detect presence of disease., Within 1 year|PRO–Patient Reported Outcomes: Percent of time patient screening behaviors changed based on recommendations made by shared decision making with the clinician, Patient behavior correlated with recommendations evaluated by type of method of engagement and various social drivers of health (SDOH) using the PRAPARE survey (https://prapare.org/the-prapare-screening-tool/), Within 3 months|PRO–Patient Reported Outcomes: compliance with post screening recommendations, Patient compliance with recommendations evaluated by type of method of engagement and various social drivers of health (SDOH) as measured by using the PRAPARE survey (https://prapare.org/the-prapare-screening-tool/), Within 3 months|Clinician–Recommendations based on multi-condition risk assessments, Types of recommendations and percent (%) of time they change based on precision risk assessments, Within 1 month | Precision Health Equity Initiative | FEMALE | ADULT, OLDER_ADULT | 10000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | RISC 1.01 | 2024-09-01 | 2034-09-01 | 2035-09-01 | 2023-05-08 | 2024-07-11 | PHEI–Precision Health Equity Initiative, Palo Alto, California, 94301, United States | ||||||
| NCT05826184 | Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors | https://clinicaltrials.gov/study/NCT05826184 | This study aims to address a critical gap in pediatric oncology survivorship care by exploring innovative solutions to addressing obesity and its comorbidities in pediatric cancer survivors. The majority (99%) of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition. Obesity, cardiovascular, and metabolic diseases are the most common treatment-related late effects among pediatric cancer survivors. Improving diet and reducing obesity has the potential to dramatically improve the quality of life and long-term health of pediatric cancer survivors. Utilization of a prebiotic fiber supplement along with TRE amy improve the gut microbiome, short-chain fatty acid synthesis, and hunger hormones to further improve weight loss with TRE and a greater decrease in cardiometabolic risk. The aims of this study are to test the safety, feasibility, and acceptability of 8-h TRE or 8-h TRE with a fiber supplement among young adult (YA) pediatric cancer survivors. The investigators further strive to examine the preliminary efficacy of TRE on body weight, body composition, glucose regulation, and cardiovascular risk markers. Data obtained will be used to inform a larger efficacy trial of TRE among adolescent and young adult pediatric cancer survivors. Given that a majority of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition exploring accessible nutritional strategies to improve long term health trajectory of 70,000+ AYA diagnosed with cancer each year in the United States. This study of TRE will provide important preliminary evidence of the benefits of this nutrition therapy for YA pediatric cancer survivors. The long-term goal of this line of inquiry is to improve both short and long-term outcomes for YA pediatric cancer survivors. | NO | Weight, Body | BEHAVIORAL: Time restircted eating|BEHAVIORAL: Time restricted eating + prebiotic | feasibility of TRE in pediatric cancer survivors, Clinicians will refer ≥ 75% of AYA pediatric cancer survivors that are eligible, we will screen and enroll ≥ 50% of those referred, participants will complete ≥ 80% of planned study visits, and we will retain ≥ 80% of participants in both study arms through the end of the intervention., 1 year|acceptance of TRE in pediatric cancer survivors, TRE will be acceptable (≥ 16 on acceptability on Diet Satistfaction questionnaire)., 12 weeks|Adherence to TRE, Adherence to TRE will be ≥ 80% throughout the intervention among participants randomized to this study arm, 12 weeks | body weight (kg), Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL)., change from week 1-12|Body composition, fat free mass and fat mass via DXA, change from week 1-12|fasting Insulin, measured by enzymatic kit (uIU/ml)\^4, change from week 1-12|fasting glucose, measured by enzymatic kit (mg/dl), change from week 1-12|insulin resistance change, fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5., change from week 1-12|Hemoglobin A1c concentration, measured by enzymatic kit, change from week 1-12|Blood pressure, systolic and diastolic blood pressure with cuff, change from week 1-12|Heart rate, Heart rate measured by blood pressure cuff, change from week 1-12|Lipid concentration, measured by enzymatic kit, change from week 1-12|Gut microbial composition, 16s RNA stool swab, Change from week 1-12|Glucagon like peptide 1 concentration, measured by enzymatic kit, change from week 1-12|peptide yy concentration, measured by enzymatic kit, change from week 1-12|circulating short chain fatty acid concentration, measured by enzymatic kit, change from week 1-12|c-reactive protein concentration, measured by enzymatic kit, change from week 1-12 | peripheral blood mononuclear cell (PBMC) telomerase activity, measured by enzymatic kit, change from week 1-12 | University of Illinois at Chicago | ALL | ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | STUDY2022-0745 | 2023-11-17 | 2024-11-16 | 2024-11-16 | 2023-04-24 | 2023-11-21 | University of Illinois at Chicago, Chicago, Illinois, 60612, United States | ||||
| NCT05819853 | Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT05819853 | RESTORE | Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities. | NO | PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries|Obese | DRUG: Semaglutide Injectable Product (Wegovy and/or Ozempic) | Change in ovulation frequency before and after semaglutide in females with PCOS, The change in ovulation will be measured at baseline and 6-10 months post treatment with semaglutide from 4 months daily urinary progesterone metabolites, 14 months | Change in Whole Body Insulin Sensitivity, Participants will undergo a 75 gram oral glucose tolerance test, and whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model using SAMM II software. This software uses participant weight, glucose and insulin concentrations at various time points during the oral glucose tolerance test to calculate the participant’s insulin sensitivity. A positive Si value means an improvement in insulin sensitivity., Baseline and 10 months|Change in ovarian morphology, Participants will have an ovarian ultrasound performed to measure change in ovarian morphology: ovarian size and number of follicles pre/post treatment with semaglutide, Baseline and 10 months | University of Colorado, Denver | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | CHILD, ADULT | PHASE3 | 80 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 21-4941|R01HD108340 | 2023-11-03 | 2028-02-01 | 2028-06-30 | 2023-04-19 | 2024-07-31 | University of Colorado Anschutz/Children’s Hospital Colorado Aurora, Aurora, Colorado, 80045, United States | |||
| NCT05805605 | Allo HSCT Using RIC and PTCy for Hematological Diseases | https://clinicaltrials.gov/study/NCT05805605 | This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis. | NO | Acute Myelogenous Leukemia|Acute Lymphocytic Leukemia|Biphenotypic Acute Leukemia|Undifferentiated Leukemia|Prolymphocytic Leukemia|Chronic Myelogenous Leukemia|Plasma Cell Leukemia|Myelodysplastic Syndromes|Leukemia, Myeloid|Myelodysplastic Syndrome With Excess Blasts-1|Burkitt Lymphoma|Relapsed T-Cell Lymphoma|Relapsed Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma|Marginal Zone Lymphoma|Follicular Lymphoma|Myeloproliferative Neoplasm|Myelofibrosis | BIOLOGICAL: Peripheral Blood Stem Cell Transplant|DRUG: Allopurinol 300 MG|DRUG: Fludarabine|DRUG: Cyclophosphamide|BIOLOGICAL: Bone Marrow Cell Transplant|RADIATION: Total Body Irradiation|DRUG: Sirolimus Pill|DRUG: Mycophenolate Mofetil | Evaluate rates of acute graft-versus-host disease (GVHD), Number of participants with GVHD grades 2-4 after one year post transplant., 12 months|Evaluate rates of chronic graft-versus-host disease (GVHD), Number of participants with chronic GVHD after one year post transplant., 12 months | Observe rates of relapse (RR), Number of participants that experienced relapse within 100 days of treatment., 100 days|Overall Survival (OS), Observe overall participant survival at Day 100 and at 1 and 3 years, 72 months|Observe transplant related mortality (TRM), Number of participants with transplant related mortality within 12 months of treatment., 12 months | Masonic Cancer Center, University of Minnesota | ALL | CHILD, ADULT, OLDER_ADULT | PHASE2 | 56 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2022LS146 | 2023-05-01 | 2027-10-22 | 2028-10-22 | 2023-04-10 | 2024-05-07 | Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, 55455, United States | |||||
| NCT05780814 | The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer | https://clinicaltrials.gov/study/NCT05780814 | COIN | The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months. | NO | Breast Cancer|Insomnia|Weight Gain | BEHAVIORAL: Cognitive-Behavioral Therapy for Insomnia (CBT-I)|BEHAVIORAL: Sleep Education Control (EDU) | Change in Weight (pounds), Our primary endpoint is % total weight loss (TWL) at 12 months. We will measure weight in light clothes without shoes, using a digital scale (in pounds) and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures., Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL. | Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, Will be measured using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, which follows an automated multiple-pass methodology., Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.|Physical activity assessed by wearing and accelerometer to track movement., Accelerometers (ActiGraph, LLC, Fort Walton Beach, FL) will be used to assess both sedentary time and moderate to vigorous physical activity., Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.|Body composition measured through DEXA scan, Body composition will be assessed by dual energy x-ray absorptiometry (DEXA), which measures total and regional fat, lean tissue and bone mass, Baseline and week 61 | Johns Hopkins University | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 250 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | IRB00376235|R01CA281220 | 2024-02-01 | 2028-12-31 | 2028-12-31 | 2023-03-23 | 2024-02-02 | Sibley Memorial Hospital, Washington, District of Columbia, 20016, United States|Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins, Baltimore, Maryland, 21218, United States|Johns Hopkins Bayview, Baltimore, Maryland, 21224, United States|Johns Hopkins Kimmel Cancer Center at Greenspring Station, Lutherville, Maryland, 21093, United States | |||
| NCT05770570 | Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity) | https://clinicaltrials.gov/study/NCT05770570 | The researchers will conduct ‘Taxi ROADmAP (Realizing Optimization Around Diet And Physical activity)’, which also utilizes MOST, and the same 4 obesity intervention components as in SANOS, but targets the overweight/obesity crisis in another at-risk, low socioeconomic status (SES) population, taxi and for-hire vehicle (FHV) drivers (Lyft, Uber, etc.). ROADMAP also utilizes an effectiveness- implementation hybrid type 1 design. Hybrid trials, which blend effectiveness and implementation studies, can lead to more rapid translational uptake and more effective implementation. Taxi and FHV drivers are a growing, multilingual, hard-to-reach, predominantly immigrant and minority essential worker population. There are over 750,000 licensed taxi and FHV drivers in in the U.S. and over 185,000 in New York City (NYC). They have higher rates of overweight/obese range body mass index (BMI) than New Yorkers in general (77% vs 56%) and have high rates of elevated waist circumference, sedentary behavior, poor diets, and health care services underutilization. ROADmAP will test 4 evidence- and theory-based (Social Cognitive Theory \[SCT\]) behavior change intervention components. We will use MOST to identify which of the 4 components contribute most significantly and cost-effectively to weight loss among NYC drivers recruited at workplace health fairs (HFs) and virtually. Objectives are to apply MOST to design an optimized version of a scalable, lifestyle intervention for taxi/FHV drivers, and then to conduct a mixed methods multistakeholder process evaluation to facilitate widespread intervention implementation. | NO | Overweight|Overweight and Obesity|Overweight or Obesity|Obesity|Obese | BEHAVIORAL: Counseling|BEHAVIORAL: Text Messages|BEHAVIORAL: Phone calls|BEHAVIORAL: Self-monitoring tools | Difference in participant body weight from baseline to 12 months, Efficacy of intervention is achieved when participants have weight loss with a minimum threshold of 5% of overall body weight lost Intervention components include: * Initial in-person individual diet and physical activity (PA) counseling * Thrice-weekly diet/PA text messages * Weekly telephone support * Self-monitoring tools., 12-months post-intake|Estimate the cost and incremental cost-effectiveness of the obesity intervention components, Costs associated with each component include: 1) In-person counseling: personnel time, participant travel time, text messaging services; 3) Telephone support: personnel time; 4) Self-monitoring tools: food diaries and digital scales., Up to 6 months|Feasibility of weight loss intervention for participants measured by the ROAmAP Process Evaluation Questionnaire, The ROADmAP Process Evaluation Questionnaire will be administered to all participants to gather data on implementation potential. Questions are on a Likert scale and will collect intervention delivery facilitators and barriers, intervention sustainability facilitators and barriers post-study completion. Feasibility will be indicated by extreme Likert scores (Strongly Agree, Neutral, Strongly Disagree)., Up to 12 months | Memorial Sloan Kettering Cancer Center | ALL | ADULT, OLDER_ADULT | PHASE2 | 1067 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 15-088A(27) | 2022-12-22 | 2026-01-11 | 2026-08-11 | 2023-03-15 | 2024-10-15 | Mexican Consulate’s Ventanilla de Salud (VDS), New York, New York, 10016, United States | ||||||
| NCT05764330 | Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance | https://clinicaltrials.gov/study/NCT05764330 | This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction \[CER\]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researchers determine which weight loss strategies can reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight or obese. | NO | Prostate Carcinoma | PROCEDURE: Biospecimen Collection|OTHER: Dietary Intervention|OTHER: Dietary Intervention|BEHAVIORAL: Fasting | Change in Body weight, Weight will be measured using a body composition monitor., Up to 6 months|Changes in prostate cancer (PCa) progression, Will assess changes in PCa progression indicated by serum prostate specific antigen (PSA) doubling time, and biopsy tumor upgrading and/or upstaging if required clinically, between the timepoints prior and post to the intervention. The timing of the intervention and data collection visits will be scheduled to correspond with the PCa patient’s regular management check-up with their physician to allow their scheduled PSA test fall within at least a 6-month time window. For patients if prostate biopsy per clinical guidance is scheduled within 6 months after the intervention, the results from the biopsy post to the intervention as well as the nearest biopsy prior to the intervention will be requested. PSA test results (level and doubling time) and pathology reports on biopsies tissues (stage and grade) will be requested from the Biomedical Research Informatics Shared Resource for both baseline and follow-up visits and defined based on clinical criteria., Up to 6 months | Dietary intake, Will confirm the extent changes in body weight are due to changes in caloric intake. Dietary intake will be assessed by the interview administered Nutrition Data System for Research., Up to 6 months|Physical activity, Will be assessed using the Paffenbarger Physical Activity Questionnaire (PAQ). The PAQ provides an estimate of calories expended per week in overall leisure time activity and in activities of light (5 kcal/min), medium (7.5 kcal/min) and high (19 kcal/min) intensity., Up to 6 months|Change from baseline in Prostate Cancer related biomarkers, Correlation of weight loss and PCa biomarkers., Up to 6 months|Change in Urinary functions, urinary function changes will be tracked using a validated questionnaire, the International Prostate Symptom Score, Up to 6 months|Improvement of Quality of life, Self-reported outcomes routinely collected at each follow up clinic visit using validated questionnaire – UCLA PCI for quality of life.The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes., Up to 6 months|Change in Sexual functions, Sexual health inventory for men (SHIM). The total score is obtained by adding all five item scores, and can range from 5 to 25. Higher scores indicate higher level of sexual function and less erectile dysfunction., Up to 6 months | Roswell Park Cancer Institute | MALE | ADULT, OLDER_ADULT | NA | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | I-2980822|NCI-2023-01092|I-2980822 | 2024-04-24 | 2025-04-30 | 2025-04-30 | 2023-03-10 | 2024-06-03 | Roswell Park Cancer Institute, Buffalo, New York, 14263, United States | |||||
| NCT05761782 | Engaging Diverse and Underserved Communities in Cancer Awareness Training and Education | https://clinicaltrials.gov/study/NCT05761782 | EDUCATE | The University of California Davis, Comprehensive Cancer Center’s (UCDCCC) Office of Community Outreach and Engagement (OCOE) serves the 19 catchment counties which approximately consists of 5 million residents. Currently, the overall catchment population cancer screening rates fall below 80%. The aim of OCOE is to increase cancer education (prevention, screening, and vaccination) and training. Through education, and encouraging participation in routine screening for early detection, this can help increase cancer knowledge. In addition to cancer education, OCOE wants to educate community members regarding modifiable risk factors which include tobacco usage, being overweight/obese (physical inactivity/poor nutrition), and lack of immunizations. By increasing knowledge of cancer prevention, screening, and vaccination this will help community members become more aware of their cancer risk. | NO | Cancer Awareness and Prevention Education | BEHAVIORAL: Education | EDUCATE Pre-Presentation Participant Survey, Assessment of participant’s experience with cancer screening (Breast, Colorectal, Cervical, Lung or Prostate), 2 years|EDUCATE Post-Presentation Participant Survey and Evaluation, Assessment of participant’s likelihood to get a cancer screening (Breast, Colorectal, Cervical, Lung or Prostate), 2 years | University of California, Davis | ALL | ADULT, OLDER_ADULT | 1500 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1992110-1 | 2023-03-07 | 2025-03-07 | 2025-03-07 | 2023-03-09 | 2024-05-09 | University of California, Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States | ||||||
| NCT05756764 | Anti-obesity Pharmacotherapy and Inflammation | https://clinicaltrials.gov/study/NCT05756764 | This study evaluates the relationship between weight loss, circulating inflammatory markers and lipids from 24 patients before and after 6 months of pharmacotherapy as a standard of care for anti-obesity treatment | NO | Obesity | DRUG: Semaglutide|DRUG: Phentermine-Topiramate combination|DRUG: Phentermine|DRUG: Tirzepatide|DRUG: Topiramate|DRUG: Diethylpropion|DRUG: Naltrexone/Bupropion|DRUG: Liraglutide | weight loss, Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100), baseline and 24 weeks|MDSC in peripheral blood, Changes in number of MDSC in blood, baseline and 24 weeks|Levels of lipids in circulation, Changes in concentration (mg/dL) of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids, baseline and 24 weeks | Systemic inflammation measured by C-reactive protein levels, Changes in concentration (mg/L) of C-reactive protein in serum, baseline and 24 weeks|Systemic inflammation measured by adipokines levels in circulation, Changes in concentration (pg/mL) of interleukin 6 (IL-6), tumor-necrosis factor alpha (TNFa) and leptin in plasma, baseline and 24 weeks | Louisiana State University Health Sciences Center in New Orleans | Tulane University|Pennington Biomedical Research Center|Ochsner Health System | ALL | ADULT | 30 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | U24DK132740-5053|U24DK132740 | 2023-06-01 | 2025-06-30 | 2025-07-15 | 2023-03-06 | 2025-01-10 | LSU Clinical & Translational Research Center (CTRC – – LSUHSC-NO, New Orleans, Louisiana, 70112, United States|Ochsner Health System – Biospecimen, New Orleans, Louisiana, 70121, United States | |||||
| NCT05751993 | Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions | https://clinicaltrials.gov/study/NCT05751993 | The purpose of this pilot study is to conduct a 12-week pilot feasibility study testing usability of a reinforcement learning model (AdaptRL) in a weight loss intervention (ADAPT study). Building upon a previous just-in-time adaptive intervention (JITAI), a reinforcement learning model will generate decision rules unique to each individual that are intended to improve the tailoring of brief intervention messages (e.g., what behavior to message about, what behavior change techniques to include), improve achievement of daily behavioral goals, and improve weight loss in a sample of 20 adults. | NO | Overweight and Obesity|Overweight|Obesity | BEHAVIORAL: ADAPT | Feasibility (success of using the AdaptRL model), Feasibility as the success of using the AdaptRL model will be defined as the mean number of messages delivered per participant per day., up to 12 weeks|Study engagement, Study engagement will be defined as the percent of person-days in which participants accessed the web app., up to 12 weeks|Self-monitoring adherence, Self-monitoring adherence will be defined as the percent of person-days in which participants tracked at least one weight loss behavior (tracked calories, wore tracker, or self-weighed)., up to 12 weeks | Message satisfaction, Message satisfaction will be defined as the percent of delivered messages that were rated as “liked” (compared to dislike or not rated)., up to 12 weeks|Percent weight loss, Percent weight loss will be defined as weight change from baseline to 12 weeks calculated as a percent from baseline weight., 12 weeks|Moderate-to-vigorous physical activity, Moderate-to-vigorous physical activity will be defined as the change in self-reported weekly minutes of moderate-to-vigorous physical activity as measured by the Paffenbarger Activity Questionnaire from baseline to 12 weeks. The minimum is 0, no maximum. Higher numbers represent higher minutes of weekly moderate-to-vigorous physical activity., Baseline, 12 weeks|Dietary intake, Dietary intake will be defined as the change in average daily calorie intake as measured by the Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 12 weeks. Daily caloric intake is measured in kcals, with higher numbers indicating higher caloric intake., Baseline, 12 weeks|Adherence to calorie goal, Adherence to the calorie goal as the percent of person-days in which participants tracked their calories and stayed at or under their calorie goal will be measured by dietary self-monitoring data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Adherence to daily active minutes goal, Adherence to daily active minutes goal, the percent of person-days in which participants met their daily active minute goal, will be measured by activity tracker data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Adherence to daily self-weighing, Adherence to daily self-weighing, the percent of person-days in which participants self-weighed will be measured by Fitbit smart scales and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Adherence to daily self-weighing at the participant-day level, Adherence to daily self-weighing at the participant-day level, the percent of person-days weighed after the message randomization time until the end of the day will be measured by Fitbit smart scales and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Adherence to the daily self-weighing percent of person-days weighed, Adherence to the daily self-weighing percent of person-days weighed the day after the message randomization will be measured by Fitbit smart scales and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Achievement of active minutes goal, Achievement of active minutes goal, percent of person-days met active minutes goal after the message randomization time until the end of the day will be measured by activity tracker data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Achievement of active minutes goal percent of person-days, Achievement of active minutes goal percent of person-days met active minutes goal the day after the message randomization will be measured by activity tracker data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Achievement of calorie goal (at or under goal), Achievement of calorie goal (at or under goal) percent of person-days met calorie goal after the message randomization time until the end of the day will be measured by dietary self-monitoring data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks|Achievement of calorie goal (at or under goal) percent of person-days, Achievement of calorie goal (at or under goal) percent of person-days met calorie goal the day after the message randomization will be measured by dietary self-monitoring data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers., up to 12 weeks | UNC Lineberger Comprehensive Cancer Center | Duke University|RTI International|National Cancer Institute (NCI) | ALL | ADULT | NA | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | 22-0149|R21CA260092 | 2025-03 | 2026-07 | 2026-07 | 2023-03-02 | 2025-01-03 | University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States | ||||
| NCT05743465 | A Study to Evaluate Available Treatment Information of Ponatinib, Bosutinib, Imatinib, Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia | https://clinicaltrials.gov/study/NCT05743465 | The aims of this study are to learn out about treatment information (including amongst others treatment patterns, safety, development of a participant’s condition) ponatinib, bosutinib, imatinib, dasatinib and nilotinib using already available data. No new data will be collected from participants as part of this study and no study medicines will be provided in this study. | NO | Leukemia | OTHER: No Intervention | Number of Chronic Myeloid Leukemia (CML) Participants Categorized by Sociodemographic Variables at Diagnosis, Socio-demographic variables included will include categories of Age (in years), Sex (male and female), and US geographic region., Baseline (Day 1)|Number of CML Participants With Baseline Clinical Characteristics of Disease Severity, Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Quan-Charlson Comorbidity Index Score, The Charlson Comorbidity Index is a 19-item measure assessing comorbid conditions. The total possible score on the Charlson Comorbidity Index ranges from 0 to 37. If a condition is not present, the score for that condition is zero. The higher scores indicate greater comorbidity., Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Number of CML Participants With Baseline Clinical Characteristics of Comorbidities, Comorbidities will include anemia, diabetes, chronic pulmonary disease, congestive heart failure, hypertension, hypercholesterolemia, obesity, renal disease, moderate to severe liver disease, dementia, acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV)., Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Number of CML Participants With Baseline Clinical Characteristics of Concomitant Medication, Concomitant medication will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta blockers and statins) and antidiabetic drugs (metformin, sulfonylurea, thiazolidinedione, insulin and other antidiabetic drugs)., Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Number of Previous Treatments of Tyrosine Kinase Inhibitors (TKI) Drugs in Participants with CML, The number of TKI drugs used prior to the index date will be identified. The type of the 1\^st and 2\^nd TKI drugs will be identified., Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Duration Between Last TKI Run-out Date to the Index Date for Participants with CML, Time from the run-out date of the last prescription to the index date will be calculated. If the run-out date passed the index date, the gap will be counted as 0., Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Number of Participants with Bone Marrow Stem Cell Transplant, Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Clinical Characteristics Assessed by Number of Participants With Major Adverse Cardiac Events (MACE), Arterial Occlusive Events (AOEs), and Venous Thrombotic Events (VTEs), MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as pulmonary embolism (PE) and deep vein thrombosis (DVT)., Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1|Treatment Patterns Based on Duration of Index Treatment, Time from the first prescription of the index drug to the run-out date of the last prescription of the index drug, or 1 day before a new TKI prescription date, whichever occurred earlier., Up to approximately 5 years | Number of Participants With BCR-ABL and Bone Marrow Testing, BCR-ABL test will include participants tested for BCR-ABL mutation, such as T315I, and participants with a diagnostic marrow test., Up to approximately 5 years|Treatment Patterns Based on Mean Starting Daily Dose and Average Daily Dose in Participants with CML, The mean daily and average dose of the first prescription in the treatment line will be calculated. The starting and average daily dose will be classified as low, standard, and high for each drug cohort., Up to approximately 5 years|Number of CML Participants With Disease Severity as per Medstat Disease Staging Clinical Criteria Version 5.21, The disease severity will include categories of low, moderate, and high severity., Up to approximately 5 years|Treatment Patterns Based on Number of Participants With CML on Concomitant Medication, The concomitant medications will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs., Up to approximately 5 years|Number of Participants With CML With Treatment-Free Gap of the Index Treatment, Up to approximately 5 years|Disease Progression, Disease progression will be defined as having a change of disease severity from low severity in the baseline period to moderate or high severity in the current line, or from moderate severity in the baseline period to high severity in the current line OR a change in TKI type, addition of chemotherapy agents, or allogeneic stem cell transplant procedure OR mortality., Up to approximately 5 years|Percentage of CML Participants With Complications, Up to approximately 5 years|Overall Survival (OS), OS is defined as the interval between the first does of study treatment and death due to any cause, censored at the last contact date when the participant was alive., Up to approximately 5 years|Progression Free Survival (PFS), PFS is defined as the time in days from the index date to the first observed disease progression., Up to approximately 5 years|Number of Participants with Atleast one Adverse Event, Major Adverse Cardiac Event (MACE), Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs), AE is any untoward medical occurrence in participant administered medicinal investigational drug. Untoward medical occurrence does not necessarily have to have causal relationship with the treatment. MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as PE and DVT., Up to approximately 5 years | Takeda | ALL | ADULT, OLDER_ADULT | 1769 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | GOR-2017-102256 | 2021-10-06 | 2022-11-30 | 2022-11-30 | 2023-02-24 | 2023-03-02 | Takeda, Cambridge, Massachusetts, 02139, United States | ||||||
| NCT05737745 | FitEx for Endometrial Cancer Survivors: Initial Efficacy | https://clinicaltrials.gov/study/NCT05737745 | The goal of this clinical trial is to compare physical activity outcomes between endometrial cancer survivors randomized to 1 of 3 conditions: 1) usual care, 2) FitEx, 3) FitEx+yoga. Survivors randomized to FitEx groups will recruit \~3 support team members to complete the intervention with them. The main question\[s\] it aims to answer are: * Do FitEx groups undertake more physical activity than the usual care group? * Are there differences in quality of life, self-compassion, flourishing, self-efficacy, social support, habit formation, and fruit /vegetable consumption Participants will: * Wear a Fitbit * Complete surveys * Participate in 30 minute weekly virtual meetings (FitEx groups only) * Receive weekly newsletters (FitEx groups only) | NO | Endometrial Cancer|Obesity|Sedentary Behavior|Quality of Life|Survivorship | BEHAVIORAL: Self-monitoring|BEHAVIORAL: Group-dynamics|BEHAVIORAL: Weekly virtual sessions- Standard|BEHAVIORAL: Newsletters- Standard|BEHAVIORAL: Newsletters- Yoga|BEHAVIORAL: Weekly virtual sessions- Yoga | Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors, Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits (continuous tracking) between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control), Change from baseline to 8 weeks (post-intervention) | Quality of Life- Survivors, Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy – Endometrial (FACT-En)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life, Change from baseline to 8 weeks (post-intervention)|Quality of Life Maintenance- Survivors, Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy – Endometrial) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life, Change from 8 weeks to 6 months (post-intervention)|Servings of Daily Fruits and Vegetables Maintenance- Survivors, Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control)., Change from 8 weeks to 6 months (post-intervention)|Servings of Daily Fruits and Vegetables- Survivors, Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control)., Change from baseline to 8 weeks (post-intervention)|Flourishing- Survivors, Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: 0-10, with higher scores indication more satisfaction/flourishing, Change from baseline to 8 weeks (post-intervention)|Flourishing Maintenance- Survivors, Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: 0-10, with higher scores indication more satisfaction/flourishing, Change from 8 weeks to 6 months (post-intervention)|Yoga Self-Efficacy- Survivors, Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (12-108) higher scores indicate higher efficacy for yoga, Change from baseline to 8 weeks (post-intervention)|Yoga Self-Efficacy Maintenance- Survivors, Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (12-108) higher scores indicate higher efficacy for yoga, Change from 8 weeks to 6 months (post-intervention)|Social Support- Survivors, Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: higher numbers indicate more support, Change from baseline to 8 weeks (post-intervention)|Social Support Maintenance- Survivors, Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: higher numbers indicate more support, Change from 8 weeks to 6 months (post-intervention)|Self-compassion- Survivors, Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (1, 5) with higher scores indicating more self-compassion, Change from baseline to 8 weeks (post-intervention)|Self-compassion Maintenance- Survivors, Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: (1, 5) with higher scores indicating more self-compassion, Change from 8 weeks to 6 months (post-intervention)|Habit Formation- Survivors, Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring (1,7), higher scores indicate more automaticity/habit formation, Change from baseline to 8 weeks (post-intervention)|Habit Formation Maintenance- Survivors, Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring (1,7), higher scores indicate more automaticity/habit formation, Change from 8 weeks to 6 months (post-intervention)|Physical activity level (active or insufficiently active) Maintenance- Survivors, Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control)., Change from 8 weeks to 6 months (post-intervention)|Physical activity level (active or insufficiently active)- Survivors, Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control). Scoring: responses are categorical, Change from baseline to 8 weeks (post-intervention)|Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance, Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control), Change from 8 weeks to 6 months (post-intervention) | Moderate to Vigorous Physical Activity- Support team members, Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga), Change from baseline to 8 weeks (post-intervention)|Moderate to Vigorous Physical Activity Maintenance- Support team members, Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga), Change from 8 weeks to 6 months (post-intervention)|Flourishing- Support team members, Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing, Change from baseline to 8 weeks (post-intervention)|Flourishing Maintenance- Support team members, Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing, Change from 8 weeks to 6 months (post-intervention)|Yoga Self-Efficacy- Support team members, Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga, Change from baseline to 8 weeks (post-intervention)|Yoga Self-Efficacy Maintenance- Support team members, Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga, Change from 8 weeks to 6 months (post-intervention)|Social Support- Support team members, Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support, Change from baseline to 8 weeks (post-intervention)|Social Support Maintenance- Support team members, Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support, Change from 8 weeks to 6 months (post-intervention)|Self-compassion- Support team members, Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion, Change from baseline to 8 weeks (post-intervention)|Self-compassion Maintenance- Support team members, Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion, Change from 8 weeks to 6 months (post-intervention)|Habit Formation- Support team members, Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation, Change from baseline to 8 weeks (post-intervention)|Physical activity level (active or insufficiently active)- Support team members, Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga), Change from baseline to 8 weeks (post-intervention)|Physical activity level (active or insufficiently active) Maintenance- Support team members, Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga), Change from 8 weeks to 6 months (post-intervention)|Habit Formation Maintenance- Support team members, Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation, Change from 8 weeks to 6 months (post-intervention)|Servings of Daily Fruits and Vegetables- Support team members, Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga), Change from baseline to 8 weeks (post-intervention)|Servings of Daily Fruits and Vegetables Maintenance- Support team members, Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga), Change from 8 weeks to 6 months (post-intervention) | Carilion Clinic | National Institutes of Health (NIH)|National Center for Advancing Translational Sciences (NCATS)|Virginia Polytechnic Institute and State University | ALL | ADULT, OLDER_ADULT | NA | 150 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IRB-22-1727|UL1TR003015 | 2023-02-01 | 2023-11-30 | 2024-06 | 2023-02-21 | 2024-03-12 | Carilion Clinic, Roanoke, Virginia, 24016, United States | |||
| NCT05732623 | Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer | https://clinicaltrials.gov/study/NCT05732623 | DEMETRA | An increase in early-onset colorectal cancers (eoCRC), defined as a CRC before 50 years, is confirmed globally. CRC pathogenesis has been associated with several risk factors (family history, germline pathogenic variants, obesity, alcohol, physical activity, red meat, and a Western diet). Design: an international, multicenter, retrospective case-control study of prospectively enrolled patients; low-risk intervention study as it will perform a fecal occult blood test Endpoint: predictive power of a semi-quantitative food frequency questionnaire (SQFFQ) developed for eoCRC. Cases: Patients with a recent diagnosis of eoCRC (within 2 years from enrollment). Controls: matched by age (matching range ± 5 years) and sex. Healthy volunteers will be mainly enrolled among workers within the participating hospital center. The enrolled healthy volunteers will perform a fecal occult blood test. Variables of interest: age, sex, ethnicity, BMI at the time of eoCRC diagnosis and at 18 years old, country, tobacco smoking at the time of eoCRC diagnosis and at 18 years old, sitting time, TV-viewing time, moderate-to-vigorous physical activity (MVPA), waist circumference (cm), home blood pressure levels (mmHg), fasting blood glucose (mg/dl), regular consumption of aspirin/NSAID, calcium and folate supplements, oral contraceptive agents, post-menopausal hormones and years of consumptions, if the filled questionnaire reflects diet for the last 5-10 years before. Cases only: date of eoCRC diagnosis, symptoms at diagnosis, eoCRC localization, eoCRC stage, histological diagnosis, type of surgery, and date (if performed), chemotherapy and radiotherapy (if performed), vital status and duration of follow-up, family history of CRC and other cancers (uterus, ovary, stomach, small intestine, urinary tract/bladder/kidney, bile ducts, brain, pancreas, skin tumors), type of germline pathogenetic variant (if performed). Before the case-control study, three non-consecutive 24-hour Dietary Recalls (24hDRs) will validate the SQFFQ. The SQFFQ will be administered to the validation study group during three non-consecutive calls, including one non-weekday (30-minute 24-h-recall computer-aided personal interview). Primary Objective To measure the relative risk of specific dietary and lifestyle factors (smoking habit, alcohol intake, physical activity) for early-onset colorectal cancer in countries where eoCRC incidence is increasing versus stable/decreasing | NO | Colorectal Cancer|Early Onset Colorectal Cancer|Diet Habit|Risk Reduction | BEHAVIORAL: Semi Quantitative Food Frequency Questionnaire (SQFFQ) | Diet and the risk of eoCRC, To quantify the relative risk of early-onset colorectal cancer for specific dietary and lifestyle risk factors (including the risk for eoCRC for * tobacco smoking at the time of eoCRC diagnosis and at 18 years old * alcohol consumption * physical activity * sex * ethnicity * BMI at the time of eoCRC diagnosis and at 18 years old * country of origin * Daily sitting time * Daily TV-viewing time * Daily moderate-to-vigorous physical activity (MVPA) * waist circumference (cm) * home blood pressure levels (mmHg) * Fasting blood glucose (mg/dl) * Regular consumption of aspirin/NSAID * Regular consumption of calcium and folate supplements * Regular use of oral contraceptive agents and years of consumptions * Regular use of post-menopausal hormones and years of consumptions Results will be stratified by countries where the incidence of eoCRC is increasing versus stable/decreasing, 10 years | San Raffaele University | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy|Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy|Centro di Riferimento Oncologico di Aviano, Aviano, Italy|Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Bari, Italy|Gastroenterology Unit, University Hospital of Padova, Padova, Italy|Clinical Gastroenterology Unit, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy|IRCCS Arcispedale S. Maria Nuova – Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy|Azienda Ospedaliera San Gerardo di Monza, Monza, Italy|Azienda ULSS5 Polesana, Rovigo, Italy|Istituto Tumori Regina Elena – IRCCS IFO, Roma, Italy|University Hospital of Padova, Padova, Italy|IRCCS De Bellis, Castellana Grotte, Italy|University Hospital HELIOS Klinikum Wuppertal, Center for Hereditary Tumors, University of Witten-Herdecke, Wuppertal, Germany|Hospital of the University of Munich (LMU), Campus Großhadern, Munich, Germany|Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain|Helsinki University Hospital, Helsinki, Finland|Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital, Oslo, Norway|Department of Medicine University of Chicago Medicine, Illinois, USA|University of Colorado Hospital, CO, USA|University of Michigan Ann Arbor, Michigan, USA|Columbia University Irving Medical Center, New York, NY|The James Comprehensive Cancer Center, Columbus, OH, USA|Ohio State University|The Cleveland Clinic|Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia | ALL | ADULT | 2300 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | DEMETRA2020.0001 | 2022-12-05 | 2030-01 | 2035-01 | 2023-02-17 | 2024-11-29 | Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital, Denver, Colorado, 80045, United States|Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine, Chicago, Illinois, 60637, United States|Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland|Department of General, Visceral and Transplant Surgery, Hospital of the University of Munich (LMU), Munich, Germany|Gabriela Moslein, Wuppertal, Germany|Prof Giulia Martina Cavestro, MD PhD, Milan, Lombardy, 20132, Italy|Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital, Oslo, Norway|Department of Gastroenterology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain | |||||
| NCT05721976 | With Love, Grandma (“Con Cariño, Abuelita”) Pilot Study | https://clinicaltrials.gov/study/NCT05721976 | The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters. | NO | Cancer, Breast|Cancer, Uterus|Cancer, Ovary|Obesity|Activity, Motor|Diet, Healthy | BEHAVIORAL: With Love, Grandma (“Con Cariño, Abuelita”) | Percent of survivor-daughter dyads retained at post-intervention (feasibility), Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures, Up to 3 months|Percent of modules completed by survivor-daughter dyads (acceptability), Calculated as number of modules completed (of 8 total modules) by survivors and daughters, Up to 3 months | Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ), Participants will self-report walking and sitting time (hours and minutes per day) using three items from the IPAQ. Mean difference in total time spent walking and sitting will be calculated from these items. The result is not reported in scales. Higher scores indicate higher time spent walking and sitting in the last 7 days., Baseline, Up to 3 months|Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire, Responses range from 0 – greater than 24, with 0 indicating no activity and a higher score indicating more activities (no maximum score)., Baseline, Up to 3 months|Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener, Participants will self-report dietary intake using the NCI All-Day Screener for fruit and vegetables and the percentage of energy from fat and fiber. Mean difference in cup equivalents of fruits and vegetables will be calculated using a scoring algorithm developed by the National Cancer Institute, Baseline, Up to 3 months | University of Miami Sylvester Comprehensive Cancer Center | The V Foundation for Cancer Research | FEMALE | ADULT, OLDER_ADULT | NA | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 20201421|2018-024 | 2023-02-22 | 2025-05-31 | 2025-05-31 | 2023-02-10 | 2024-05-21 | University of Miami, Miami, Florida, 33136, United States | ||||
| NCT05687604 | Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors | https://clinicaltrials.gov/study/NCT05687604 | STELLAR | The goal of this clinical trial is to improve cancer patient’s health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients who are cancer survivors. The main question\[s\] STELLAR aims to answer are: * How best to combine three behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment. * Evaluate the reach of the program. We will look at the number, proportion, and representativeness of participants in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity. * Evaluate the effects of the STELLAR program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, and communication. Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and 12 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the Facilitated group will complete 16 telehealth sessions with study staff to discuss progress towards their study goals. Researchers will compare the Facilitated group to the Self Guided group to see if the Facilitated intervention group is able to reach more participants that enhances care only. | NO | Obesity|Smoking Cessation|Physical Inactivity | BEHAVIORAL: multiple behavior change therapy | Reach/Access, A) We will evaluate the Reach of the risk behavior screening system by assessing the number of cancer survivors exposed to EHR screening and the proportion and representativeness of those who enroll in the study and are randomized. B) We will also evaluate the Reach of the STELLAR intervention by assessing the proportion and representativeness (in terms of disease characteristics, socioeconomic status, telehealth access, technology literacy, race/ethnicity, and insurance status) of those randomized to active intervention who attend at least one treatment session., Baseline | Smoking, Assessed using Timeline Followback interview, participants who report any smoking, even a puff, in the 7 days prior to the visit will be classified as a current smoker, baseline, 3, 6, 9, and 12 months|Body Weight, patient reported body weight in lbs., baseline, 3, 6, 9, and 12 months|Self-Reported Weekly Amount (in days and minutes) of Moderate Intensity Physical Activity, Patient-reported weekly amount of moderate intensity physical activity in days and minutes will be assessed at each time point. Participants will be asked in the last 7 days, how many days they engaged in moderate intensity activity. Then on the days they were active, about how many minutes they were active (Less than 30 Minutes; 30 minutes to less than 1 hour; 1 hour to less than 1.5 hours; 1.5 hours to less than 2 hours; 2 hours to less than 2.5 hours; Over 2.5 hours), baseline, 3, 6, 9 and 12 months|Godin Leisure Time Exercise Questionnaire, It is a valid and reliable measure of PA participation. Participants will indicate frequency of participation in strenuous, moderate, and mild exercise over the past 7 days and average time spent in each activity, baseline, 3, 6, 9 and 12 months|Total Healthcare Cost and Amount of Patient Care Utilization, The following data will be extracted from the medical record: unplanned, all-cause hospital admissions; potentially avoidable, all-cause emergency department use; 7-day hospital readmissions; and use of triage clinic. Since not all patients receive all their care within the NMHC system, they will also be asked to self-report these data., baseline, 3, 6, 9, and 12 months|Rating of Care Quality as Measured by the Consumer Assessment of Healthcare Providers & Systems Cancer Care Survey), Relevant subscales from AHRQ’s Consumer Assessment of Healthcare Providers \& Systems (CAHPS) Cancer Care Survey will be used: The specific subscales include: 1. How Well the Cancer Care Team Communicates with Patients. This subscale asks the participant about provider communication on a 4-point scale from “never” to “always” in terms of how well the provider explained things in an easy-to-understand way, listened carefully to patient, showed respect to patient, and spent enough time with patient. 2. Availability of Interpreters. This subscale asks yes/no if the patient ever needed an interpreter for visits, and if yes, how often they received one on a 4-point scale from “never” to “always” 3. Overall Rating of Cancer Team and Cancer Care. This is a single question asking patients to rate their provider on a 1-10 scale with 1 being the worst provider possible and 10 being the best provider possible, baseline, 3, 6, 9, and 12 months|Rating of Patient-Provider Communication and Shared Decision-Making as Measured by The Interpersonal Process of Care (IPC32), The Interpersonal Process of Care (IPC32), will assess the patient’s thoughts on physician-patient interpersonal interactions. The IPC evaluates: 1. The patients’ assessment of their physician’s communication quality by asking how often physicians perform certain activities (e.g. eliciting concerns, explanations) on a scale from 1 = never to 5 = always. 2. The patient’s assessment of how often their provider includes them in decisions about their own health (shared-decision making) on a scale from 1 = never to 5 = always. 3. The patient’s assessment of their provider’s interpersonal style based on how often the provider displayed certain behaviors (e.g. compassion, respect) on a scale from 1 = never to 5 = always., baseline, 3, 6, 9, and 12 months|Rating of Symptoms and Functioning as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile, The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile assesses fatigue, depression, anxiety, ability to participate in social roles and activities, sleep disturbance, physical function, and pain interference/intensity on a 1-5 rating scale with 1 being the worst rating and 5 being the best., baseline, 3, 6, 9, and 12 months|Rating of Quality of Life Using the Health Related Quality of Life Short Form (HRQOL SF-12), Quality of Life will be assessed using the Health Related Quality of Life Short Form (HRQOL SF-12). The tool measures two independent dimensions of HRQOL: physical (physical functioning, role functioning, bodily pain, and general health) and emotional (vitality, social functioning, role functioning and mental health) as well as an aggregate score. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning., baseline, 3, 6, 9, and 12 months | Northwestern University | ALL | ADULT, OLDER_ADULT | NA | 3000 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | P50CA271353 | 2024-09-24 | 2026-07 | 2027-07 | 2023-01-18 | 2024-11-25 | Northwestern University-Feinberg School of Medicine, Chicago, Illinois, 60611, United States | ||||
| NCT05687188 | Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations | https://clinicaltrials.gov/study/NCT05687188 | This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations. | NO | Pancreatic Cancer | OTHER: Blood Sample Collection|OTHER: Tissue Sample Collection|OTHER: Data Collection|OTHER: Medical Image Collection | Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity, Investigators will compare gene prevalence, type and expression of genetic mutations and radiomic features in African American participants vs Non-Hispanic White participants, at 36 months|Compare biological properties of Adipose Tissue dysfunction, Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants., at 36 months|Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response, Investigators will compare the biological interactions of Adipose Tissue and PDAC tumor growth between African American vs. Non-Hispanic White participants to develop new and/or targeted drug combinations., at 36 months | H. Lee Moffitt Cancer Center and Research Institute | United States Department of Defense | ALL | ADULT, OLDER_ADULT | 125 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | MCC-21962|PA210192, W81XWH2211021 | 2023-02-22 | 2026-12 | 2026-12 | 2023-01-18 | 2024-10-01 | Moffitt Cancer Center, Tampa, Florida, 33612, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States | ||||||
| NCT05682742 | Clinical Investigation of the da Vinci Surgical System | https://clinicaltrials.gov/study/NCT05682742 | This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures. | NO | Thymoma|Mediastinal Tumor|Gynecologic Disease|Gynecologic Cancer|Pelvic Organ Prolapse|Prostate Disease|Prostate Cancer|Inguinal Hernia|Ventral Hernia|Obesity, Morbid | DEVICE: Robotic-assisted Surgery | Incidence of conversion, Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open., Intra-operative | Incidence of adverse events, Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period., 30-day follow-up | Intuitive Surgical | ALL | ADULT, OLDER_ADULT | NA | 53 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | 1097341C | 2022-12-12 | 2023-05-24 | 2028-08-31 | 2023-01-12 | 2024-06-03 | Orlando Health, Inc., Orlando, Florida, 32806, United States|Sparrow Health System, Lansing, Michigan, 48912, United States|The Valley Hospital, Ridgewood, New Jersey, 07450, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States | |||||
| NCT05629858 | Time Restricted Eating for the Treatment of PCOS | https://clinicaltrials.gov/study/NCT05629858 | Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called “time restricted eating” (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS. Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity. Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions). | NO | Polycystic Ovary Syndrome|Obesity | OTHER: 6-h Time restricted eating (TRE)|OTHER: Calorie restriction (CR)|OTHER: Control | Change in body weight, Measured by an electronic scale, Measured at month 0 and 6 | Change in fat mass, lean mass, visceral fat mass, Measured by DXA, Measured at month 0 and 6|Change in bone mineral density, Measured by DXA, Measured at month 0 and 6|Change in waist circumference, Measured by a measuring tape, Measured at month 0 and 6|Change in Insulin sensitivity, Measured by oral glucose tolerance test (OGTT), Measured at month 0 and 6|Change in Fasting glucose, Measured by a commercial lab (Medstar, IL), Measured at month 0 and 6|Change in Fasting insulin, Measured by a commercial lab (Medstar, IL), Measured at month 0 and 6|Change in HbA1c, Measured by a commercial lab (Medstar, IL), Measured at month 0 and 6|Change in Blood pressure, Measured by a blood pressure cuff, Measured at month 0 and 6|Change in heart rate, Measured by a blood pressure cuff, Measured at month 0 and 6|Change in Plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides), Measured by a commercial lab (Medstar, IL), Measured at month 0 and 6|Change in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP), Measured by ELISA, Measured at month 0 and 6|Change in oxidative stress (8-isoprostane), Measured by ELISA, Measured at month 0 and 6|Change in reproductive hormones (testosterone, DHEA, SHBG, androstenedione), Measured by ELISA, Measured at month 0 and 6|Change in energy and nutrient intake, Measured by 7-day food record, Measured at month 0 and 6|Change in physical activity (steps/d), Measured by pedometer, Measured at month 0 and 6|Change in mood, Measured by 36-Item Short Form Survey (SF-36), total score 0-100. Higher scores mean worse outcome., Measured at month 0 and 6|Change in appetite, Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite., Measured at month 0 and 6 | University of Illinois at Chicago | FEMALE | ADULT | NA | 300 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 2022-1500 | 2023-01-15 | 2028-01-01 | 2028-01-01 | 2022-11-29 | 2024-07-03 | University of Illinois Chicago, Chicago, Illinois, 60612, United States | |||||
| NCT05602194 | Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma | https://clinicaltrials.gov/study/NCT05602194 | This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients. | NO | B Acute Lymphoblastic Leukemia|B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1|B Acute Lymphoblastic Leukemia, BCR-ABL1-Like|Lymphoblastic Lymphoma|Mixed Phenotype Acute Leukemia|T Acute Lymphoblastic Leukemia | PROCEDURE: Biospecimen Collection|DRUG: Calaspargase Pegol|DIETARY_SUPPLEMENT: Levocarnitine|DRUG: Pegaspargase|OTHER: Quality-of-Life Assessment | Incidence of conjugated hyperbilirubinemia >3 mg/dL during induction therapy, For patients assigned to arms A and B, the investigators will separately estimate the proportion of patients who experience conjugated hyperbilirubinemia \> 3mg/dL during induction chemotherapy by arm along with corresponding 95% confidence intervals., During induction therapy (up-to 35-days after initiating induction chemotherapy) | Incidence of grade >= 3 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations during induction therapy, For patients assigned to arms A and B, the investigators will separately estimate the proportion of patients who experience grade \>= 3 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations during induction chemotherapy by arm along with corresponding 95% confidence intervals., During induction therapy (up-to 35-days after initiating induction chemotherapy)|Incidence of minimal residual disease (MRD) positivity (MRD >= 0.01%), For patients assigned to arms A and B, the proportion having MRD positivity at the end of induction chemotherapy will be estimated separately by arm along with corresponding 95% confidence intervals. For patients assigned to arms A and B, the proportion having MRD positivity at the end of consolidation chemotherapy will be estimated separately by arm along with corresponding 95% confidence intervals (only patients with end of consolidation MRD evaluated and who did not get placed on the rescue arm C will be included)., At end of induction chemotherapy (up-to 35-days after initiating induction chemotherapy), and at end of consolidation chemotherapy (up-to day 56 days after initiating induction chemotherapy) | Incidence of CTCAE grade >= 4 adverse events during induction chemotherapy, For patients assigned to arms A and B, the proportion experiencing CTCAE grade \>=4 adverse events by the end of induction chemotherapy will be estimated along with 95% confidence intervals., Up to 35 days (induction phase)|Incidence of daunorubicin, vincristine, and/or asparaginase chemotherapy dose reductions during induction chemotherapy, For patients assigned to arms A and B, the proportion receiving a dose reduction during induction chemotherapy relative to planned doses at the beginning of induction chemotherapy for daunorubicin, vincristine, and/or asparaginase will be estimated along with 95% confidence intervals, Up to 35 days (induction phase)|Percentage of planned dose given for daunorubicin, vincristine, and/or asparaginase during induction chemotherapy, For patients assigned to arms A and b, the median percent planned dose given during induction will also be calculated as well as 95% confidence intervals., Up to 35 days (induction phase)|Peak levels during induction of conjugated bilirubin, For patients assigned to arms A and B, the investigators will calculate median peak conjugated bilirubin as well as corresponding 95% confidence intervals., Up to 35 days (induction phase)|Peak levels during induction of total bilirubin, For patients assigned to arms A and B, the investigators will calculate median peak ALT as well as corresponding 95% confidence intervals., Up to 35 days (induction phase)|Peak levels of AST during induction chemotherapy, For patients assigned to arms A and B, the investigators will calculate median peak ALT as well as corresponding 95% confidence intervals., Up to 35 days (induction phase)|Peak levels of ALT during induction chemotherapy, For patients assigned to arms A and B, the investigators will calculate median peak ALT as well as corresponding 95% confidence intervals., Up to 35 days (induction phase)|Days of conjugated hyperbilirubinemia (> 3 mg/dL) to <=3 mg/dL during induction, For patients assigned to arms A, B, and C, the investigators will calculate the median days from onset of conjugated hyperbilirubinemia as well as 95% confidence intervals., Up to 35 days (induction phase)|Severity of patient-reported chemotherapy induced peripheral neuropathy (CIPN) as measured by the 11-question Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) survey, The 11-question FACT/GOG-NTX survey will be used to assess patient reported CIPN, where a higher score indicates more severe CIPN. For patients on arms A and B, a median and corresponding 95% confidence interval will be estimated and reported., Up to 35 days (induction phase)|Event free survival (EFS), For EFS analysis, 3-year EFS probabilities and corresponding 95% CI will be estimated for Arms A and B, separately, using the Kaplan Meier method. A log-rank test will be used to compare EFS between Arm A versus Arm B (Arm C patients will not contribute to this analysis after they start levocarnitine rescue). Additional EFS analyses comparing Arms A versus B will also be performed using Cox regression models adjusted for "levocarnitine rescue" (i.e., Arm C patients/time) as a time-varying covariate. Hazard ratio and the corresponding 95%CI will be reported for each arm., The time from randomization to first event (relapse, second malignant neoplasm, remission or death) or date of last contact for those who are disease-free, assessed up to 3 years|Overall survival (OS), For OS analysis, 3-year OS probabilities and corresponding 95% CI will be estimated for Arms A and B, separately, using the Kaplan Meier method., Time from study entry to death or date of last contact for those alive at last contact, assessed up to 3 years|Asparaginase activity, Spearman's correlation coefficients and corresponding 95% confidence intervals will be reported comparing asparaginase activity to age and BMI., Days 8, 15, and 22|Association of body-mass-index (BMI) percentile (or absolute BMI for young adults) with asparaginase activity and asparaginase-associated hepatotoxicity during induction therapy, The association of BMI percentile with asparaginase activity will be assessed using Spearman's correlation. Logistic regression will be used to separately assess the relationship of BMI (considered as a continuous variable and an ordinal variable) and asparaginase activity with hepatotoxicity (conjugated hyperbilirubinemia, ALT) dichotomized as conjugated hyperbilirubinemia \>3 versus =\< 3 mg/dl and CTCAE grade \>= 3 versus \< 3 AST or ALT, respectively. Analyses will be performed separately for asparaginase activity measured on Days \~8, 15, and 22 and for Arms A and B., Days 8, 15, and 22|Adherence to oral levocarnitine during induction chemotherapy measured by percentage of pills returned relative to those prescribed, Descriptive statistics (mean (sd) or median (range) as appropriate) will be used to summarize adherence to levocarnitine tablets during induction in AYA patients randomized to the intervention Arm A as assessed by self-report (% doses compliant) and pill-counts (% pills returned). The percentage of doses compliant will be calculated as: the number of reported missed doses / total prescribed doses for the entire induction period. And the percentage of pills returned will be calculated as the number of pills returned / (number of pills dispensed - number of pills prescribed not taken \[i.e., for prescribed dose reductions for toxicity for the entire induction period\])., Up to 35 days (induction phase)|Adherence to oral levocarnitine measured by percentage dose compliance (% doses reported taken relative to prescribed), The investigators will report the median percentage dose compliance across patients assigned to arm A as well as a 95% confidence interval., Up to 35 days (induction phase)|Mean plasma levels of carnitine, The Investigators will calculate mean plasma levels of carnitine at baseline and at steady state for patients in arms A and B who do and do not experience conjugated hyperbilirubinemia \>3 mg/dL and will calculate corresponding 95% confidence intervals., Up to 3 years|Impact inherited genetic variation on hepatoxicity and levocarnitine efficacy, This aim will use specimens banked for future research to describe the association of candidate genes (PNPLA3, SOD2, GST family, other) with conjugated hyperbilirubinemia \>3 mg/dL and CTCAE Grade ≥3 AST or ALT elevations between treatment arms. Analyses will include ethnic and racial differences, with ancestry determined by self-report and complementary admixture mapping. The association of observed genetic differences with oxidant stress markers (e.g., protein oxidation, lipid peroxidation, total oxidant capacity) pre- and post-asparaginase will be assessed. In general, a multivariable logistic regression model will be used to examine the association between the occurrence of the primary endpoint and the genetic variant of interest, inclusive of covariates: age, obesity, and treatment versus control arm (1:1)., Up to 3 years | Children’s Oncology Group | ALL | CHILD, ADULT | PHASE3 | 440 | NETWORK | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | ACCL1931|NCI-2022-08058|ACCL1931|COG-ACCL1931|ACCL1931|U24CA196173|UG1CA189955 | 2023-08-24 | 2028-06-30 | 2028-12-30 | 2022-11-02 | 2025-01-13 | Children’s Hospital of Alabama, Birmingham, Alabama, 35233, United States|Kingman Regional Medical Center, Kingman, Arizona, 86401, United States|Banner University Medical Center – Tucson, Tucson, Arizona, 85719, United States|Arkansas Children’s Hospital, Little Rock, Arkansas, 72202-3591, United States|Kaiser Permanente-Anaheim, Anaheim, California, 92806, United States|PCR Oncology, Arroyo Grande, California, 93420, United States|Kaiser Permanente-Bellflower, Bellflower, California, 90706, United States|Kaiser Permanente Downey Medical Center, Downey, California, 90242, United States|City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States|Kaiser Permanente-Fontana, Fontana, California, 92335, United States|Miller Children’s and Women’s Hospital Long Beach, Long Beach, California, 90806, United States|Children’s Hospital Los Angeles, Los Angeles, California, 90027, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Valley Children’s Hospital, Madera, California, 93636, United States|UCSF Benioff Children’s Hospital Oakland, Oakland, California, 94609, United States|Stanford Cancer Institute Palo Alto, Palo Alto, California, 94304, United States|Kaiser Permanente-San Diego Mission, San Diego, California, 92108, United States|Kaiser Permanente-San Diego Zion, San Diego, California, 92120, United States|UCSF Medical Center-Mission Bay, San Francisco, California, 94158, United States|Children’s Hospital Colorado, Aurora, Colorado, 80045, United States|Alfred I duPont Hospital for Children, Wilmington, Delaware, 19803, United States|Golisano Children’s Hospital of Southwest Florida, Fort Myers, Florida, 33908, United States|University of Florida Health Science Center – Gainesville, Gainesville, Florida, 32610, United States|Memorial Regional Hospital/Joe DiMaggio Children’s Hospital, Hollywood, Florida, 33021, United States|Nemours Children’s Clinic-Jacksonville, Jacksonville, Florida, 32207, United States|Nicklaus Children’s Hospital, Miami, Florida, 33155, United States|Miami Cancer Institute, Miami, Florida, 33176, United States|AdventHealth Orlando, Orlando, Florida, 32803, United States|Nemours Children’s Hospital, Orlando, Florida, 32827, United States|Sacred Heart Hospital, Pensacola, Florida, 32504, United States|Tampa General Hospital, Tampa, Florida, 33606, United States|Saint Joseph’s Hospital/Children’s Hospital-Tampa, Tampa, Florida, 33607, United States|Children’s Healthcare of Atlanta – Arthur M Blank Hospital, Atlanta, Georgia, 30329, United States|Memorial Health University Medical Center, Savannah, Georgia, 31404, United States|Northwestern University, Chicago, Illinois, 60611, United States|University of Illinois, Chicago, Illinois, 60612, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States|Advocate Children’s Hospital-Oak Lawn, Oak Lawn, Illinois, 60453, United States|Advocate Children’s Hospital-Park Ridge, Park Ridge, Illinois, 60068, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States|Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, 46260, United States|Blank Children’s Hospital, Des Moines, Iowa, 50309, United States|University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242, United States|University of Kansas Cancer Center, Kansas City, Kansas, 66160, United States|University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, 66205, United States|University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536, United States|Norton Children’s Hospital, Louisville, Kentucky, 40202, United States|Ochsner Medical Center Jefferson, New Orleans, Louisiana, 70121, United States|Maine Children’s Cancer Program, Scarborough, Maine, 04074, United States|Sinai Hospital of Baltimore, Baltimore, Maryland, 21215, United States|Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, 21287, United States|C S Mott Children’s Hospital, Ann Arbor, Michigan, 48109, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States|Bronson Battle Creek, Battle Creek, Michigan, 49017, United States|Children’s Hospital of Michigan, Detroit, Michigan, 48201, United States|Michigan State University Clinical Center, East Lansing, Michigan, 48824, United States|Corewell Health Grand Rapids Hospitals – Butterworth Hospital, Grand Rapids, Michigan, 49503, United States|Corewell Health Grand Rapids Hospitals – Helen DeVos Children’s Hospital, Grand Rapids, Michigan, 49503, United States|Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, 49503, United States|Bronson Methodist Hospital, Kalamazoo, Michigan, 49007, United States|West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States|Ascension Borgess Cancer Center, Kalamazoo, Michigan, 49009, United States|Ascension Borgess Hospital, Kalamazoo, Michigan, 49048, United States|Trinity Health Muskegon Hospital, Muskegon, Michigan, 49444, United States|Corewell Health Lakeland Hospitals – Niles Hospital, Niles, Michigan, 49120, United States|Cancer and Hematology Centers of Western Michigan – Norton Shores, Norton Shores, Michigan, 49444, United States|Corewell Health Reed City Hospital, Reed City, Michigan, 49677, United States|Corewell Health Lakeland Hospitals – Marie Yeager Cancer Center, Saint Joseph, Michigan, 49085, United States|Corewell Health Lakeland Hospitals – Saint Joseph Hospital, Saint Joseph, Michigan, 49085, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|University of Michigan Health – West, Wyoming, Michigan, 49519, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Children’s Mercy Hospitals and Clinics, Kansas City, Missouri, 64108, United States|Mercy Hospital Saint Louis, Saint Louis, Missouri, 63141, United States|Children’s Hospital and Medical Center of Omaha, Omaha, Nebraska, 68114, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Carson Tahoe Regional Medical Center, Carson City, Nevada, 89703, United States|Comprehensive Cancer Centers of Nevada – Henderson, Henderson, Nevada, 89052, United States|Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson, Nevada, 89052, United States|OptumCare Cancer Care at Seven Hills, Henderson, Nevada, 89052, United States|Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, 89074, United States|GenesisCare USA – Henderson, Henderson, Nevada, 89074, United States|Las Vegas Urology – Green Valley, Henderson, Nevada, 89074, United States|Las Vegas Urology – Pebble, Henderson, Nevada, 89074, United States|Urology Specialists of Nevada – Green Valley, Henderson, Nevada, 89074, United States|Las Vegas Urology – Pecos, Las Vegas, Nevada, 89074, United States|OptumCare Cancer Care at Charleston, Las Vegas, Nevada, 89102, United States|University Medical Center of Southern Nevada, Las Vegas, Nevada, 89102, United States|Hope Cancer Care of Nevada, Las Vegas, Nevada, 89103, United States|Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, 89106, United States|Urology Specialists of Nevada – Central, Las Vegas, Nevada, 89106, United States|GenesisCare USA – Las Vegas, Las Vegas, Nevada, 89109, United States|Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109, United States|Las Vegas Urology – Sunset, Las Vegas, Nevada, 89113, United States|Urology Specialists of Nevada – Southwest, Las Vegas, Nevada, 89113, United States|Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, 89119, United States|Ann M Wierman MD LTD, Las Vegas, Nevada, 89128, United States|Comprehensive Cancer Centers of Nevada – Northwest, Las Vegas, Nevada, 89128, United States|GenesisCare USA – Vegas Tenaya, Las Vegas, Nevada, 89128, United States|Las Vegas Urology – Cathedral Rock, Las Vegas, Nevada, 89128, United States|Las Vegas Urology – Smoke Ranch, Las Vegas, Nevada, 89128, United States|OptumCare Cancer Care at MountainView, Las Vegas, Nevada, 89128, United States|Urology Specialists of Nevada – Northwest, Las Vegas, Nevada, 89128, United States|Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, 89135, United States|Comprehensive Cancer Centers of Nevada – Town Center, Las Vegas, Nevada, 89144, United States|Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, 89144, United States|Summerlin Hospital Medical Center, Las Vegas, Nevada, 89144, United States|Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, 89148, United States|GenesisCare USA – Fort Apache, Las Vegas, Nevada, 89148, United States|OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, 89148, United States|Comprehensive Cancer Centers of Nevada – Central Valley, Las Vegas, Nevada, 89169, United States|Hope Cancer Care of Nevada-Pahrump, Pahrump, Nevada, 89048, United States|Renown Regional Medical Center, Reno, Nevada, 89502, United States|Saint Mary’s Regional Medical Center, Reno, Nevada, 89503, United States|Radiation Oncology Associates, Reno, Nevada, 89509, United States|Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Saint Joseph’s Regional Medical Center, Paterson, New Jersey, 07503, United States|Presbyterian Hospital, Albuquerque, New Mexico, 87106, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87106, United States|Albany Medical Center, Albany, New York, 12208, United States|Montefiore Medical Center-Einstein Campus, Bronx, New York, 10461, United States|Montefiore Medical Center-Weiler Hospital, Bronx, New York, 10461, United States|Children’s Hospital at Montefiore, Bronx, New York, 10467, United States|Montefiore Medical Center – Moses Campus, Bronx, New York, 10467, United States|NYU Langone Hospital – Long Island, Mineola, New York, 11501, United States|The Steven and Alexandra Cohen Children’s Medical Center of New York, New Hyde Park, New York, 11040, United States|NYP/Weill Cornell Medical Center, New York, New York, 10065, United States|Stony Brook University Medical Center, Stony Brook, New York, 11794, United States|New York Medical College, Valhalla, New York, 10595, United States|UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States|Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, 28203, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States|Sanford Broadway Medical Center, Fargo, North Dakota, 58122, United States|Children’s Hospital Medical Center of Akron, Akron, Ohio, 44308, United States|Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Rainbow Babies and Childrens Hospital, Cleveland, Ohio, 44106, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Nationwide Children’s Hospital, Columbus, Ohio, 43205, United States|Dayton Children’s Hospital, Dayton, Ohio, 45404, United States|ProMedica Toledo Hospital/Russell J Ebeid Children’s Hospital, Toledo, Ohio, 43606, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|Geisinger Medical Center, Danville, Pennsylvania, 17822, United States|Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, 15224, United States|Saint Francis Hospital, Greenville, South Carolina, 29601, United States|BI-LO Charities Children’s Cancer Center, Greenville, South Carolina, 29605, United States|Saint Francis Cancer Center, Greenville, South Carolina, 29607, United States|Sanford USD Medical Center – Sioux Falls, Sioux Falls, South Dakota, 57117-5134, United States|East Tennessee Childrens Hospital, Knoxville, Tennessee, 37916, United States|The Children’s Hospital at TriStar Centennial, Nashville, Tennessee, 37203, United States|Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, 37232, United States|Dell Children’s Medical Center of Central Texas, Austin, Texas, 78723, United States|Medical City Dallas Hospital, Dallas, Texas, 75230, United States|El Paso Children’s Hospital, El Paso, Texas, 79905, United States|Cook Children’s Medical Center, Fort Worth, Texas, 76104, United States|Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, 77030, United States|M D Anderson Cancer Center, Houston, Texas, 77030, United States|Covenant Children’s Hospital, Lubbock, Texas, 79410, United States|UMC Cancer Center / UMC Health System, Lubbock, Texas, 79415, United States|Children’s Hospital of San Antonio, San Antonio, Texas, 78207, United States|Methodist Children’s Hospital of South Texas, San Antonio, Texas, 78229, United States|University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States|University of Virginia Cancer Center, Charlottesville, Virginia, 22908, United States|Children’s Hospital of The King’s Daughters, Norfolk, Virginia, 23507, United States|Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, 23298, United States|Carilion Children’s, Roanoke, Virginia, 24014, United States|Valley Medical Center, Renton, Washington, 98055, United States|Seattle Children’s Hospital, Seattle, Washington, 98105, United States|Providence Sacred Heart Medical Center and Children’s Hospital, Spokane, Washington, 99204, United States|Mary Bridge Children’s Hospital and Health Center, Tacoma, Washington, 98405, United States|Madigan Army Medical Center, Tacoma, Washington, 98431, United States|North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, 98902, United States|Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, 53105, United States|Aurora Saint Luke’s South Shore, Cudahy, Wisconsin, 53110, United States|Aurora Health Care Germantown Health Center, Germantown, Wisconsin, 53022, United States|Aurora Cancer Care-Grafton, Grafton, Wisconsin, 53024, United States|Aurora BayCare Medical Center, Green Bay, Wisconsin, 54311, United States|Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, 53142, United States|University of Wisconsin Carbone Cancer Center – University Hospital, Madison, Wisconsin, 53792, United States|Aurora Bay Area Medical Group-Marinette, Marinette, Wisconsin, 54143, United States|Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, 54449, United States|Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, 53209, United States|Aurora Saint Luke’s Medical Center, Milwaukee, Wisconsin, 53215, United States|Children’s Hospital of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Aurora Sinai Medical Center, Milwaukee, Wisconsin, 53233, United States|Vince Lombardi Cancer Clinic – Oshkosh, Oshkosh, Wisconsin, 54904, United States|Aurora Cancer Care-Racine, Racine, Wisconsin, 53406, United States|Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, 53081, United States|Aurora Medical Center in Summit, Summit, Wisconsin, 53066, United States|Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, 54241, United States|Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, 53226, United States|Aurora West Allis Medical Center, West Allis, Wisconsin, 53227, United States|IWK Health Centre, Halifax, Nova Scotia, B3K 6R8, Canada|Children’s Hospital, London, Ontario, N6A 5W9, Canada|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada | ||||
| NCT05590624 | Metabolic Impact of Prospective Controlled Mediterranean Type Diets on Prostate Cancer | https://clinicaltrials.gov/study/NCT05590624 | The purpose of this study is to examine the impact of Mediterranean-type diets on the metabolism of men with localized prostate cancer. The optimal diet for men with a suspected diagnosis of Prostate Cancer (PCa) is currently unknown. More specifically, the suggested benefits of low carbohydrate and low fat diets in PCa are not determined. | NO | Prostate Cancer | OTHER: Lower-Carbohydrate Med-t-Diet|OTHER: Low-Fat Med-t-Diet | Evaluate the impact of Med-t-Diets on non-malignant prostate tissue metabolism, Change in non-malignant prostate tissue metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure., Change from diagnostic biopsy (Week 2) at confirmatory biopsy | Changes in blood metabolomics, Change in blood metabolomics using mass spectrometry to assess differences in ions/metabolites and corresponding metabolic pathways after different dietary interventions expressed as a fold-change. As an exploratory study, metabolomics will be untargeted and as such is not run with a standard curve and does not have a unit of measure, Change from baseline at two weeks on diet|Changes in energy substrate(s), Change measured by respiratory exchange ratio (VCO2/VO2) difference between baseline and at two weeks on diet, Change from baseline at two weeks on diet|Changes in blood glucose (mg/dL), Change as measured by the difference between blood glucose levels at baseline and at week two on diet, Change from baseline at two weeks on diet|Changes in ketone levels (mM or mcg/mL), Change measured by the difference between ketone levels between baseline and at two weeks on diet, Change from baseline at two weeks on diet|Changes in hemoglobin A1C (HbA1C) (%), Change measured by the difference between A1C levels at baseline and at 2 weeks on diet, Change from baseline at two weeks on diet|Changes in C-reactive protein (CRP) (mg/L), Change measured by the difference between CRP levels at baseline and at 2 weeks on diet, Change from baseline at two weeks on diet|Changes in lipid particle size (nm), Change measured by the difference in lipid particle size at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR)., Change from baseline at two weeks on diet|Changes in lipid particle number (nmol/L and/or μmol/L), Change measured by the difference in lipid particle number at baseline and at 2 weeks on diet using Nuclear Magnetic Resonance (NMR), Change from baseline at two weeks on diet|Changes in insulin sensitivity [(Homeostatic Model Assessment of Insulin Resistance (HOMA-IR score)], Change as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score using fasting insulin and glucose from longitudinal blood specimens at baseline and at two weeks on diet. The HOMA-IR test tests how resistant a participant is to insulin. A score of less than 1 indicates that a participant is insulin-sensitive, a score greater than 1.9 indicates some insulin resistance, and a score greater than 2.9 indicates significant insulin resistance., Change from baseline at two weeks on diet|Prostate health changes, As measured by changes in the Prostate Health Index, Change from baseline at two weeks on diet|Safety and tolerability of the diets, Safety and tolerability measured by the number of adverse events and by the gastric tolerance questionnaire, Through study completion, an average of 7.5 month|Changes in alpha and beta diversity of the gut microbiome, Changes measured by Shannon or Simpson diversity index (alpha diversity) and pairwise Bray-Curtis metric values (beta diversity), Change from baseline at two weeks on diet|Changes in dietary behavior, Behavioral changes measured by validated 24 hour dietary recalls collected by trained dietetics personnel on 2 week days and 1 weekend to capture specific dietary information, Through study completion, an average of 7.5 months|Diet compliance, Compliance measured by \>90% of provided calories consumed, throughout controlled feeding period(s), two weeks per diet | Case Comprehensive Cancer Center | MALE | ADULT, OLDER_ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER | CASE4822 | 2024-09-03 | 2025-06-01 | 2025-12-31 | 2022-10-21 | 2024-11-27 | Case Comprehensive Cancer Center, Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States | |||||
| NCT05579444 | Systems Biology of Gastrointestinal and Related Diseases | https://clinicaltrials.gov/study/NCT05579444 | This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease. | NO | Ulcerative Colitis|Crohn Disease|Obesity|Colon Polyp|Eosinophilic Esophagitis|GERD|Gastro Esophageal Reflux|Barrett Esophagus|Esophageal Cancer|Gastritis|Gastric Ulcer|Duodenal Ulcer|Intestinal Metaplasia|Gastric Cancer|Lymphocytic Colitis|Microscopic Colitis|Celiac Sprue|IBS|Irritable Bowel Syndrome|SIBO|NAFLD|Gallstone Disease | Identification of human determinants of gastrointestinal diseases., Identification of biomarkers that indicate gastrointestinal diseases., Up to 10 years|Identification of microbial determinants of gastrointestinal diseases., Identification of microbial species that indicate gastrointestinal disease., Up to 10 years | Prediction of efficacy of biologics in treating IBD., Prediction of the efficacy of a biologic medication against IBD based on molecular data and metadata., Up to 10 years.|Development of a molecular test for C. difficile infection (CDI), Development of a molecular test for C. difficile infection (CDI), Up to 10 years.|Quantify change in microbial species over time post colonoscopy, Quantification of changes observed in the microbiome post colonoscopy., Up to 10 years. | Viome | ALL | ADULT, OLDER_ADULT | 17 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | V263 | 2022-11-11 | 2023-11-29 | 2023-11-29 | 2022-10-13 | 2023-12-15 | Viome Life Sciences, Bothell, Washington, 98011, United States | |||||||
| NCT05565638 | PROFAST Intervention in Precursor Multiple Myeloma | https://clinicaltrials.gov/study/NCT05565638 | PROFAST | This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and smoldering waldenstrom macroglobulinemia (SWM). The purpose of this study is to understand if fasting for a prolonged period of time during the nighttime hours is a strategy to prevent overweight and obese individuals from developing blood cancer. Participants will be randomized into the following two groups: * Group A: PROFAST intervention for 4 months * Group B: Healthy Lifestyle Control group for 4 months | NO | Cancer Prevention|Weight Loss|Smoldering Waldenstrom Macroglobulinemia(WM)|MGUS|Fasting|Multiple Myeloma | BEHAVIORAL: Prolonged Fasting Intervention|BEHAVIORAL: EDUCATION CONTROL | Changes in body composition, assessed via whole body DXA scans, baseline to 4-months | M-Protein change by Serum Protein Electrophoresis and Serum Free Light Chain assay, Monoclonal (M-)proteins produced in excess by an abnormal clonal proliferation of plasma (MM) cells that can be measured in the serum using Serum Protein Electrophoresis (SPEP) and the Serum Free Light Chain Assay., baseline to 4-months|(M-)protein concentrations/light chains change by mass spectrometry, Baseline to 4-months|Changes in bone marrow adiposity, Baseline to 4-months|Changes in plasma metabolites measured by liquid chromatography-mass spectrometry, Baseline to 4-months | Dana-Farber Cancer Institute | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 22-071|R21CA256644-01A1 | 2023-03-06 | 2025-01-31 | 2025-05-31 | 2022-10-04 | 2024-09-24 | Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States | |||
| NCT05561595 | Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma | https://clinicaltrials.gov/study/NCT05561595 | HEARTS | Stigma due to health conditions increases disease burden and adversely impacts health. The internalization of health-related stigma is associated with impaired mental health and quality of life. The current project will test the effects of a novel, transdiagnostic, group counseling intervention, and peer support, to determine the optimal method for helping patients cope with health-related stigma, reducing its internalization, and enhancing patient quality of life. | NO | Obesity|Skin Disease|Cancer|HIV|Diabetes|Chronic Pain | BEHAVIORAL: Healing HEARTS|BEHAVIORAL: Peer Support | Change in Internalized Health-Related Stigma Scale score at Week 12, Estimated mean change score for the total scale (primary outcome) and three subscales (Perceived and Anticipated Stigma, Stereotype Application and Self-Devaluation, and Stigma Resistance); scale scores are averaged and range from 1-7, with higher scores indicating greater internalized health-related stigma., Baseline to Week 12 | Change in Internalized Health-Related Stigma Scale score at Week 26, Estimated mean change score for the total scale (primary outcome) and three subscales (Perceived and Anticipated Stigma, Stereotype Application and Self-Devaluation, and Stigma Resistance); scale scores are averaged and range from 1-7, with higher scores indicating greater internalized health-related stigma., Baseline to Week 26|Change in Internalized Shame Scale score at Week 12, Estimated mean change score for two subscales: Shame (summed scores range from 0-96, higher scores indicate greater shame) and Self-Esteem (summed scores range from 0-24, higher scores indicate higher self-esteem)., Baseline to Week 12|Change in Internalized Shame Scale score at Week 26, Estimated mean change score for two subscales: Shame (summed scores range from 0-96, higher scores indicate greater shame) and Self-Esteem (summed scores range from 0-24, higher scores indicate higher self-esteem)., Baseline to Week 26|Change in UCLA Loneliness Scale score at Week 12, Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation)., Baseline to Week 12|Change in UCLA Loneliness Scale score at Week 26, Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation)., Baseline to Week 26|Change in Patient Health Questionnaire-9 score at Week 12, Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms)., Baseline to Week 12|Change in Patient Health Questionnaire-9 score at Week 26, Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms)., Baseline to Week 26|Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 12, Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety)., Baseline to Week 12|Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 26, Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety)., Baseline to Week 26|Change in Severity Measure for Social Anxiety Disorder score at Week 12, Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety)., Baseline to Week 12|Change in Severity Measure for Social Anxiety Disorder score at Week 26, Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety)., Baseline to Week 26|Change in 4-item Perceived Stress Scale score at Week 12, Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress)., Baseline to Week 12|Change in 4-item Perceived Stress Scale score at Week 26, Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress)., Baseline to Week 26|Change in General Self-Efficacy Scale score at Week 12, Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy)., Baseline to Week 12|Change in General Self-Efficacy Scale score at Week 26, Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy)., Baseline to Week 26|Change in Revised Illness Perceptions Questionnaire scores at Week 12, Estimated mean change scores on four subscales: Consequences, Personal Control, Illness Coherence, and Emotional Representations. Scores for each subscale are averaged, with ratings ranging from 1-5, and higher scores Indicating greater perceived consequences, control, understanding, and emotional impacts of health conditions, respectively., Baseline to Week 12|Change in Revised Illness Perceptions Questionnaire scores at Week 26, Estimated mean change scores on four subscales: Consequences, Personal Control, Illness Coherence, and Emotional Representations. Scores for each subscale are averaged, with ratings ranging from 1-5, and higher scores Indicating greater perceived consequences, control, understanding, and emotional impacts of health conditions, respectively., Baseline to Week 26|Change in SF-12v2 scores at Week 12, Estimated mean change scores in mental and physical health component t-scores, with a population mean score of 50 and standard deviation of 10 (higher scores indicate better mental and physical health-related quality of life, respectively)., Baseline to Week 12|Change in SF-12v2 scores at Week 26, Estimated mean change scores in mental and physical health component t-scores, with a population mean score of 50 and standard deviation of 10 (higher scores indicate better mental and physical health-related quality of life, respectively)., Baseline to Week 26|Change in CDC Healthy Days Core Measure at Week 12, Estimated mean change scores in items assessing the number of unhealthy days due to physical and mental health, respectively (range 0-30 days), the number of days of impairment due to poor health (0-30 days), and an unhealthy days index score of total combined physically and mentally unhealthy days (0-30 days)., Baseline to Week 12|Change in CDC Healthy Days Core Measure at Week 26, Estimated mean change scores in items assessing the number of unhealthy days due to physical and mental health, respectively (range 0-30 days), the number of days of impairment due to poor health (0-30 days), and an unhealthy days index score of total combined physically and mentally unhealthy days (0-30 days)., Baseline to Week 26 | Change in Brief COPE scores at Week 12, Estimated mean change in scores on the following subscales (all with two items rated 1-4, summed to produce scores ranging from 2-8, with higher scores indicating greater use of the respective coping strategy): self-distraction; active coping; denial; substance use; use of emotional support; use of instrumental support; behavioral disengagement; venting; positive reframing; planning; humor; acceptance; religion; and self-blame. Coping strategies may also be analyzed by grouping coping strategies into three broad categories and averaging scores for items within each category: active coping (active coping, positive reframing, planning, humor, acceptance); disengaged coping (self-distraction, denial, substance use, behavioral disengagement, venting, self-blame); and support coping (emotional support, instrumental support, religion)., Baseline to Week 12|Change in Brief COPE scores at Week 26, Estimated mean change in scores on the following subscales (all with two items rated 1-4, summed to produce scores ranging from 2-8, with higher scores indicating greater use of the respective coping strategy): self-distraction; active coping; denial; substance use; use of emotional support; use of instrumental support; behavioral disengagement; venting; positive reframing; planning; humor; acceptance; religion; and self-blame. Coping strategies may also be analyzed by grouping coping strategies into three broad categories and averaging scores for items within each category: active coping (active coping, positive reframing, planning, humor, acceptance); disengaged coping (self-distraction, denial, substance use, behavioral disengagement, venting, self-blame); and support coping (emotional support, instrumental support, religion)., Baseline to Week 26|Change in 6-Item Social Support Questionnaire scores at Week 12, Estimated mean change scores on two subscales assessing (1) the average number of support persons (N subscale) and (2) the average level of satisfaction with social support (the S subscale, with scores ranging from 1-6, and higher scores indicating greater satisfaction with social support)., Baseline to Week 12|Change in 6-Item Social Support Questionnaire scores at Week 26, Estimated mean change scores on two subscales assessing (1) the average number of support persons (N subscale) and (2) the average level of satisfaction with social support (the S subscale, with scores ranging from 1-6, and higher scores indicating greater satisfaction with social support)., Baseline to Week 26|Treatment Acceptability ratings at Week 12, To assess treatment acceptability, participants in the two active treatment groups (not the waitlist control group) rate from 1-7 how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items are averaged. Participants also rate (1-7) how likely they would be to recommend the program to others and the extent to which they learned new things, changed their attitudes about themselves, and the program helped with managing their health conditions. Participants also rate how much they learned and used specific skills from the program; these item responses are averaged on a 1-7 scale for learned skills and on a 1-5 scale for used skills. Higher scores indicate greater treatment acceptability., Week 12|Treatment Acceptability ratings at Week 26, To assess treatment acceptability, participants in the two active treatment groups (not the waitlist control group) rate from 1-7 how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items are averaged. Participants also rate (1-7) how likely they would be to recommend the program to others and the extent to which they learned new things, changed their attitudes about themselves, and the program helped with managing their health conditions. Participants also rate how much they learned and used specific skills from the program; these item responses are averaged on a 1-7 scale for learned skills and on a 1-5 scale for used skills. Higher scores indicate greater treatment acceptability., Week 26 | University of Florida | National Institute of Mental Health (NIMH)|National Institutes of Health (NIH) | ALL | ADULT, OLDER_ADULT | NA | 195 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | IRB202201862|DP2MH132938|PRO00041153 | 2024-10-03 | 2026-12-31 | 2027-03-31 | 2022-09-30 | 2025-01-15 | University of Florida, Gainesville, Florida, 32610, United States | ||
| NCT05558384 | Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors | https://clinicaltrials.gov/study/NCT05558384 | This is a pilot feasibility study of an investigation of the influence of excess adiposity on cardiorespiratory fitness (CRF), insulin-like growth factor-1 (IGF-1), and metabolic responses to a standardized aerobic exercise program in cancer survivors. This investigation attempts to isolate the influence of adiposity on these responses. We will enroll overweight, obese, and normal weight cancer survivors with a primary diagnosis of breast, prostate, or colorectal cancer who have completed all cancer-related treatment. Participants will engage in a 15-week aerobic exercise intervention with pre- and post-intervention assessments. | NO | Cancer|Overweight and Obesity | BEHAVIORAL: Aerobic Exercise | Recruitment, Number of participants joining the study per month, up to 12 months|Study Adherence, Percentage of participants completing pre- and post-intervention assessments, up to 12 months|Intervention Adherence, Average percentage of prescribed exercise sessions completed by participants, 15 weeks | Serum IGF-1, Collected via venipuncture, Baseline, Week 15|Estimated VO2max, Maximal oxygen consumption estimated from a 3 minute step test (Tecumseh Step Test), Baseline, Week 15|Total visceral adiposity, Collected with dual-energy x-ray absorptiometry, Baseline, Week 15 | University of Colorado, Denver | ALL | ADULT, OLDER_ADULT | NA | 12 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 22-0356.ccc | 2023-03-22 | 2024-10-01 | 2026-09-30 | 2022-09-28 | 2024-12-04 | University of Colorado Hospital, Aurora, Colorado, 80045, United States | |||||
| NCT05556616 | A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma | https://clinicaltrials.gov/study/NCT05556616 | iinnovate-2 | The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Participants will be given modakafusp alfa through a vein. | NO | Multiple Myeloma | DRUG: Modakafusp alfa|DRUG: Lenalidomide|DRUG: Bortezomib|DRUG: Carfilzomib|DRUG: Daratumumab|DRUG: Pomalidomide | Number of Participants With Dose-limiting Toxicities (DLTs), DLT will be defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions; Delay in Cycle 2 by more than 14 days due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities., Cycle 1 (Cycle length is 28 days)|Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs), Up to approximately 5 years | Progression Free Survival (PFS), PFS is defined as the time from the date on which the first dose of study drug is administered to the date of first documentation of confirmed progression of disease (PD) or death due to any cause, whichever occurs first. PD will be determined by International Myeloma Working Group (IMWG) criteria. PD: increase of \>=25 percent (%) from lowest response value in any one or more of the following: serum M-component increase \>=0.5 gram per deciliter (g/dL) or urine M-component increase \>=200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (\>) 10 milligram per deciliter (mg/dL); bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder., Up to approximately 5 years|Overall Response Rate (ORR), ORR is defined as the percentage of participants who achieved a confirmed partial response rate (PR) or better during the study as defined by IMWG Uniform Response Criteria and the response is determined by investigator. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or less than (\<) 200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required., Up to approximately 5 years|Duration of Response (DOR), DOR is defined as the time from the date of first documentation of confirmed PR or better to the date of first documentation of PD or death due to any cause. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder., Up to approximately 5 years|Groups 2 and 3: Overall Survival (OS), OS is defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive., Up to approximately 5 years|Groups 2 and 3: Time to Progression (TTP), TTP is defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder., Up to approximately 5 years|Groups 2 and 3: Time to Next Treatment (TTNT), TTNT is defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason., Up to approximately 5 years|Groups 2 and 3: Disease Control Rate (DCR), DCR is defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator’s disease assessment as defined by IMWG Uniform Response Criteria. SD is defined as no known evidence of progressive disease or new bone lesions., Up to approximately 5 years|Groups 2 and 3: Event-free Survival, EFS is defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD will be determined by International Myeloma Working Group (IMWG) criteria. PD: increase of \>=25 % from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be \> 10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder., Up to approximately 5 years|Groups 2 and 3: Time to Response (TTR), TTR is defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria., Up to approximately 5 years|Group 1: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5, Rate of MRD negativity at a sensitivity of 10\^-5 is defined as the percentage of participants who have achieved MRD negative status in participants in the MRD-evaluable analysis set., At 6 months, 1 year, and 2 years after the start of treatment.|Groups 2 and 3: Percentage of Participants with MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator, Rate of MRD negativity CR status a sensitivity of 10\^-5 is defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required., Up to approximately 2 years after CR confirmation|Group 1: Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity, Duration of MRD negativity (10\^-5) is defined as the time from the date of first documentation of MRD \[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurs first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder., Up to approximately 2 years after treatment|Group 2 and 3: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5, Rate of MRD negativity at a sensitivity of 10\^-5 is defined as the percentage of participants who have achieved MRD negative status., Up to approximately 5 years|Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity, Duration of MRD negativity (10\^-5) is defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurs first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder., Up to approximately 5 years|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb), Up to approximately 5 years | Takeda | ALL | ADULT, OLDER_ADULT | PHASE1 | 15 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT | TAK-573-1502|2022-001418-20 | 2022-10-27 | 2024-06-04 | 2024-06-04 | 2022-09-27 | 2024-12-24 | University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States|Scripps Health, San Diego, California, 92121, United States|The University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States|Cancer Center At Greater Baltimore Medical Center, Baltimore, Maryland, 21153, United States|Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, 89119, United States|NYU Langone Hospital – Long Island, Mineola, New York, 11501, United States|New York University School of Medicine, New York, New York, 10016, United States|Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York, 10021, United States|Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States|Memorial Sloan Kettering Cancer Center – Main Campus, New York, New York, 10065, United States|Novant Health Cancer Institute, Charlotte, North Carolina, 28204, United States|Novant Health Cancer Institute – Forsyth Medical Center, Winston-Salem, North Carolina, 27103, United States|Gabrail Cancer Center Research, Canton, Ohio, 44718, United States|The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States|CHU UCL Namur site Godinne, Yvoir, Namur, 5530, Belgium|AZ Delta, Roeselare, Roeselare West-Vlaanderen, 8800, Belgium|Rambam Health Care Campus (RHCC) – Meyer Children’s Hospital – Pediatric Diabetes & Obesity Clinic, Haifa, 31999, Israel|Clinica Universidad de Navarra-Sede Madrid, Madrid, 28027, Spain|Hospital Universitario Virgen de la Victoria, Malaga, 29010, Spain|Clinica Universidad de Navarra, Dept of Oncology, Pamplona, 31008, Spain|Hospital Universitario La Fe de Valencia, Valencia, 46026, Spain | ||||
| NCT05542407 | ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer | https://clinicaltrials.gov/study/NCT05542407 | Endometrial cancer (EC) is the fourth most common cancer in United States women, and alarmingly, the frequency and mortality from EC continues to rise, in part due to the obesity epidemic. Obese women with EC have a 6.3-fold increased risk of death from this disease, as compared to their non-obese counterparts. Patients with advanced/recurrent EC are unlikely to be cured by surgery, conventional chemotherapy (paclitaxel + carboplatin is the standard first-line treatment), radiation, or a combination of these. Thus, new treatments for EC are desperately needed as well as a better understanding of the impact of obesity on EC biology and treatment. The purpose of this study is to test the safety of a combination of treatments, atezolizumab and ONC201, given based on body weight, to treat endometrial cancer. Using the combination of atezolizumab and ONC201, has not been approved by the Food and Drug Administration (FDA) for the treatment of endometrial cancer. This clinical trial will examine the treatment of atezolizumab + ONC201 in obese and non-obese subjects with metastatic/recurrent EC. | NO | Endometrial Cancer|Metastasis | DRUG: Atezolizumab|DRUG: ONC201 | Recommended phase 2 dose (RP2D), The RP2D will be determined based on the incidence of dose-limiting toxicities (DLT)s. A DLT is defined as all grade 3 or above toxicities that are related to study treatment and occur within the first cycle of therapy. Adverse events are assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE). A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate Instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE., Up to 3 weeks | Overall Response Rate (ORR), ORR is defined as the proportion of subjects achieving response complete response (CR) or partial response(PR) assessed by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions., Up to 2 years|Progression Free Survival (PFS), PFS is defined as time from first day of treatment until disease progression as defined by RECIST v1.1 or death from any cause., Up to 2 years|Overall Survival (OS), OS is defined as the time of the start of study treatment to death from any cause., Up to 2 years | UNC Lineberger Comprehensive Cancer Center | Genentech, Inc.|Oncoceutics, Inc. | FEMALE | ADULT, OLDER_ADULT | PHASE1 | 58 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | LCCC2036 | 2023-10-23 | 2025-01-15 | 2025-07-31 | 2022-09-15 | 2024-07-12 | Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States | ||||
| NCT05515978 | Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients | https://clinicaltrials.gov/study/NCT05515978 | Metformin is used widely in the treatment of type 2 diabetes. It has off-label indications for use in the prevention of diabetes and in hyperinsulinar obesity. In medical practices, the implementation of metformin for these off-label indications is variable, often at the level of the provider. Multiple retrospective investigations have also shown a clinical benefit in men with prostate cancer who are incidentally treated with metformin. This pragmatic study will test the feasibility of enrolling patients who have glucose intolerance (as defined by HbA1c of 5.7-6.4%) and/or who have increased BMI (BMI greater than or equal to 25 kg/m2) to a randomized pragmatic study of metformin plus lifestyle modification information versus lifestyle modification information only. For purposes of the scope of this project and the study’s feasibility, this will be implemented in a group of prostate cancer patients, who may have additional benefits from metformin. | NO | Prostate Cancer | DRUG: Metformin|BEHAVIORAL: Lifestyle Modification | Successful accrual of 200 patients to the pragmatic trial in the first two years, Once there are 6 months of follow-up data on the first 200 patients, a formal analysis will be done to determine the completeness of data and the potential for a powered study., Two years | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Body Mass Index, Metabolic response. Key metabolic parameters assessed as part of routine care: Body Mass Index (BMI), 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Weight, Metabolic response. Key metabolic parameter assessed as part of routine care: Weight, 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on HbA1C, Metabolic response. Key metabolic parameters assessed as part of routine care: HbA1C, 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Blood Pressure, Metabolic response. Key metabolic parameters assessed as part of routine care: blood pressure, 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Glucose Levels, Metabolic response. Key metabolic parameters assessed as part of routine care: random glucose level., 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters – BMI, Metabolic response. Key metabolic parameter assessed as part of routine care: Body Mass Index (BMI), 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters – Weight, Metabolic response. Key metabolic parameters assessed as part of routine care: Weight, 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters – HbA1C, Metabolic response. Key metabolic parameters assessed as part of routine care: HbA1C, 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters – blood pressure, Metabolic response. Key metabolic parameters assessed as part of routine care: blood pressure, 2 years|Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters – blood glucose levels, Metabolic response. Key metabolic parameters assessed as part of routine care: random glucose level., 2 years|Effectiveness: 1b: To determine the effectiveness of metformin prescribed in a pragmatic trial on the development of diabetes., Metabolic response. Key metabolic parameters assessed as part of routine care: 1b: Initiation of any additional diabetes medication, and new diagnoses of diabetes. All new diagnoses of diabetes will be reviewed by the adjudication committee, 2 years|Determine the number of additional diabetes medications initiated, Metabolic response. Key metabolic parameters assessed as part of routine care: Initiation of any additional diabetes medication, 2 years|Determine the number of new diagnoses of diabetes, Metabolic response. Key metabolic parameters assessed as part of routine care: New diagnoses of diabetes. All new diagnoses of diabetes will be reviewed by the adjudication committee, 2 years|Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse cardiac events (MACE)., All major adverse cardiac events will undergo chart review and categorized as major cardiac and limb events (MI, stroke, CV death, acute limb ischemia, major vascular amputation)., 2 years|Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse limb events (MALE)., All major adverse cardiac events will undergo chart review and categorized as major cardiac and limb events (MI, stroke, CV death, acute limb ischemia, major vascular amputation)., 2 years|Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial in progression-free survival defined as doubling of PSA level or all-cause mortality., PSA doubling as surrogate for progression, defined using a modified approach from the prostate cancer working group 3(PCWG 2016)1.. First all PSA values less than 1 ng/dL will be set to 1 ng/dL. If this PSA value is 1 ng/dL an event (i.e., PSA doubling or death) will be defined as the next PSA value that was greater than or equal to 2 ng/dL or death. Alternatively, if a patient’s first PSA is greater than 1 ng/dL the nadir was identified. If the variability in PSA values prior to the nadir is low (i.e., there was less than a 5% difference between the nadir and previous PSA values) the first value prior to the nadir that is within 5% will be selected as the baseline PSA. An event will be defined as the next PSA value that was greater or equal to 2 times the baseline PSA or death. Patients that never experienced a PSA doubling or death will be censored at their last known PSA measurement., 2 years|Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial on PSA response of prostate cancer., A modified PSA biochemical response: PSA response defined as a ≥50% decline in PSA from the baseline level at the start of the study. The study-associated provider will receive a clinical decision support query with any PSA response observed: “Is it likely that any other intervention such as additional medical or local therapy besides metformin may have caused the subjects recent PSA response?”, 2 years|Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on radiographic progression of prostate cancer., Following every scan, the study associated provider will be asked “Does the subject have evidence of radiographic progression in your opinion”, 10 years|Effectiveness: To determine the effectiveness of metformin prescribed on a pragmatic trial ion overall and prostate cancer specific survival., Overall and prostate cancer specific mortality: The Colorado State Death Registry, which is integrated with Health Data Compass (HDC), will be used to determine the overall survival status. The subject’s trial-associated provider will receive a clinical decision support query from the study regarding any subject who dies on the trial: “Did this subject die due to complications of prostate cancer?” (Investigator assessment). Every death will be chart reviewed., 10 years|Safety: To determine the safety, assessed by Adverse Events, of providing metformin via this pragmatic approach., Safety endpoints via HDC (death, hospitalization, and metformin-associated lactate level elevation diagnosis codes frequency). Lab values, such as a lactate level, may also be utilized for specific diagnosis. The PI and steering committee will review these on a regular basis any notify the IRB with a notable difference between the arms. Metformin-associated lactic acidosis will specifically be an AE of interest., 2 years|Reach: To determine the proportion of patients approached who enroll and the characteristics and representativeness of those enrolled., The number, proportion, and demographics of eligible patients: eligible patients include those deemed eligible to receive a consent in MHC/Epic through assessment of the demographic information. The proportion will be determined by dividing the number of patients who sign the second consent by those who received the first consent. The demographics of those who signed the second consent will be compared with those who signed the initial consent., 2 years|Implementation: To determine the accuracy of the Epic screening process to identify, Accuracy of Epic screening process: The charts of the first 50 patients identified by Epic will be reviewed manually by the PI and study team., 2 years|Implementation: To determine the effectiveness of different approaches to presenting the consent to patients in MHC/Epic., The consent completion rate as determined by the electronic signature of the consent in MHC/Epic within one month of availability or posting and also at any timepoint thereafter (early versus late completion)., 2 years|Implementation: To determine the time period required to identify and enroll 200 eligible patients, Study Enrollment: The number of patients who sign the second consent (consent #2 or #3) in MHC/Epic will be counted toward study accrual and the time it takes to enroll 200 will be assessed., 2 years|Implementation: To determine the accuracy of TriNetX in predicting the number of eligible patients identified each month., Accuracy of TriNetX estimates of eligible patients, including filtering for appointments with participating providers, will be compared with the number of consents released in MHC/Epic monthly., 2 years|Adherence: To determine the number and proportion of patients who adhere to the assigned treatment plan., The proportion of patients with active metformin prescription at one year after enrollment and then annually will be assessed. The number of patients in the non-metformin arm who start metformin and/or another anti-diabetes medication during the study period will be assessed., 10 years | University of Colorado, Denver | MALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 200 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 19-1536.cc|NCI-2021-05911 | 2022-10-17 | 2035-10-20 | 2036-11-06 | 2022-08-25 | 2024-09-19 | Colorado Research Center, Aurora, Colorado, 80045, United States|UCHealth-Southern Colorado, Colorado Springs, Colorado, 80863, United States|UCHealth-Metro Denver, Denver, Colorado, 80217-3364, United States|UCHealth-Northern Colorado, Fort Collins, Colorado, 80521, United States | |||||
| NCT05501899 | Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia | https://clinicaltrials.gov/study/NCT05501899 | Acute lymphoblastic leukemia (ALL) is the most common cancer seen in pediatric oncology. The necessary chemotherapy for pediatric and adolescent and young adult (AYA) patients with ALL includes steroids, anthracyclines, asparaginase, and vincristine. One of the most hepatotoxic chemotherapy agents is asparaginase, with treatment-associated hepatotoxicity (TAH) observed in up to 60% of patients. The frequency of TAH is increased in overweight or obese patients of Latino heritage. Carnitine is a naturally-derived compound that is produced in the liver and kidneys; it is found in certain foods, such as meat, poultry, fish, and some dairy products. Endogenous carnitine transports long-chain fatty acids into the mitochondria, where they are oxidized to produce energy, and acts as scavengers of oxygen free radicals. Thus, carnitine can reduce oxidative stress and modulate inflammatory response. Levocarnitine is a supplement form of carnitine used typically in the care and management of patients with carnitine deficiency. Pediatric and AYAs with ALL will be given oral levocarnitine as a supplement during their initial phases of treatment, when the most hepatotoxic agents are administered, to determine if the incidence of liver toxicity can be reduced or eliminated. | NO | Acute Lymphoblastic Leukemia|Hepatotoxicity | DRUG: Levocarnitine | Primary Outcome #1, Calculate proportion of patients who experience hepatotoxicity, as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade ≥ 3 elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total and direct bilirubin., 1.5 years|Primary Outcome #2, Calculate prevalence of hepatotoxicity in patients who self-identify as Latino or non-Latino, using laboratory assessments and self-reported measures of ethnicity and/or race., 1.5 years | Secondary Outcome #1, Calculate body mass index (BMI), from recorded height and weight obtained at time of initial diagnosis and determine if there is increased risk of hepatotoxicity in patients who are overweight or obese at diagnosis as determined by Centers for Disease Control and Prevention (CDC) clinical growth charts for study participants 5 to \< 20 years of age and by a BMI of ≥ 25.0 for study participants 20 to \< 30 years of age., 1.5 years|Secondary Outcome #2, Quantify disease response, using end of Induction minimal residual disease (MRD) results, where an MRD value \< 0.01 is considered "negative.", 1.5 years|Secondary Outcome #3, Calculate incidence of nonalcoholic fatty liver disease (NAFLD), using ultrasound elastography, in pediatric and AYA patients newly diagnosed with ALL., 1.5 years|Secondary Outcome #4, Calculate proportion of patients who experience other known toxicities of asparaginase treatment, as measured by CTCAE version 5.0 grade ≥ 3 hyper/hypoglycemia, hypertriglyceridemia, pancreatitis, and thrombosis., 1.5 years | Children’s Hospital of Orange County | University of California, Irvine | ALL | CHILD, ADULT | EARLY_PHASE1 | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 2110145 | 2023-03-03 | 2024-12-31 | 2024-12-31 | 2022-08-16 | 2024-08-21 | Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, 92868, United States|Children’s Hospital of Orange County, Orange, California, 92868, United States | ||||
| NCT05471414 | Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer | https://clinicaltrials.gov/study/NCT05471414 | WFPBD | The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT). | NO | Prostate Cancer | BEHAVIORAL: Whole-food, Plant-Based Diet|BEHAVIORAL: General Nutritional Counseling | Change in weight from baseline to 4 weeks post-randomization, All participates will be weighed at the baseline visit and at 4 weeks. A two-sample t-test will be used to compare the average change in weight (baseline weight minus 4-week weight)., Baseline; 4 weeks post-randomization | Change in levels of serum hsCRP from baseline to 4, 8, and 26 weeks post-randomization, hsCRP is being measured as a marker of inflammation. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of serum IL-6 from baseline to 4, 8, and 26 weeks post-randomization, IL-6 is being measured as a marker of inflammation. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of serum glucose from baseline to 4, 8, and 26 weeks post-randomization, Glucose is being measured as a marker of insulin resistance. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of serum leptin from baseline to 4, 8, and 26 weeks post-randomization, Leptin is being measured as a marker of metabolism. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of serum adiponectin from baseline to 4, 8, and 26 weeks post-randomization, Adiponectin is being measured as a marker of metabolism. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of serum direct LDL from baseline to 4, 8, and 26 weeks post-randomization, Direct LDL is being measured as a marker of cardiovascular risk. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of HDL from baseline to 4, 8, and 26 weeks post-randomization, HDL is being measured as a marker of cardiovascular risk. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of fasting triglycerides from baseline to 4, 8, and 26 weeks post-randomization, Fasting triglycerides are being measured as a marker of cardiovascular risk. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in levels of serum insulin from baseline to 4, 8, and 26 weeks post-randomization, Insulin is being measured as a marker of insulin resistance. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in FACT-P score as an indicator of quality of life from baseline to 4, 8, and 26, The FACT-P is a self-administered questionnaire that asks patients with prostate cancer about well-being in different aspects of life. It provides different statements and patients record how much they agree or disagree on a Likert scale. FACT-P scores will be calculated based on the participant responses to the questionnaire given at baseline, 4 weeks, 8 weeks, and 26 weeks. Scores can range from 0 to 156 with higher scores indicating a higher quality of life. Mean scores for all participants in each arm will be calculated and compared using a two-way ANOVA., Baseline; 4, 8, and 26 weeks post-randomization|Change in mean measures of body fat percentage, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization, All participants will receive a DEXA scan at baseline, 4 weeks, and 26 weeks to determine body fat percentage. Average body fat percentage will be calculated for each study arm and compared using a two-way ANOVA., Baseline; 4 weeks and 26 weeks post-randomization|Change in the diversity of the fecal microbiome from baseline to 4 and 26 weeks post-randomization, For the microbiome data obtained through 16S rRNA sequencing, DADA2 based approach will be used to generate the counts data for the amplicon sequence variants (ASVs). Taxonomy assignment will be based on commonly used reference databases. Alpha diversity such as the Shannon index will be calculated for each sample and summarized and evaluated similarly as other continuous endpoints. Between sample composition differences will be assessed based on beta diversity measures such as weighted/unweighted Unifrac and Bray-Curtis distances and evaluated using PERMANOVA type of approaches such as adonis. Differential abundance analysis will be carried out using DESeq2 or a non-parametric approach such as Wilcoxon signed rank test on the data with variance stabilizing transformation., Baseline; 4 weeks and 26 weeks post-randomization|Change in mean fat free body mass, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization., All participants will receive a DEXA scan at baseline, 4 weeks, and 26 weeks to determine fat free body mass. Average fat free body mass will be calculated for each study arm and compared using a two-way ANOVA., Baseline; 4 weeks and 26 weeks post-randomization|Change in mean body mass including fat, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization., All participants will receive a DEXA scan at baseline, 4 weeks, and 26 weeks to determine body mass including fat. Average body mass including fat will be calculated for each study arm and compared using a two-way ANOVA., Baseline; 4 weeks and 26 weeks post-randomization|Change in levels of hemoglobin A1c from baseline to 4, 8, and 26 weeks post-randomization, Hemoglobin A1C is being measured as a marker of insulin resistance. All participants will have a blood draw at baseline, and 4, 8, and 26 week visits. Serum marker levels will be measured in a CLIA-approved laboratory. Graphical displays will be used to illustrate the change in values over time for continuous measures. There will be a line for each patient. A different color will be used for each treatment group. The average at each timepoint for each group will be computed. A two-way ANOVA will be used (or Kruskal-Wallis test if more appropriate) will be used to determine whether there are changes in the measures over time as well as between groups. The first analysis will be to determine whether there is a significant interaction between time and treatment. Subsequent analyses will depend on whether the interaction is statistically significant or not. Effect sizes will be summarized with point estimates and 95% confidence intervals., Baseline; 4, 8, and 26 weeks post-randomization|Change in BMI from baseline to 4, 8, and 26 weeks post-randomization., Height (in meters) and weight (in kilograms) will be measured at baseline, 4 weeks, 8 weeks, and 26 weeks. BMI (kg/m\^2) will be derived from these measures. Average BMI will be calculated for each study arm and compared using a two-way ANOVA., Baseline; 4, 8, and 26 weeks post-randomization | Weill Medical College of Cornell University | Plantable Inc.|Prostate Cancer Foundation | MALE | ADULT, OLDER_ADULT | NA | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 20-07022346 | 2022-09-22 | 2025-02 | 2025-07 | 2022-07-22 | 2024-03-29 | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, 21231, United States|Weill Cornell Medicine, New York, New York, 10021, United States|Columbia University Medical Center, New York, New York, 10032, United States | |||
| NCT05465174 | Nivolumab and Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults | https://clinicaltrials.gov/study/NCT05465174 | PNOC029 | The current study assesses the tolerability and efficacy of combination therapy with PD-1 (nivolumab) and pan-RAF-kinase (Tovorafenib) inhibition for the treatment of children and young adults with craniopharyngioma. | NO | Craniopharyngioma, Child|Craniopharyngioma|Recurrent Craniopharyngioma | DRUG: Nivolumab|DRUG: Tovorafenib | Progression free survival rate (PFS), Progression-free survival is defined as the time of documented response until disease progression as defined by Response assessment in neuro-oncology criteria (RANO) criteria. PFS will be reported by overall group at 12 months., Up to 12 months|Changes in scores on the Physical functioning subscale of the Pediatric Quality of Life Inventory (PedsQL) over time, Scores over time from the PedsQL 4.0 Generic Core physical function domain rating form, which have multidimensional child self-report and parent proxy report scales to assess health-related quality of life (QOL) in children, adolescents, and young adults ages 2 – 25 years will be reported. Physical functioning, is the sub-scale of interest for this protocol. Items on the physical functioning sub-scale are scored on a 5-point Likert scale with raw scores ranging from 0- 4. Items are reversed scored and linearly transformed to a 0-100 scale. If more than 50% of the items in the scale are missing, the Scale Scores should not be computed. Higher scores indicate a higher level of physical functioning, Up to 12 months | Proportion of participants with visual deficits over time, Teller acuity testing using Teller Acuity Cards® (TAC) II will be performed on every time participants undergo a radiographic disease assessment. Visual acuity (VA) testing will be performed in each eye separately at a distance of 55 centimeters in all participants. The tester will use the “two down, one up” protocol to achieve the best VA score. Acuity will be reported in logarithm of the minimum angle of resolution (logMAR). Visual field testing will be performed by confrontation and reported as the number of quadrants (0, 1, 2, 3, or 4) with visual field deficits. Optic discs will be assessed for the presence or absence of pallor and edema.The proportion of participants with recorded visual deficits over time based on these assessments will be reported., Up to 5 years|Proportion of participants with neuroendocrine deficits, The proportion of participants with presence of new neuroendocrine deficits defined as hypothalamic obesity, diabetes insipidus, growth hormone deficiency, adrenal insufficiency from baseline will be reported., Up to 5 years | Sabine Mueller, MD, PhD | Bristol-Myers Squibb|Day One Biopharmaceuticals, Inc. | ALL | CHILD, ADULT | PHASE2 | 56 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 210828|NCI-2022-05356 | 2022-09-12 | 2027-03-01 | 2028-03-01 | 2022-07-19 | 2024-12-19 | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|Rady Children’s Hospital/University of California, San Diego, San Diego, California, 92037, United States|University of California, San Francisco, San Francisco, California, 94143, United States|Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois, 60611, United States|Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, 46202, United States|John Hopkins University, Baltimore, Maryland, 21218, United States|Dana-Farber/Boston Children’s Harvard Medical School, Boston, Massachusetts, 02215, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|Children’s Minnesota, Minneapolis, Minnesota, 55404, United States|St. Louis Children’s Hospital Washington University, Saint Louis, Missouri, 63110, United States|NYU Langone Health, New York, New York, 10016, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19103, United States|Texas Children’s Hospital / Baylor College of Medicine, Houston, Texas, 77030, United States|University of Utah, Salt Lake City, Utah, 84112, United States | |||
| NCT05414396 | Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities | https://clinicaltrials.gov/study/NCT05414396 | This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors. | NO | Diabetes Mellitus|Obesity-Related Malignant Neoplasm | BEHAVIORAL: Behavioral Intervention|OTHER: Questionnaire Administration | Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12, Attitudes and beliefs regarding causes of diabetes asked in questionnaire, measured by endorsing one of the Likert-type scale values ranging from 1 (Agree) to 7 (Disagree)., Baseline and week 12|Changes in behavior as measured by questionnaires from baseline to week 12, Behaviors related to food consumption asked in questionnaires, measured by endorsing one of “None”, “1”, “2-3”, “4-6”, “7 or more”., Baseline and week 12|Changes in height from baseline to week 12, Height measured in meters, Baseline to 12 weeks|Changes in weight from baseline to week 12, Weight measured in Kilograms, Baseline to 12 weeks|Changes in waist circumference from baseline to week 12, Hip circumference measured in centimeters, Baseline to 12 weeks|Changes in chest circumference from baseline to week 12, Chest circumference measured in centimeters, Baseline to 12 weeks|Changes in right upper arm circumference from baseline to week 12, Right upper arm circumference measured in centimeters, Baseline to 12 weeks|Changes in left upper arm circumference from baseline to week 12, Left upper arm circumference measured in centimeters, Baseline to 12 weeks|Changes in right upper thigh circumference from baseline to week 12, Right upper thigh circumference measured in centimeters, Baseline to 12 weeks|Changes in left upper thigh circumference from baseline to week 12, Left upper thigh circumference measured in centimeters, Baseline to 12 weeks|Changes in body fat percentage from baseline to week 12, Body fat percentage measured in percent using a handheld BMI machine that calculates body fat percentage., Baseline to 12 weeks|Changes in systolic blood pressure from baseline to week 12, Systolic blood pressure measured in mmHG, Baseline to 12 weeks|Changes in diastolic blood pressure from baseline to week 12, Diastolic blood pressure measured in mmHG, Baseline to 12 weeks|Changes in hip circumference from baseline to week 12, Hip circumference measured in centimeters, Baseline to 12 weeks|Changes in biomarkers, Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines., Baseline to 12 weeks | City of Hope Medical Center | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 347 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 17410|NCI-2022-00180|17410|P30CA033572 | 2018-03-20 | 2025-06-02 | 2025-06-02 | 2022-06-10 | 2024-12-31 | City of Hope Medical Center, Duarte, California, 91010, United States | |||||
| NCT05410574 | Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia | https://clinicaltrials.gov/study/NCT05410574 | A single-arm, non-randomized four-month trial of the adapted family-based behavioral weight loss treatment (FBT) intervention will be conducted to evaluate its acceptability, feasibility, and preliminary indications of efficacy including measures of relative weight change and associated secondary outcomes (e.g., weight related health behaviors, health related quality of life), among 40 childhood acute lymphoblastic leukemia (ALL) survivors and their families. | NO | Acute Lymphoblastic Leukemia | BEHAVIORAL: Family-based Behavioral Weight Loss Treatment | Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM), -4 questions about acceptability of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher acceptability of the intervention measure., At completion of intervention (estimated to be at 4 months)|Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM), -4 questions about appropriateness of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher appropriateness of the intervention measure., At completion of intervention (estimated to be at 4 months)|Acceptability of Family-Based Behavioral Treatment as measured by the Client Satisfaction Questionnaire (CSQ-8), -8 questions asking about satisfaction of intervention. The CSQ-8 offers four response options for each item (1-4) and an overall score is calculated by summing the respondent’s rating score for each item. Scores range from 8-32 with higher scores indicating higher satisfaction., At completion of intervention (estimated to be at 4 months)|Feasibility of Family-Based Behavioral Treatment as measured by Feasibility of Intervention Measure (FIM), -4 questions about feasibility of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher feasibility of the intervention measure., At completion of intervention (estimated to be at 4 months) | Change in relative height (children only), Baseline, end of intervention (at 4 months), 6 months, and 12 months|Change in dietary intake, -Two assisted 24-hour dietary recalls encompassing one weekday and one weekend day and guided by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) will be completed for each participant. This data will be used to measure dietary quality according to the Healthy Eating Index (HEI). The HEI includes a total score as well as sub scores for items such as total fruit intake, whole fruit intake, and total vegetable intake. Total score and sub-scores will be presented., Baseline, end of intervention (at 4 months), 6 months, and 12 months|Change in relative weight, Baseline, end of intervention (at 4 months), 6 months, and 12 months|Change in physical activity as measured by HBSC adaptation, -Self- (for children 10+ years) and parent-reported physical activity behavior will be collected via an adapted version of the Health Behavior in School Age Children survey. This three-question survey assesses the amount of time spent on moderate to vigorous physical activity and sedentary behaviors., Baseline, end of intervention (at 4 months), 6 months, and 12 months|Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short), -The IPAQ measures duration and frequency of activity over the past seven days. An overall score can be calculated, as well as sub-scores for moderate- and vigorous-intensity activity, Baseline, end of intervention (at 4 months), 6 months, and 12 months | Washington University School of Medicine | ALL | CHILD, ADULT, OLDER_ADULT | NA | 17 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 202205124 | 2022-07-22 | 2023-07-31 | 2024-03-26 | 2022-06-08 | 2024-05-03 | Washington University School of Medicine, Saint Louis, Missouri, 63110, United States | |||||
| NCT05410353 | Choosing Healthy Activities and Lifestyle Management Through Portal Support | https://clinicaltrials.gov/study/NCT05410353 | CHAMPS | The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD\* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for underserved groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group. \*The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE). | NO | Weight Loss|Overweight and Obesity|Behavior, Health | BEHAVIORAL: Active Intervention Group|BEHAVIORAL: Comparison Group | Relative percentage change in weight, This is calculated for each follow-up visit as ((weight at FU visit – baseline weight) / (baseline weight)) × 100%., 12 months | Relationship of social determinants of health (screening tool) with weight change over time, How social determinants of health, assessed via the Social Needs Screening Tool, relate to patient success with weight loss, 12 months|Relationship of social determinants of health (BRFSS) with weight change over time, How social determinants of health, assessed via the Social Determinants of Health Questions Adapted from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 Questionnaire, relate to patient success with weight loss, 12 months|Relationship of social determinants of health (z codes) with weight change over time, How social determinants of health, assessed using z codes for Social Determinants of Health constructs abstracted from the Electronic Health Record using ICD -10 codes, relate to patient success with weight loss, 12 months | University of Tennessee | National Cancer Institute (NCI) | ALL | CHILD, ADULT, OLDER_ADULT | NA | 250 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 20-07328-FB|5R01CA267643-03 | 2023-02-24 | 2026-12-31 | 2026-12-31 | 2022-06-08 | 2024-12-16 | University of Tennessee Health Science Center / Department of Preventive Medicine, Memphis, Tennessee, 38105, United States | |||
| NCT05398783 | A Natural History Study of Metabolic Sizing in Health and Disease | https://clinicaltrials.gov/study/NCT05398783 | Background: Scientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism. Objective: This natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people. Eligibility: Healthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer. Design: Participants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet. Participants will undergo many tests: They will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath. They will lie on a padded table for about 15 minutes while their body is scanned. They will stand on a platform while a 3D scanner measures their body. They will have a test to measure how fast an electric signal moves through their body. They will grip an instrument to measure the strength of their hands. They will drink salty water and provide blood and urine samples. Participants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart. | NO | Metabolic Disorders|Cancer|Chronic Kidney Disease|Diabetes|Normal Physiology | Increase in R^2, Increase in R2 when measured BSA is added to equations predicting REE, Per study visit|Mean difference and limits of agreement between measured and predicted BSA, Mean difference and limits of agreement between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight, Per study visit | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ALL | CHILD, ADULT, OLDER_ADULT | 2000 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 10000617|000617-DK | 2022-10-25 | 2031-07-01 | 2031-07-01 | 2022-06-01 | 2024-12-16 | National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States | ||||||||
| NCT05396794 | Bariatric Education for Women With Obesity and Endometrial Cancer | https://clinicaltrials.gov/study/NCT05396794 | SCC-BAREDU | The purpose of this study is to examine whether a standardized video education tool will improve knowledge regarding obesity and bariatric surgery and increase bariatric surgery referrals for obese women with endometrial cancer. | NO | Obesity|Endometrial Cancer|Bariatric Surgery Candidate | BEHAVIORAL: Standard weight loss education|BEHAVIORAL: Standard weight loss education + Educational Video | Proportion of patient’s obesity relevant knowledge pre- and post-education intervention, Proportion of patient will complete a pre and post (6 months after enrollment) survey to examine the knowledge of obesity, endometrial cancer and bariatric surgery. These measures will be self-reported 6 months after the patient was educated on the benefits of weight loss., 6 Months|Proportion of patients who chose to take part in bariatric surgery., Based on these pre-and post-educational surveys patient’s decision to participate or to decline the bariatric surgery referral will be recorded, including the patients experience with bariatric surgery program., 6 Months | University of Oklahoma | FEMALE | ADULT, OLDER_ADULT | 80 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | OU-SCC-BAREDU | 2023-08-30 | 2025-08 | 2026-08 | 2022-05-31 | 2024-08-05 | Stephenson Cancer Center, Oklahoma City, Oklahoma, 73117, United States | ||||||
| NCT05396846 | My Best GI Eating Study | https://clinicaltrials.gov/study/NCT05396846 | The MyBestGI study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps. The study website is www.MyBestGI.org . Participants in the study will be asked to follow one of three eating plans, as best they can, for 12 months. Study participants can choose the foods they prefer within healthy food groups. Two of the eating plans involve ten brief telephone support calls and use of a web-based app (MyBestGI App). The study primarily evaluates improvements in eating and any weight change that may result. Secondary goals for the research are to evaluate how changes in eating affect metabolic pathways. All study participants will receive written materials that encourage making room for preventive foods in your daily eating. All participants also receive the results of their own diet analyses, and results of their own measures at study visits. The measures are the Veggie Meter skin reflectance test, Ketoscan breath test, and body composition measures. Study visits also involve providing a small blood sample from the arm. Study visits are in Ann Arbor at the start of the study, and at 6 and 12 months. The long-term goal of this research is to provide better options for supporting individuals who seek to achieve and maintain a preventive style of eating. | NO | Colorectal Neoplasms | BEHAVIORAL: Eating Plan 1|BEHAVIORAL: Eating Plan 2|BEHAVIORAL: Eating Plan 3 | Preventive Food Score, a score of 10 dietary components (0-10, with 10 being the most optimal score), Change over 12 months|Weight Loss, change in weight from baseline (in pounds), Change over 12 months | Breath Ketone Concentration, Ketoscan measure, Change over 12 months|Skin Carotenoids, Veggie Meter reading, Change over 12 months | University of Michigan | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 240 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH | HUM00197337|R01CA255743 | 2023-06-13 | 2026-09 | 2026-09 | 2022-05-31 | 2024-04-16 | University of Michigan, Ann Arbor, Michigan, 48109, United States | ||||
| NCT05389332 | A Mobile Health Intervention Among Hispanics | https://clinicaltrials.gov/study/NCT05389332 | Hypothesis: More than 80% of the participants (n=40) will complete the intervention at three month (intervention completion) and the six month follow-up (retention rate as feasibility). More than 70% of the participants will report high overall study satisfaction (acceptability) with the intervention and study. This pre-pilot will inform intervention and procedural refinements for the pilot. Hypothesis: Participants who receive the intervention (n=57) will report more skin cancer-related preventive behaviors (e.g., mean of summed score of sun protection behaviors such as use of sunscreen, etc.) at three month and six month follow-up compared to those in the control condition (n=57, who will receive general information about physical activity and nutrition). | NO | Cancer of Skin | BEHAVIORAL: Hispanics Skin Cancer intervention|BEHAVIORAL: Control group: physical activity and nutrition for Hispanics | Sun protection behavior by self-report, Mean score of use sunscreen with an SPF 30 or higher, seek shade, wear protective clothing, wear wide-brimmed hat, wear sunglasses, The change is being assessed at baseline, three month and six month follow-up intervals | Seek shade behavior by self-report, Seek shaded areas, The change is being assessed at baseline, three month and six month follow-up intervals|Wear protective clothing behavior by self-report, Wear protective clothing, The change is being assessed at baseline, three month and six month follow-up intervals|Wear wide-brimmed hat behavior by self-report, Waer a wide brim hat, The change is being assessed at baseline, three month and six month follow-up intervals|Wear sunglasses behavior by self-report, Wear sunglasses, The change is being assessed at baseline, three month and six month follow-up intervals|Skin self-examination, Skin examination by oneself, Changes at baseline, three month and six month follow-up intervals|Skin examination by a health care professional, skin examination by a health care professional, Changes at baseline, three month and six month follow-up intervals | Rutgers, The State University of New Jersey | ALL | ADULT, OLDER_ADULT | NA | 114 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 132206|Pro2022000533 | 2025-04-15 | 2026-09-30 | 2026-09-30 | 2022-05-25 | 2024-12-17 | Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, 08901, United States | |||||
| NCT05386719 | Cardiometabolic Screening Program | https://clinicaltrials.gov/study/NCT05386719 | This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management. | NO | Breast Cancer|Early-stage Breast Cancer | OTHER: Prescreening|OTHER: Screening and Enrollment|BEHAVIORAL: Baseline|BEHAVIORAL: Interpret BMI|OTHER: Interpret HbA1c|OTHER: Interpret lipid panel and assess other risk factors|BEHAVIORAL: Assess 10 year risk of cardiovascular event|BEHAVIORAL: Recommendations|BEHAVIORAL: Follow-Up | Prevalence of prediabetes, The proportion of women with early stage breast cancer who have prediabetes: The number is determined through medical history, laboratory results, and baseline survey. Prevalence of prediabetes, will be estimated with an exact 95% confidence interval., 3 years|Prevalence of diabetes, The proportion of women with early stage breast cancer who have diabetes: The number is determined through medical history, laboratory results, and baseline survey. Prevalence of diabetes, will be estimated with an exact 95% confidence interval., 3 years|Prevalence of hyperlipidemia, The proportion of women with early stage breast cancer with hyperlipidemia as determined by medical history and laboratory results. Prevalence of hyperlipidemia will be estimated with an exact 95% confidence interval., 3 years|Change in HbA1c, The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline., Baseline, 6 months, 12 months|Change in LDL cholesterol, The percent change in LDL cholesterol (mg/dL) laboratory results at 6 and 12 months compared to baseline., Baseline, 6 months, 12 months|Prevalence of obesity/ overweight, The proportion of women with early stage breast cancer with BMI \>/= 25kg/mg squared. Body Mass Index (BMI) as recorded in participant electronic medical record will be evaluated to determine the percent change in Body Mass Index from baseline at 6 and 12 months., Baseline, 6 months, 12 months|Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30, Participants will complete the Quality of Life Questionnaire C30 The Quality of Life Questionnaire-C30, which includes 30 items. The 30 items assess physical, role, emotional, cognitive and social functioning, global health status or Quality Of Life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. The Quality of Life Questionnaire-C30 is scored on the basis of classical test theory (CTT), and uses the total item score as the scale score. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). The percent change in Patient Reported Outcome scores from baseline is accessed at 6 months and 12 months., Baseline, 6 months, 12 months|Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23, Participants to complete the EORTC Quality of Life Questionnaire-BR23. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23 has demonstrated validity and reliability as a quality of life questionnaires specific for breast cancer. The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss. The scoring approach for the QLQ-BR23 is identical to QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state). The percent change in scores from baseline is assessed at 6 months and 12 months., Baseline, 6 months, 12 months | Cardiovascular risk factors (tobacco use), The cardiovascular risk factor of tobacco use will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factor will be summarized descriptively., 3 years|Cardiovascular risk factors (family history), The cardiovascular risk factor of family history will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factor will be summarized descriptively., 3 years|Cardiovascular risk factors (hypertension), The cardiovascular risk factor of hypertension will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factors will be summarized descriptively., 3 years|Referrals for individuals with pre-diabetes, Total number of individuals with (prediabetes) referred to established institutional programs and resources. The number of referrals overall, by disease type, and per patient will be summarized descriptively., 3 years|Referrals for individuals with diabetes, Total number of individuals with diabetes referred to established institutional programs and resources. The number of referrals overall, by disease type, and per patient will be summarized descriptively., 3 years|Referrals for individuals with risk of cardiovascular disease, Total number of individuals with risk factors for cardiovascular disease referred to established institutional programs and resources. The number of referrals by disease type, and per patient will be summarized descriptively., 3 years|Prevalence of prediabetes in women with breast cancer versus healthy individuals, Compare the prevalence of prediabetes in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of prediabetes to the observed number in The investigators’ cohort, adjusting for age and race., 3 years|Prevalence of diabetes in women with breast cancer versus healthy individuals, Prevalence of of diabetes in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of diabetes to the observed number in The investigators’ cohort, adjusting for age and race., 3 years|Prevalence of hyperlipidemia in women with breast cancer versus healthy individuals, Prevalence of hyperlipidemia in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of hyperlipidemia to the observed number in The investigators cohort, adjusting for age and race., 3 years | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ALL | ADULT, OLDER_ADULT | NA | 450 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING | J21125|IRB00285627 | 2022-06-03 | 2025-06-01 | 2027-06-01 | 2022-05-23 | 2024-06-20 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-1000, United States | |||||
| NCT05351164 | Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL) | https://clinicaltrials.gov/study/NCT05351164 | Patients (homozygous MFN2 \[gene that provides instructions to produce the Mitofusin 2 protein\] R707W) will be treated with Metreleptin, and effects on body composition, metabolic parameters and safety will be assessed over a 6 month intervention period. Additional safety will be assessed for 1 more year (up to 1.5 years total) in which adverse event data will be collected. | NO | Lipomatosis, Multiple Symmetrical | DRUG: Metreleptin | Change in truncal adiposity, Measured using a Dual-energy X-ray absorptiometry (DEXA) scan, Baseline, Week 24|Change in total adiposity, Measured using a Dual-energy X-ray absorptiometry (DEXA) scan, Baseline, Week 24 | University of Michigan | Amryt Pharma | ALL | CHILD, ADULT | PHASE2 | 4 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | HUM00206598 | 2023-08-01 | 2024-04-08 | 2025-04 | 2022-04-28 | 2024-04-19 | University of Michigan, Ann Arbor, Michigan, 48109, United States | |||||
| NCT05315908 | COVID-19 Testing in Underserved and Vulnerable Populations | https://clinicaltrials.gov/study/NCT05315908 | As part of National Institutes of Health Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program, the goal of the RADxUP study is to develop, test, and evaluate a rapid, scalable capacity building project to enhance COVID-19 testing in three regional community health centers (CHCs) in San Diego County, California. In collaboration with CHC partners, their consortium organization, Health Quality Partners (HQP), investigators are pursuing the following Specific Aims: 1) Compare the effectiveness of automated calls vs text messaging for uptake of COVID-19 testing among asymptomatic adult patients with select medical conditions and those 65 years of age and older receiving care at participating CHCs. Secondarily, investigators will invite all study participants to receive flu vaccination and will assess feasibility and acceptability of study participants to refer adult family household members who are essential workers for COVID-19 testing. 2) Gather patient, provider, CHC leadership, and community stakeholder insights to establish best practices for future scale-up of COVID-19 testing sustainability and vaccination. | YES | Heart Failure|Coronary Artery Disease|Cancer|Chronic Kidney Diseases|COPD|Obesity|Sickle Cell Disease|Diabetes Mellitus, Type 2 | OTHER: Community outreach method | Percentage of Tested Patients, The percentage of patients who undergo testing within one month of initial contact (automated call vs text messaging) and by the end of the study period (to consider individuals who could not come to the clinic within one month), 1 month|Number (%) Tested (Total and by Clinic), Number (%) of patients who complete COVID-19 test (total and by clinic), 1 month|Number (%) Infected (Total and by Clinic), Number (%) of patients with positive COVID-19 test (total and by clinic), 1 month|Timeliness of Testing, From time of contact to testing, 1 month | Number Vaccinated With Flu Vaccine, Number of patients who receive flu vaccine, 1 month|Proportion of Patients Who Refer for Testing, The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing, 1 month|Number of Household Members Referred for Testing, The number of household members referred for COVID-19 testing, 1 month | Jesse Nodora | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 9120 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER | 201505|3UH3CA233314-02S1 | 2020-11-01 | 2021-11-15 | 2021-11-15 | 2022-04-07 | 2024-02-28 | 2024-02-28 | University of California, San Diego, La Jolla, California, 92093, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/08/NCT05315908/Prot_SAP_000.pdf | ||
| NCT05265715 | A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT05265715 | The scientific premise for this study is the known impact of overweight/obesity on breast cancer risk and outcomes, the association between advanced glycation end-products (AGE) and high fat, highly processed foods common in Western diets, and the preclinical evidence suggesting a link between AGE and breast cancer independent of weight. The association between dietary and serum AGE in breast cancer survivors and prognosis has not been previously evaluated. However, preclinical studies suggest that AGE may represent a novel, lifestyle-linked, modifiable, prognostic biomarker, which could be targeted through lifestyle (diet and exercise) and/or pharmaceutical interventions to improve breast cancer prognosis. The proposed study will pave the way for a large scale randomized controlled trial to evaluate the impact of a low AGE diet on weight (BMI), known (IL-6 and CRP) and novel (AGE and RAGE) prognostic biomarkers, and ultimately on breast cancer prognosis. | NO | Breast Cancer | OTHER: Low AGE diet|PROCEDURE: Research blood draw | Feasibility as measured by adherence rate, * Feasibility is a defined adherence rate of at least 80% of participants enrolled * Diet adherence will be categorized by the study dietitian at the end of the study and before the results of AGEs in serum or any analysis of outcomes to avoid bias. Following each phone session with the participants, the dietitian will elicit answers to the following question: since the last call did the participant use any cooking methods they were advised to avoid for certain food items? (yes/no). * The information will be used to calculate an adherence score. Adherence score is % phone calls of patient’s report for full maintaining instructions to reduce AGEs. * Very high adherence= ≥80%; good adherence= 60-80%; partial adherence= 40-60%; lack of adherence but intention to adhere more in the future= ≤40%; lack of adherence and no intention to adhere more= ≤40%, At study completion for all enrolled participants (estimated to be 15 months)|Feasibility as measured by dropout rate, -Feasibility is defined as a dropout rate of less than 20% of participants enrolled, At study completion for all enrolled participants (estimated to be 15 months) | Change in dietary AGE, -Dietary AGE is estimated based on analysis of the 3 day food record patients will complete at baseline and study completion. A specific dietary AGE value will be assigned to each item on the 3 day food recall by consultant and dietary AGE expert Jaime Uribarri, MD. This value is based on his published dietary AGE database which accounts for type of food, portion size and cooking methods., At baseline and study completion (24 weeks)|Change in serum AGE, * Blood specimens for serum AGE analysis will be shipped from the University of San Diego Biorepository to the Medical University of South Carolina to be analyzed in the lab of study team member and expert AGE analyst, Dr. David Turner. * AGE (measured by the AGE metabolite carboxymethyllysine (ug/ml)) will be assessed in serum using commercially available 96-well format ELISA’s and ROS detection kits (Cell Biolabs). Nε-carboxymethyllysine (CML) is an AGE metabolite extensively studied in animal models of disease and with regard to food content., Baseline, week 12, and week 24|Correlation between serum AGE levels and BMI, -The relationship between serum AGE levels and BMI will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between serum AGE levels and serum CRP, -The relationship between serum AGE levels and serum CRP will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between serum AGE levels and IL6, -The relationship between serum AGE levels and IL6 will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between serum AGE levels and glucose, -The relationship between serum AGE levels and glucose will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between serum AGE levels and leptin, -The relationship between serum AGE levels and leptin will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between serum AGE levels and adiponectin, -The relationship between serum AGE levels and adiponectin will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between dietary AGE and BMI, -The relationship between dietary AGE and BMI will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between dietary AGE and serum CRP, -The relationship between dietary AGE and serum CRP will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between dietary AGE and IL6, -The relationship between dietary AGE and IL6 will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between dietary AGE and insulin, -The relationship between dietary AGE and insulin will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between dietary AGE and glucose, -The relationship between dietary AGE and glucose will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between dietary AGE and leptin, -The relationship between dietary AGE and leptin will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks|Correlation between dietary AGE and adiponectin, -The relationship between dietary AGE and adiponectin will be assessed using rank based correlation., Baseline, 12 weeks, and 24 weeks | Washington University School of Medicine | American Cancer Society, Inc. | FEMALE | ADULT, OLDER_ADULT | NA | 14 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 202201100 | 2022-10-14 | 2024-03-22 | 2024-03-22 | 2022-03-03 | 2025-01-08 | Washington University School of Medicine, Saint Louis, Missouri, 63110, United States | ||||
| NCT05210049 | Non-endoscopic Esophageal Sampling to Detect Barrett’s Esophagus and Esophageal Cancer in Veterans | https://clinicaltrials.gov/study/NCT05210049 | This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper endoscopy and increases the detection of Barrett’s esophagus and esophageal cancer. | NO | Barrett Esophagus|GERD|Obesity|Esophageal Cancer | DIAGNOSTIC_TEST: Esocheck/Esoguard | Sensitivity and Specificity of Esocheck/Esoguard in a Veteran population, The accuracy of a test which reports the presence or absence of a condition, in comparison to a ‘Gold Standard’, Through study completion, up to 2.5 years | Number/percentage of screened patients with diagnosis of Barrett’s esophagus and/or esophageal adenocarcinoma, Compare diagnostic yield of EGD to diagnostic yield of Esocheck/Esoguard in Veterans, Through study completion, up to 2.5 years|Cost of two screening strategies, Compare the cost of screening all enrolled patients by EGD alone vs. cost of selective screening by EGD in patients who have had a positive Esocheck/Esoguard test, Through study completion, up to 2.5 years | Cleveland VA Medical Research and Education Foundation | United States Department of Defense | ALL | ADULT, OLDER_ADULT | NA | 125 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING | 1641950-1 | 2022-03-01 | 2024-08-31 | 2024-08-31 | 2022-01-27 | 2022-12-15 | Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, 44016, United States | ||||
| NCT05193149 | Inspiratory Muscle Training in Obese Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT05193149 | IMOCS | The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors. | NO | Cancer Survivors|Obesity|Breast Cancer | BEHAVIORAL: Inspiratory muscle training|BEHAVIORAL: Exercise training | Change in exercise tolerance, Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes., Baseline to 4 weeks|Change in exercise tolerance, Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes., Baseline to 16 weeks | Change in inspiratory muscle strength, Continuous variable, Maximal inspiratory pressure. Units: cm H20, Baseline to 4 weeks|Change in inspiratory muscle strength, Continuous variable, Maximal inspiratory pressure. Units: cm H20, Baseline to 16 weeks|Change in inspiratory muscle endurance, Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min, Baseline to 4 weeks|Change in inspiratory muscle endurance, Continuous variable, Maximal voluntary ventilation in 12 seconds. Units: L/min, Baseline to 16 weeks|Change in exercise capacity, Continuous variable, peak oxygen uptake. Units: L/min, Baseline to 4 weeks|Change in exercise capacity, Continuous variable, peak oxygen uptake. Units: L/min, Baseline to 16 weeks|Change in dyspnea, Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4, Baseline to 4 weeks|Change in dyspnea, Continuous variable, mMRC dyspnea scale score. Units: score 0 to 4, Baseline to 16 weeks|Change in fatigue, Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52, Baseline to 4 weeks|Change in fatigue, Continuous variable, FACIT:F version 4 total score. Units: score 0 to 52, Baseline to 16 weeks | Ohio State University Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 78 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | OSU-22220 | 2023-11-13 | 2028-06-30 | 2029-06-30 | 2022-01-14 | 2024-12-31 | The Ohio State University, Columbus, Ohio, 43210, United States | ||||
| NCT05114798 | Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers | https://clinicaltrials.gov/study/NCT05114798 | Approximately 42% of American adults are obese, and this condition is strongly related to the development of colorectal cancer. Innovative lifestyle strategies to treat obesity and reduce colorectal cancer risk are critically needed. This research will demonstrate that time-restricted eating, a type of intermittent fasting, is an effective therapy to help obese individuals reduce and control their body weight and prevent the development of colorectal cancer. | NO | Time Restricted Eating|Obesity|Weight Loss|Colorectal Cancer | BEHAVIORAL: Time restricted eating|BEHAVIORAL: Calorie Restriction | Weight change (% kg), Body weight in kg, Baseline to month 6 | Total and regional body fat composition and distribution, Total and regional body fat composition and distribution will be measured via whole body DEXA scan, Baseline, 6 month and 12 month|Intervention adherence, Measured through electronic diet records and 24 hour dietary recalls, Monthly, through month 6|Fasting plasma glucose, From fasting venous blood measured by a commercial lab, Baseline, month 3, month 6, month 9, month 12|Plasma cytokines TNF-α, IL-6, IL1-β, and IL-10, %, Multiplex ELISA, Baseline, month 3, month 6, month 9, month 12|Plasma 8-isoprostane, ELISA, Baseline, month 3, month 6, month 9, month 12|Colonic mucosa gene expression profiling, Commercially available targeted transcriptomics platform, Baseline, month 6, month 12|Ki-67, proliferation, Healthy colonic mucosa, immunohistochemistry, Baseline, month 6, month 12|c-caspase-3, Bax, apoptosis, Healthy colonic mucosa, immunohistochemistry,, Baseline, month 6, month 12|CD3, CD163, pIKKa/b, tissue markers of inflammation, Healthy colonic mucosa, immunohistochemistry, Baseline, month 6, month 12|Weight maintenance (% kg), Maintenance of weight loss, Month 6 to month 12|Fasting plasma insulin, From fasting venous blood measured at a commercial lab, Baseline, month 3, month 6, month 9, month 12|HOMA-IR, calculated from fasting glucose and insulin using a standard formula, Baseline, month 3, month 6, month 9, month 12|Gut Microbiome, Shotgun metagenomics, Baseline, month 3 and month 6|Fecal Metabolites, Untargeted Metabolomics, Baseline, month 3 and month 6|Saliva microbiota, Untargeted Metabolomics, Baseline, month 3, month 6 | University of Illinois at Chicago | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 255 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 2020-1627|1R01CA257807 | 2022-05-17 | 2026-07 | 2026-09 | 2021-11-10 | 2024-05-09 | University of Illinois at Chicago, Chicago, Illinois, 60612, United States | ||||
| NCT05113485 | UCLA Breast Cancer Survivor Health Promotion Research Study | https://clinicaltrials.gov/study/NCT05113485 | Pilot randomized controlled parallel group behavior change comparative effectiveness trial involves 30 breast cancer survivors interested in losing excess body fat. Both interventions include dietary + exercise prescriptions that hold promise for reducing the survivors’ risk of cancer recurrence. Both interventions are consistent with the Dietary Guidelines for Americans but the Diabetes Prevention Program (DPP)-based approach focuses on weight loss through calorie restriction and increased physical activity while the Highly Microbiota-Accessible Foods (HMAFs) approach is intended to be a low-numeracy version of a Mediterranean-style diet and increased physical activity. The DPP approach is considered to be a high-numeracy intervention because it requires that consumers keep track of all calories consumed and expended per day and to endeavor to maintain a calorie deficit each day during the active weight loss phase. For both conditions, the 12 to 13-week intervention includes 2 virtual home visits, 2 virtual group education sessions and 7 telephone or Zoom-based coaching sessions by well-trained intervenors. Assessments occur at baseline and six months, with systemic inflammation (high sensitivity C-reactive protein) being the primary outcome measure and visceral fat being a secondary outcome. Other prespecified secondary outcomes include gut microbiota alpha-1 diversity, insulin resistance, HDL-cholesterol, daily count of highly microbiota-accessible foods, waist circumference, BMI, systolic blood pressure, ratio of fecal Proteobacteria to short chain fatty acid-generating bacteria and health-related quality of life. | NO | Breast Cancer | BEHAVIORAL: Diabetes Prevention Program-based lifestyle change intervention (DPP)|BEHAVIORAL: Highly Microbiota-Accessible Foods (HMAFs) intervention | High-sensitivity C-Reactive Protein (CRP), CRP is commonly used by researchers as a biomarker for systemic inflammation., Change from baseline to 6 months follow-up | Visceral fat as assessed by DXA, Visceral fat is also known as intra-abdominal fat. It is located inside the peritoneal cavity, packed in between internal organs and torso. It is the most metabolically active adipose tissue and positively associated with systemic inflammation., Change from baseline to six months follow-up|Shannon index of alpha diversity of fecal microbial species, Fecal DNA from the V4 region of the 16S ribosomal RNA will be amplified, sequenced and filtered for quality before statistical analysis. The Shannon index measures both gene richness and evenness., Change from baseline to six months follow-up|Number of highly microbiota-accessible foods consumed per day, From participants’ 24-hour diet recalls – The daily sum of different carbohydrate-rich food sources minimally processed and unaccompanied by pro-inflammatory components, especially saturated fat and added sugar., Change from baseline to six months follow-up | Insulin resistance, Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) is a recognized measure of insulin resistance, calculated from fasting glucose and fasting insulin values, Change from baseline to six months follow-up|Waist circumference, Waist circumference is measured via non-stretchable measuring tape around the waist at a midpoint between the lowest rib and the iliac crest, upon breath exhalation., Change from baseline to six months follow-up|Body mass index (BMI), Height measured via wall-mounted stadiometer and weight measured via calibrated digital scale will be used to compute BMI ((kg/(m x m)), Change from baseline to six months follow-up|Systolic blood pressure (mm), Regularly calibrated digital sphygmomanometer will be used to assess the participant’s resting systolic blood pressure in millimeters of mercury, Change from baseline to six months follow-up|Ratio of abundance of fecal Proteobacteria to fecal short chain fatty acid-generating bacteria, Fecal DNA from the V4 region of the 16S ribosomal RNA will be amplified, sequenced and filtered for quality before statistical analysis. The ratio of fecal Proteobacterial abundance to the abundance of short-chain fatty acid-generating fecal microbes is expected to be reduced in healthier guts., Change from baseline to six months follow-up|Health-related quality of life, RAND Short Form-20 (SF-20) is recognized instrument for assessing participants’ health-related quality of life. Minimum score = 0; maximum score = 100. Higher scores represent higher quality of life., Change from baseline to six months follow-up|HDL-cholesterol, Fasting serum HDL-cholesterol concentration expected to reflect the experimental differences in dietary patterns. Serum triglycerides will be generated as part of a standard lipid panel., Change from baseline to six months follow-up | University of California, Los Angeles | FEMALE | ADULT, OLDER_ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | B27IB3856 | 2022-04-01 | 2023-01 | 2023-06 | 2021-11-09 | 2022-04-11 | UCLA Center for Cancer Prevention & Control Research, Los Angeles, California, 90095-6900, United States | ||||
| NCT05094466 | Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families | https://clinicaltrials.gov/study/NCT05094466 | This clinical trial compares the effects of parent/caregiver-focused programs to family-focused programs in reducing obesity risk in racial ethnic minority families. Obesity tends to run in families, thus family-based interventions have been strongly recommended. Parent and family obesity programs may reduce obesity risk and ultimately reduce the risk of obesity-related cancer. | NO | Obesity-Related Malignant Neoplasm | BEHAVIORAL: Behavioral Intervention|OTHER: Counseling|PROCEDURE: Discussion|OTHER: Educational Intervention|OTHER: Informational Intervention|OTHER: Interview | The correlation between the feasibility of the Parent and Family obesity interventions., Up to 4 years|The correlation between the acceptability of the Parent and Family obesity interventions., Up to 4 years | M.D. Anderson Cancer Center | ALL | CHILD, ADULT, OLDER_ADULT | NA | 120 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2017-0557|NCI-2021-09374|2017-0557 | 2019-07-16 | 2027-02-02 | 2027-02-02 | 2021-10-26 | 2024-07-30 | M D Anderson Cancer Center, Houston, Texas, 77030, United States | ||||||
| NCT05082519 | Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL | https://clinicaltrials.gov/study/NCT05082519 | IDEAL2 | This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight. This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient’s ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient’s leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month. | NO | B-cell Acute Lymphoblastic Leukemia|Obesity | BEHAVIORAL: IDEAL2 Intervention | EOI MRD positivity >= 0.01%, To compare the rate of MRD \>=0.01% at end of induction between experimental arm and control arm, Prior to day 5 until end of induction (~day 35 from start of chemotherapy)|Change in fat mass, To compare the % change in fat mass from baseline to end of induction between the experimental arm and control arm, Prior to day 5 until end of induction (~day 35 from start of chemotherapy) | Proportion of patients with >=75% adherence to diet intervention, To assess the self-reported adherence to the diet component of the IDEAL2 intervention, Prior to day 5 until end of induction (~day 35 from start of chemotherapy)|Proportion of patients with >=75% adherence to exercise intervention, To assess the self-reported adherence to the exercise component of the IDEAL2 intervention, Prior to day 5 until end of induction (~day 35 from start of chemotherapy) | Etan Orgel | Therapeutic Advances in Childhood Leukemia Consortium | ALL | CHILD, ADULT | PHASE2 | 240 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | T2020-003 | 2022-03-12 | 2026-10-15 | 2031-10-15 | 2021-10-19 | 2023-10-26 | Children’s Hospital Los Angeles, Los Angeles, California, 90027, United States|Children’s Hospital Orange County, Orange, California, 92868, United States|UCSF School of Medicine, San Francisco, California, 94158, United States|Colorado Children’s Hospital, Denver, Colorado, 80045, United States|Children’s Healthcare of Atlanta at Egleston, Atlanta, Georgia, 30322, United States|Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois, 60611, United States|Johns Hopkins / Sydney Kimmel Cancer Center, Baltimore, Maryland, 21231, United States|C.S. Mott University of Michigan, Ann Arbor, Michigan, 48109, United States|Children’s Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, 55404, United States|Columbia University Medical Center, New York, New York, 10032, United States|Levine Children’s Hospital, Charlotte, North Carolina, 28203, United States|Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Nationwide Children’s Hospital, Columbus, Ohio, 43205, United States|Oregon Health & Science University, Portland, Oregon, 97239, United States|Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|University of Texas, Southwestern, Dallas, Texas, 75235, United States|Cook Children’s Medical Center, Fort Worth, Texas, 76104, United States|Baylor Texas Children’s Hospital, Houston, Texas, 77030, United States|Primary Children’s Hospital, Salt Lake City, Utah, 84113, United States|Children’s Hospital of Wisconsin, Milwaukee, Wisconsin, 53226, United States | |||
| NCT05053113 | Utilization of a Peer-Based Approach for the Promotion of Physical Activity in Inactive Women | https://clinicaltrials.gov/study/NCT05053113 | This clinical trial tests the effect of a physical activity intervention that emphasizes support between partners in women who are not physically active. Decisions about and participation in physical activity often involve others in one’s social circle, including family and friends. Social support for physical activity and having someone with whom to engage in physical activity may promote behavioral change and help increase moderate-intensity physical activity in inactive women. | NO | Obesity-Related Malignant Neoplasm | DEVICE: Activity Monitor|DEVICE: Activity Monitor|OTHER: Educational Intervention|OTHER: Survey Administration|BEHAVIORAL: Telephone-Based Intervention | Change in objective minutes per week of moderate-intensity physical activity, Will use a linear mixed model (LMM) analysis, which includes the intervention as a fixed effect predictor and a dyad-specific random intercept to account for the dependent nature of the nested design (in the dyadic intervention group) to assess if the dyadic intervention led to increased moderate-intensity physical activity, relative to the individual intervention. will also assess changes in physical activity across time (i.e., at 6 and 12 months after baseline) using longitudinal data, where both within-dyad and within-subject (repeated measures across time points) correlations will be accounted for. Relevant covariates (e.g., age, race/ethnicity, dyad relationship, education, household income and composition, employment status, neighborhood environmental characteristics) will be adjusted for in the analysis. Potential effect modifiers, e.g., depressive symptoms, perceived stress, neighborhood environmental characteristics, will be explored., Through study completion, an average of 1 year | M.D. Anderson Cancer Center | National Heart, Lung, and Blood Institute should be included as a Collaborator. | FEMALE | ADULT, OLDER_ADULT | NA | 500 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2020-0809|NCI-2020-13914|2020-0809|R01HL155310 | 2022-07-27 | 2025-08-31 | 2025-08-31 | 2021-09-22 | 2024-11-27 | M D Anderson Cancer Center, Houston, Texas, 77030, United States | |||||
| NCT05050539 | Adaptive Implementation to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings | https://clinicaltrials.gov/study/NCT05050539 | “Together, We Inspire Smart Eating” (WISE) is an intervention that improves children’s diets in ECE. WISE includes 4 key evidence-based practices (EBPs): (1) hands-on exposures to fruits and vegetables, (2) role modeling by educators, (3) positive feeding practices, and (4) a mascot associated with fruits and vegetables. Standard implementation approaches to WISE result in suboptimal implementation of WISE EBPs. Additional implementation strategies are needed to increase adoption and fidelity to EBPs. To date, most studies have employed an “all-or-nothing” approach, comparing multifaceted strategies to control groups without implementation support. Thus, there is an urgent need for optimized strategies that tailor implementation support intensity to the unique challenges and limited resources of the ECE context. The overall objectives of this application are to determine the effectiveness and cost-effectiveness of an adaptive implementation approach to improve adoption of the EBPs of WISE while also examining implementation mechanisms. The central hypothesis is that the addition of high-intensity strategies at sites that do not respond to low-intensity strategies will improve implementation and health outcomes. | NO | Obesity, Childhood|Nutrition Aspect of Cancer | BEHAVIORAL: Low Intensity|BEHAVIORAL: High Intensity | Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure, Fidelity to the WISE Evidence-Based Practices at the classroom level measured with the the WISE fidelity observational measure. The measure includes 2 to 3 items per evidence-based practice (EBP) on a 1 (minimum) to 4 (maximum) scale to receive an average, continuous fidelity score with 4 representing the highest fidelity (i.e., higher scores reflect better fidelity). For each item, values are anchored to concrete, observable behaviors., Through study completion, an average of 2 years | University of Arkansas | Louisiana Tech University | ALL | CHILD, ADULT, OLDER_ADULT | NA | 1850 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 262638 | 2022-06-14 | 2026-06-30 | 2026-12-30 | 2021-09-20 | 2025-01-17 | University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/39/NCT05050539/Prot_SAP_000.pdf | ||||
| NCT05048108 | Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT05048108 | RACIRO-3 | Majority of breast cancer survivors are overweight or obese at time of diagnosis, putting them at increased risk for insulin resistance and Type 2 Diabetes Mellitus (T2DM). Women with insulin resistance at time of breast cancer diagnosis often have larger tumors, later stages of cancer and worse prognosis. Additionally, chemotherapy often leads to increases in insulin resistance and cognitive impairment. Many cancer survivors experience memory and brain function decline following chemotherapy that can last for years, and insulin resistance may contribute to worse cognitive outcomes in cancer survivors. Omega-3 polyunsaturated fatty acids (PUFAs) are anti-inflammatory nutrients that may help reduce insulin resistance and negative cognitive outcomes from cancer treatments. The purpose of this observational study with cross-sectional design is to investigate the relationship of omega-3 PUFAs with insulin resistance and cognitive function in obese breast cancer survivors. Due to the global pandemic caused by the coronavirus disease of 2019 (COVID-19), this study will be conducted entirely remotely using electronic data collection and remote finger-stick blood sample collection. The study will aim to enroll 80 racially and ethnically diverse female breast cancer survivors (age 45-75) who are postmenopausal, and 1 to 4 years post breast cancer diagnosis. Participants will complete study questionnaires online, and some cognitive tests will be completed through zoom sessions with trained study personnel. Participants will be mailed kits with thorough instructions to complete fingerstick blood sample collections and mail them back to the research lab. Upon receipt of blood samples and completion of all study questionnaires, participation will be complete. | NO | Breast Cancer|Obesity | Determine number of participants with insulin resistance via HOMA-IR from remote dried blood spot collection, Homeostatic model assessment for insulin resistance (HOMA-IR) is calculated by fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Insulin and glucose measures will be obtained from the dried blood spot collection., One day | Remote assessment of cognition using the Hopkins Verbal Learning Test, Assess cognition remotely through a zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning., One day|Remote assessment of cognition using the WAIS-IV Digit Span, Assess cognition remotely through a zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory., One day|Remote assessment of cognition using the Oral Trail Making Test, Assess cognition remotely through a zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention., One day|Remote assessment of cognition using the COWA Test, Assess cognition remotely through a zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function., One day | Ohio State University Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | 65 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | OSU-21100 | 2022-01-18 | 2023-11-30 | 2025-06 | 2021-09-17 | 2024-10-30 | Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States | ||||||
| NCT05040152 | Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio | https://clinicaltrials.gov/study/NCT05040152 | HERO | This study determines the feasibility of a telephone-based weight lost intervention in reducing cancer risk and health disparities in rural Ohio. Obesity is the leading preventable cause of cancer, and obesity-related inflammation is linked to elevated cancer risk, independent of obesity itself. Rural populations are a vulnerable population in need of increased access to tailored strategies and benefit from weight loss interventions. This study aims to see whether a telephone-based intervention may help obese people in rural area to reduce body weight, so as to prevent obesity-related cancer. | NO | Obesity-Related Malignant Neoplasm | BEHAVIORAL: Dietary Counseling and Surveillance|OTHER: Exercise Intervention|OTHER: Informational Intervention|OTHER: Questionnaire Administration|BEHAVIORAL: Telephone-Based Intervention | Feasibility of a 15-week telephone-based weight loss intervention, Will be defined as the percentage of enrolled participants who complete the study., Up to 15 weeks | Changes in body weight (KG), Changes in body weight (KG)will be measured by a weight scale, Up to 15 weeks|Changes in body fat mass, Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100, Up to 15 weeks | Changes body fat percentage, Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100, Up to 15 weeks|Lipid profiles, Total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be obtained by fasting capillary blood sampling from fingerstick and analyzed using Cholestech LDX, Up to 15 weeks|C-reactive protein (CRP) concentration (ng/L), C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer, Up to 15 weeks|Interleukin (IL)-6 concentration (pg/mL), Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays, Up to 15 weeks|TNF-alpha concentration (pg/mL), TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme, Up to 15 weeks|Physical fitness, Participants will be asked to complete two valid and reliable timed performance-related mobility tasks, including 400-meter walk and lift and carry task, Up to 15 weeks|Physical activity, Self-reported using Leisure-Time Exercise Questionnaires118. Objectively measured physical activity will be recorded using the LIFECORDER Plus Accelerometer for 7 days in the 1st and 15th week, Up to 15 weeks|Exercise-Related Self-Efficacy Exercise-Related, Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales, Up to 15 weeks|Dietary intake, Self-reported using the National Institutes of Health Daily Food List, Up to 15 weeks | Ohio State University Comprehensive Cancer Center | National Cancer Institute (NCI) | ALL | ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | OSU-21007|NCI-2021-03973|F99CA253745 | 2021-11-06 | 2022-05-17 | 2022-05-17 | 2021-09-10 | 2024-04-03 | Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States | ||
| NCT05012176 | An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT05012176 | This clinical trial evaluates the use of an Episodic Future thinking Intervention to promote weight loss in breast cancer survivors. Obesity is associated with multiple negative health sequelae in breast cancer survivors. This includes an increased risk of cancer recurrence and mortality, multiple quality of life issues, and increased risk of co-morbidities. Delay Discounting is a behavioral health economic target that refers to the “discounting” of a larger benefit in the future for a smaller, more immediate reward in the present. A high delay discounting rate is correlated with poor dietary choices and sedentary lifestyle. Episodic Future Thinking (EFT) simulates positive events that may occur in one’s future, engaging the science of prospection. EFT decreases delay discounting rate, resulting in healthier diet choices and weight reduction. However, valuation of the future may impact cancer survivors differently due to adjusted mortality perception and cancer-related stress. This study will determine the feasibility and preliminary efficacy of remotely delivered (smartphone application) EFT as a behavioral intervention for weight loss in breast cancer survivors. Implementation of EFT as a complementary approach to standard lifestyle interventions could lead to improvement in weight loss, food choice, and quality of life, thereby positively impacting overall health and longevity in cancer survivors. | NO | Anatomic Stage 0 Breast Cancer AJCC v8|Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage IA Breast Cancer AJCC v8|Anatomic Stage IB Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage IIA Breast Cancer AJCC v8|Anatomic Stage IIB Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IIIA Breast Cancer AJCC v8|Anatomic Stage IIIB Breast Cancer AJCC v8|Anatomic Stage IIIC Breast Cancer AJCC v8|Breast Ductal Carcinoma In Situ|Invasive Breast Carcinoma|Prognostic Stage 0 Breast Cancer AJCC v8|Prognostic Stage I Breast Cancer AJCC v8|Prognostic Stage IA Breast Cancer AJCC v8|Prognostic Stage IB Breast Cancer AJCC v8|Prognostic Stage II Breast Cancer AJCC v8|Prognostic Stage IIA Breast Cancer AJCC v8|Prognostic Stage IIB Breast Cancer AJCC v8|Prognostic Stage III Breast Cancer AJCC v8|Prognostic Stage IIIA Breast Cancer AJCC v8|Prognostic Stage IIIB Breast Cancer AJCC v8|Prognostic Stage IIIC Breast Cancer AJCC v8 | BEHAVIORAL: Behavioral Intervention|BEHAVIORAL: Behavioral Intervention|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Feasibility measured by Adherence, A one-sample t-test will be used to evaluate adherence (average proportion of smartphone prompts participants open and attended to during the 12-week trial recorded by the web application), Up to 12 weeks | Change in total body weight, Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 and 24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual., Up to 12 weeks|Change in total body weight, Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 and 24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual., Up to 24 weeks|Change in delay discounting rate, Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (12 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual., Baseline to 12 weeks|Change in delay discounting rate, Evaluated using a linear mixed effects model. The model will include baseline measure, timepoint (24 weeks), treatment assignment, and the timepoint by treatment interaction as fixed effects. A subject-level random effect will be included to account for the correlation of multiple measurements of the same individual., Baseline to 24 weeks | Change in patient reported outcome (PRO), PRO measured by standard instruments: PROMIS® scales 29 Profile v2.1 (domains: physical function, social roles, fatigue, depression, anxiety, pain, sleep disturbance) and Global Health Short Form (general physical and mental health), Baseline to 12 weeks|Change in Insulin Resistance, Insulin Resistance will be measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), Baseline to 12 weeks|Change in quantity of serum high-sensitivity C-reactive protein, Inflammatory Biomarker, Baseline to 12 weeks|Change in diet quality, Measured by Health Eating Index 2015., Baseline to 12 weeks | Ohio State University Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | OSU-20408|NCI-2021-01597 | 2021-11-01 | 2023-12-31 | 2024-12-31 | 2021-08-19 | 2023-09-13 | Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States | ||||
| NCT04967209 | Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer | https://clinicaltrials.gov/study/NCT04967209 | This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn’t like), the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it. | NO | Cancer|Breast Cancer|Obesity|Overweight and Obesity|Overweight | Functional Assessment of Cancer Therapy – Breast quality-of-life instrument, Self reported measure of multidimensional quality of life (QL) in patients with breast cancer., 4 weeks|Qualitative interviews, Data analyses will content analyze key themes in participants’ experiences using the program, including their likes and dislikes for the program., 4 weeks | Noom Inc. | FEMALE | ADULT, OLDER_ADULT | 30 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | 00055029 | 2021-07-05 | 2021-08-12 | 2021-08-12 | 2021-07-19 | 2023-03-31 | Noom, Inc, New York, New York, 10001, United States | ||||||||
| NCT04965246 | Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04965246 | TALIEHO | The Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition. | NO | Inflammation|Cognitive Impairment|Anxiety|Alcohol Drinking | BEHAVIORAL: Physical Activity|OTHER: Usual Care | Markers of inflammation: C-reactive protein, A cytokine multiplex will assess markers of inflammation, including C-reactive protein, Baseline|Markers of inflammation: C-reactive protein, A cytokine multiplex will assess markers of inflammation, including C-reactive protein, 15 weeks | Markers of inflammation-Interleukin 6, A cytokine multiplex will assess markers of inflammation, including Interleukin 6, Baseline|Markers of inflammation-Interleukin 6, A cytokine multiplex will assess markers of inflammation, including Interleukin 6, 15 weeks|Markers of inflammation-Tumor Necrosis Factor Alpha, A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha, Baseline|Markers of inflammation-Tumor Necrosis Factor Alpha, A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha, 15 weeks|The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments, The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life., Baseline|The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments, The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life., 15 weeks|The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life, The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life scores range from 0-16, higher scores indicate better quality of life., Baseline|The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life, The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life scores range from 0-16, higher scores indicate better quality of life., 15 weeks|The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others, The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life., Baseline|The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others, The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life., 15 weeks|The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities, The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life., Baseline|The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities, The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life., 15 weeks|Anxiety Symptoms-State-Trait Anxiety Inventory, State and trait anxiety are measured using the State and Trait subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol).The State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the subscales. State-Trait Anxiety Inventory varies from a minimum score of 20 to a maximum score of 80, higher scores indicate higher anxiety., Baseline|Anxiety Symptoms-State-Trait Anxiety Inventory, State and trait anxiety are measured using the State and Trait subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol).The State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the subscales. State-Trait Anxiety Inventory varies from a minimum score of 20 to a maximum score of 80, higher scores indicate higher anxiety., 15 weeks|Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Anxiety subscale measures patient reported anxiety symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher anxiety, Baseline|Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Anxiety subscale measures patient reported anxiety symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher anxiety, 15 weeks|Depressive Symptoms, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – depression subscale measures patient reported depressive symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher depression, Baseline|Depressive Symptoms, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – depression subscale measures patient reported depressive symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher depression, 15 weeks|Physical Function-The Patient-Reported Outcomes Measurement Information System, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – physical function subscale measures patient reported physical function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher physical function, Baseline|Physical Function-The Patient-Reported Outcomes Measurement Information System, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – physical function subscale measures patient reported physical function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher physical function, 15 weeks|Fatigue, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – fatigue subscale measures patient reported fatigue. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher fatigue., Baseline|Fatigue, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – fatigue subscale measures patient reported fatigue. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher fatigue., 15 weeks|Sleep Disturbance, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviationof 10. Higher scores indicate higher Sleep Disturbance., Baseline|Sleep Disturbance-PROMIS-57, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Sleep Disturbance., 15 weeks|Ability to Participate in Social Roles and Activities, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Ability to Participate in Social Roles and Activities subscale measures patient reported Ability to Participate in Social Roles and Activities. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Ability to Participate in Social Roles and Activities, baseline|Ability to Participate in Social Roles and Activities, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Ability to Participate in Social Roles and Activities subscale measures patient reported Ability to Participate in Social Roles and Activities. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Ability to Participate in Social Roles and Activities, 15 weeks|Pain interference, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain interference, Baseline|Pain interference, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain interference, 15 weeks|Pain intensity, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain intensity, Baseline|Pain intensity, The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 – Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain intensity, 15 weeks|Alcohol consumption, A questionnaire probing the number of alcohol drinks consumed in the past 7 days, Baseline|Alcohol consumption, A questionnaire probing the number of alcohol drinks consumed in the past 7 days, 15 weeks|Physical Function-walk test, The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes. Further distances indicate greater physical function, Baseline|Physical Function-walk test, The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes. Further distances indicate greater physical function, 15 weeks|Mobile Monitoring of Cognitive Change, Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments., Week 1-2|Mobile Monitoring of Cognitive Change, Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments., Week 7-8|Mobile Monitoring of Cognitive Change, Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments., Week 14-15|Alcohol consumption-daily, Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts, Week 1-2|Alcohol consumption-daily, Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts, Week 7-8|Alcohol consumption-daily, Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts, Week 14-15|Alcohol Use Disorder, The Alcohol Use Disorders Identification Test is a simple and effective method of screening for unhealthy alcohol use, defined as risky or hazardous consumption or any alcohol use disorder. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence., Baseline|Telephone Interview for Cognitive Status, The Telephone Interview for Cognitive Status is a brief, standardized test of cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical or inefficient. The Telephone Interview for Cognitive Status will be used to screen for moderate-to-severe cognitive impairment. Scores 20 of lower indicate moderate-to-severe cognitive impairment, Baseline|Demographics, Age, height, weight, family income, education level, age at diagnosis, time since diagnosis, injury history, diabetic status, and whether they are currently receiving treatment for mental health will be assessed at baseline, Baseline|Acceptability-the proportion of older adults who agree to participate, The proportion of older adults who agree to participate among those deemed eligible., Baseline|Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention, The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the physical activity log, will be deemed compliant., Week 15 | Milton S. Hershey Medical Center | FEMALE | OLDER_ADULT | NA | 46 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | PSCI 21-045 | 2021-11-22 | 2024-07-08 | 2024-07-08 | 2021-07-16 | 2025-01-15 | Hershey Medical Center, Hershey, Pennsylvania, 17033, United States | ||||
| NCT04931017 | Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer | https://clinicaltrials.gov/study/NCT04931017 | This phase II trial determines the effect of metformin extended release on the risk for developing lung cancer in overweight/obese patients that are at high-risk for developing lung cancer. Metformin is widely used to treat type II diabetes and has a long history of safety and minimal side effects. At similar dosage, the drug may have potential anti-cancer activity. Metformin use has been associated with improved survival in patients with non-small cell lung carcinoma, a specific type of lung cancer, and it has also been shown to enhance immune mobilization against tumors. This trial aims to see whether metformin extended release as a preventative treatment may lower the chance of developing lung cancer, and whether it may help patients’ immune system learn (“reprogram”) to lower a certain type of immune cell (called regulatory T cells) that are linked to tumor development. | NO | Lung Carcinoma | PROCEDURE: Biopsy|PROCEDURE: Biospecimen Collection|PROCEDURE: Bronchoscopy|DRUG: Extended Release Metformin Hydrochloride|OTHER: Questionnaire Administration | PD-1 expression of pulmonary regulatory T cells (Tregs) before and after metformin extended release (ER) treatment, Change from pre- to post-metformin extended release (ER) treatment in cell surface PD-1 expression levels of pulmonary (BAL) Tregs, measured as mean fluorescent intensity (MFI). Changes in MFI due to metformin ER treatment among all n = 40 subjects will be used for the primary analysis., Pre- to post-treatment | Estimated PD-1 expression of pulmonary Tregs change in cohort B during the wait period (6 months with no treatment), This is the estimate of change in MFI following the 6-month wait period among n = 20 subjects randomized to the wait-list arm. This will confirm the stability of the PD-1 expression of pulmonary Tregs over time., Randomization to week 26|Circulating immune cells, Circulating immune cell composition between blood samples collected pre- and post-metformin ER treatment to assess the effect of metformin ER on circulating immune cells and to identify potential biomarkers of metformin ER response., Pre- to post-treatment | Airway gene expression, RNA sequencing of endobronchial biopsies will be performed at visually normal mainstem airway for each participant. The analysis of the RNA seq data will be an unsupervised comparison of differentially expressed genes with and without metformin ER exposure., Up to study completion|Examination of the immune profile of pulmonary parenchyma represented by bronchoalveolar lavage, This will compare the immune composition of bronchoalveolar lavage samples of participants before and after metformin exposure. Specifically, the prevalence and composition of myeloid derived suppressor cells (MDSCs) as well as monocyte, macrophage and dendritic cells will be assessed., Pre- to post-treatment|Histologic progression, Bronchoscopic biopsies of at least 6 standard sites will be graded on the World Health Organization (WHO) scale of dysplasia and assigned numerical scores from 1 (normal) to 8 (invasive cancer). Each lesion will be classified as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and each response rate will be calculated on a per-site and a per-participant basis. Additional measures of dysplasia will include the average dysplastic score and the dysplasia index (% of sites with dysplasia score \>= 3 (mild dysplasia)). Changes in maximum dysplasia will be analyzed using a paired t test to determine whether a reduction occurs., Up to study completion|Examination of the effect of metformin on systemic adipokines and inflammatory cytokines, Frozen sera will be analyzed by commercial enzyme-linked immunosorbent assay kits for levels of leptin, adiponectin, resistin, IL6 and TNFalpha. Pre- and post-treatment serum levels will be compared in parametric paired testing., Pre- to post-treatment | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | PHASE2 | 50 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION | NCI-2021-06112|NCI-2021-06112|NCI20-04-01|NWU20-04-01|P30CA060553|UG1CA242643 | 2022-09-09 | 2026-04-01 | 2026-11-01 | 2021-06-18 | 2024-10-15 | Rocky Mountain Regional VA Medical Center, Aurora, Colorado, 80045, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|BC Cancer Research Centre, Vancouver, British Columbia, V5Z 1L3, Canada|University of British Columbia Hospital, Vancouver, British Columbia, V6T 2B5, Canada | ||||
| NCT04920084 | A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM) | https://clinicaltrials.gov/study/NCT04920084 | This study will test whether a plant-based diet is practical (feasible) for overweight people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The researchers will decide how practical the diet is by looking at how much weight participants lose and how well they are able to stick to the diet. The researchers will also determine whether the diet is effective in preventing multiple myeloma in participants. In addition, they will look at how safe the plant-based diet is for participants, and see if the diet affects participants’ quality of life. | NO | Monoclonal Gammopathy of Undetermined Significance|Smoldering Multiple Myeloma | OTHER: Plant based meals | Weight loss- body mass index (BMI) reduction, Weight loss is defined as the average decrease in BMI at 12 weeks, 12 weeks|Patient adherence to the diet, Intervention defined as ≥70% of participants consuming a WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey)., 12 weeks | Memorial Sloan Kettering Cancer Center | ALL | ADULT, OLDER_ADULT | NA | 23 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 21-135 | 2021-06-03 | 2025-06 | 2025-06 | 2021-06-09 | 2024-03-29 | Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen, Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Commack, Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States | ||||||
| NCT04913064 | Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer | https://clinicaltrials.gov/study/NCT04913064 | This clinical trial studies the effects of dietary white button mushroom on inflammation (the body’s process of fighting against harmful things) and immune cells (white blood cells) in postmenopausal women with both high body mass index or BMI (percentage of body fat) and high risk of breast cancer. The body is in a constant state of alert when inflammation lingers at a low level and becomes chronic, as with having button mushroom is a dietary supplement that may improving responses of immune cells (white blood cells) and decreasing chronic inflammation. Information gathered from this study may help researchers determine whether white button mushroom have any effects on body fat and breast cancer risk. | NO | Breast Carcinoma | OTHER: Questionnaire Administration|DRUG: White Button Mushroom Extract | Relative change in levels of circulating myeloid-derived suppressor cells (MDSCs) within the peripheral blood mononuclear (PBMC) compartment, Will assess relative change in % of MDSCs of PBMCs., Baseline up to 3 months|Relative change in immune cell composition within the peripheral blood mononuclear (PBMC) compartment, Will assess relative change in % of mononuclear cells of PBMCs, Baseline up to 3 months | Relative change in inflammatory cytokine gene expression in PBMC compartment, Will assess relative change in % cytokine gene expression, Baseline up to 3 months|Incidence of adverse events, Toxicity will be defined per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version. 5.0., Up to 3 months | City of Hope Medical Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 26 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 20171|NCI-2021-02148|20171|P30CA033572 | 2021-07-27 | 2026-01-12 | 2026-01-12 | 2021-06-04 | 2024-12-31 | City of Hope Medical Center, Duarte, California, 91010, United States | ||||
| NCT04874415 | Behavioral Economics for Activity Motivation in Adolescents (BEAM) | https://clinicaltrials.gov/study/NCT04874415 | There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a proposed mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes. | NO | Type 2 Diabetes|PreDiabetes|Insulin Resistance|Polycystic Ovary Syndrome | BEHAVIORAL: 1RLD|BEHAVIORAL: 1RLW|BEHAVIORAL: 1RGD|BEHAVIORAL: 1RGW|BEHAVIORAL: 2RLD|BEHAVIORAL: 2RLW|BEHAVIORAL: 2RGD|BEHAVIORAL: 2RGW|BEHAVIORAL: 1FLD|BEHAVIORAL: 1FLW|BEHAVIORAL: 1FGD|BEHAVIORAL: 1FGW|BEHAVIORAL: 2FLD|BEHAVIORAL: 2FLW|BEHAVIORAL: 2FGD|BEHAVIORAL: 2FGW | Moderate to Vigorous Physical Activity (MVPA), Effects of time spent in MVPA will be measured by assessing the weekly mean minutes in MVPA per day, 12 weeks | Daily Step Count, Daily step count will be measured by assessing the daily mean steps, 12 weeks | University of Pittsburgh | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ALL | CHILD, ADULT | NA | 75 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER | STUDY21040122|K23DK125719-01 | 2021-11-16 | 2024-10-04 | 2024-10-04 | 2021-05-05 | 2024-11-06 | UPMC Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/15/NCT04874415/ICF_000.pdf | |||
| NCT04855552 | Telehealth Weight Loss Program for Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04855552 | TWL | This is a single-arm longitudinal group to examine patient-reported outcomes, body mass and mammographic density changes pre- and post- weight loss intervention of breast cancer survivors using video conferencing telehealth visits. | NO | Cancer Survivors|Cancer of Breast|Body Weight|Overweight and Obesity | BEHAVIORAL: Behavioral Weight-loss Program Via Telehealth|BEHAVIORAL: Behavioral Weight-Loss Program Via Telehealth – Weight Measures|BEHAVIORAL: Validated Surveys of Patient-Reported Outcomes | Determine feasibility and Acceptability Using the City of Hope Quality of Life Instrument – Breast Cancer Patient to Assess Changes in Quality of Life, To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the City of Hope Quality of Life Instrument (COH-QOL) – Breast Cancer Patient (QOL-BC) at two time points: baseline (pre-) and treatment end (at week 24). * COH-QOL Instrument – Breast Cancer Patient (QOL-BC) – 46 items * The scoring is based on a scale of 0 = worst outcome to 10 = best outcome. Some items have reverse anchors and the value should be scored as the reverse of the item circled, e.g., if a patient selected “4” then their score on a reverse anchor would be 10 – 4 = 6., 24 weeks|Determine feasibility and Acceptability Using the International Physical Activity Questionnaire to Assess Changes in Physical Activity, To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the International Physical Activity Questionnaire (IPAQ) at two time points: baseline (pre-) and treatment end (at week 24). * The International Physical Activity Questionnaire (IPAQ) Short Form * This is an open-ended questionnaire surrounding individuals’ last 7-day recall of physical activity., 24 weeks|Determine feasibility and Acceptability Using the Patient Health Questionnaire to Assess Changes in Measures of Depression, To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Patient Health Questionnaire (PHQ-9) (Depression) at two time points: baseline (pre-) and treatment end (at week 24). – The PHQ-9 is a nine item questionnaire and the scoring is based on a scale of 0= best outcome to 3 = worst outcome. Total scores range from 0 to 27 and higher scores are associated with higher severities of depression, ranging from minimal to severe., 24 weeks|Using the Acceptability of Intervention Measure to Assess Acceptability and Feasibility, To determine the feasibility and acceptability of a weight loss program via telehealth for breast cancer survivors. The participants will be asked to complete the Acceptability of Intervention Measure at two time points: baseline (pre-) and treatment end (at week 24). – The Acceptability of Intervention Measure is a four item questionnaire and the scoring is based on a scale ranging from 1 = completely disagree to 5= Completely Agree. Higher scores are associated with greater acceptability of the intervention., 24 weeks|Requesting Direct Verbal Feedback From Participants to Assess Elements of the Program that Work Well, to Acquire Suggestions, and to Seek Suggestions to Determine Feasibility and Acceptability, Finally, investigators will conduct an exit interview with each participant to assess the acceptability of the intervention, the delivery of the intervention via telehealth, and their satisfaction with their treatment outcomes. Investigators will also solicit suggestions for improvements to the program for future interventions., 24 weeks | To measure changes from pre- to post-weight-loss intervention for 1) body mass., To assess change in body mass index (BMI), height (measured in meters) and weight (measured in kilograms) will be combined to report BMI in kg/m\^2. Weight will be reported at baseline and after week 24 of the intervention. Participants’ height (in meters) will be collected from the electronic medical record at baseline., 24 Months|To measure changes from pre- to post-weight-loss intervention for 2) Qualitative Changes in Mammographic Breast Density, To assess mammographic breast density changes, investigators will measure mammographic density of annual mammogram pre- and post-weight-loss program. The qualitative MBD as reported by Breast Imaging-Reporting and Data System (BI-RADS) scores are collected from the clinical radiologist reports., 24 Months|To measure changes from pre- to post-weight-loss intervention for 2) Quantitative Changes in Mammographic Breast Density, To assess mammographic breast density changes, investigators will measure mammographic density of annual mammogram pre- and post-weight-loss program. Quantitative MBD will be analyzed using LIBRA, which is a fully-automated, free, and publicly available program that estimates MBD. Following digital segmentation, the LIBRA software analysis provides breast area, absolute dense area, and area percent density for each image of a mammographic study. Mean breast area (cm\^2), mean dense area (cm\^2), and quantitative MBD (%) will be calculated for each mammographic study as described., 24 months | Abramson Cancer Center at Penn Medicine | FEMALE | ADULT, OLDER_ADULT | NA | 22 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | UPCC 17120|844762 | 2021-07-19 | 2025-07 | 2025-12 | 2021-04-22 | 2024-09-19 | University of Pennsylvania (Hospital of the University of Pennsylvania), Philadelphia, Pennsylvania, 19104, United States | ||||
| NCT04839614 | Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia | https://clinicaltrials.gov/study/NCT04839614 | To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients). | NO | Endometrial Carcinoma|Obesity|EIN|Endometrial Intraepithelial Neoplasia|Endometrial Cancer Stage I | OTHER: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral | proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment, 50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible, 2 Weeks|proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients), concurrent surgery will be considered feasible if 50% (7-8 patients) of patients who undergo an initial consultation at the CMBS actually undergo concurrent surgery within 8 weeks of diagnosis (or 12 weeks for EIN)., up 12 weeks | Safety of the concurrent surgeries, compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population, 3 weeks|Postoperative complications, compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population, 3 weeks|Time under anesthesia, compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population, 1 Day|Total time in operating room, compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population, 1 Day|Postoperative weight loss, Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses, 6 months, 1 year|Changes in lab values reflecting comorbid conditions, Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses, 6 months, 1 year|Post Operative 12-item Short Form Healthy Survey (SF-12) Survey, 12-item Short Form Healthy Survey (SF-12) Survey, 6 months | Dana-Farber Cancer Institute | FEMALE | ADULT, OLDER_ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | 19-419 | 2021-08-01 | 2025-06-30 | 2026-06-30 | 2021-04-09 | 2024-07-16 | Brigham and Women’s Hospital, Boston, Massachusetts, 02115, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States | |||||
| NCT04839952 | Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer | https://clinicaltrials.gov/study/NCT04839952 | This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer. | NO | Pediatric Cancer | BEHAVIORAL: Healthy Lifestyles|BEHAVIORAL: Education-Only Control | Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire, Knowledge of nutrition recommendations, as evidenced by scores on the General Nutrition Knowledge Questionnaire – Revised (higher scores indicate greater knowledge)., Pre-intervention and 2 months after the intervention concludes|Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire, Knowledge of physical activity recommendations, as evidenced by scores on the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire (higher scores indicate greater knowledge)., Pre-intervention and 2 months after the intervention concludes|Change in Physical activity as assessed by Fitbit data, Physical activity total weekly minutes, as evidenced by weekly Fitbit data (activity measured in minutes)., Pre-intervention and 2 months after the intervention concludes|Change in Nutrition as assessed by the Rapid Eating Assessment for Patients score, Adherence to United States Department of Agriculture recommendations, as evidenced by the Rapid Eating Assessment for Patients (higher scores indicate better adherence to recommendations)., Pre-intervention and 2 months after the intervention concludes|Intervention feasibility as assessed by the fidelity rating, Feasibility of conducting the intervention with high clinician fidelity, as evidenced by fidelity ratings for each session (fidelity represented as a percentage based on the extent to which the clinician covered all planned information for each session). Average intervention fidelity ratings should meet or exceed 80% fidelity., Immediately following intervention|Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile, Patient and caregiver acceptability of the newly developed intervention, as evidenced by the Abbreviated Acceptability Rating Profile (higher scores indicate greater acceptability, with scores equal to or greater than 30 indicating good acceptability per published standards)., Immediately following intervention | Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form, Self-efficacy managing weight, as evidenced on scores on the Weight Efficacy Lifestyle Questionnaire Short Form (greater scores indicate greater self-efficacy)., Pre-intervention and 2 months after the intervention concludes|Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II, Self-efficacy maintaining healthy lifestyle behaviors, as evidenced by scores on the Healthy Promoting Lifestyle Profile II ((greater scores indicate greater self-efficacy)., Pre-intervention and 2 months after the intervention concludes|Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents, Body satisfaction, as evidenced by scores on the Body Esteem Scale for Adults and Adolescents (higher scores indicate greater body satisfaction)., Pre-intervention and 2 months after the intervention concludes|Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form, Depressive symptoms, as evidenced by scores on the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form (greater scores indicate greater depressive symptoms)., Pre-intervention and 2 months after the intervention concludes|Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form, PROMIS Pediatric Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form (greater scores indicate greater anxiety symptoms)., Pre-intervention and 2 months after the intervention concludes|Change in Self-esteem as assessed by the Rosenberg Self Esteem Scale, Self-esteem, as evidenced by scores on the Rosenberg Self Esteem Scale (greater scores indicate greater self-esteem)., Pre-intervention and 2 months after the intervention concludes | Johns Hopkins All Children’s Hospital | ALL | CHILD, ADULT | NA | 59 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | IRB00238848 | 2020-06-11 | 2023-08-31 | 2023-08-31 | 2021-04-09 | 2023-09-05 | Johns Hopkins All Children’s Hospital, Saint Petersburg, Florida, 33701, United States | |||||
| NCT04799665 | Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona | https://clinicaltrials.gov/study/NCT04799665 | The overall objective of this clinical study is to determine the feasibility of breast CT for breast density assessment and association of CT-derived density measures with metabolic syndrome in overweight/obese Mexican-origin women in Southern Arizona. These evaluations will help support follow-up clinical research utilizing breast density acquired by breast CT as a surrogate endpoint biomarker to evaluate breast cancer preventive strategies. The long-term goal of these research efforts is to develop safe and effective preventive strategies to reduce obesity-associated breast cancer burden in our catchment area. | NO | Metabolic Syndrome|Obesity Associated Disorder | DIAGNOSTIC_TEST: Breast CT | Measurement of breast density, To determine the feasibility of applying a novel clinical prototype of breast CT to assess breast density on non-compressed breasts. Feasibility will be evaluated by the proportion of unmeasurable breast density within our study population utilizing computerized tomography (CT) scan., Baseline | Determine the association between metabolic syndrome and breast CT-derived density measures., To determine the association between metabolic syndrome and breast CT-derived density measures through comparison of CT-derived breast density measures between women with or without metabolic syndrome, characterized by having at least three components among abdominal obesity, high serum triglycerides, low high-density lipoprotein cholesterol, high serum glucose, and high blood pressure., Two years|Comparison of CT-derived breast density measures versus the individual components of metabolic syndrome., To compare the CT-derived breast density measures versus the individual components of metabolic syndrome to reveal associations between breast density and specific metabolic characteristics., Two years | University of Arizona | FEMALE | ADULT, OLDER_ADULT | 92 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2012285106 | 2022-04-28 | 2024-05-01 | 2024-05-01 | 2021-03-16 | 2024-05-21 | University of Arizona, Tucson, Arizona, 85724, United States | ||||||
| NCT04780477 | Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer | https://clinicaltrials.gov/study/NCT04780477 | This study tests whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in persons at highest risk, namely overweight or obese, post-polypectomy patients. | NO | Colon Cancer|Obesity | DIETARY_SUPPLEMENT: High Fiber Diet Featuring Legumes (HLD)|DIETARY_SUPPLEMENT: Healthy American Diet | Change in Body Weight, Participants will have their body weight measured (in pounds) on a regularly calibrated digital scale while wearing light clothing without shoes., Baseline, Month 6 (end of intense intervention)|Change in Ki-67+ Level, Colonic mucosal proliferative biomarker Ki-67+ will be measured., Baseline, Month 6 (end of intense intervention) | Body Weight, Participants will have their body weight measured (in pounds) on a regularly calibrated digital scale while wearing light clothing without shoes., Month 12|Ki-67+ level, Colonic mucosal proliferative biomarker Ki-67+ will be measured, Month 12|Change in Gut Transit Time, Gut transit time is assessed using an indigestible single-use SmartPill capsule, a receiver, and display software. The SmartPill capsules were discontinued and no longer available after 2023 so participants beginning after January 19, 2024 will not complete this assessment., Baseline, Month 6 (end of intense intervention)|Change in Fasting Plasma Insulin Level, Fasting plasma insulin, a biomarker of insulin resistance is measured by blood test., Baseline, Month 6, Month 12|Change in Fasting Plasma Glucose Level, Fasting plasma glucose, a biomarker of insulin resistance, is measured by blood test., Baseline, Month 6, Month 12|Change in Serum C-reactive Protein, Serum C-reactive protein, an indicator of systemic inflammation, is measured by blood test., Baseline, Month 6, Month 12|Change in CD3+ Intraepithelial Lymphocytes Count, CD3+ intraepithelial lymphocytes, a colonic mucosal inflammatory biomarker of colon cancer risk, will be measured by mucosal biopsy., Baseline, Month 6, Month 12|Change in CD68+ Lamina Propia Macrophages Count, CD68+ lamina propia macrophages, a colonic mucosal inflammatory biomarker of colon cancer risk, will be measured by mucosal biopsy., Baseline, Month 6, Month 12 | Emory University | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 70 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | STUDY00000563|R01CA245063 | 2021-06-29 | 2025-09-30 | 2025-12-31 | 2021-03-03 | 2024-05-14 | Rollins School of Public Health, Emory University, Atlanta, Georgia, 30322, United States | ||||
| NCT04757519 | Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention. | https://clinicaltrials.gov/study/NCT04757519 | This study seeks to establish the efficacy of identifying weight loss nonresponders early in a Diabetes Prevention Program (DPP) intervention in 20 community settings (primarily churches and community centers) and providing them with individual-level, enhanced treatment through telephone contacts and access to additional resources. Additionally, potential mediators and moderators of the relationship between intervention status and weight loss response at 6 months in both nonresponders and responders will be examined and a cost-effectiveness analysis to evaluate the cost of the intervention will be conducted. This study addresses key gaps in the literature about the weight loss effects of identifying nonresponders early and characterizing individuals who need more intense personalized strategies. The investigators hypothesize that changes between baseline and 3 months will be more pronounced among the nonresponders in the intervention group compared to the nonresponders in the active control group. | NO | Diabetes | BEHAVIORAL: DPP-GLB Standard|BEHAVIORAL: DPP-GLB Enhanced | Change in Weight at 12 Weeks, Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks., 12 weeks (at baseline and12 weeks)|Change in Weight at 6 Months, Weight will be measured in pounds using a cellular scale at baseline and at 6 months., 6 months (at baseline and 6 months) | Change in Blood Pressure at 12 Weeks, Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks., 12 weeks (at baseline and 12 weeks)|Change in Blood Pressure at 6 Months, Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months., 6 months (at baseline and 6 months)|Change in Physical Activity at 12 Weeks, Change in Physical Activity will be measured at baseline and 12 weeks using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration. Scoring is open-ended; higher scores indicate increased activity., 12 weeks (at baseline and 12 weeks)|Change in Physical Activity at 6 Months, Change in Physical Activity will be measured at baseline and 6 months using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration. Scoring is open-ended; higher scores indicate increased activity., 6 months (at baseline and 6 months)|Change in Dietary Intake at 12 Weeks, Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake., 12 weeks (at baseline and 12 weeks)|Change in Dietary Intake at 6 Months, Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake., 6 months (at baseline, 12 weeks, 6 months)|Cost Analysis, Investigator-developed instrument. At 6 months, conduct a cost-effectiveness analysis to evaluate the cost of the intervention arm by comparing the incremental cost and weight loss with the active control arm., 6 months|Impact of Weight on Quality of Life, Quality of life will be measured using Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite). This is a 31-item self-report scale. Scores range from 0-100; higher scores indicate greater quality of life., 6 months | Lovoria Williams | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ALL | ADULT, OLDER_ADULT | NA | 500 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 58766|1R01DK125801-01 | 2021-02-18 | 2025-01-30 | 2025-06-30 | 2021-02-17 | 2024-07-15 | First Corinthian Baptist Church, Frankfort, Kentucky, 40601, United States|Heavenly Outpour, Frankfort, Kentucky, 40601, United States|Consolidated Baptist Church, Lexington, Kentucky, 40505, United States|Historic St. Paul AME Church, Lexington, Kentucky, 40507, United States|First African Baptist Church, Lexington, Kentucky, 40508, United States|Pilgrim Baptist Church, Lexington, Kentucky, 40508, United States|Shiloh Baptist Church, Lexington, Kentucky, 40508, United States|Redeemed Christian Church of God, Lexington, Kentucky, 40509, United States|First Baptist Church Brackstown, Lexington, Kentucky, 40511, United States|Lima Drive Seventh Day Adventist Church, Lexington, Kentucky, 40511, United States|Kingdom Fellowship, Louisville, Kentucky, 40202, United States|Bates Memorial Baptist Church, Louisville, Kentucky, 40203, United States|St. Stephen Baptist Church, Louisville, Kentucky, 40210, United States|Greater Gaililee CDC, Louisville, Kentucky, 40211, United States|Historic Calvary MBC, Louisville, Kentucky, 40211, United States|Spirit Filled New Life Church, Louisville, Kentucky, 40214, United States|Forest Baptist Church, Louisville, Kentucky, 40218, United States|Burnett Ave BC, Louisville, Kentucky, 40291, United States|Marnel C. Moorman Family Life Center, Shelbyville, Kentucky, 40065, United States|New Mt. Zion Baptist Church, Shelbyville, Kentucky, 40065, United States|First Baptist Winchester, Winchester, Kentucky, 40391, United States | ||||
| NCT04753268 | Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04753268 | The purpose of this study is to evaluate the preliminary efficacy of a Noom Breast Cancer Weight Loss Program on weight loss outcomes, quality of life, and physical activity. Also, to qualitatively determine acceptability of this novel program among breast cancer survivors with overweight or obesity. | NO | Weight Loss|Behavior, Health | BEHAVIORAL: Noom Healthy Weight Program | Weight, Self-reported weight, baseline to 6 months|Program engagement, Engagement with the Noom program; measured as 1. Number of App opens 2. Messages to coach 3. Number of Steps 4. Logged food 5. Logged exercise 6. Group messages and likes 7. Articles read, weeks 1-26|Program retention, i.e. % = (total participants – number of drop out) / Total number of participants) \* 100%, weeks 1-26|Program satisfaction, Satisfaction assessed via an in-house survey, week 1 – 26 week | Noom Inc. | FEMALE | ADULT, OLDER_ADULT | NA | 30 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | 00048814 | 2021-03-24 | 2021-10-01 | 2021-10-01 | 2021-02-15 | 2022-10-06 | Noom, Inc, New York, New York, 10001, United States | ||||||
| NCT04753359 | Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer | https://clinicaltrials.gov/study/NCT04753359 | Bridge CRC | A Mediterranean Diet (MedDiet), a largely plant-based dietary pattern, is relevant to CRC prevention and microbial production of anti-cancer metabolites in observational studies. A MedDiet can shift BA metabolism as shown in primates and when combined with calorie restriction, shows superior adherence and weight control in humans, given its palatability. To date, no studies have tested in an RCT the effects of a MedDiet alone (MedA), WL through lifestyle intervention (WL-A) or a calorie-restricted MedDiet for WL (WL-Med) on the BA-gut microbiome axis and its relevance to CRC prevention among AAs. A multidisciplinary team combining expertise in psychology, nutrition, microbiology, molecular cell biology, computational biology, medicine and biostatistics, proposes to conduct a four-arm RCT in which 232 obese AAs, 45-75 years old complete one of the following 6-month interventions: Med-A, weight stable; WL-A, calorie restriction with no diet pattern change; WLMed; or Control. The investigators will use samples and data collected at baseline, mid-study (month-3) and post-intervention to compare the effects of the interventions on 1) Concentration and composition of circulating and fecal BAs; 2) Gut microbiota and metabolic function; and 3) Gene expression profiles of exfoliated intestinal epithelial cells. | NO | Colorectal Cancer|Diet Habit | OTHER: Med|OTHER: WL | Circulating and fecal bile acids, Absolute measurement of BAs in stool and serum obtained at baseline will be performed under the direction of Co-I Ridlon. Samples will be extracted, and supernatants will be dried and resuspended for LC/MS analysis following validated and published methods. We will quantify all major primary and secondary BAs (e.g., DCA) and glycine and taurine conjugates and their ratios, as well as total BAs and total unconjugated BAs. Authentic reference BAs will be purchased from Sigma-Aldrich and Steraloids. Blind duplicate samples will be used to assess inter- and intra-batch precision., baseline|Circulating and fecal bile acids, Absolute measurement of BAs in stool and serum obtained at mid-study (3 month follow up) will be performed under the direction of Co-I Ridlon. Samples will be extracted, and supernatants will be dried and resuspended for LC/MS analysis following validated and published methods. We will quantify all major primary and secondary BAs (e.g., DCA) and glycine and taurine conjugates and their ratios, as well as total BAs and total unconjugated BAs. Authentic reference BAs will be purchased from Sigma-Aldrich and Steraloids. Blind duplicate samples will be used to assess inter- and intra-batch precision., 3 month|Circulating and fecal bile acids, Absolute measurement of BAs in stool and serum obtained at post-intervention (6 month follow up) will be performed under the direction of Co-I Ridlon. Samples will be extracted, and supernatants will be dried and resuspended for LC/MS analysis following validated and published methods. We will quantify all major primary and secondary BAs (e.g., DCA) and glycine and taurine conjugates and their ratios, as well as total BAs and total unconjugated BAs. Authentic reference BAs will be purchased from Sigma-Aldrich and Steraloids. Blind duplicate samples will be used to assess inter- and intra-batch precision., 6 month|Gut microbiota for metabolic function, The UIC Genomics core will PCR amplify genomic DNA with primers CS1_515F and CS2_806R (modified from the set used by the Earth Microbiome Project) targeting the V4 region of microbial small subunit ribosomal RNA genes. Amplicons will be generated using a two-stage PCR protocol. The V4 region of the 16S rRNA gene will be sequenced with the Illumina MiSeq platform to generate 2×250 bp paired end reads per sample. Environmental controls will be included in the sequences to distinguish from any contaminants in reagents or the lab environment., baseline|Gut microbiota for metabolic function, The UIC Genomics core will PCR amplify genomic DNA with primers CS1_515F and CS2_806R (modified from the set used by the Earth Microbiome Project) targeting the V4 region of microbial small subunit ribosomal RNA genes. Amplicons will be generated using a two-stage PCR protocol. The V4 region of the 16S rRNA gene will be sequenced with the Illumina MiSeq platform to generate 2×250 bp paired end reads per sample. Environmental controls will be included in the sequences to distinguish from any contaminants in reagents or the lab environment., 3 month|Gut microbiota for metabolic function, The UIC Genomics core will PCR amplify genomic DNA with primers CS1_515F and CS2_806R (modified from the set used by the Earth Microbiome Project) targeting the V4 region of microbial small subunit ribosomal RNA genes. Amplicons will be generated using a two-stage PCR protocol. The V4 region of the 16S rRNA gene will be sequenced with the Illumina MiSeq platform to generate 2×250 bp paired end reads per sample. Environmental controls will be included in the sequences to distinguish from any contaminants in reagents or the lab environment., 6 month|Gene expression, From stool preserved in Ambion Denaturation Solution, eukaryotic polyA+ RNA will be isolated using the Active Motif mTRAP Maxi kit followed by DNA removal with DNAFree (Invitrogen). Libraries will be quantified using the Library Quantification kit (Kapa Biosystems), and sequencing will be performed on an Illumina HiSeq 2500 platform using standard Illumina protocols. RNA reads will be mapped with the STAR aligner using the default parameters to the Ensembl GRCh38 human reference. Reads will be examined for quality control using FastQC and quantified using HTSeq-count. Sequencing reads will be filtered to remove genes present in low abundance. For stool exfoliated cells, the RNA-seq gene count matrix is very sparse, with most entries corresponding to zero transcripts; thus, genes in stool will be removed if \>33% of the samples contain only 0 or 1 read., baseline|Gene expression, From stool preserved in Ambion Denaturation Solution, eukaryotic polyA+ RNA will be isolated using the Active Motif mTRAP Maxi kit followed by DNA removal with DNAFree (Invitrogen). Libraries will be quantified using the Library Quantification kit (Kapa Biosystems), and sequencing will be performed on an Illumina HiSeq 2500 platform using standard Illumina protocols. RNA reads will be mapped with the STAR aligner using the default parameters to the Ensembl GRCh38 human reference. Reads will be examined for quality control using FastQC and quantified using HTSeq-count. Sequencing reads will be filtered to remove genes present in low abundance. For stool exfoliated cells, the RNA-seq gene count matrix is very sparse, with most entries corresponding to zero transcripts; thus, genes in stool will be removed if \>33% of the samples contain only 0 or 1 read., 3 month|Gene expression, From stool preserved in Ambion Denaturation Solution, eukaryotic polyA+ RNA will be isolated using the Active Motif mTRAP Maxi kit followed by DNA removal with DNAFree (Invitrogen). Libraries will be quantified using the Library Quantification kit (Kapa Biosystems), and sequencing will be performed on an Illumina HiSeq 2500 platform using standard Illumina protocols. RNA reads will be mapped with the STAR aligner using the default parameters to the Ensembl GRCh38 human reference. Reads will be examined for quality control using FastQC and quantified using HTSeq-count. Sequencing reads will be filtered to remove genes present in low abundance. For stool exfoliated cells, the RNA-seq gene count matrix is very sparse, with most entries corresponding to zero transcripts; thus, genes in stool will be removed if \>33% of the samples contain only 0 or 1 read., 6 month|Exfoliated intestinal epithelial cell transcriptomics, Exfoliated intestinal epithelial cells separated from stool with gene expression analysis, Baseline|Exfoliated intestinal epithelial cell transcriptomics, Exfoliated intestinal epithelial cells separated from stool with gene expression analysis, 3 months|Exfoliated intestinal epithelial cell transcriptomics, Exfoliated intestinal epithelial cells separated from stool with gene expression analysis, 6 months | Body weight, Body weight will be measured with a digital scale, baseline|Body weight, Body weight will be measured with a digital scale, 3 month|Body weight, Body weight will be measured with a digital scale, 6 month|Body mass index, Calculated from measured weight and height, baseline|Body mass index, Calculated from measured weight and height, 3 month|Body mass index, Calculated from measured weight and height, 6 month|Mediterranean Diet Adherence, Measured with a food frequency questionnaire, 24-hour diet recalls, and screener which will be aggregated to evaluate a total adherence score, Baseline|Mediterranean Diet Adherence, Measured with a food frequency questionnaire, 24-hour diet recalls, and screener which will be aggregated to evaluate a total adherence score, Month 1|Mediterranean Diet Adherence, Measured with a food frequency questionnaire, 24-hour diet recalls, and screener which will be aggregated to evaluate a total adherence score, Month 2|Mediterranean Diet Adherance, Measured with a food frequency questionnaire, 24-hour diet recalls, and screener which will be aggregated to evaluate a total adherence score, Month 3|Mediterranean Diet Adherence, Measured with a food frequency questionnaire, 24-hour diet recalls, and screener which will be aggregated to evaluate a total adherence score, Month 4|Mediterranean Diet Adherence, Measured with a food frequency questionnaire, 24-hour diet recalls, and screener which will be aggregated to evaluate a total adherence score, Month 5|Mediterranean Diet Adherence, Measured with a food frequency questionnaire, 24-hour diet recalls, and screener which will be aggregated to evaluate a total adherence score, Month 6|Physical activity, Number of steps measured for 7-days with FitBit wearable tracker, Baseline|Physical activity, Number of steps measured for 7-days with FitBit wearable tracker, 3 month|Physical activity, Number of steps measured for 7-days with FitBit wearable tracker, 6 month|Total and regional body composition (fat and muscle), DXA whole-body composition scan to measure total body composition fat% vs bone% vs lean%, baseline|Total and regional body composition (fat and muscle), DXA whole-body composition scan to measure total body composition fat% vs bone% vs lean%, 3 month|Total and regional body composition (fat and muscle), DXA whole-body composition scan to measure total body composition fat% vs bone% vs lean%, 6 month|Circulating cytokines, Measured from serum using a commercial multiplex kit, Baseline|Circulating cytokines, Measured from serum using a commercial multiplex kit, 3 month|Circulating cytokines, Measured from serum using a commercial multiplex kit, 6 month|Fasting glucose, Measured from plasma at a local commercial lab, Baseline|Fasting glucose, Measured from plasma at a local commercial lab, 3 month|Fasting glucose, Measured from plasma at a local commercial lab, 6 month|Fasting insulin, Measured from plasma at a local commercial lab, Baseline|Fasting insulin, Measured from plasma at a local commercial lab, 3 month|Fasting insulin, Measured from plasma at a local commercial lab, 6 month | Adverse events, Obtained via interview, Through study completion, an average of 6 months|Psychosocial health, survey, Baseline|Psychosocial health, survey, 3 month|Psychosocial health, survey, 6 month|Medication use, Survey, interview, baseline|Medication use, Survey, interview, 3 month|Medication use, Survey, interview, 6 month|Bowel habits, survey, baseline|Bowel habits, survey, 3 month|Bowel habits, survey, 6 month | University of Illinois at Chicago | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 232 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 2020-1342|1R01CA250390-01A1 | 2022-02-01 | 2025-03-31 | 2025-03-31 | 2021-02-15 | 2024-08-21 | University of Illinois at Chicago, Chicago, Illinois, 60612, United States | ||
| NCT04741802 | TOPS for African American Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04741802 | For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study. To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change. Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC). Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT (randomized controlled trial). | YES | Feasibility and Acceptability of the TOPS Program|Obesity|Breast Cancer|Weight Loss | BEHAVIORAL: TOPS | Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session, One-time invitation|Number of Women Who Attended the Information Session and Joined the TOPS Program, One-time information session|Number of Women Who Remained in the Program for 12 Weeks, Measured by the number of women who reported to the 12-week weigh in., up to 12 weeks|Number of Women Who Remained in the Program for 24 Weeks, Measured by the number of women who reported to the 24-week weigh in., up to 24 weeks | Percent Change in Participants’ Weight as Measured by Scale Reading, baseline, 3 months, 6 months, 12 months | Duke University | National Institutes of Health (NIH) | FEMALE | ADULT, OLDER_ADULT | NA | 26 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | Pro00107615 | 2021-06-11 | 2022-03-16 | 2022-08-30 | 2021-02-05 | 2024-02-28 | 2024-02-28 | Duke University Health System, Durham, North Carolina, 27710, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/02/NCT04741802/Prot_001.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/02/NCT04741802/ICF_002.pdf | ||
| NCT04720209 | Taking AIM at Breast Cancer | https://clinicaltrials.gov/study/NCT04720209 | The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue. | NO | Breast Cancer|Breast Cancer Stage I|Breast Cancer Stage II|Breast Cancer Stage III | OTHER: CARE|OTHER: TARE|OTHER: Home-Based Stretching | Decrease in adipose tissue levels of inflammation., Adipose tissue inflammation will be assessed by measuring: M1 and M2 adipose tissue macrophages (ATMs), 16 Weeks|Decrease in adipose tissue levels of inflammation., Adipose tissue inflammation will be assessed by measuring: leptin, adiponectin, IL-6 and IL-8, 16 weeks|Decrease in adipose tissue levels of inflammation., Adipose tissue inflammation will be assessed by measuring: hs-CRP and TNF-a, 16 weeks | 4-month CARE intervention on sarcopenic obesity., sarcopenic obesity will be assessed via dual energy X-ray absorptiometry using a validated equation., 16 Weeks | Dana-Farber Cancer Institute | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 300 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 20-172 | 2021-08-13 | 2025-06-15 | 2026-06-15 | 2021-01-22 | 2024-01-23 | Brigham and Women’s Hospital, Boston, Massachusetts, 02115, United States|Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States | ||||
| NCT04717050 | Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity | https://clinicaltrials.gov/study/NCT04717050 | This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors. | NO | Breast Cancer|Coronary Artery Disease|Stroke|Type2 Diabetes | BEHAVIORAL: Progressive combine training (PCT)|BEHAVIORAL: Attention Control (AC) | Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance, Changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA), 16 weeks|Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Visceral adiposity, Changes from baseline in visceral adiposity (VA) measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA), 16 weeks|Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -metabolic syndrome (MSY), Frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA), 16 weeks | Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups -Insulin Resistance, Compare changes from baseline in insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) in Progressive Combine Training (PCT) and Attention (AC) groups, 16 weeks|Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups – Visceral adiposity, Compare changes from baseline in Visceral adiposity (VA) measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA) in Progressive Combine Training (PCT) and Attention (AC) groups, 16 weeks|Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups – metabolic syndrome (MSY), Compare frequency of metabolic syndrome (MSY) diagnosed by criteria accepted by the American Heart Association (AHA) in Progressive Combine Training (PCT) and Attention (AC) groups – metabolic syndrome (MSY), 16 weeks|Metabolic Dysregulation (MetD) Status During 4 month follow up period – insulin resistance (IR), Change in insulin resistance (IR) status from end of study PCT to 4 month follow up measured by Homeostasis Model Assessment (HOMA)., 16 weeks|Metabolic Dysregulation (MetD) Status During 4 month follow up period – Visceral adiposity (VA), Change in Visceral adiposity (VA) status from end of study PCT to 4 month follow up measured by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology (BIA)., 16 weeks|Metabolic Dysregulation (MetD) Status During 4 month follow up period – metabolic syndrome (MSY), Change in metabolic syndrome (MSY) frequency from end of study PCT to 4 month follow up diagnosed by criteria accepted by the American Heart Association (AHA), 16 weeks | Dana-Farber Cancer Institute | American Cancer Society, Inc. | FEMALE | ADULT, OLDER_ADULT | NA | 160 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 20-221 | 2021-08-12 | 2025-06-15 | 2026-06-15 | 2021-01-20 | 2024-10-30 | Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States | ||||
| NCT04659837 | Training Response Inhibition to Obesogenic Foods | https://clinicaltrials.gov/study/NCT04659837 | Dietary choices, and in particular, excess calorie intake leading to obesity, are strong, but reversible risk factors for cancer. For example, foods high in added sugars are low-nutrient, high calorie foods that increase the risk of cancer by promoting weight gain. As such, the reduction of sweets is consistent with American Institute for Cancer Research and the American Cancer Society dietary recommendations. Behavioral interventions to alter diet have limited long-term efficacy, most likely because eating decisions are governed by automatic neurocognitive processes that are not addressed in conventional interventions. In particular, the ability to refrain from consuming unhealthy, but widely available, palatable foods, is increasingly understood to depend on inhibitory control, i.e., the ability to cut off action tendencies that are put in motion by innate drives towards rewarding behaviors. Recent work by our team and others have demonstrated that computer-based inhibitory control trainings result in short-term, specific changes in behavior, such as reducing intake of salty snack food, chocolate, and alcoholic beverages. An automatized, home computer-based inhibitory control training offers the potential of an inexpensive and highly disseminable method of lowering cancer risk across wide swaths of the population. As such, we aim to evaluate the feasibility, acceptability, mechanism of action, effectiveness and persistence of a home computer-based inhibitory control training. In particular, we hypothesize that a high-repetition training in inhibitory control will result in increased adherence to a low-sugar diet, and that effects will be mediated through improved inhibitory control. We further hypothesize that gamefying the training will improve efficacy because it will boost compliance with the daily trainings. We also hypothesize that the training will be most effective for those starting of with impaired inhibitory control, as well as those with strongest desire for palatable foods and those with strongest explicit health goals. Lastly, we aim to examine the impact of inhibitory control training on secondary outcomes, including on overall caloric intake, and on short-term weight loss. To achieve these aims, the proposed study will recruit 100 overweight and obese individuals who currently eat high-sugar diets, and who wish to improve their diets. Participants will be assigned a reduced-sugar diet for 8 weeks. After a baseline period, participants will be randomized, via a 2 x 2 factorial design, to receive 6 weeks of either inhibitory control training or a sham training, and either a gamified or non-gameified training. The 6-week intervention will consist of 15 minutes per day of home computer- based inhibitory control training, and will be followed by a 1-week booster and then 1-week follow-up period. Dietary adherence will be measured via a food frequency questionnaire and via automated 24-hour food recall. Neurocognitive variables will be assessed pre and post-training in order to test trainings’ mechanism of action, and moderation will be assessed through baseline trait measures of explicit health goals, implicit attitudes towards appetitive stimuli, body mass index, and responsivity to food cues. | NO | Inhibitory Control Training|Gameifaction | BEHAVIORAL: No-Added-Sugar Diet | Weight, 8 weeks|Sweets consumption, 8 weeks|Inhibitory control in response to high-sugar foods, Inhibitory control in response to high-sugar foods is measured via performance (i.e., speed of inhibiting prepotent responses to high-sugar food stimuli) on the daily inhibitory control training (i.e., Go/No-Go) task., 8 weeks | Compliance with daily inhibitory control training prescription, Compliance with completing the daily inhibitory control training prescription will be measured as the number of days the task was completed out of the total number of days it was prescribed., 8 weeks|Enjoyment of the daily training task, Enjoyment and acceptability of the inhibitory control training will be assessed using self-report. Participants will be asked to rate how ‘fun’ and ‘boring’ the training was on a Likert scale., 8 weeks | Drexel University | ALL | ADULT, OLDER_ADULT | NA | 125 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | R21CA191859 | 2016-06-01 | 2019-08-07 | 2019-12-01 | 2020-12-09 | 2020-12-09 | Drexel University, Philadelphia, Pennsylvania, 19104, United States | |||||
| NCT04655391 | Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation | https://clinicaltrials.gov/study/NCT04655391 | This phase Ib trial evaluates the best dose and effect of glasdegib in combination with venetoclax and decitabine, or gilteritinib, bosutinib, ivosidenib, or enasidenib in treating patients with acute myeloid leukemia that has come back (relapsed) after stem cell transplantation. Chemotherapy drugs, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Glasdegib, bosutinib, ivosidenib, and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Glasdegib inhibits the Sonic the Hedgehog gene. Venetoclax inhibits BCL-2 gene. Bosutinib is a tyrosine kinase inhibitor that inhibits BCR-ABL gene fusion. Ivosidenib inhibits isocitrate dehydrogenase-1 gene or IDH-1. Enasidenib inhibits isocitrate dehydrogenase-2 gene or IDH-2. This study involves an individualized approach that may allow doctors and researchers to more accurately predict which treatment plan works best for patients with relapsed acute myeloid leukemia. | NO | Recurrent Acute Myeloid Leukemia | DRUG: Bosutinib Monohydrate|DRUG: Decitabine|DRUG: Enasidenib Mesylate|DRUG: Gilteritinib Fumarate|DRUG: Glasdegib Maleate|DRUG: Ivosidenib|DRUG: Venetoclax | Ability to obtain a molecular diagnosis (Molecular Diagnosis Segment), Outcome will be dichotomized based on return in =\< 10 calendar days (Yes/No). Assessed by the proportion of successful participants., From study enrollment to return of Molecular Diagnosis Report, assessed up to 30 days|Ability to make a treatment arm assignment by the Treatment Assignment Committee (TAC) (Molecular Diagnosis Segment), Outcome will be dichotomized based on return in =\< 14 calendar days (Yes/No). Assessed by the proportion of participants who receive treatment assignment from TAC., From enrollment to treatment arm assignment by the TAC, assessed up to 30 days|Incidence of adverse events (Treatment Segment), Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be based on the assessment of dose limiting toxicity during cycle 1 and cycle 2. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome., Up to 30 days | Proportion of patients with successful sequencing (Molecular Diagnosis Segment), Successful sequencing is defined as passing quality control, and will be determined by City of Hope pathology among those with less than 20% blasts in the marrow aspirate., Up to 30 days|Proportion of patients with successful treatment arm registration (Molecular Diagnosis Segment), Successful placement defined as the enrollment of a participant into one of the treatment arms., Up to 30 days|Incidence of adverse events (Molecular Diagnosis Segment), Toxicity will be graded according to the NCI-CTCAE version 5.0. Safety will be based on the assessment of unacceptable toxicity during glasdegib monotherapy. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome., Up to 30 days|Overall response (Treatment Segment), Response will be based on Dohner et al., 2017 criteria. Response dates recorded will be the date of the first of 2 successive bone marrows showing said response. For this trial, will assess the complete remission rate calculated as the percent of evaluable patients that have confirmed complete response (CR) or incomplete blood count recovery (CRi). 95% Clopper Pearson binomial confidence interval will be calculated. Response rates will also be explored based on number/type of prior therapy(ies)., Up to the date of the first of 2 successive bone marrows showing said response, assessed up to 30 days|Duration of remission (Treatment Segment), Time from the first of two consecutive bone marrow aspirates showing CR or CRi until such time as the bone marrow or peripheral blood mononuclear cells shows signs of relapse, assessed up to 30 days | Change in leukemia stem cell (LSC) burden (Treatment Segment), Measured by limiting dilution and engraftment into non-obese diabetic severe combined immunodeficiency gamma severely immunocompromised mice. Graphical statistics will be used. To assess the association between the LSC reduction and the response to the treatment, the median change from baseline to post-treatment (2 cycles) in engraftment levels of secondary mice recipients (n=12 mice/patient, 6 females and 6 males) will be compared by two-sample t test between response and non-response patient groups as LSC donors, across all treatment arms. The effect of treatment on the target genes will be assessed for each arm by linear mixed models (pre- versus multiple post-treatment time points) as well., Baseline up to post-treatment (2 cycles) (each cycle = 28 days) | City of Hope Medical Center | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | PHASE1 | 0 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 20456|NCI-2020-10595|20456|P30CA033572 | 2022-06-25 | 2023-12-15 | 2023-12-15 | 2020-12-07 | 2022-06-09 | City of Hope Meidcal Center, Duarte, California, 91010, United States | |||
| NCT04656496 | NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors | https://clinicaltrials.gov/study/NCT04656496 | NOURISH-T+ | Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease – the leading cause of death in this population. The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves. | NO | Obesity, Childhood|Cancer|Survivorship | BEHAVIORAL: NOURISH-T+|BEHAVIORAL: Brief NOURISH-T+ | Change in Child BMI z-score, Height and weight will be measured to obtain BMI z-score for gender and age., baseline to 6 months|Change in Child BMI z-score, Height and weight will be measured to obtain BMI z-score for gender and age., baseline to 12 months | Change in Child Physical Activity Behaviors, Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time., baseline to 6 months|Change in Child Physical Activity Behaviors, Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time., baseline to 12 months|Change in Child Eating Behaviors, Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations., baseline to 6 months|Change in Child Eating Behaviors, Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations., baseline to 12 months|Change in Parent BMI, Height and weight will be measured and used to calculate continuous adult BMI score., baseline to 6 months|Change in Parent BMI, Height and weight will be measured and used to calculate continuous adult BMI score., baseline to 12 months | University of South Florida | National Cancer Institute (NCI) | ALL | CHILD | NA | 520 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | STUDY000244|R01CA240319 | 2020-12-08 | 2025-10-30 | 2025-11-30 | 2020-12-07 | 2024-12-11 | Children’s National Hospital, Washington, District of Columbia, 20010, United States|University of Florida Health System, Gainesville, Florida, 32611, United States|University of Miami Health System, Miami, Florida, 33136, United States|Nicklaus Children’s Hospital, Miami, Florida, 33155, United States|USF Pediatrics, Tampa, Florida, 33612, United States|Emory University, Atlanta, Georgia, 30322, United States|Johns Hopkins Medicine, Baltimore, Maryland, 21287, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Hackensack Meridian Health, Hackensack, New Jersey, 07601, United States|Virginia Commonwealth University, Richmond, Virginia, 23298, United States | |||
| NCT04644224 | Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families | https://clinicaltrials.gov/study/NCT04644224 | This study tests the effectiveness of parent and family oriented support interventions that are designed to help with weight loss among African American families. Obesity tends to run in families, thus family based interventions, with parents as main change agents have been strongly recommended. The parent and family oriented support Interventions may help facilitate weight loss among African American families. | NO | Obesity-Related Malignant Neoplasm | OTHER: Educational Activity|OTHER: Educational Intervention|OTHER: Informational Intervention|OTHER: Questionnaire Administration|PROCEDURE: Support Group Therapy | Weight loss of parents, Will use the generalized linear mixed model (GLMM) regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest., Up to 18 months|Reach (Part 1 of the RE-AIM framework), Measured as the number of churches invited to participate, number enrolled, and differences between the two groups., Up to 18 months|Effectiveness (Part 2 of the RE-AIM framework), Measured as the impact on weight loss: 6 focus groups and 15 individual interviews at 18 months to understand unanticipated outcomes; interview lay health workers (LHWs) about implementation., Up to 18 months|Adoption (Part 3 of the RE-AIM framework), Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed., Up to 18 months|Implementation (Part 4 of the RE-AIM framework), Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices., Up to 18 months|Maintenance (Part 5 of the RE-AIM framework), Long-term maintenance in parent/families at 18 months measured by family and church attrition, to assess church’s ability to maintain employment of LHWs and their willingness to remain in this role., Up to 18 months | Child’s body mass index (BMI) z-score, Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest., Up to 18 months|Fruit and vegetable consumption, Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest., Up to 18 months|Physical activity, Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest., Up to 18 months|Blood pressure, Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest., Up to 18 months|Body fat percentage, Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest., Up to 18 months|Waist circumference, Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest., Up to 18 months | M.D. Anderson Cancer Center | ALL | CHILD, ADULT, OLDER_ADULT | NA | 1200 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2017-0827|NCI-2020-07645|2017-0827 | 2019-01-17 | 2028-12-31 | 2028-12-31 | 2020-11-25 | 2024-09-19 | M D Anderson Cancer Center, Houston, Texas, 77030, United States | |||||
| NCT04633512 | Safety and Feasibility of ActivSightTM in Human | https://clinicaltrials.gov/study/NCT04633512 | ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC). | NO | Acute Cholecystitis|Colorectal Cancer|Diverticulitis, Colonic|Obesity, Morbid|Inflammatory Bowel Diseases | DEVICE: ActivSight | Incidence of Adverse Events in 28 days following use of ActivSightTM, To determine safety of ActivSightTM in patients undergoing intestinal anastomoses, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSightTM will be deemed safe if hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered. Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test., 28 days|Preparation time of ActivSightTM., Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied – 5 = no training required or very satisfied): How easy was ActivSight to set up?, 1 day|Latency of display of ActivSightTM., Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied – 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?, 1 day|Resolution of display of ActivSightTM., Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied – 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?, 1 day|Specificity of display of ActivSightTM., Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: “Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?”, 1 day|Usability of ActivSightTM by surgeon, as quantified by Likert scale., Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): “ActivSightTM was easy to use while operating.”, 1 day|Support personnel satisfaction with ActivSightTM, as quantified by Likert scale., Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): “ActivSightTM was easy to set up for the procedure.”, 1 day | Ability of ActivSightTM to display perfusion., ActivSightTM ability to display perfusion at a tissue level during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: “Does ActivSightTM display tissue perfusion of the anatomy during anastomoses in comparison to ICG?”, 1 day|Ability of ActivSightTM to display blood vessels., ActivSightTM ability to display blood vessels during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: “Does ActivSightTM display vascularity of the anatomy during anastomoses in comparison to ICG?”, 1 day|Ability of ActivSightTM to display biliary tree., The clinical metrics for displaying biliary tree will be evaluated using the following question: “Which of the following biliary structures are you able to identify using ActivSightTM with ICG? (Select all that apply): common bile duct (CD), right hepatic duct (RHD), common hepatic duct (CHD), common bile duct (CBD), cystic common bile duct junction (CCBDJ), cystic gallbladder junction (CGJ), accessory ducts (AD).”, 1 day | Activ Surgical | The University of Texas Health Science Center, Houston|University at Buffalo|Ohio State University | ALL | ADULT, OLDER_ADULT | NA | 67 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY | ACF0012020 | 2020-11-17 | 2025-01 | 2025-01 | 2020-11-18 | 2024-02-21 | Kaleida Health, University of Buffalo, Buffalo, New York, 14203, United States|Memorial Hermann Texas Medical Center, Houston, Texas, 77030, United States|Memorial Hermann Sugar Land Hospital, Sugar Land, Texas, 77479, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/12/NCT04633512/Prot_000.pdf | |||
| NCT04623190 | Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors | https://clinicaltrials.gov/study/NCT04623190 | Health information technology (HIT) has the potential to improve the quality, efficiency, consistency, and availability of cancer survivor care. PREVENT is a novel HIT tool designed by our team for adolescents (12-19 years). PREVENT aggregates and displays the American Heart Association’s (AHA) Life Simple 7 cardiovascular health (CVH) risk factors and provides tailored, evidence-based, behavior change recommendations inclusive of community resources that are delivered to overweight/obese adolescents at the point-of-care to improve CVH. The investigators seek to expand this tool for patients beyond 19 years of age to increase this tool’s reach to the entire adolescent and young adult (AYA) age range and then evaluate its effectiveness among AYA cancer survivors. | NO | Cardiovascular Disease|Young Adult Cancer Survivors | BEHAVIORAL: Wait-List Control|BEHAVIORAL: PREVENT tool | Change in minutes of physical activity, Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days., At baseline and 3-months|Change in food intake behaviors, Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior \& Attitudes Survey., At baseline and 3-months|Change in body mass index (BMI), Collected from patient’s medical record., At baseline and 3-months|Change on patient’s attitudes toward behavior change, A survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change. Questions are asked using a 5-point Likert scale (range: 0-30) with a higher score indicating more positive attitudes., At baseline and 3-months | Change in patients’ satisfaction of PREVENT tool: survey, Within 48 hours of clinic visit and at 3-months|Provider’s satisfaction of PREVENT tool: survey, A survey (15-questions) will assess provider’s satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 15-75) with a higher score indicating greater satisfaction, 3-months|Change on patient’s average systolic and diastolic blood pressure, Collected from patient’s medical record, At baseline and 3-months|Change in patient’s cholesterol, Collected from patient’s medical record, At baseline and 3-months|Change in patient’s fasting blood glucose, Collected from patient’s medical record, At baseline and 3-months|Provider’s motivation for sustained use of PREVENT tool, -A survey (12-questions) will assess provider’s intent to change their behavior and continue using PREVENT were adapted from Legare’s CPD Reaction Questionnaire. Questions are asked using a 7-point Likert scale (range: 12-84) with a higher score indicating greater motivation for sustained use., 3-months|Fidelity of PREVENT tool implementation, -Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended., 0-3 months | Washington University School of Medicine | American Cancer Society, Inc. | ALL | ADULT | NA | 26 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH | 202011075 | 2021-06-23 | 2022-03-25 | 2022-03-25 | 2020-11-10 | 2022-08-25 | Washington University School of Medicine, Saint Louis, Missouri, 63110, United States | ||||
| NCT04611087 | Self-monitoring Focus Groups With Vibrant Lives Pasadena Participants | https://clinicaltrials.gov/study/NCT04611087 | This study investigates how individuals feel about a dietary mobile application. Information collected from focus groups and interviews may help doctors and mobile application developers to determine preferences and participant feedback about the appeal and usefulness of a mobile application. | NO | Obesity-Related Malignant Neoplasm | BEHAVIORAL: Discussion|OTHER: Interview|OTHER: Survey Administration | Preferences of food and beverage self-monitoring methodology and respective feedback messages, Thematic and narrative analyses will be conducted from the transcriptions to gain an understanding for the preferences of food and beverage self-monitoring methodology and respective feedback messages., Up to 3 years | M.D. Anderson Cancer Center | ALL | CHILD, ADULT, OLDER_ADULT | 39 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PA18-0407|NCI-2020-07542|PA18-0407 | 2018-07-03 | 2025-04-30 | 2025-04-30 | 2020-11-02 | 2024-08-16 | M D Anderson Cancer Center, Houston, Texas, 77030, United States | |||||||
| NCT04576247 | Combined Modality Exercise and Appetite in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04576247 | CARE | The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS). | NO | Breast Cancer Female|Overweight and Obesity | BEHAVIORAL: Combined aerobic and resistance exercise | Recruitment and enrollment feasibility, Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study, Through study completion, up to two years|Subjective exercise adherence, Participants will be asked to rate on a 1-10 Likert scale: 1) how adherent they were to the prescribed exercise over the past week, 2) how difficult it was to adhere to the prescribed exercise over the past week, and 3) how likely they feel they can adhere to the prescribed exercise for the next month., Changes across weeks 4, 8, and 12|Exercise self efficacy, Self Efficacy for Exercise Scale; 9 items; score range: 0-9, with higher scores indicating higher exercise self-efficacy, Changes across weeks 4, 8, and 12|Exercise enjoyment, Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment, Changes across weeks 4, 8, and 12|Intervention acceptability, Subjective ability to adhere to combined AEx/REx, 12 weeks|Intervention acceptability, Barriers to completing AEx/REx, 12 weeks|Intervention acceptability, Open-ended opinions on the structure and content of the exercise training sessions, 12 weeks|Intervention acceptability, Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention, 12 weeks|Objective exercise adherence, Adherence to additional study-specific AEx will be tracked through heart rate monitor data, logs of attendance, and participant diaries and compared to the REx-only intervention, 12 weeks | Changes in ghrelin, Fasting ghrelin, ghrelin area under the curve in response to a control meal, Baseline, 12 weeks|Changes in peptide-YY (PYY), Fasting PYY, PYY area under the curve in response to a control meal, Baseline, 12 weeks|Changes in subjective appetite ratings, Changes in hunger, satiety, and prospective food consumption via visual analog scales, Baseline, 12 weeks|Changes in ad libitum energy intake, Energy intake from buffet-style meal, Baseline, 12 weeks|Changes in physical activity, Step count measured by accelerometers, Baseline, 12 weeks|Changes in sedentary behavior, Time in sedentary activities measured by accelerometers, Baseline, 12 weeks | Changes in resting energy expenditure, Resting energy expenditure measured by metabolic cart and adjusted for body composition changes, Baseline, 12 weeks|Changes in body composition, Fat mass and fat-free mass in kg, measured by dual X-ray absorptiometry, Baseline, 12 weeks|Changes in fatigue, Measured by the Functional Assessment of Chronic Illness and Therapy – Fatigue; 13 questions; score range: 0-52, with higher score indicating higher fatigue, Baseline, 12 weeks | University of Colorado, Denver | Colorado Clinical & Translational Sciences Institute|National Cancer Institute (NCI) | FEMALE | ADULT | NA | 3 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | 19-3032.cc | 2020-06-05 | 2021-09-20 | 2021-09-20 | 2020-10-06 | 2022-06-03 | Univeristy of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|University of Colorado Cancer Center, Denver, Colorado, 80238, United States | ||
| NCT04569591 | Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s Disease | https://clinicaltrials.gov/study/NCT04569591 | Background: Cushing s disease is caused by a pituitary gland tumor. Patients with Cushing s disease suffer obesity, diabetes, osteoporosis, weakness, and hypertension. The cure is surgery to remove the pituitary tumor. Currently, MRI is the best way to find these tumors. But not all tumors can be seen with an MRI. Researchers hope giving the hormone CRH before a PET scan can help make these tumors more visible. Objective: To test whether giving CRH before a PET scan will help find pituitary gland tumors that might be causing Cushing s disease. Eligibility: People ages 8 and older with Cushing s disease that is caused by a pituitary gland tumor that cannot be reliably seen on MRI Design: Participants will be screened with their medical history, a physical exam, an MRI, and blood tests. Participants will have at least one hospital visit. During their time in the hospital, they will have a physical exam and a neurological exam. They will have a PET scan of the brain. A thin plastic tube will be inserted into an arm vein. A small amount of radioactive sugar and CRH will be injected through the tube. Participants will lie in a darkened room for about an hour and be asked to urinate. Then they will lie inside the scanner for about 40 minutes. After the scan, they will be asked to urinate every 2-3 hours for the rest of the day. Blood will be drawn through a needle in the arm. Participants will have surgery to remove their tumor within 3 months after the scan. Participants will then continue regular follow-up in the clinic. | NO | Cushing’s Disease|Pituitary Adenoma | DRUG: Acthrel | CRH-stimulated PET imaging demonstrates tumor in MRI-negative cases., The primary outcome measure will be defined as whether or not CRH- stimulated PET imaging demonstrates tumor in MRI-negative cases. This will be demonstrated by assessing the accuracy and sensitivity of 18F-FDG high-resolution PET-imaging detection of ACTH-adenomas that could not be reliably detected on MR-imaging. Measures will include determining the rate of true tumor detection using PET-imaging compared to histologically-confirmed tumor location., Baseline | Elevation of SUV of 18F-FDG, To measure the elevation of SUV of 18F-FDG within adenomas compared to surrounding normal gland following CRH stimulated PET imaging., Baseline | National Institute of Neurological Disorders and Stroke (NINDS) | ALL | CHILD, ADULT, OLDER_ADULT | NA | 22 | NIH | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 200048|20-N-0048 | 2025-01-22 | 2025-12-31 | 2025-12-31 | 2020-09-30 | 2025-01-17 | National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States | |||||
| NCT04562636 | Evaluating a Messaging Campaign in the United States | https://clinicaltrials.gov/study/NCT04562636 | Purpose: To evaluate reactions to and opinions of a messaging campaign. Participants: Participants will be recruited through Prime Panels and will be US-based adults (18 years old and older) who consumed red meat in the past 30 days. Procedures (methods): After completing a screening question about meat consumption, participants will review a consent form. If they select to participate in the study, participants will be randomly assigned to view control messages, red meat-related environment messages, or red meat-related health messages. They will be asked a series of questions about these messages. Participants will also be asked about grocery shopping preferences and standard demographics questions. | NO | Obesity|Heart Diseases|Cancer | OTHER: Environmental message|OTHER: Health message|OTHER: Neutral Message | Perceived Message Effectiveness (PME), Perceived effectiveness of the messages will be measured during the message using 4 items adapted from Baig et al. (2018): concern, unpleasantness, and discouragement. The averaged responses on the 4 items will be used to create a PME score. All 4 items are measured using a a 1 to 5 likert scale, with higher scores representing a higher amount of the construct. Questions: How much do these messages… * make you concerned about the health effects of eating red meat? * make you concerned about the environmental effects of eating red meat? * discourage you from wanting to eat red meat? * make eating red meat seem unpleasant to you? 1. Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal)., ~10 minute computer survey immediately after seeing messages | Attention, How much the message grabs one’s attention. Measured using a a 1 to 5 likert scale, with higher scores representing a higher amount of the construct., ~10 minute computer survey immediately after seeing messages|Negative affect, How much the messages make one feel scared. Measured using a a 1 to 5 likert scale, with higher scores representing a higher amount of the construct., ~10 minute computer survey immediately after seeing messages|Cognitive elaboration, How much the messages make one think about the environmental/health harms caused by eating meat. Measured using a a 1 to 5 likert scale, with higher scores representing a higher amount of the construct., ~10 minute computer survey immediately after seeing messages|Social interactions, How much one is likely to talk about the message with others in the next week. Measured using a 1 to 5 likert scale, with higher scores representing a higher amount of the construct., ~10 minute computer survey immediately after seeing messages|Intention to reduce meat consumption, How much one intends to reduce red meat consumption in the next 30 days. Measured using a a 1 to 5 likert scale, with higher scores representing a higher amount of the construct., ~10 minute computer survey immediately after seeing messages | University of North Carolina, Chapel Hill | Wellcome Trust | ALL | ADULT, OLDER_ADULT | NA | 1244 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 20-2552|14380 | 2020-09-29 | 2020-10-01 | 2020-10-01 | 2020-09-24 | 2020-10-05 | Carolina Population Center, Chapel Hill, North Carolina, 27599, United States | Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/36/NCT04562636/SAP_000.pdf | |||
| NCT04557540 | Weight Loss Interventions for Black Adults of Faith | https://clinicaltrials.gov/study/NCT04557540 | This trial compares the effect of intermittent fasting versus continuous caloric reduction for the reduction of body weight in Black adults of faith. Intermittent fasting and continuous caloric reduction interventions may help Black adults of faith lose weight, improve their health, and help reduce cancer risk. | NO | Obesity-Related Malignant Neoplasm | BEHAVIORAL: Lifestyle Therapy|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration|OTHER: Short-Term Fasting | Change in body weight, Up to 6 months|Changes in body composition, up to 6 months|Change in height, up to 6 months|Change in heart rate, Up to 6 months|Change in blood pressure, AT 6 months|Change in waist circumference, Up to t 6 months|Change in hip circumference, Up to 6 months | Dietary intake, Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR)., Up to 6 months|Obesity-related biomarker analysis, Will measure biomarkers related to , including C-peptide, as a marker of insulin secretion Will assay for 6 adipokines including leptin, adiponectin, adipsin, lipocalin-2/NGAL, resistin, and PAI-1 (total) as markers of adiposity and adiposity-related metabolic dysfunction, including insulin resistance, and CRP as a well-characterized and validated marker for systemic inflammation., Up to 6 months|glucose metabolism, Change from baseline, UP to 6 months|changes in Adipokine levels, blood concentration measure, Up to 6 months|C-Peptide level, Up to 6 months | Roswell Park Cancer Institute | ALL | ADULT, OLDER_ADULT | NA | 44 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | I 684220|NCI-2020-06640|I 684220 | 2021-09-25 | 2022-12-07 | 2022-12-07 | 2020-09-21 | 2024-01-16 | Roswell Park Cancer Institute, Buffalo, New York, 14263, United States | |||||
| NCT04554316 | Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery | https://clinicaltrials.gov/study/NCT04554316 | All patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Elkins Park will be offered participation into the study. Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders will be excluded from the study. Risks and benefits of the study as well as risks and benefits of the procedure will be discussed with the patient by one of the investigators. If the patient elects to participate in the study, they will be assigned to incisional dressing at the time of operation with either in-line or perpendicular placement of Steri-Strips based on the patient’s computer-generated randomization assignment. The patient’s chart will be reviewed to determine the patient’s age and comorbid conditions including obesity (pre-operative BMI), diabetes mellitus, use of anti-platelet or anticoagulant medication, or smoking. This information will be utilized to ensure that our study groups are similar in baseline demographics and pre-existing conditions. Additionally, the primary medical reason for needing breast surgery will be reviewed as well as treatment with pre-operative or post-operative chemotherapy or radiation therapy to the breast. Steri-Strips will not be removed and will be allowed to fall off naturally. At regularly scheduled 30-day and 90-day follow-up appointments, pictures will be taken of the incisional area. These photographs will be reviewed by a blinded, independent surgeon who will grade each incision according to the modified Hollander Cosmesis Scale. Statistical analysis with t-testing of the means and chi-squared testing of dichotomous variables will be performed to determine significance of the findings. | NO | Scar|Breast Neoplasms|Breast Diseases|Surgical Wound | DEVICE: Steri-strip | Cosmesis score 30 days, Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 30 days, 30 days|Cosmesis score 90 days, Hollander cosmesis scale (0-6, 6 being best cosmetic grade) grade of scar appearance at 90 days, 90 days | Surgical site infection, Presence or absence of surgical site infection, 90 days|Wound dehiscence, Presence or absence of wound dehiscence, 90 days | Albert Einstein Healthcare Network | ALL | ADULT, OLDER_ADULT | NA | 94 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | IRB-2019-118 | 2020-11-01 | 2023-06-15 | 2023-07-15 | 2020-09-18 | 2023-08-14 | Albert Einstein Medical Center Montgomery, East Norriton, Pennsylvania, 19403, United States|Albert Einstein Medical Center, Philadelphia, Pennsylvania, 19141, United States | |||||
| NCT04540081 | Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer | https://clinicaltrials.gov/study/NCT04540081 | CLOVER | The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older. | NO | Colon Cancer|Lung Cancer|Tobacco Use Cessation|Obesity|Pneumonia, Bacterial|Shingles|Hepatitis C | OTHER: Epic Healthy Planet Population Health Module | Overall Adherence to CLOVER Metrics, This is the proportion of patients who appropriately completed screenings and vaccinations that they were eligible for, 6 months | Colon cancer screening, Proportion of eligible patients who completed colon cancer screening., 6 months|Lung cancer screening, Proportion of eligible patients who completed lung cancer screening., 6 months|Tobacco cessation counseling, Proportion of eligible patients who completed tobacco cessation counseling., 6 months|Obesity counseling, Proportion of eligible patients who completed obesity counseling., 6 months|Pneumonia vaccination, Proportion of eligible patients who completed pneumonia vaccination., 6 months|Shingles vaccination, Proportion of eligible patients who completed shingles vaccination., 6 months|Hepatitis C screening, Proportion of eligible patients who completed hepatitis C screening., 6 months | University of California, Davis | University of California, Irvine | ALL | ADULT, OLDER_ADULT | NA | 20000 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 1624888 | 2020-10-05 | 2022-10-05 | 2022-10-05 | 2020-09-07 | 2023-12-27 | UC Davis Medical Center, Sacramento, California, 95817, United States | |||
| NCT04534309 | Behavioral Weight Loss Program for Cancer Survivors in Maryland | https://clinicaltrials.gov/study/NCT04534309 | ASPIRE | Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project | NO | Breast Cancer|Prostate Cancer|Melanoma (Skin)|Endometrial Cancer|Gallbladder Cancer|Rectal Cancer|Kidney Cancer|Bladder Cancer | BEHAVIORAL: Written Weight Loss Material|BEHAVIORAL: Weight Loss App|BEHAVIORAL: Behavioral Lifestyle Weight Loss Intervention (Coaching) | Weight change at 6 months in Coach-Directed Program, Evaluate the “effectiveness” of the Coach-Directed weight loss programs in a real world setting by examining weight change \[in kilograms (kg)\] at 6-months., Baseline and 6 months | Weight change at 6 months in Self-Directed and App-Directed Weight Loss Programs, Evaluate the “effectiveness” of the Self-Directed and App-Directed weight loss programs in a real world setting by examining weight change \[in kilograms (kg)\] at 6-months., Baseline and 6 months | Program participation as assessed by participant enrollment, Examine the enrollment in each program as a measure of program participation., End of enrollment, up to 2 years|Adoption of weight loss program activities as assessed by app use frequency, Evaluate the “adoption” of the App-Directed Weight Loss Program and Coach-Directed Weight Loss Program by examining app-use frequency at six months., 6 months|Implementation of weight loss program as assessed by a participant survey, Evaluate the implementation of the Coach-Directed Weight Loss Program through a participant survey., 6 months|Weight change at 12 months by program, Evaluate the “maintenance” of the Self-Directed, App-Directed and Coach-Directed weight loss programs in a real world setting by examining weight change \[in kilograms (kg)\] at 12-months by program., Baseline and 12 months | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Cigarette Restitution Fund | ALL | ADULT, OLDER_ADULT | NA | 340 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | IRB00229163 | 2020-09-22 | 2022-12-15 | 2023-06-30 | 2020-09-01 | 2023-10-10 | Johns Hopkins ProHealth, Baltimore, Maryland, 21207, United States | ||
| NCT04504201 | Patient-centered Communication About Healthy Weight in Early Breast Cancer | https://clinicaltrials.gov/study/NCT04504201 | Comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. Many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. This study tinvestigates how messages and messaging about healthy weight can be tailored for racially diverse breast cancer survivors with obesity in order to ensure that clinic-based communications between patients and their oncology provider are patient-centered and culturally sensitive. | NO | Breast Cancer | OTHER: Focus Group | Feedback from patients regarding healthy weight communication through focus groups, Summary of conversation based on 5A’s Behavioral Change Model, 3 year | Feedback from oncology providers regarding healthy weight communication through semi-structured interview, Provider suggestions on how to implement 5A’s Behavioral change model into patient care, 3 year | UNC Lineberger Comprehensive Cancer Center | American Cancer Society, Inc.|Pfizer | ALL | ADULT, OLDER_ADULT | 39 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | LCCC 1954 | 2020-06-15 | 2020-09-29 | 2020-09-29 | 2020-08-07 | 2022-07-29 | University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States | |||||
| NCT04499950 | Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study | https://clinicaltrials.gov/study/NCT04499950 | A-NEW | This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome. | NO | Breast Cancer|Overweight or Obesity | DRUG: Contrave|BEHAVIORAL: Behavioral Weight Loss | Number of patients with 5 percent weight loss (in SLOW-BWL), To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9., 6 months | Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21. The higher the score, the worse the sleep quality, Baseline, 2 months and 6 Months|Change in Scores on PROMIS Physical Function – Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Physical Function. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased depression symptoms., Baseline, 2 months and 6 Months|Change in Scores on PROMIS Pain Interference – Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Pain Interference. A t-score of 55-60 indicates mild pain interference, a t-score of 60-70 indicates moderate pain interference and a t-score of 70 or above indicates severe pain interference., Baseline, 2 months and 6 Months|Change in Scores on PROMIS Fatigue – Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Fatigue. A t-score of 55-60 indicates mild fatigue, a t-score of 60-70 indicates moderate fatigue and a t-score of 70 or above indicates severe fatigue., Baseline, 2 months and 6 Months|Change in Scores on PROMIS Emotional Distress – Depression – Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Depression. A t-score of 55-60 indicates mild depression, a t-score of 60-70 indicates moderate depression and a t-score of 70 or above indicates severe depression., Baseline, 2 months and 6 Months|Change in Scores on PROMIS Emotional Distress – Anxiety – Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Anxiety. Scores range 4-20, with higher scores representing more severe anxiety symptoms., Baseline, 2 months and 6 Months|Change in Scores on the MOS Sexual Functioning Scale among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Sexual Function. Four items are rated on a 5-point scale (1=not a problem, 2=little of a problem, 3=somewhat of a problem, 4=very much of a problem, and 5=not applicable). Score range 4-20 with higher score less functioning., Baseline, 2 months and 6 Months|Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to, To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for FACT-ES. Scores ranging from 0 to 76. Higher scores indicate greater impact from symptoms., Baseline, 2 months and 6 Months | Number of patients with 5% weight loss (in FAST-BWL), To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months., 6 months | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | American Institute for Cancer Research|Breast Cancer Research Foundation|Hopkins-WellSpan Cancer Research Fund | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 55 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER | IRB00223131 | 2021-02-08 | 2024-01-10 | 2024-01-10 | 2020-08-05 | 2024-11-18 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231, United States | ||
| NCT04454086 | Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04454086 | This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors. | NO | Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage IA Breast Cancer AJCC v8|Anatomic Stage IB Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage IIA Breast Cancer AJCC v8|Anatomic Stage IIB Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IIIA Breast Cancer AJCC v8|Anatomic Stage IIIB Breast Cancer AJCC v8|Anatomic Stage IIIC Breast Cancer AJCC v8|Cancer Survivor|Obesity|Overweight|Prognostic Stage I Breast Cancer AJCC v8|Prognostic Stage IA Breast Cancer AJCC v8|Prognostic Stage IB Breast Cancer AJCC v8|Prognostic Stage II Breast Cancer AJCC v8|Prognostic Stage IIA Breast Cancer AJCC v8|Prognostic Stage IIB Breast Cancer AJCC v8|Prognostic Stage III Breast Cancer AJCC v8|Prognostic Stage IIIA Breast Cancer AJCC v8|Prognostic Stage IIIB Breast Cancer AJCC v8|Prognostic Stage IIIC Breast Cancer AJCC v8 | OTHER: Aerobic Exercise|OTHER: Exercise Counseling|OTHER: Nutritional Assessment|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration|OTHER: Resistance Training | Mobility disability, Assessed with the 400-meter walk test. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the last observation carried forward (LOCF) approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Baseline up to 6 months | Self-reported physical function, Measure with the abbreviated Late-Life Function and Disability Inventory. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Baseline up to 6 months|Objective functional performance, Using 3 valid and reliable timed performance-related mobility tasks: 400-meter walk (the primary outcome), stair-climb, and lift and carry task. Assessments of Mobility-Related Self-Efficacy to complete each functional task will also be completed with the tests. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Baseline up to 6 months|Balance deficits assessment, Estimate standing and reaching balance using a balance plate. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Baseline up to 6 months|Muscular strength assessement, Using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Baseline up to 6 months|Body composition, Dual-energy x-ray absorptiometry (DEXA) for all outcome measures. The DEXA scans were used to determine total body composition including bone-mineral density, as well as, percentage body fat and fat-free mass for all body regions. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Baseline up to 6 months|Body weight, Measured to the nearest 0.1 kilogram using a calibrated and certified balance beam scale. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Baseline up to 6 months|Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12), The SF-12 questionnaire is a 12 -item scale that assesses the Physical (PCS) and Mental Health (MCS) composite summary scales composed of 6 items each on a 5-point rating scale. PCS and MCS scores range from 0-30 with higher scores indicating more favorable outcomes., Baseline up to 6 months|Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B)., The Functional Assessment of Cancer Therapy-Breast is a disease specific measures including the satisfaction with life scale. The Functional Assessment of Cancer Therapy-breast will be used to analyze sample T-tests., Baseline up to 6 months|Brief Fatigue Inventory (BFI), The Brief Fatigue Inventory is a 9-item scale scored on an 11-point rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores represent greater levels of fatigue. In this form, there are 5 overarching questions. The first one asks, "Have you felt unusually tired or fatigued in the last week?" which is simply a Yes or No response. The next 4 questions then have answers in terms of a scale. The next 3 have the following sliding scale: 0= No Fatigue, 10= As bad as you can imagine, with 1-9 each representing intermediate responses. For the last question, the scale is: 0= Does not interfere, 10= Completely interferes, with 1-9 representing individual intermediate responses., Baseline up to 6 months|Adherence assessment, Will be defined via attendance at prescribed sessions and will be assessed using exercise logs, upon which participants will record all exercise performed at the center or independently. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Up to 6 months|Feasibility measures, Descriptive statistics for assessments of recruitment rates, adverse events, and retention rates will be calculated prospectively throughout the trial. Feasibility assessments of participants? satisfaction with the exercise and dietary intervention will also be completed at the end of the 24-week intervention. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome., Up to 24 weeks | Ohio State University Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 21 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | OSU-17122|NCI-2019-00570 | 2019-03-06 | 2021-07-27 | 2021-07-27 | 2020-07-01 | 2024-04-02 | Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States | |||||
| NCT04453072 | A Study to See if an iPhone Weight Management App Can Help Promote Weight Loss in Adolescents and Young Adults After a Stem Cell Transplant | https://clinicaltrials.gov/study/NCT04453072 | This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits. | NO | Obesity|Malignant Neoplasm | OTHER: Interview|OTHER: Media Intervention|OTHER: Questionnaire Administration|OTHER: Scale Device|BEHAVIORAL: Telephone-Based Intervention|OTHER: Text Message | Change in body mass index (BMI) status, The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m\^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies., Baseline up to 12 months | Adherence, Compliance with app intervention will be measured by daily interaction with the application and the coach. A point system has been designed in the application to measure compliance with the app intervention, measured by +/- weight measured daily, logging of problem foods, logging of snacking panel, and logging of meals. The coach interacts with the participants through text daily, and through phone calls weekly., Up to 12 months|Fasting lab test analysis: HbA1c, HbA1c: Glycated hemoglobin (A1C) test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of your hemoglobin is coated with sugar. The healthy range is between 4% and 5.6%, At four months up to 12 months|Fasting lab test analysis: Total cholesterol, Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is \< 170 mg/dL, At four months up to 12 months|Fasting lab test analysis: Low density lipoprotein, LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is \<100 mg/dL, At four months up to 12 months|Fasting lab test analysis: High density lipoprotein, HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is \> 45 mg/dL, At four months up to 12 months|Fasting lab test analysis: triglycerides, TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is \< 150 mg/dL, At four months up to 12 months|Fasting lab test analysis: aspartate/alanine aminotransferase, AST/ALT: aspartate/alanine aminotransferase (AST/ALT) are liver enzymes to measure liver health. The healthy range or AST is 10-34 IU/L and the healthy range for ALT is 8-37 IU/L., At four months up to 12 months|Fasting lab test analysis: glucose, Glucose: This measures the amount of sugar in your blood. We measure this after fasting for 8 hours. The healthy range is 70-99 mg/dL, At four months up to 12 months|Yale Food Addiction Scale, visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating, Up to 12 months|Center for epidemiologic studies depression scale, 4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression, Up to 12 months|Perceived stress scale, Likert Scale (0: never to 4:very often). Higher scores suggests higher stress, Up to 12 months|Satisfaction with program, Measured by "Satisfaction Survey". This Likert Scale will be completed by the participant and their parent at the end of the study. This scale uses a Likert Scale where 1 = completely disagree to 7 = completely agree. Higher scores suggest greater satisfaction with the intervention., Up to 12 months|Demographic questionnaire, 10 questions with varying options to inquire about common demographic questions (gender, age, primary language, etc). Questions are descriptive in nature and no score is assigned., Up to 12 months|Food craving questionnaire, Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings, Up to 12 months|Binge eating disorder screen, 4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder, Up to 12 months|Physical activity questionnaire, participants identify number of times (0 to more than 7) that they conducted a particular physical activity in the past 7 days. This includes skipping, rowing, etc., Up to 12 months|S weight, Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight, Up to 12 months|Height encounters questionnaire, six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned., Up to 12 months | Jonsson Comprehensive Cancer Center | eHealth International, INC. | ALL | CHILD, ADULT | NA | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 19-001992|NCI-2020-02687 | 2020-07-01 | 2024-12-31 | 2025-12-31 | 2020-07-01 | 2024-04-15 | UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States | ||||
| NCT04447313 | Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study | https://clinicaltrials.gov/study/NCT04447313 | This phase III trial compares telephone delivered Acceptance and Commitment Therapy to standard behavioral therapy for improving weight loss in overweight or obese participants. Acceptance and Commitment Therapy focuses on increasing willingness to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. Acceptance and Commitment Therapy may work better at improving weight loss compared to standard behavioral therapy. | NO | Obesity-Related Malignant Neoplasm | OTHER: Survey Administration|BEHAVIORAL: Telephone-Based Intervention|BEHAVIORAL: Telephone-Based Intervention | 10% or more weight loss, Will be measured remotely by cellular-enabled scales. Will compare the two telephone interventions, using logistic regression., At 12 months after randomization | Percent weight change, Will be measured remotely by cellular-enabled scales., At 6, 12, and 24-months post randomization|Dietary intake, Will be measured with the Fitbit smartphone app food logging feature., At 6, 12, and 24-months post randomization|Physical activity, Will be measured with the Fitbit Inspire mailed to participants., At 6, 12, and 24-months post randomization|Trajectories of weight change, Will compare between the two arms, with time as the independent variable using mixed effects modeling with linear, quadratic, and cubic effects of time., At 6, 12, and 24-months post randomization | Fred Hutchinson Cancer Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ALL | ADULT, OLDER_ADULT | PHASE3 | 418 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | RG1007177|NCI-2020-01624|10404|R01DK124114 | 2021-03-05 | 2025-11-10 | 2026-11-10 | 2020-06-25 | 2024-08-19 | Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/13/NCT04447313/ICF_000.pdf | |||
| NCT04373434 | Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers | https://clinicaltrials.gov/study/NCT04373434 | This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number. | NO | Weight Change, Body | BEHAVIORAL: Health Homes/Healthy Families (HH/HF) Intervention|BEHAVIORAL: Control | Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI), The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 “Dietary Guidelines for Americans”. Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 “Dietary Guidelines for Americans”., Baseline, Month 4, Month 9 | Change in Kcal per day intake, Kcal per day will be calculated and recorded. The most recent version of the Automated Self-Administered 24-hour dietary recall (ASA24) program prompts for food description details and automatically codes and calculates nutrient intakes using the USDA Food and Nutrient Database for Dietary Studies. The average of one weekday and one weekend day will be used to estimate Kcal per day at each time point., Baseline, Month 4, Month 9|Change in self-reported weight, Participants will self-report weight in pounds each time point, Baseline, Month 4, Month 9|Changes to food environment, A home environment survey will be administered via telephone at each time point to assess household food inventory, food preparation methods, meals/snacks with the television on, use of non-home food sources for family meals, and frequency of shopping for fruits and vegetables., Baseline, Month 4, Month 9 | Emory University | Centers for Disease Control and Prevention | ALL | ADULT, OLDER_ADULT | NA | 512 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | IRB00112359|CDC-IRB00112359 | 2020-09-18 | 2023-08-28 | 2023-08-28 | 2020-05-04 | 2024-02-12 | Emory University, Rollins School of Public Health, Atlanta, Georgia, 30322, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/34/NCT04373434/ICF_000.pdf | |||
| NCT04365569 | Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program | https://clinicaltrials.gov/study/NCT04365569 | More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program. | NO | Breast Cancer | BEHAVIORAL: Nutrition and physical activity counseling program | Percent of participants achieving 10% weight loss, Efficacy of intervention as assessed by percent of participants achieving 10% weight loss, At baseline|Percent of participants achieving 10% weight loss, Efficacy of intervention as assessed by percent of participants achieving 10% weight loss, At 3 months|Percent of participants achieving 10% weight loss, Efficacy of intervention as assessed by percent of participants achieving 10% weight loss, At 6 months|Compliance to the recommended dietary pattern, Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9, At 3 months|Compliance to physical activity goal, Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months, At 6 months | Body fat percentage, Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis, Baseline|Body fat percentage, Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis, 3 months|Body fat percentage, Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis, 6 months|Glycemic control as measured by HbA1c, Glycemic control as measured by HbA1c, At 3 months|Glycemic control as measured by HbA1c, Glycemic control as measured by HbA1c, At 6 months|Cholesterol, Effect of the intervention on lipid profile as measured by high density cholesterol levels, At 3 months|Cholesterol, Effect of the intervention on lipid profile as measured by high density cholesterol levels, At 6 months|Low density lipoprotein, Effect of the intervention on lipid profile as measured by low density lipoprotein levels, At 3 months|Low density lipoprotein, Effect of the intervention on lipid profile as measured by low density lipoprotein levels, At 6 months|high density lipoprotein, Effect of the intervention on lipid profile as measured by high density lipoprotein levels, At 3 months|high density lipoprotein, Effect of the intervention on lipid profile as measured by high density lipoprotein levels, At 6 months|Triglycerides, Effect of the intervention on lipid profile as measured by triglyceride levels, At 3 months|Triglycerides, Effect of the intervention on lipid profile as measured by triglyceride levels, At 6 months|Serum vitamin D, Effect of the intervention on serum vitamin D, At 3 months|Serum vitamin D, Effect of the intervention on serum vitamin D, At 6 months|Serum C-reactive protein (CRP), Effect of the intervention on CRP, At 3 months|Serum C-reactive protein (CRP), Effect of the intervention on CRP, At 6 months|Maximum oxygen uptake as measured by VO2 max, Maximum oxygen uptake as measured by VO2 max, Baseline|Maximum oxygen uptake as measured by VO2 max, Maximum oxygen uptake as measured by VO2 max, At 3 months|Maximum oxygen uptake as measured by VO2 max, Maximum oxygen uptake as measured by VO2 max, At 6 months | Quality of life as measured by Functional Assessment of Cancer Therapy – Breast Cancer (FACT-B), Quality of life as measured by Functional Assessment of Cancer Therapy – Breast Cancer (FACT-B), a 36-item self-report questionnaire to assess the quality of life as reported by breast cancer survivors with scores ranging from 0 to 123, and lower scores indicating better health., Baseline, 3 months and 6 months|Quality of life as measured by Brief Pain Inventory (BPI), Quality of life as measured by Brief Pain Inventory (BPI), a 9-item self-administered questionnaire that can evaluate the effect of an individual’s pain on their daily functioning. This is a 10-point scale with 0 being the best possible score, meaning “no pain”, and 10 being the worst possible score, meaning “pain as bad as you can imagine”, Baseline, 3 months and 6 months|Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7), Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire measuring anxiety which uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. with a possible score range of 0 to 21 with higher scores indicating worse anxiety., Baseline, 3 months and 6 months|Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9), Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9), which objectifies degree of depression severity with a possible score range of 0 to 27 and higher scores indicating worse outcomes, Baseline, 3 months and 6 months|Quality of life as measured by NCCN Distress Thermometer, Quality of life as measured by NCCN Distress Thermometer, which measures distress on a scale of 0 to 10, with higher scores indicating worse distress, Baseline, 3 months and 6 months|Factors associated with adherence to the program, Factors to be assessed include age, race, time since diagnosis, time since last chemotherapy, medical comorbidities and other lifestyle factors such as alcohol consumption and smoking, At 6 months | Case Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 60 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | CASE11119 | 2021-01-06 | 2025-06-01 | 2025-06-01 | 2020-04-28 | 2024-11-19 | Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center, Weston, Florida, 33331, United States | ||||
| NCT04352530 | Culturally Appropriate Nutrition Communication for Mexican American Women | https://clinicaltrials.gov/study/NCT04352530 | A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women. | NO | Lifestyle Risk Reduction|Nutrition Poor|Chronic Disease|Obesity|Cancer, Breast | OTHER: Health Communication | Perceived effectiveness, Perceived effectiveness of the message is known to affect intention to engage in a given health behavior. Therefore, perceived effectiveness of the stimuli was assessed as a proxy measure for intention to reduce sugary beverage consumption using a 5-point, 13-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. This scale comprised 3 subscales namely (1) Message Acceptance – 2 items, (2) Argument Strength – 4 items, (3) Personalized Perceived Effectiveness – 7 items. Greater scores on this scale represented greater levels of perceived effectiveness of the message., Immediately post-intervention | Identification with the message, responses ranging from Strongly Agree=5 to Strongly Disagree=1. Two sample items from the scale are, “During viewing, I felt I could really get inside the person’s head”, and “At key moments in the video, I felt I knew exactly what they were going through”. Greater scores on this scale represent greater degree of identification with the character in the video., Immediately post-intervention|Activation of social justice values, Activation of social justice values was measured using a 5-point, 2-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. The two items are, “The message made me think that when I choose to eat healthy, I’m helping to make the world a better place” and “The message made me think that when I eat healthy, I’m doing my part to protect people who are being manipulated by sugary beverage companies”. Greater scores on this scale represent greater levels of activation of social justice values., Immediately post-intervention|Sugary beverage related media literacy, Sugary beverage related media literacy was measured using a 5-point, 8-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. This scale measured how much the participants understood the ways in which sugary beverage industry used media to influence and manipulate their sugary beverage consumption behaviors. Some sample items are as follows: “Certain sugary drink brands are designed to appeal to people like me”, “Sugary drink ads show a healthy lifestyle to make people forget about the health risks, such as weight gain and diabetes” and “Sugary drink ads link drinking these beverages to things people want, like love, good looks, and power”. Greater scores on this scale represent greater levels of sugary beverage media literacy., Pre-test and Immediately post-intervention|Public health literacy, Public health literacy is defined here as an understanding of the social determinants of health. This was measured using a 5-point and 7-item Likert scale with responses ranging from Strongly Agree=5 to Strongly Disagree=1. The seven items measured opinions about how much different external factors affect health because these best reflected an understanding of the social determinants of health: (1) money, (2) education, (3) safe and affordable housing, (4) early childhood experiences, and (5) government policies and programs (6) lifestyle choices and (7) consequences of system failure on the under-resourced. Greater scores on this scale represented greater levels of public health literacy., Pre-test and Immediately post-intervention|Empowerment, Empowerment to engage in civic action was measured using a two-item index that assessed the perceived effectiveness of engaging in civic actions. Each question was a 4-point Likert item with responses ranging from “Very Effective=4” to “Very Ineffective=1”. The two items were as follows, “How effective would it be to boycott sugary beverages as a way to convince corporations to stop pushing sugar to my community?” and “How effective would it be to use social media to convince corporations to stop pushing sugar to vulnerable groups?”. Greater scores on this index represented greater levels of efficacy to engage in civic action., Pre-test and Immediately post-intervention|Beverage knowledge, Knowledge increases self-efficacy and empowers people to make better health choices for themselves and knowledge of the negative consequences of a given health behavior increases the intention to reduce that behavior. Therefore, better knowledge of the negative consequences of sugary beverage consumption directly impacts both individual level sugary beverage consumption as well as social level psychological empowerment to advocate for reduction in sugary beverage consumption at the community level. A sugary beverage knowledge scale comprised 6 true or false items adapted from multiple studies. The statements were as follows: Excessive sugar consumption causes, (1) health problems (2) weight gain (3) dental caries (4) diabetes (5) cancer and (6) heart disease”. Greater scores on this scale represented greater levels of sugary beverage knowledge., Pre-test and Immediately post-intervention|Engagement, Engagement with the message was assessed with 2 items from the Narrative Transportation Scale (Green et al.)., Immediately post-intervention|Similarity, Perceived similarity of the participant with the main character (poet/speaker) in the video was assessed with a 2-item scale adapted from Cohen and colleagues (2018)., Immediately post-intervention|Elaboration, Elaboration of the message arguments was assessed using a 4-point scale created by Kahlor and colleagues (2003) and a 3-point sugar-specific elaboration scale created by Dixon and colleagues (2015)., Immediately post-intervention | University of California, Merced | National Cancer Institute (NCI) | ALL | ADULT | NA | 881 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | K01CA190659|K01CA190659 | 2019-03-25 | 2020-12-25 | 2022-12-25 | 2020-04-20 | 2023-05-09 | University of California Merced SONA System (Online Platform), Merced, California, 95343, United States | ||||
| NCT04331717 | Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer | https://clinicaltrials.gov/study/NCT04331717 | BASH-PC | The standard of care for obese men starting Androgen deprivation therapy (ADT) is physician based dietary and exercise counseling. Interventions to lessen the harmful effects of ADT are needed yet have been limited. Exercise is one strategy that has been attempted however there is conflicting data as to whether or not exercise effectively improves body mass, results in sustained weight loss, improvements in metabolic risk profiles including glucose tolerance and lipid profiles in men starting ADT, or has any effect of progression of cancer. Dietary interventions have been attempted without clear improvement in weight, metabolic factors, quality of life or cancer progression. Bariatric arterial embolization (BAE), given it results in weight loss in obese men and women without cancer, may be able to stave off the harmful side effects of ADT by inducing weight loss. Therefore, the investigators hypothesize that Bariatric Arterial embolization (BAE), done prior to initiation of ADT, will mitigate the weight gain and metabolic side effects associated with ADT, by inducing weight loss of at least 5% in obese men with biochemical recurrent prostate cancer starting ADT. The primary objective is to determine if BAE, done prior to ADT initiation in obese men (with obesity related comorbid condition) with biochemically recurrent prostate cancer, can induce 5% or greater weight loss at 6 months. | NO | Prostate Adenocarcinoma|Obesity, Morbid | DEVICE: Bead Block 300-500 um|BEHAVIORAL: Weight Management|DRUG: Lupron | Number of participants who experience at least 5 percent weight loss, Number of participants who experience at least 5 percent weight loss at 6 months after BAE., At 6 months | Number of adverse events, Number of adverse events will be assessed to determine if there are any increased adverse events in men with prostate cancer undergoing BAE., Up to 6 months|Change in Blood Pressure, Blood pressure (mmHg) will be assessed for changes over the specified time points., Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48|Change in Respiratory Rate, Respiratory rate in breaths per minute will be assessed for changes over the specified time points., Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48|Change in Oxygen saturation, Oxygen saturation (percentage) will be assessed for changes over the specified time points., Baseline, weeks 4, 8, 12, 16, 20, 24, 36 and 48 | Time to disease progression, The amount of Time (months) till prostate-specific antigen (PSA) progression which will be assessed by PSA blood test at screening, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. With PSA progression defined as first PSA increase that is 25% and 2ng/mL above the nadir, and which is confirmed by a second value at least 3 weeks later, or the amount of Time till radiographic progression which will be assessed by RECIST v1.1 using conventional CT chest/abd/pelvis or NM Bone scan. Radiographic progression will be defined as visceral and nodal disease or at least 2 new bone lesions., Up to 51 weeks|Change in C-Reactive Protein level, C-Reactive Protein (CRP) levels in mg/dL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Erythrocyte Sedimentation Rate, Erythrocyte Sedimentation Rate (ESR) in millimeters per hour., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Interleukin 6 level, Interleukin 6 (IL-6) levels in pg/ml., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Interleukin 8 level, Interleukin 8 (IL-8) levels in pg/mL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Tumor Necrosis Factor Alpha level, Tumor Necrosis Factor Alpha (TNF-α) levels in pg/mL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Interleukin 1 alpha level, Interleukin 1 alpha (IL-1α) levels in pg/mL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Interleukin 1 beta level, Interleukin 1 beta (IL-1β) levels in pg/mL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Ghrelin level, Ghrelin levels in pg/mL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in leptin level, Leptin levels in percentage., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in active Glucagon-like Peptide-1 level, Active Glucagon-like Peptide-1 (GLP-1) levels in pmol/L., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Peptide YY level, Peptide YY (PYY) levels in pmol/L., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Insulin-like growth factor 1 level, Insulin-like growth factor 1 (IGF-1) levels in ng/mL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Adiponectin level, Adiponectin levels in mL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in microbiome, To evaluate changes in the microbiome of men with prostate cancer before and after undergoing BAE and starting ADT., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in high density lipoprotein level, High density lipoprotein (HDL) levels in mg/dL., At 12 weeks, 24 weeks, 36 weeks and 48 weeks|Change in triglycerides level, Triglycerides level in mg/dL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in fasting glucose level, Fasting glucose (mg/dL) will be assessed at specified time points for any changes. Fasting glucose within normal is \<126 mg/dL., At 12 weeks, 24 weeks, 36 weeks and 48 weeks|Change in hemoglobin A1c level, Hemoglobin A1c levels in percentage will be assessed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in low density lipoprotein level, Low density lipoprotein (LDL) levels in mg/dL., At 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Quality of life as assessed by Abbreviated version of the medical outcomes, short-form 36 (SF-12), Quality of Life scored on a scale from 0 to 48, higher scores representing highest level of functioning possible., Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Quality of life as assessed by Impact of Weight on Quality of Life Questionnaire (IWQOL), Impact of Weight on Quality of Life all 31 questions are scored on a scale from 1 to 5, higher scores representing poorer quality of life., Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI), The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality., Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Quality of life as assessed by Expanded Prostate Cancer Index Composite-26 question assessment (EPIC-26), All questions are scored on a scale from 0 to 100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100 with 100 representing the highest level of functioning possible., Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks|Change in Fatigue as assessed by the Brief Fatigue Inventory (BFI), Fatigue Rated by 9 each item on a 0-10 and 1 on a yes no scale, higher scores representing more fatigue., Baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Cigarette Restitution Fund | MALE | ADULT, OLDER_ADULT | PHASE2 | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | J1943|IRB00207275 | 2020-11-16 | 2023-08 | 2023-12 | 2020-04-02 | 2022-05-02 | Johns Hopkins School of Medicine – Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, 21205, United States | ||
| NCT04330339 | Prolonged Nightly Fasting in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04330339 | This study is being done to examine whether fasting for 13 hours every night is feasible and if it can help breast cancer survivors lose weight and improve their health. * Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring. Recent research suggests that prolonged nighttime fasting (\>13 hours) may improve the risk of recurrence for breast cancer. * This study will examine if fasting for 13 hours per night is doable for participants and will also study what the effect of fasting is on quality of life, mood, fatigue, body size, and markers of health in the blood. | NO | Fasting|Breast Cancer|Survivorship|Breast Cancer Recurrent | BEHAVIORAL: Fasting | Percentage of Participants adhere to 13 hours of fasting, Feasibility will be demonstrated if ≥60% of participants adhere to 13 hours of fasting nightly at least 70% of the nights during the intervention. Adherence will be assessed through patient-reported fasting logs., 12 weeks | Change in body mass index (BMI) (kg/m^2), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (kg/m\^2). Body mass index calculated using patient height (meters) and weight (kilograms) measured at baseline and at the completion of the study intervention. BMI = weight in kilograms divided by the square of height in meters., 12 weeks|Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G), FACT-G is a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), 6 and 12 weeks|Change in Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression), Effects of prolonged nightly fasting on psychological well-being using The Hospital Anxiety and Depression Scale (HADS). Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), 6 and 12 weeks|Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy – Fatigue, 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 – 4 response scale with anchors ranging from “Not at all” to “Very much so”. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Higher scores represent better functioning or less fatigue.Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences, 6 and 12 weeks|Change in physical activity using the Godin Leisure-Time Exercise Questionnaire, Calculated score where patient-reported weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula: Weekly leisure activity score = (9 x Strenuous) + (5 x Moderate) + (3 x Light), 6 and 12 weeks|Change in lipid profile, Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). (total cholesterol: mg/dL; triglycerides: mg/dL; high-density lipoprotein cholesterol mg/dL; low-density lipoprotein cholesterol mg/dL; very low-density lipoprotein cholesterol: mg/dL; cholesterol/HDL ratio mg/dL)., 12 weeks|Change in hemoglobin A1c (%), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), hemoglobin A1c reported as percentage of average blood sugar level (mg/dL or mmol/L), higher % corresponds to higher average blood sugar levels (normal A1C level is below 5.7%), 12 weeks|Change in c-reactive protein (mg/L), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), mg/L (hs-CRP level of 1 mg/L or lower indicates low risk of CVD, hs-CRP level of 1-3 mg/L indicates moderate risk of CVD, hs-CRP level of greater than 3 mg/L indicates high risk of CVD), 12 weeks|Change in interleukin-6 (pg/mL), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL, 12 weeks|Change in tumor necrosis factor alpha (pg/mL), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL, 12 weeks|Change in insulin (mcU/mL), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (mcU/mL), 12 weeks|Change in leptin (ng/mL), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL), 12 weeks|Change in adiponectin level (microgram/mL), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (microgram/mL), 12 weeks|Change in insulin-like growth factor (ng/mL), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL), 12 weeks|Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population), Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). Plasma glucose: mmol/L (or mg/dL), Insulin: pmol/L (or microunits/mL), 12 weeks | Massachusetts General Hospital | Kully Family Foundation | FEMALE | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 19-586 | 2020-07-24 | 2021-01-31 | 2022-07-05 | 2020-04-01 | 2022-07-21 | Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States | ||||
| NCT04326660 | SCOPE-Chinese Women Study | https://clinicaltrials.gov/study/NCT04326660 | SCOPE | This project examines the feasibility of a smartphone-based intervention to reduce obesity and breast cancer risk among Chinese women in China. The proposed intervention is to use the mobile application and an activity tracker device to promote a healthier lifestyle and physical activity. The intervention will be tailored to the participants’ behaviors, personal needs, and preferences. The aim is to reduce abdominal obesity and improve healthy lifestyle behaviors in premenopausal women with children in order to reduce the growing cancer burden in China. | NO | Cancer, Breast|Obesity, Abdominal | OTHER: SCOPE-Chinese Women | Mean Change in Waist Circumference Over Time, The National Institutes of Health (NIH) waist circumference measurement protocol will be used to measure change in waist circumference for each participant over time., Baseline, 3 months, and 6 months | Mean Change in Body Mass Index (BMI) Over Time, Weight and height will be used to compute the BMI with the formula=weight (kilograms(kg)) / height in (meters squared (m2). Changes in BMI will be collected for each participant over time., Baseline, 3 months, and 6 months|Mean Change in Scores on the Self-Rated Abilities for Health Practices Scale Over Time, The Self Rated Abilities for Health Practices Scale (SRAHP) is a 28-item survey, with each item scored on a 5-point scale, with item scores ranging from 0=Not at all to 4=Completely. The survey is designed to measure self-perceived ability to implement health-promoting behaviors across four subscales: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being, and overall. The total score ranges from 0 – 112, with higher scores indicating greater abilities for health practices. Changes in scores will be collected for each participant over time., Baseline, 3 months, and 6 months|Mean Changes in China Food Frequency Questionnaire (FFQ) over time., Food intake using the China food frequency questionnaire (FFQ), which includes a list of 118 food items will be used to measure aggregate changes in food intake over time., Baseline, 3 months, and 6 months|Mean Changes in Overall Physical Activity, Change in overall Physical activity over time will be measured using the Fitbit Alta-HR device for 10 hours while participants are awake., Baseline, 3 months, and 6 months|Mean Change in Blood Pressure Over Time, Changes in blood pressure will be measured using the YuWell YE690A monitor for each participant over time., Baseline, 3 months, and 6 months|Mean Change in Hemoglobin A1C (HbA1C) Over Time, A blood sample will be collected to measure change in HbA1C over time for each participant, using an established cut off value at 6.4%., Baseline and 6 months|Mean Change in Serum Lipid Levels Over Time, A blood sample will be collected to measure change in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides (all measured in milligrams per deciliter (mg/dL)) over time for each participant, Baseline and 6 months|Mean Change in Cortisol over time, A blood sample will be collected to measure change in total cortisol levels over time for each participant., Baseline and 6 months | Percentage of Eligible participants Who Agree To Be Screened, The number of overall eligible participants and the number of eligible participants who agree to be screened will be used to compute the percentage used for enrollment., At Baseline|Number of Uses of The Tracking App Over Time, The number of uses of the tracking app and frequency of accessing the 12 modules, to measure change in usability over time, Baseline to 6 months|Percentage of Participants who completed assessments, The percentage of completed assessments by participants at each visit will be used to measure adherence over time, Up to 6 months | University of California, San Francisco | Central South University | FEMALE | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | 18-27025|217516 | 2020-07-20 | 2021-12-30 | 2021-12-30 | 2020-03-30 | 2022-12-22 | University of California, San Francisco, San Francisco, California, 94143, United States|Central South University, Yuelu, Changsha, Hunan, 410083, China | ||
| NCT04321135 | Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04321135 | This study examine the feasibility and efficacy of Avanzando Juntas, a four-month community-based lifestyle intervention rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with Hispanic/Latina BC \& GC survivors. It will offer twice-weekly sessions aimed at supporting adherence to ACS nutrition and physical activity guidelines to promote weight loss and improved quality of life. | NO | Breast Cancer|Gynecologic Cancer | BEHAVIORAL: Guided Lifestyle Program Intervention|BEHAVIORAL: Self-Guided Lifestyle Program (Control Arm) | Change in body composition, Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable, Baseline to 4 month|Change in intake of fruits and vegetables, ASA24 dietary analysis of self reported food consumption, Baseline to 4 month|Change of intake of red meat/processed meat, ASA24 dietary analysis of self reported food consumption, Baseline to 4 month|Change in levels of physical activity- minutes per week, Change of ActiGraph monitored activity, Baseline to 4 month|Change in levels of physical activity- #times per week, Change of ActiGraph monitored activity, Baseline to 4 month|Change in resistance training- Handgrip strength, Jamar Plus Digital Hand Dynamometer, Baseline to 4 month|Change in resistance training- Strength and endurance, 30-Second Chair Stand (Sit to Stand), Baseline to 4 month|Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System), Patient Reported Outcomes Measurement Information System (PROMIS) T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average., Baseline to 4 month|Changes in Systolic and Diastolic Blood Pressure, Participants systolic and diastolic blood pressure will be measured using a digital, automated unit, Baseline to 4 month|Change in Biomarkers- Lipids, Lipid blood tests measured by Wisconsin Diagnostic Laboratory, Baseline to 4 month|Change in Biomarkers- Glycohem, Glycohem blood tests measured by Wisconsin Diagnostic Laboratory, Baseline to 4 month|Change in Biomarkers- Glucose, Glucose blood tests measured by Wisconsin Diagnostic Laboratory, Baseline to 4 month|Change in Biomarkers- C-Peptide, C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory, Baseline to 4 month|Change in Biomarkers- Insulin, Insulin blood tests measured by Wisconsin Diagnostic Laboratory, Baseline to 4 month|Change in Biomarkers- hs CRP, hs CRP blood tests measured by Wisconsin Diagnostic Laboratory, Baseline to 4 month|Change in Biomarkers-Adipokines- Adiponectin, Adiponectin blood tests, Baseline to 4 month|Change in Biomarkers-Adipokines- Leptin, Adiponectin blood tests, Baseline to 4 month|Change in waist circumference, Change in waist circumference measurement, Baseline to 4 month | Medical College of Wisconsin | Loyola University Chicago | FEMALE | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | PRO00030295 | 2019-11-01 | 2022-07-30 | 2022-07-30 | 2020-03-25 | 2022-12-16 | Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States | |||||
| NCT04300478 | Appetite and Exercise in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT04300478 | EARNESt | The overall aim of this research is to investigate the acute effects of resistance exercise (REx) on the hormonal and behavioral indices of energy balance regulation in breast cancer survivors. This pilot study is designed to provide preliminary data to support future exercise interventions with more comprehensive energy balance profiling. | NO | Overweight|Breast Cancer|Obesity | BEHAVIORAL: REx Condition First|BEHAVIORAL: Sedentary Control Condition First | Ghrelin area under the curve (AUC) in response to exercise or control, Ghrelin will be collected through serial IV collection. Each serum sample will be stored at -80C until analysis Radioimmunoassays will be used to determine serum total ghrelin (Milliipore). Total AUC will be calculated with the Trapezoid method, using all time points over the three hours following the control meal., 2 years | Peptide-YY (PYY) area under the curve (AUC) in response to exercise or control, PYY will be collected through serial IV collection. Each serum sample will be stored at -80C until analysis Radioimmunoassays will be used to determine PYY (Millipore). Total AUC will be calculated with the Trapezoid method58, using all time points over the three hours following the control meal., 2 years|Subjective ratings of hunger in response to exercise or control, Appetite Ratings will be completed using 100 mm visual analogue scale (VAS) questions (hunger, fullness, and desire to eat) at time points described above. Total AUC will be calculated using the Trapezoid method., 2 years|Subjective ratings of food-related cravings in response to exercise or control, Subjects will rate ‘food appeal’, ‘food pleasantness’, and ‘desire to eat’ of validated hedonic and non-hedonic food items using the ImageRate software with 0-100mm VAS scales., 2 years|Subjective ratings of appeal/desire for hedonic foods in response to exercise or control, Subjects will rate ‘food appeal’, ‘food pleasantness’, and ‘desire to eat’ of validated hedonic and non-hedonic food items using the ImageRate software with 0-100mm VAS scales., 2 years|Subjective ratings of satiety in response to exercise or control, Appetite Ratings will be completed using 100 mm visual analogue scale (VAS) questions (hunger, fullness, and desire to eat) at time points described above. Total AUC will be calculated using the Trapezoid method., 2 years|Ad libitum absolute and relative energy intake (EI), Acute ad libitum EI will be measured during the buffet lunch via the weight and measure method by the dietary staff at the CTRC to measure energy and macronutrient intake following the REx and control conditions. The buffet lunch will consist of 15% more food than predicted requirements and the option to get more food as desired., 2 years|Free-living energy intake (EI) for three days following each study day, Acute ad libitum EI will be measured during the buffet lunch via the weight and measure method by the dietary staff at the CTRC to measure energy and macronutrient intake following the REx and control conditions. The buffet lunch will consist of 15% more food than predicted requirements and the option to get more food as desired., 2 years|Free-living physical activity for three days following each study day, Activity and sedentary behaviors will be measured with ActivPAL accelerometers for 3 days after each study visit, 2 years|Total step count for three days following each study day, Activity and sedentary behaviors will be measured with ActivPAL accelerometers for 3 days after each study visit, 2 years|Sedentary time for three days following each study day, Activity and sedentary behaviors will be measured with ActivPAL accelerometers for 3 days after each study visit, 2 years | Resting energy expenditure (REE), REE will be measured for 20-25 minutes after a period of 30 minutes of quiet rest using an indirect calorimeter with ventilated hood (Parvo Medics metabolic cart). This test measures oxygen consumed and carbon dioxide exhaled to calculate REE (in kilocalories/day) using the Weir formula., 2 years|Body composition (fat mass[FM]), Data on participant’s FM will be collected using a full body dual X-ray absorptiometry (DEXA; Hologic Delphi-W, Hologic Inc., Bedford, MA). The scanner will be calibrated according to the manufacturer’s guidelines. All participants will undergo a pregnancy test before body composition testing. Body composition variables will be expressed in absolute terms and controlling for height (e.g. FM index: FM \[kg\]/height \[m2\]), 2 years|Body composition (Fat-free mass [FFM]), Data on participant’s FFM will be collected using a full body dual X-ray absorptiometry (DEXA; Hologic Delphi-W, Hologic Inc., Bedford, MA). The scanner will be calibrated according to the manufacturer’s guidelines. All participants will undergo a pregnancy test before body composition testing. Body composition variables will be expressed in absolute terms and controlling for height (e.g. FFM will also be expressed in relation to FM (FM:FFM)., 2 years|Gonadal hormones (estradiol and progesterone), Additional blood for a single assessment of estradiol (Beckman Coulter) and progesterone (Beckman Coulter) will be collected at baseline during the first study visit to control for these hormones in the statistical analyses., 2 years | University of Colorado, Denver | Colorado Clinical & Translational Sciences Institute|National Center for Advancing Translational Sciences (NCATS)|National Cancer Institute (NCI) | FEMALE | ADULT | NA | 21 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 19-1974.cc|UL1TR002535|KL2TR002534|TL1TR002533|P30CA046934 | 2020-02-07 | 2022-02-02 | 2022-02-05 | 2020-03-09 | 2024-12-06 | Univeristy of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|University of Colorado Cancer Center, Denver, Colorado, 80238, United States | ||
| NCT04298086 | A Study of the Body’s Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer | https://clinicaltrials.gov/study/NCT04298086 | The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life. | NO | Breast Cancer|Primary Hormone Receptor Positive Breast Cancer | OTHER: Exercise Treatment|OTHER: Plant-Based Diet|OTHER: Physical activity|OTHER: Nutrition counseling|OTHER: Replication Exercise Test | change in breast aromatase levels, Will explore the data using descriptive statistics and graphical methods, such as summarizing the aromatase levels at baseline and at 24 weeks using means and medians and plotting the data to visualize changes over time. To compare the aromatase levels at 24 weeks post-intervention between the groups, an analysis of covariance (ANCOVA) model will be used., 24 weeks post-intervention | Memorial Sloan Kettering Cancer Center | American Cancer Society, Inc.|McGill University|University of Kansas Medical Center|Wake Forest University | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 43 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 19-486 | 2020-03-04 | 2025-03 | 2025-03 | 2020-03-06 | 2024-08-02 | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States | |||||
| NCT04291950 | Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women | https://clinicaltrials.gov/study/NCT04291950 | A key tenet of this project is that of reaching translational human diagnosis and biomarker end points. To lay a foundation and make progress towards these translational goals, investigators will address the following specific aim: To determine if BMI/ obesity differentially influence expression and epigenetic signatures in triple negative breast cancer (TNBC) from Hispanic compared to NHW women. | NO | Triple Negative Breast Cancer | PROCEDURE: Needle core biopsy | To determine if BMI/ obesity differentially influence expression and epigenetic signatures in TNBC from Hispanic compared to NHW women., DXA studies will be completed prior to surgery or port placement. Blood draws will be done in OR by research staff. Tissue will be obtained at the time of their definitive surgery or at the time of port placement. For women going to surgery first, four (4) 16-gauge core needle biopsies will be obtained by research staff after the tumor has been removed from the patient and the specimen is on the collection table in the OR. For women who are getting neo-adjuvant therapy prior to surgery, the core needle biopsies will be collected at the time of port placement in the OR., Two years | University of Arizona | FEMALE | ADULT, OLDER_ADULT | 0 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2001272738|32097 | 2022-08-30 | 2025-08-30 | 2025-08-30 | 2020-03-02 | 2022-12-20 | University of Arizona Cancer Center, Tucson, Arizona, 85724, United States | |||||||
| NCT04290299 | Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive | https://clinicaltrials.gov/study/NCT04290299 | Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility. The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up. Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the “template” in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria. | NO | Endometrial Cancer | OTHER: Data collection | Proportion of complete regression, 10 years|Duration of response, 10 years|Frequency of relapse, 10 years|Pattern of relapse, 10 years|Frequency of metachronous ovarian cancer, 10 years|Tumor-related deaths, 10 years | Treatment related morbidity, 10 years|Frequency of spontaneous pregnancies, 10 years|Frequency of pregnancies after ART, 10 years|Frequency of residual disease on definitive surgical specimens, 10 years | National Cancer Institute, Naples | FEMALE | ADULT | 100 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 13/15 oss | 2015-09-15 | 2025-02-01 | 2025-04-08 | 2020-02-28 | 2021-10-13 | Cooperative Ovarian Cancer Group (COGI), Stanford, California, United States|ANZGOG – Australia and New Zealand Gynecological Oncology Group, Sydney, Australia|AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie, Vienna, Austria|EORTC – European Organization for Research and Treatment of Cancer, Brussels, Belgium|NCIC Clinical Trials Group (Canadian Cancer Society Research Institute), Ottawa, Canada|PMHC (Princess Margaret Hospital Consortium), Toronto, Canada|SGOG (Shanghai Gynecologic Oncology Group), Shangai, China|NSGO (Nordic Society of Gynecologic Oncology), Copenhagen, Denmark|GINECO – Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, Paris, France|AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom, Berlin, Germany|NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie), Berlin, Germany|ICORG – Ireland Cooperative Oncology Research Group, Dublin, Ireland|MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies), Naples, Italy|GOTIC – Gynecologic Oncology Trial and Investigation Consortium, Katō, Japan|JGOG – Japanese Gynecologic Oncology Group, Tokyo, Japan|KGOG – Korean Gynecologic Oncology Group, Seul, Korea, Republic of|DGOG – Dutch Gynecologic Oncology Group, Amsterdam, Netherlands|GEICO – Grupo Espanol de Investigacion en Cancer de Ovario, Madrid, Spain|SGCTG (Scottish Gynaecological Cancer Trials Group), Edinburgh, United Kingdom | ||||||
| NCT04265638 | Exercise Intervention in Adolescent and Young Adult Cancer Survivors | https://clinicaltrials.gov/study/NCT04265638 | Adolescent and young adult (AYA) survivors of cancer face a future of persistent medical issues across a wide spectrum of diseases One study examining health data from this cohort (ages 15-29) reported significantly higher rates of smoking, obesity, cardiovascular disease, hypertension, asthma, and poorer mental health among the cancer survivors when compared to healthy controls. Prescribed exercise has broad and far-reaching beneficial physiological effects that cut across multiple body systems and consistently improves emotional well-being, decreases fatigue and depression, and enhances quality of life. Although a growing body of evidence consistently demonstrates the physiological and psychological benefits of exercise interventions in adults with cancer, there are no studies examining the effects of individualized, prescribed, supervised exercise in pediatric, adolescent and young adult cancer survivors. | NO | Long-term Effects Secondary to Cancer Therapy in Adults|Pediatric Cancer | BEHAVIORAL: Exercise | Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire, The Participant Evaluation of Feasibility and Acceptability Questionnaire consists of 6 items arranged on a Likert scale ranging from 1- 5, and 4 additional open-ended questions designed to elicit information concerning the benefits and barriers to participating in the resistance exercise intervention., weeks 12 and 24|Change of Balance Assessment, The BOT2 Balance subtests 5, Number 2: Walking forward on a line and Subtest 5, Number 7: Standing on One leg on a balance beam – Eyes Open will evaluate motor-control skills that are integral for maintaining posture when standing, walking, or reaching. This motor-area composite measures control and coordination of the large musculature that aids in posture and balance. Scores are assessed to determine stability dynamically and statically, on one leg and utilizing both legs, on a balance beam when the eyes are open for more than 10 seconds and if the patient can likely do so when the eyes are closed for about 5 to 10 seconds and also a twenty-four foot straight line., baseline, weeks 6, 12, and 24|Change of Cardiovascular Systems – VO2 Peak (mL·kg-1·min-1), The subject’s VO2 Peak (mL-kg-1-min-1) will be used to assess the cardiovascular system., baseline, weeks 6, 12, and 24|Change of Cardiovascular Systems – FEV1, The subject’s forced expiratory volume in one second (FEV1) will be used to assess the cardiovascular system. FEV1: Male = \[0.0566 (ht in cm)\] – \[0.0233 (age)\] – 4.91, baseline, weeks 6, 12, and 24|Change of Cardiovascular Systems – FCV, The subject’s estimated forced vital capacity (FVC) will be used to assess the cardiovascular system. FVC: Male = \[0.0774 (ht in cm)\] – \[0.0212 (age)\] – 7.75 Female = \[0.0414 (ht in cm)\] – \[0.0232 (age)\] – 2.2, baseline, weeks 6, 12, and 24|Change of Fatigue, The Revised Piper Fatigue Scale: Fatigue will be measured using the Piper Fatigue Inventory, which evaluates total cancer-related fatigue, as well as subscales of fatigue such as affective, behavior, cognitive, mood, and sensory. There are 4 individual subscales comprise 22 items with the average score representing total fatigue. The subscales are behavioral/severity (6 items), affective meaning (5 items), sensory (5 items) and cognitive/mood (6 items). Standardized alpha for the entire scale (n = 22 items) is 0.97, indicating that some redundancy still may exist among the items. The scale ranges from 0 to 10. A score of 0 indicates that the participant shows no signs of fatigue; a score from 1 to 3 indicates mild fatigue, 4-6 indicates moderate fatigue and a score greater than 7 indicates severe fatigue., baseline, weeks 6, 12, and 24|Change of Neuropathy 15-17 year olds, Pediatric Total Neuropathy Score (Peds-TNS): A multidimensional instrumentused to measure peripheral neuropathy symptoms and signs in children from 15-17 years old. This instrument assesses proximal extension of numbness, tingling, and neuropathic pain, motor function, vibration and touch sensation, strength, tendon reflexes, dizziness. These parameters provide qualitative information on symptoms, nerve conduction and sensory tests on a scale of 0 for none to 4 for severe. The individual scores are added together to provide a single measure of neuropathy called a Total Neuropathy Score., baseline, weeks 6, 12, and 24|Change of Pulmonary Systems – VO2 Peak (mL·kg-1·min-1) – FEV1, The subject’s VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in one second (FEV1). FEV1: Male = \[0.0566 (ht in cm)\] – \[0.0233 (age)\] – 4.91, baseline, weeks 6, 12, and 24|Change of Pulmonary Systems – VO2 Peak (mL·kg-1·min-1) – FVC, The subject’s VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in estimated forced vital capacity (FVC). FVC: Male = \[0.0774 (ht in cm)\] – \[0.0212 (age)\] – 7.75 Female = \[0.0414 (ht in cm)\] – \[0.0232 (age)\] – 2.2, baseline, weeks 6, 12, and 24|Change of Cancer Therapy Fatigue, Functional Assessment of Cancer Therapy Fatigue Scale (FACIT-F) Brief: A questionnaire assessing fatigue and anemia-related concerns in people with cancer., baseline, weeks 6, 12, and 24|Change of Neuropathy over 17 years of age, Total Neuropathy Score Clinical Evaluation (TNS): The best acknowledged method to assess the severity and changes in chemotherapy-induced peripheral neurotoxicity for individuals over 17. The TNSc consists of items with scores correlating significantly with the National Cancer Institute-Common Toxicity Criteria v. 2.0, baseline, weeks 6, 12, and 24 | Depression – BDI, Beck Depression Inventory (BDI): The BDI is a 21-item self-report rating inventory for characteristics of depression with ratings from 0 to 3, with 3 being the most intense. The BDI is for individuals 19 and older., Baseline, weeks 12 and 24.|Depression – CDI, Title: Children’s Depression Inventory (CDI): The CDI is a 27-item scale that is self-rated and symptom-oriented. It is a validated test for children 18 and under. There are 27 items with scores ranging from 0-2, so there is a possible total score of 0-54, with 0 being no depression to 54 being the worst. The non-clinical cut off score is 19-20, which will be the one we are using., Baseline, weeks 12 and 24.|Beck Anxiety Inventory, The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs\[4\] are: 0-7: minimal anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety, Baseline, weeks 12 and 24.|Measure health-related Quality of Life, Pediatric Quality of Life Inventory (PedsQL 4.0): The PedsQL is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL integrates generic core scales and disease-specific modules into one measurement system. The 23-item PedsQL generic core scales and disease-specific scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. This measure is tailored to 5 different age groups: however, we will only use the section designed for teens (13-18) which is made up of 23 items comprising 4 dimensions. Ferrans \& Powers Quality of Life Index: Total quality of life will be measured using the Ferrans and Powers Quality of Life Index Version III and is a 66-question index designed to evaluate social, psychological, family, and health satisfaction. This assessment is valid for ages 18 and up., Baseline, weeks 12 and 24.|Healthy Days Core Module (CDC HRQOL-4, The HRQOL is a 4-question assessment of overall health, both physical and mental health. The questionnaire is scored as follows: First unhealthy days are calculated as an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. The score for obtaining unhealthy days is done by combining the responses to questions 2 and 3 to calculate a summary index of overall unhealthy days, with a logical maximum of 30 unhealthy days., baseline, weeks 6, 12, and 24|Pain scale, Visual Analogue Scale (VAS): The VAS is a validated pain measurement for individuals age seven and older. The scale is a single line with one end denoting no pain and the other, the worst pain possible. The scale was validated in 1976 with a reliability score of 0.94. The VAS is a scale of 100-mm and ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain81, baseline, weeks 6, 12, and 24|Pittsburgh Sleep Quality Index Survey, The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 ques-tions are combined into 7 clinically-derived component scores, each weighted equally from 0-3. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality., baseline, weeks 6, 12, and 24|Adverse Event Pain Assessment, The NCI Common Terminology Criteria for Adverse Events (CTCAE) V4.02: The NCI Common Terminology Criteria for Adverse Events Version 4.02 is a descriptive scale that grades adverse events occurring after chemotherapy in cancer patients and explores the quality of life (QOL) findings among post therapy cancer patients. A grading (severity) scale is provided for each AE term. The grading scale is 0-5 with Grade 0: no signs or symptoms of the Adverse Event to Grade 5: death., baseline, weeks 6, 12, and 24 | Indiana University | ALL | CHILD, ADULT | NA | 66 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IUSCC-0696 | 2019-06-05 | 2024-05 | 2024-05 | 2020-02-11 | 2023-11-28 | IU Health North Hospital, Carmel, Indiana, 46032, United States|Riley Hospital for Children – Indiana University, Indianapolis, Indiana, 46202, United States|Indianapolis Healthplex, Indianapolis, Indiana, 46222, United States | |||||
| NCT04257500 | Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/obese Women with PCOS | https://clinicaltrials.gov/study/NCT04257500 | RING-PCOS | A prospective study to determine the metabolic effects of the contraceptive vaginal ring among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a total of 40 participants and study use of the vaginal ring over a 4-month period. | NO | Polycystic Ovary Syndrome | DRUG: Etonogestrel/ethinyl estradiol vaginal ring | Incidence of Metabolic Syndrome, Metabolic Syndrome defined according to the updated Adult Treatment Panel III as 3 or more of the following criteria: blood pressure ≥130/85 mm Hg, waist circumference \>35 inches, fasting glucose ≥110 mg/dL, TG ≥150 mg/dL, HDL-C \<50 mg/dL., 4 months | Change in low-density lipoprotein (LDL) measure, 4 months|Change in high-density lipoprotein (HDL) measure, 4 months|Change in triglycerides measure, 4 months|Change in apolipoprotein A, 4 months|Change in apolipoprotein B, 4 months|Change in advanced lipid testing measure, 4 months|Change in cholesterol efflux capacity, 4 months|Change in fasting insulin level, 4 months|Change in fasting 2 hour oral Glucose Tolerance Test result, 4 months|Change in Testosterone, 4 months|Change in Ferriman-Gallwey Hirsutism score, A lower score indicates less hirsutism. The F-G scoring system has a minimum value of 0, and a maximum value of 36., 4 months|Body Mass Index, 4 months|Change in scoring on the Center for Epidemiologic Studies Depression Scale, The range of values is zero to 60, with the higher scores indicating the presence of more depressive symptoms., 4 months|Change in scoring on the State-Trait Anxiety Inventory, The State-Trait Anxiety Inventory measures both state and trait anxiety, the scores range from 20 to 80, with higher scores correlating with greater anxiety., 4 months|Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire, Worse quality of life is associated with a lower score on the questionnaire, with a range score from 30 to 210., 4 months | Andrea Roe, MD, MPH | FEMALE | ADULT | PHASE4 | 28 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 834422 | 2020-09-03 | 2025-12 | 2025-12 | 2020-02-06 | 2024-12-06 | University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States | ||||
| NCT04210128 | Glucose Monitoring to Predict and Treat High Glucose Levels After Steroid Treatment | https://clinicaltrials.gov/study/NCT04210128 | The purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic. | NO | Breast Cancer|Pancreatic Cancer|Diabetes|Pre Diabetes | severe hyperglycemia, glucose \> 400 mg/dL for over 3 contiguous hours, 1 year | Memorial Sloan Kettering Cancer Center | FEMALE | ADULT, OLDER_ADULT | 3 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 19-315 | 2019-12-20 | 2023-10-31 | 2023-10-31 | 2019-12-24 | 2023-11-01 | Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States | ||||||||
| NCT04170335 | Effects of Bariatric Surgery on Breast Density Improvement and Impact on Breast Cancer Risk in Severe Obese Patients | https://clinicaltrials.gov/study/NCT04170335 | Breast cancer is the most common cancer in women in the US, and obese women have a 20% to 40% increase in the risk of developing breast cancer compared with normal-weight women. Bariatric surgery is now considered the first line option for weight loss management in morbidly obese patients with failure of medical treatment. There is strong evidence that in early stages of cancer the breast undergoes inflammatory and subsequently density changes that are observable in mammography. The aforementioned alterations have been suggested to be magnified by obesity, potentially due to its pro-inflammatory state. The investigators hypothesized that rapid weight loss following bariatric surgery and henceforth the reduction of inflammatory stress in the breast tissue could potentially have a positive effect in improving breast density and consequently, reducing the risk of breast cancer. In this order of ideas, with this study, the investigators aim to evaluate how breast density is modified after bariatric surgery, and how it impacts the risk of developing breast cancer using The Breast Cancer Surveillance Consortium (BCSC) risk score and calculator in our population. | NO | Breast Cancer|Morbid Obesity|Bariatric Surgery Candidate | PROCEDURE: Bariatric surgery | Mammogram findings before and after intervention: BI-RADS, Mammogram findings according to the BI-RADS® breast density score (radiologic assessment of the density of breast tissue, 12 months|Mammogram findings before and after intervention:LIBRA, Mammogram findings according to the The LIBRA (Laboratory for Individualized Breast Radiodensity Assessment) software, 12 months|Inflammatory markers before and after intervention: C-reactive protein, Serum measurements of Inflammatory marker including C-reactive protein (CRP), 12 months|Inflammatory markers before and after intervention: Interleukin-6, Serum measurements of Inflammatory marker including Interleukin-6 (IL-6), 12 months|Inflammatory markers before and after intervention: Insulin Growth Factor-1 (IGF-1), Serum measurements of Inflammatory marker including Insulin Growth Factor-1 (IGF-1), 12 months|Inflammatory markers before and after intervention: Tumor Necrosis, Serum measurements of Inflammatory marker including Tumor Necrosis Factor (TNF), 12 months|Breast cancer risk calculation, Breast cancer risk calculation using The Breast Cancer Surveillance Consortium (BCSC) Risk Calculator, 12 months|Biometric measurements: weight, Weight will be assessed before surgery and at one year after surgery., 12 months|Biometric measurements: Height, Height will be assessed before surgery and at one year after surgery., 12 months|Biometric measurements: Body mass index, Body mass index will be assessed before surgery and at one year after surgery., 12 months|Biometric measurements: Waist circumference., Waist circumference. will be assessed before surgery and at one year after surgery., 12 months | The Cleveland Clinic | FEMALE | ADULT, OLDER_ADULT | 0 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | FLA 18-057 | 2021-02-22 | 2023-12-01 | 2023-12-31 | 2019-11-20 | 2023-09-15 | Cleveland Clinic Florida, Weston, Florida, 33331, United States | |||||||
| NCT04132219 | Daughters, dUdes, Mothers and othErs Fighting Cancer Together | https://clinicaltrials.gov/study/NCT04132219 | DUET | The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese cancer survivor of an obesity-related cancer and an overweight or obese “buddy” of his or her choosing) would be assigned either to a 6-month, diet- and exercise-based weight loss intervention delivered via an interactive website with tailored text messages, or to a 6-month wait-listed control group. The overall goals of the eHealth intervention are to reduce obesity and select circulating biomarkers (tumor necrosis factor alpha \[TNFα\], insulin, and insulin-like growth factor-1 \[IGF-1\]), as well as improve diet quality, physical activity, health-related quality of life (QoL), physical functioning and performance as compared to the control over the 6-month study period. | NO | Cancer|Overweight and Obesity | BEHAVIORAL: eHealth Intervention | Body Weight, Change in measured body weight, baseline|Body Weight, Change in measured body weight, 6 months | Waist Circumference, measured with a non-stretch tape, baseline|Waist Circumference, measured with a non-stretch tape, 6 months|Physical Activity (self-reported), Godin Leisure Time Physical Activity Questionnaire (4-item survey) – individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 – theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is “typical.” The higher the number of minutes of totaled moderate + vigorous activity, the better., Baseline|Physical Activity (self-reported), Godin Leisure Time Physical Activity Questionnaire (4-item survey) – individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 – theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is “typical.” The higher the number of minutes of totaled moderate + vigorous activity, the better., 3 months|Physical Activity (self-reported), Godin Leisure Time Physical Activity Questionnaire (4-item survey) – individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 – theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is “typical.” The higher the number of minutes of totaled moderate + vigorous activity, the better., 6 months|Physical Activity (objective), Accelerometry (7-day assessment), baseline|Physical Activity (objective), Accelerometry (7-day assessment), 6 months|Diet Quality, Two 24-hour dietary recalls, baseline|Diet Quality, Two 24-hour dietary recalls, 6 months|Physical Performance (endurance), 2-minute step test, Baseline|Physical Performance (endurance), 2-minute step test, 6 months|Physical Performance (lower body strength), 30-second chair stand, Baseline|Physical Performance (lower body strength), 30-second chair stand, 6 months|Physical Performance (agility), 8′ foot up and go, Baseline|Physical Performance (agility), 8′ foot up and go, 6 months|Physical Performance (gait speed), 8′ walk, baseline|Physical Performance (gait speed), 8′ walk, 6 months|Physical Performance (Balance), Side-by-side, semi-tandem and tandem stances, baseline|Physical Performance (Balance), Side-by-side, semi-tandem and tandem stances, 6 months|Self-efficacy for calorically restricted diet, Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero), baseline|Self-efficacy for calorically restricted diet, Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero), 3 months|Self-efficacy for calorically restricted diet, Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero), 6 months|Self-efficacy for increased physical activity, Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%)., baseline|Self-efficacy for increased physical activity, Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%)., 3 months|Self-efficacy for increased physical activity, Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%)., 6 months|Social support for calorically restricted diet, Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from (“never”= 0 to “everyday” = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero), baseline|Social support for increased physical activity, Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from (“never”= 0 to “everyday” = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero), baseline|Social support for calorically restricted diet, Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from (“never”= 0 to “everyday” = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero), 3 months|Social support for increased physical activity, Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from (“never”= 0 to “everyday” = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero), 3 months|Social support for calorically restricted diet, Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from (“never”= 0 to “everyday” = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero), 6 months|Social support for increased physical activity, Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from (“never”= 0 to “everyday” = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero), 6 months|Barriers for increased physical activity, (15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better., baseline|Barriers for increased physical activity, (15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better., 3 months|Barriers for increased physical activity, (15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better., 6 months|Circulating insulin, assays on dried blood spot eluents, baseline|Circulating insulin, assays on dried blood spot eluents, 6 months|Circulating glucose, assays on dried blood spot eluents, baseline|Circulating glucose, assays on dried blood spot eluents, 6 months|Circulating IL-6, assays on dried blood spot eluents, baseline|Circulating IL-6, assays on dried blood spot eluents, 6 months|Circulating CRP, assays on dried blood spot eluents, baseline|Circulating CRP, assays on dried blood spot eluents, 6 months|Circulating Total Cholesterol, assays on dried blood spot eluents, baseline|Circulating Total Cholesterol, assays on dried blood spot eluents, 6 months|Circulating HDL Cholesterol, assays on dried blood spot eluents, baseline|Circulating HDL Cholesterol, assays on dried blood spot eluents, 6 months|Circulating Tryglycerides, assays on dried blood spot eluents, baseline|Circulating Tryglycerides, assays on dried blood spot eluents, 6 months|Circulating Adiponectin, assays on dried blood spot eluents, baseline|Circulating Adiponectin, assays on dried blood spot eluents, 6 months|Circulating Leptin, assays on dried blood spot eluents, baseline|Circulating Leptin, assays on dried blood spot eluents, 6 months|Duke OARS Co-Morbidity Index, 43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item), baseline|Duke OARS Co-Morbidity Index, 43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item), 3 months|Duke OARS Co-Morbidity Index, 43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item), 6 months|PROMIS v.1.2 GLOBAL HEALTH, 10-item Likert scale assessment of Quality of Life, Baseline|PROMIS v.1.2 GLOBAL HEALTH, 10-item Likert scale assessment of Quality of Life, 3 months|PROMIS v.1.2 GLOBAL HEALTH, 10-item Likert scale assessment of Quality of Life, 6 months|EQ-5D-5L, 6-item Likert scale assessment of Quality of Life, Baseline|EQ-5D-5L, 6-item Likert scale assessment of Quality of Life, 3 months|EQ-5D-5L, 6-item Likert scale assessment of Quality of Life, 6 months|HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006), 7-item scale to assess e-health literacy. Two items were added from eHEALS to understand consumer’s interest in using eHealth in general., Baseline|HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006), 7-item scale to assess health and e-health literacy. Two items were added from eHEALS to understand consumer’s interest in using eHealth in general., 3 months|HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006), 7-item scale to assess health and e-health literacy. Two items were added from eHEALS to understand consumer’s interest in using eHealth in general., 6 months|Barriers to Eating a Healthy Low Calorie Diet, (10 items) Respondents either affirm or deny common barriers to low calorie diet., Baseline|Barriers to Eating a Healthy Low Calorie Diet, (10 items) Respondents either affirm or deny common barriers to low calorie diet., 3 months|Barriers to Eating a Healthy Low Calorie Diet, (10 items) Respondents either affirm or deny common barriers to low calorie diet., 6 months|PROMIS Emotional Distress: Depression – Short Form 8a, (8 items) Likert scale assessment of depression, Baseline|PROMIS Emotional Distress: Depression – Short Form 8a, (8 items) Likert scale assessment of depression, 3 months|PROMIS Emotional Distress: Depression – Short Form 8a, (8 items) Likert scale assessment of depression, 6 months|Smoking status, 2 items that ask whether respondent has ever smoked \>100 cigarettes and current smoking status., Baseline|Smoking status, 2 items that ask whether respondent has ever smoked \>100 cigarettes and current smoking status., 3 months|Smoking status, 2 items that ask whether respondent has ever smoked \>100 cigarettes and current smoking status., 6 months | Relationship to chosen partner, 1 item question that asks for relationship of chosen partner to cancer survivor, Baseline|Socio-Demographic (George, et al, 1984), 3-items that ask about income and perceptions of economic well-being, Baseline|Socio-Demographic (George, et al, 1984), 3-items that ask about income and perceptions of economic well-being, 3 months|Socio-Demographic (George, et al, 1984), 3-items that ask about income and perceptions of economic well-being, 6 months|Circulating Insulin (TSH), assays on dried blood spot eluents, Baseline|Circulating Insulin (TSH), assays on dried blood spot eluents, 6 months | University of Alabama at Birmingham | ALL | ADULT, OLDER_ADULT | NA | 112 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | IRB-300003882 | 2020-10-15 | 2022-02-15 | 2022-02-15 | 2019-10-18 | 2022-12-15 | UAB School of Health Professions, Department of Nutrition Sciences, Birmingham, Alabama, 35294, United States | |||
| NCT04129346 | Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB | https://clinicaltrials.gov/study/NCT04129346 | This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching. | YES | Metastatic Breast Cancer|Obesity | BEHAVIORAL: Fit2ThriveMB App|BEHAVIORAL: Fitbit|BEHAVIORAL: Physical Activity Coaching Calls|BEHAVIORAL: Healthy Living Coaching Calls|BEHAVIORAL: Cancer.net app | Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period, Feasibility will be assessed via participant retention during the intervention period \[(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized\]., 12 weeks|Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients, Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app. This measure the average percentage of days each participant in the Fit2ThriveMB intervention group wore the Fitbit., 12 weeks|Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients, Acceptability will be measured via a process evaluation of perceptions of MBC patients’ experiences with Fit2ThriveMB. Acceptability will be measured as the number of intervention participants who are satisfied/very satisfied with their overall study experience., 12 weeks | Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients, Physical activity will be measured at baseline and at 12 weeks. The change between physical activity at baseline and 12-weeks will be assessed. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020)., Baseline and 12 weeks|Change in Quality of Life From From Baseline to 12-weeks, Quality of life will be measured at baseline and 12 weeks using the Functional Assessment of Cancer Therapy-Breast (FACT-B). Totals scores range from 0 to 148. Higher scores indicate better quality of life., Baseline and 12 weeks|Change in Anxiety From Baseline to 12-weeks, Anxiety will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a health measure. T-scores range from 37.1 to 83.1. Higher scores indicate more anxiety. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population., Baseline and 12 weeks|Change in Depression From Baseline to 12-weeks, Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population., Baseline and 12 weeks|Change in Fatigue From Baseline to 12-weeks, Fatigue will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population., Baseline and 12 weeks|Change in Pain Interference From Baseline to 12-weeks, Pain Interference will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Interference 8a health measure. T-scores range from 40.7 to 77.0 Higher scores indicate more pain interference., Baseline and 12 weeks|Change in Physical Function From Baseline to 12-weeks, Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population., Baseline and 12 weeks|Change in Sleep Disturbance From Baseline to 12-weeks, Sleep disturbance will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-sleep disturbance 8a health measure. T-scores range from 30.5 to 77.5. Higher scores more sleep disturbance. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population., Baseline and 12 weeks|Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks, Participants will complete the Short Physical Performance Battery which includes assessments of gait speed, chair stands and standing balance that are combined to obtain a SPPB score. This test will be conducted at baseline and 12 weeks. SPPB scores range from 0 to 12. Higher scores mean better physical functioning., Baseline and 12 weeks|Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks, The Senior Fitness Test measures physical function. The arm curl test assesses the number of times (repetitions) a 5lb hand-weight is curled in 30 seconds. The 2-minute step test evaluates the number of times (repetitions) the right knee reaches a distance half way between the iliac crest and patella during 2-minutes. Increased number of repetitions on both tests represents better physical function., Baseline and 12 weeks|Change in 6-minute Walk Test Distance Between Baseline and 12-weeks., Participants will complete a 6 minute walk test at baseline and 12 weeks. Distance is measured in meters. Increases in distance represent better performance., Baseline and 12 weeks|Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks, The Senior Fitness Test measures physical function. The one leg stand test assesses how long an individual can stand on each of their feet (right and left) in seconds up to 30-seconds. Increases in time on the one leg stand tests indicate better functioning. The 8-foot up and go test assesses how long it takes in seconds to stand from a chair, walk 8 feet around an object and return to sitting. Decreases in time indicate better functioning., Baseline and 12 weeks | Northwestern University | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 49 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | SP00049673|R21CA239130 | 2019-11-26 | 2021-05-01 | 2021-05-01 | 2019-10-16 | 2022-11-10 | 2022-11-10 | Northwestern University, Chicago, Illinois, 60611, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/46/NCT04129346/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/46/NCT04129346/ICF_001.pdf | ||
| NCT04117438 | Tell us Your Food Story | https://clinicaltrials.gov/study/NCT04117438 | In 2017, it is estimated that 318,590 Americans, men and women, will be diagnosed with breast cancer (American Cancer Society, 13). It was predicted in the 1970s that 1 in 11 Americans would be diagnosed with breast cancer, currently, it is 1 in 8 people. A person is twice as likely to be diagnosed with breast cancer if they have one first-degree female with a diagnosis, 3-4 times if there is more than one first-degree female relative with a diagnosis. Reasons for this increase in breast cancer diagnoses are that people are living longer, changes in reproductive patterns, increases or decreases in menopausal hormone use, increased numbers of detection through screening including genetic testing, and the rising prevalence of obesity (American Cancer Society). The purpose of this study is to better understand how a diagnosis of breast cancer supports change in diet and their food story. Qualitative methodology and specifically the long interview is the method the team will use to gain insight into adult patients’ perceptions of their food story. | NO | Breast Neoplasms | OTHER: no intervention | Breast cancer patients relationship with food., A patient recently diagnosed with breast cancer will be more aware of the relationship they have with diet then those patients that have been in treatment for an extended period of time. The investigators will analyze the data for thick description and for themes that emerge during the analysis by following procedures developed by Corbin and Strauss., 10 years | Medical College of Wisconsin | FEMALE | CHILD, ADULT, OLDER_ADULT | 0 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PRO00034502 | 2019-10-01 | 2020-11-20 | 2020-11-20 | 2019-10-07 | 2023-04-07 | Medical College of Wisconsin, Milwaukee, Wisconsin, 53222-3100, United States | |||||||
| NCT04097353 | Improving Health Behaviors for Pediatric Cancer Survivors | https://clinicaltrials.gov/study/NCT04097353 | The objective of this study is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers. | NO | Cancer | BEHAVIORAL: Harvesting Hope for Kids (HH4K)|BEHAVIORAL: Surviving Strong for Kids (SS4K) | Change in Fruit and Vegetable Intake, Skin carotenoid score, with total scores ranging from 10,000-89,000+ and higher scores indicating more fruit and vegetable intake, Month 0 (baseline) to Month 2 (post-intervention)|Change in Physical Activity, Daily step count, with higher counts indicating more physical activity, Month 0 (baseline) to Month 2 (post-intervention) | Change in Child Quality of Life, Children will complete the Pediatric Quality of Life Inventory (PedsQL), with total scores ranging from 0-92 and subscale scores ranging from 0-20/32; Higher scores indicate better quality of life, Month 0 (baseline) to Month 2 (post-intervention)|Change in Parent-rated Child Quality of Life, Parents will complete the Pediatric Quality of Life Inventory (PedsQL) for parents, with total scores ranging from 0-92 and subscale scores ranging from 0-20/32; Higher scores indicate better quality of life, Month 0 (baseline) to Month 2 (post-intervention)|Change in Body Mass Index (BMI), Height, weight, and age will be combined to report BMI in kg/m\^2, with lower scores indicating lower cardiometabolic risk, Month 0 (baseline) to Month 2 (post-intervention)|Change in Blood Pressure, Lower scores indicate lower cardiometabolic risk, Month 0 (baseline) to Month 2 (post-intervention)|Change in Blood Lipids and Glucose, Blood lipids and glucose will provide TC/HDL ratio, non-HDL cholesterol, and LDL cholesterol, with lower scores indicating lower cardiometabolic risk, Month 0 (baseline) to Month 2 (post-intervention)|Change in Microbial Diversity, Stool samples will examine microbiome α- and β- diversity, with higher scores indicating greater microbial diversity, Month 0 (baseline) to Month 2 (post-intervention) | Cynthia Gerhardt | Ohio State University | ALL | CHILD | NA | 31 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | IRB1700469 | 2017-05-01 | 2019-12-31 | 2019-12-31 | 2019-09-20 | 2023-03-13 | Nationwide Children’s Hospital, Columbus, Ohio, 43205, United States|The Ohio State University, Columbus, Ohio, 43210, United States | ||||
| NCT04073706 | Sentinel Node Biopsy in Endometrial Cancer | https://clinicaltrials.gov/study/NCT04073706 | ENDO-3 | Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \& similar to a lymph node dissection, the value to patients, cost effectiveness \& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 – 444 patients. Stage 2 additional 316 patients. Primary Outcome Stage 1: Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities. Primary Outcome Stage 2: Treatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and/or histological results. | NO | Endometrial Cancer Stage I|Sentinel Lymph Node|Surgery | PROCEDURE: TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted|PROCEDURE: TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted | Stage 1: Return to usual activities, Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities., 12 months from surgery|Stage 2: Disease Free Survival, Compare disease-free survival for participants randomised to receive hysterectomy, bilateral salpingo-oophorectomy with SNB compared to participants randomised to hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection, 4.5 years from surgery | Cost Effectiveness using QALYs using EuroQoL-5D (EQ-5D) Questionnaire, An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society, and whether this represents a sound investment in terms of the improvement in quality of life. We will also measure the quality-adjusted life years (QALYs) gained with the intervention and use this to undertake a cost-utility analysis. The QALY calculations will be based on health status measures for trial participants, with valuations of changes in health status and quality of life based on the EQ-5D, 12 months from surgery|Cost Effectiveness measuring Intervention costs, An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society., 12 months from surgery|Cost Effectiveness measuring GP and specialist consultations, An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society, and whether this represents a sound investment in terms of the improvement in quality of life., 12 months from surgery|Cost Effectiveness measuring radiology and imaging requirements, An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society., 12 months from surgery|Cost Effectiveness measuring prescriptions and over the counter medicine requirements, An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society, and whether this represents a sound investment in terms of the improvement in quality of life., 12 months from surgery|Cost Effectiveness measuring community and health service requirements and days off work and informal care required by family and friends using a combination of the Health Services Questionnaire and clinical files, An assessment will be performed on the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society, and whether this represents a sound investment in terms of the improvement in quality of life., 12 months from surgery|Cost Effectiveness: direct costs using a bottom-up approach by recording the volume of resource use in both groups of the trial, and then applying a unit cost to each component, Direct costs wukk be ibtained for smaples of participants, stratified by hospital, operation and outcome to assess the cost-effectiveness of TH + SNB relative to TH alone, calculated as the incremental cost per unit of improvement in functional outcome, measured in terms of the primary outcome. This will assess how much more money the proposed intervention will cost the health system and society., 12 months from surgery|Perioperative Outcomes: Adverse Events, Compare perioperative outcomes and the incidence of intra- and postoperative adverse events within 12 months from surgery between groups using Common Terminology Criteria for Adverse Events (CTCAE version 5), 12 months from surgery|Perioperative Outcomes: Length of Surgery, Compare the length of surgery between the two groups. This will be recorded in hh:mm on the surgery form., At time of surgery|Perioperative Outcomes: Blood Loss during Surgery, Compare the blood loss between the two groups during surgery. This will be recorded in ml., At time of surgery|Perioperative Outcomes: Blood Transfusion Requirements during Surgery, Compare the blood transfusion requirements between the two groups. This will be recorded in units and recorded on the Surgery Form and the Concomitant Medication Form., At time of surgery|Perioperative Outcomes: Length of Hospital Stay, Compare the length of hospital stay between the two groups. The duration will be measured in days. Date of surgery being day 0., At time of discharge from hospital following surgery|Health Related Quality of Life and Fear of Recurrence, Change in Quality of Life using Functional Assessment of Cancer General (FACT-EN), Fear of Recurrence and PROMS between baseline and 1 year after surgery, 12 months from surgery|Incidence of Lymphedema, Compare lower limb lymphedema between groups, 12 months from surgery|Adjuvant Treatment Requirements, Compare the need for postoperative (adjuvant) treatments between groups and evaluate the impact of SNB on clinical decisions regarding adjuvant treatment. Any chemotherapy or radiation therapy required will be recorded on specific chemotherapy or radiation forms. Chemotherapy will be recorded in mg received and number of doses required including start/end dates. Radiation treatment received will be recorded as total dose of Gy and how many fractions, including start and end dates., 12 months from surgery|Value of Molecular Biomarkers, Translational Research – Compare Molecular profile from surgery between the groups that require adjuvant therapy for 24 months., 24 months from surgery|Value of Molecular Biomarkers, Translational Research – Compare the Molecular profile of Germline DNA at 12 months from surgery between the groups, 12 months from surgery|Value of Molecular Biomarkers, Translational Research – Compare the Molecular profile of Circulating Tumour DNA at 12 months from surgery between the groups, 12 months from surgery|Value of Molecular Biomarkers, Translational Research – Compare the Molecular profile of Plasma at 12 months from surgery between the groups, 12 months from surgery|Value of Molecular Biomarkers, Translational Research – Compare the Molecular profile of Serum at 12 months from surgery between the groups, 12 months from surgery|Overall Survival, Compare overall survival for participants randomised to receive hysterectomy, bilateral salpingo-oophorectomy with SNB compared to participants randomised to hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection, 4.5 years from surgery|Patterns of Recurrence – date and localization of 1st recurrence, Date and localization of 1st recurrence as confirmed histologically and/or radiologically – Compare these patterns of recurrences between the groups. These will also be adjudicated by an independent committee to ensure accuracy of documented recurrence, 4.5 years from surgery|Impact of body composition (sarcopenia) on surgical complications, recovery and overall survival, Body mass measures are practical \& sensitive for predicting health risks \& outcomes. Sarcopenia is defined as loss of skeletal muscle mass \& strength. It’s been found to be associated with procedure-related morbidity, survival in cancer patients and increased use of healthcare. The concurrent appearance of low muscle mass with high adiposity (sarcopenic obesity) is common in people with chronic diseases. The trial will determine the role sarcopenia has on participants pre-operatively (via CT images \& Bioimpedance Spectroscopy (BIS – if available at site) \& postoperatively using the BIS in regard to survival in gynaecological malignancies, if it is a predictive factor for treatment adverse events \& participants tolerability of treatment \& compare diagnostic methods to determine medical fitness for surgery. BIS sends non-detectable electrical currents, at a range of frequencies through the body allowing precise measurement \& analysis of impedance to currents by extracellular fluid, 4.5 years from surgery|Impact of frailty on surgical complications, recovery and overall survival, It has been reported consistently that frailty has a significant impact on the occurrence of adverse postoperative outcomes. Therefore, measuring frailty is important to estimate risks, determine the best treatment options, and to aid diagnosis and care planning. Frailty will be measured prior to surgery suing the validated tool – Frailty Phenotype. This may determine the impact frailty has on survival, quality of life, lymphedema, peri-, intra- and postoperative outcomes, 4.5 years from surgery|Follow-Up Strategies, Current institutional \& clinical guidelines suggest patients need to be seen at regular follow up visits. The risk of developing a recurrence is higher within the initial period after surgery \& the majority of recurrences develop within those first 3 years. Participants will ideally be seen 3 monthly for the first 3 years \& 6 monthly until 4.5 years. The objective of follow up is that local recurrences from endometrial cancer are potentially curable. It helps to diagnose local recurrences as early as possible so that they are amenable for curative or effective palliative management. We will compare these clinical findings to a symptom checklist that will be completed by participants every 3 months from surgery until 4.5 years. This records patient reported symptoms that may indicate a recurrence. Comparing these findings should determine effective follow up strategies for this group of patients., 4.5 years from surgery | Queensland Centre for Gynaecological Cancer | The University of Queensland | FEMALE | ADULT, OLDER_ADULT | PHASE3 | 760 | OTHER_GOV | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | ENDO-3 | 2021-01-18 | 2031-01 | 2031-01 | 2019-08-29 | 2024-08-28 | Houston Methodist Hospital, Houston, Texas, 77030, United States|Chris O’Brien Lifehouse, Camperdown, New South Wales, 2050, Australia|Liverpool Hospital, Liverpool, New South Wales, 2170, Australia|The Wesley Hospital, Auchenflower, Queensland, 4066, Australia|Buderim Private Hospital, Buderim, Queensland, 4556, Australia|North West Private Hospital, Everton Park, Queensland, 4053, Australia|Royal Brisbane and Women’s Hospital, Herston, Queensland, 4029, Australia|Mater Hospital, South Brisbane, Queensland, 4101, Australia|Gold Coast University Hospital, Southport, Queensland, 4215, Australia|St Andrews War Memorial Hospital, Spring Hill, Queensland, 4000, Australia|Royal Hobart Hospital, Hobart, Tasmania, 7000, Australia|Mercy Hospital for Women, Heidelberg, Victoria, 3084, Australia|Royal Women’s Hospital, Parkville, Victoria, 3052, Australia|Hospital de Base, São José Do Rio Preto, Sao Paulo, 15090-000, Brazil|Tata Medical Center, Kolkata, Delhi, India|Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), Udine, Via Pozzuolo, 33100, Italy|National University Hospital and National University Cancer Institute, Singapore, NUH Zone B, 119074, Singapore | |||
| NCT04068896 | Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy | https://clinicaltrials.gov/study/NCT04068896 | Study of NGM120 in subjects with advanced solid tumors and and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3). | NO | Pancreatic Cancer|Metastatic Castration-resistant Prostate Cancer|Bladder Cancer|Melanoma|Non-small Cell Lung Cancer|Colorectal Cancer|Gastric Cancer|Esophageal Cancer|Ovarian Cancer|Head Neck Squamous Cell Carcinoma|Prostate Cancer | BIOLOGICAL: NGM120|BIOLOGICAL: NGM120|BIOLOGICAL: NGM120|BIOLOGICAL: NGM120|BIOLOGICAL: NGM120|BIOLOGICAL: NGM120|OTHER: Placebo | Number of patients with Dose-Limiting Toxicities:, A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 28 days after the first dose of study treatment., 12 weeks|Incidence of Adverse Events, Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug, 12 weeks|Number of Patients with Clinically Significant Laboratory Abnormalities:, Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing., 12 weeks | Pharmacokinetics (PK) of NGM120, Pharmacokinetics (PK) of NGM120 by measuring serum concentration of NGM120 at specified timepoints, 19 weeks|Immunogenicity against NGM120, Immunogenicity against NGM120 by measuring percentage of subjects to develop antidrug antibodies and neutralizing antibodies, 19 weeks|Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria, Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria, 19 weeks|Body weight during therapy with NGM120, Body weight during therapy with NGM120 by measuring change in body weight (in lb)., 19 weeks|Skeletal muscle index during therapy with NGM120, Skeletal muscle index during therapy with NGM120 by measuring skeletal muscle mass and adiposity at level of L3 on serial CT scan., 19 weeks | NGM Biopharmaceuticals, Inc | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 90 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 18-0402 | 2019-10-16 | 2023-09-21 | 2024-01-08 | 2019-08-28 | 2024-07-09 | NGM Clinical Study Site, Tucson, Arizona, 85719, United States|NGM Clinical Study Site, Los Angeles, California, 90048, United States|NGM Clinical Study Site, Los Angeles, California, 90084, United States|NGM Clinical Study Site, Sacramento, California, 98517, United States|NGM Clinical Study Site, San Diego, California, 92123, United States|NGM Clinical Study Site, Santa Monica, California, 90404, United States|NGM Clinical Study Site, Aurora, Colorado, 80045, United States|NGM Clinical Study Site, Washington, District of Columbia, 20007, United States|NGM Clinical Study Site, Miami, Florida, 33136, United States|NGM Clinical Study Site, Chicago, Illinois, 60611, United States|NGM Clinical Study Site, Baltimore, Maryland, 21201, United States|NGM Clinical Study Site, Cincinnati, Ohio, 45219, United States|NGM Clinical Study Site, Philadelphia, Pennsylvania, 19111, United States|NGM Clinical Study Site, Charleston, South Carolina, 29425, United States|NGM Clinical Study Site, Myrtle Beach, South Carolina, 29572, United States|NGM Clinical Study Site, Nashville, Tennessee, 37203, United States|NGM Clinical Study Site, Dallas, Texas, 75390, United States|NGM Clinical Study Site, Houston, Texas, 77030, United States|NGM Clinical Study Site, Seattle, Washington, 98101, United States|NGM Clinical Study Site, Milwaukee, Wisconsin, 53226, United States | |||||
| NCT04063410 | Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients With Breast Cancer Undergoing Breast Reconstruction With Free-Flap Methods After Mastectomy | https://clinicaltrials.gov/study/NCT04063410 | This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. Free flaps are units of tissue transferred from one area of the body to another with an intact blood supply. pPCA uses magnetic resonance imaging (MRI) to create images of blood vessels inside the body. Using pPCA may help doctors develop better surgical plans for patients with breast cancer undergoing post-mastectomy reconstruction surgery with free flap methods. | NO | Mammoplasty Patient | PROCEDURE: Angiography|PROCEDURE: MRI-Based Angiogram|OTHER: Quality-of-Life Assessment | Occurrence rate of surgical plan scenarios, When all participating plastic surgeons reach a consensus decision on the final surgical plan after jointly reviewing the perforator phase contrast angiography (pPCA)-based and contrast-enhanced computed (CTA) based preliminary plans, one of four scenarios may occur: I. The pPCA-based and CTA-based plans are identical. Both are accepted as the final plan; II. There is substantial discrepancy between the two preliminary plans. The pPCA-based plan is eventually accepted as the final plan; III. There is substantial discrepancy between the two preliminary plans. The CTA-based plan is eventually accepted as the final plan; IV. There is substantial discrepancy between the two preliminary plans, but neither the pPCA-based plan nor the CTA-based plan is deemed acceptable. The final plan is proposed based upon comprehensive assessment of both image sets. The occurrence rate of scenario I-IV cases will be estimated with 95% confidence interval, respectively., Up to 2 years|Acceptance rate for pPCA-based surgical plans, The acceptance rate for pPCA-based plans will be evaluated using one-sided non-inferiority test of correlated proportions with non-inferiority margin of 15%. Perforator size measurements obtained with pPCA or CTA will be summarized separately, and be compared between pPCA and CTA using paired t-test., Up to 2 years|Postoperative major complication rate, Will be calculated and exact binomial 95% confidence interval will be provided. The calculated major complication rate will be compared with historical data. The association of complications with demographic and clinical characteristics (e.g., age, obesity, laterality and radiation) will be explored using two sample t-test or Wilcoxon test for continuous variables, and chi-square test or Fisher?s exact test for categorical variables. Logistic regression model will also be used to study the association between the complications and the pPCA/CTA-based plans, controlling those significant confounders., At 2 years|Quality of life questionnaire (BREAST-Q), Patient reported outcome for breast reconstruction questionnaire (BREAST-Q) score for satisfaction with breast will be summarized using descriptive statistics (mean and standard deviation) at baseline, 1 year postoperative, 2 years postoperative, as well as the change from baseline to postoperative. BREAST-Q score at 2 years will be compared with historical data., Baseline up to 2 years | University of Cincinnati | ALL | ADULT, OLDER_ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING | OSU-18094|NCI-2018-03417 | 2023-01-01 | 2024-12-31 | 2024-12-31 | 2019-08-21 | 2024-01-18 | Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States | ||||||
| NCT04003038 | Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery | https://clinicaltrials.gov/study/NCT04003038 | This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery. | NO | Body Mass Index Greater Than or Equal to 30|Malignant Breast Neoplasm|Mammoplasty Patient|Obesity | PROCEDURE: Negative Pressure Wound Therapy|PROCEDURE: Wound Care Management | Rate of wound dehiscence, Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant., Up to 3 months|Wound healing complications, Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant., Up to 3 months | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 80 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2018-0004|NCI-2019-02777|2018-0004|P30CA016672 | 2019-05-02 | 2026-04-30 | 2026-04-30 | 2019-07-01 | 2024-10-16 | M D Anderson Cancer Center, Houston, Texas, 77030, United States | |||||
| NCT03976284 | Garden-fresh Produce and Exercise Reduce Colon Cancer Risk | https://clinicaltrials.gov/study/NCT03976284 | GFPE | The investigators propose a church-based health promotion program designed to reduce colon cancer risk in a mostly African American community served by the Lincoln Memorial Church in South Los Angeles. The investigators propose involving 20 overweight/obese community members in a 10-session health promotion program featuring weekly cooking classes, didactic nutrition instruction and brief bouts of exercise. Behavioral aim is to increase participants’ fiber intake from commonly consumed plant foods and reduce their intake of pro-inflammatory foods. They will be followed for 3 months from time of enrollment. Intervention is expected to increase participants’ mean stool weight and improve their Bristol Stool Chart score. Intervention is expected to reduce waist circumference and systolic blood pressure of participants. These effects are expected to be accompanied by self-reports of increased fiber intake and reduced intake of saturated fat and refined sugar as well as evidence of increased physical activity. | NO | Garden-fresh Produce and Exercise (GFPE) | BEHAVIORAL: Garden-fresh produce and exercise | Stool weight, Mean stool weight of single bowel evacuation using precision digital scale, At baseline and 3 months post-enrollment | Bristol Stool Chart score, Bristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid), At baseline and 3 months post-enrollment|Waist circumference, Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device, At baseline and 3 months post-enrollment|Systolic blood pressure, Resting blood pressure assessed in participant seated quietly at a table with legs uncrossed, At baseline and 3 months post-enrollment|Ratio of fruit and vegetable fiber intake to total solid food intake, The ratio of fruit and vegetable fiber intake relative to total gram weight of foods consumed per day based on data from Block Food Frequency questionnaire., At baseline and 3 months post-enrollment|Saturated fat intake, Mean grams (g) of saturated fat intake consumed daily based on retrospective food consumption data obtained from administration of the Block Food Frequency questionnaire. The Daily Value for saturated fat is less than 20 g per day, based on a 2,000 calorie diet. Meat-eating Americans generally consume more than 20 g per day but usually don’t exceed 80 g per day. Humans make all the saturated fat that they need, so consuming zero g of saturated fat per day is consistent with good health., At baseline and 3 months post-enrollment|Sugary beverage intake, Percent of daily calorie intake attributable to sugary beverage intake, At baseline and 3 months post-enrollment | University of California, Los Angeles | Charles Drew University of Medicine and Science | ALL | ADULT, OLDER_ADULT | NA | 21 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | U54CA14393009 | 2019-03-17 | 2019-07-30 | 2019-08-30 | 2019-06-06 | 2019-06-06 | UCLA Center for Cancer Prevention & Control Research, Los Angeles, California, 90095-6900, United States | |||
| NCT03971591 | Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors | https://clinicaltrials.gov/study/NCT03971591 | MMF | This study will examine the efficacy of Men Moving Forward (MMF), a four-month community-based lifestyle intervention designed for AA PC survivors. MMF is rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with AA PC survivors. It will offer twice weekly sessions aimed at supporting adherence to the ACS nutrition and physical activity guidelines to promote improved body composition (i.e., decreased adiposity, increased lean mass). | NO | Prostate Cancer | BEHAVIORAL: Immediate Guided Lifestyle Program Intervention | Change in body composition, Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable., Change from Baseline to 4 month|Change in body composition, Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable., Change from Baseline to 12 month|Increase in intake of fruits and vegetables, VioScreen’s dietary analysis of self reported food consumption, Change from Baseline to 4 month|Increase in intake of fruits and vegetables, VioScreen’s dietary analysis of self reported food consumption, Change from Baseline to 12 month|Decrease of intake of red meat/processed meat, VioScreen’s dietary analysis of self reported food consumption, Change from Baseline to 4 month|Decrease of intake of red meat/processed meat, VioScreen’s dietary analysis of self reported food consumption, Change from Baseline to 12 month|Increase in levels of physical activity- minutes per week, Change of ActiGraph monitored activity, Change from Baseline to 4 month|Increase in levels of physical activity- minutes per week, Change of ActiGraph monitored activity, Change from Baseline to 12 month|Increase in levels of physical activity- #times per week, Change of ActiGraph monitored activity, Change from Baseline to 4 month|Increase in levels of physical activity- #times per week, Change of ActiGraph monitored activity, Change from Baseline to 12 month|Increase in resistance training- Lower extremity strength, Isokinetic dynamometer (HUMAC Norm, Stoughton, MA)., Change from Baseline to 4 month|Increase in resistance training- Lower extremity strength, Isokinetic dynamometer (HUMAC Norm, Stoughton, MA)., Change from Baseline to 12 month|Increase in resistance training- Handgrip strength, Takei 5401 Hand Grip Digital Dynamometer, Change from Baseline to 4 month|Increase in resistance training- Handgrip strength, Takei 5401 Hand Grip Digital Dynamometer, Change from Baseline to 12 month|Increase in resistance training- Strength and endurance, 30-Second Chair Stand (Sit to Stand), Change from Baseline to 4 month|Increase in resistance training- Strength and endurance, 30-Second Chair Stand (Sit to Stand), Change from Baseline to 12 month|Change in Quality of Life- PROMIS, PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function., Change from Baseline to 4 month|Change in Quality of Life-PROMIS, PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function., Change from Baseline to 4 month|Change in Urban life stress inventory- Crisys, Measure change of mean in positive/negative/neutral and resolved/ongoing, Change from Baseline to 4 month|Change in Urban life stress inventory-Crisys, Measure change of mean in positive/negative/neutral and resolved/ongoing, Change from Baseline to 12 month|Changes in Blood Pressure, Participants blood pressure will be measured using a digital, automated unit, Change from Baseline to 4 month|Change in Blood Pressure, Participants blood pressure will be measured using a digital, automated unit, Change from Baseline to 12 month|Change in Biomarkers- Hemoglobin, Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers-Hemoglobin, Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers- A1C, A1C blood tests measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers- A1C, A1C blood tests measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers- Hormones-Testosterone, Testosterone blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers- Hormones-Testosterone, Testosterone blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers- Hormones- Estradiol, Estradiol blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers- Hormones- Estradiol, Estradiol blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers- Hormones- SHBG, SHBG blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers- Hormones- SHBG, SHBG blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers-Adipokines- Leptin, Leptin blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers-Adipokines- Leptin, Leptin,blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers-Adipokines-Adiponectin, Adiponectin blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers-Adipokines-Adiponectin, Adiponectin blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers-Inflammation- IL-6, IL-6 blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers-Inflammation- IL-6, IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin, Change from Baseline to 12 month|Change in Biomarkers-Inflammation-TNFα, TNFα blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers-Inflammation-TNFα, TNFα blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers-Insulin Resistance-C-Peptide, C-Peptide blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers-Insulin Resistance- C-Peptide, C-Peptide blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month|Change in Biomarkers-Insulin Resistance-IGF-1, IGF-1 blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 4 month|Change in Biomarkers Insulin Resistance-IGF-1, IGF-1 blood test measured by Wisconsin Diagnostic Laboratory, Change from Baseline to 12 month | Medical College of Wisconsin | Loyola University Chicago|Marquette University|University of Illinois at Chicago | MALE | ADULT, OLDER_ADULT | NA | 200 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | PRO00031416 | 2019-06-01 | 2024-06-30 | 2024-06-30 | 2019-06-03 | 2023-10-19 | Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States | ||||
| NCT03937934 | Study Title: Food Rx | https://clinicaltrials.gov/study/NCT03937934 | Researchers are trying to determine if subjects with lack of access to healthy food and a long term health problem, are helped by a weekly box of healthy groceries and nutrition education. | NO | Diabetes|High Blood Pressure|Obesity|Hypertension|Heart Diseases|Stroke|TIA|Osteoarthritis|Cancer | BEHAVIORAL: Nutrition Education | Change in the number of self-reported fruits per day, Number of self-reported fruits per day, Baseline, 3 months, 6 months|Change in the number of self-reported vegetables per day, Number of self-reported vegetables per day, Baseline, 3 months, 6 months|Change in number of days a week and minutes per day participants participate in physical activity and sedentary activity, Measured using self-reported Food Rx Pilot survey, Baseline, 3 months, 6 months | Change in A1c, Identified through chart review, 6 months and 12 months|Change in BMI kg/m2 (weight in kg, height in meters), Identified through chart review, 6 months and 12 months|Change in Systolic and/or Diastolic Hypertension mmHg, Identified through chart review, 6 months and 12 months | Mayo Clinic | ALL | ADULT, OLDER_ADULT | NA | 24 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | 18-006630 | 2019-05-20 | 2019-11-20 | 2020-05-20 | 2019-05-06 | 2020-06-09 | Mayo Clinic Health System, Mankato, Minnesota, 56001, United States | |||||
| NCT03910387 | Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer | https://clinicaltrials.gov/study/NCT03910387 | This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity. | NO | Locally Advanced Unresectable Pancreatic Adenocarcinoma|Metastatic Pancreatic Adenocarcinoma|Recurrent Pancreatic Adenocarcinoma|Stage III Pancreatic Cancer AJCC v8|Stage IV Pancreatic Cancer AJCC v8 | DRUG: Gemcitabine|DRUG: Nab-paclitaxel|DRUG: Telotristat Ethyl | Weight stability, Weight stability will be documented as percent weight change at 3 months compared to baseline., Baseline up to 3 months after study start | Change in serum 5-hydroxyindoleacetic acid (5-HIAA) levels, The change will be summarized as mean and standard deviation., Baseline up to 4 months after study start|Change in 24-hr urine 5-hydroxyindoleacetic acid (5-HIAA) levels, The change will be summarized as mean and standard deviation., Baseline up to 4 months after study start|Mid arm circumference (MAC) measured in inches, Mid arm circumference (MAC) will be reviewed on cross sectional imaging and will be assessed with imaging guided measurements of the psoas and rectus abdominis muscle., Up to 2 years after study start|Quality of life (QOL), Quality of life (QOL) will be assessed by the Obesity Related Quality of Life (OWL-QOL)-17 questionnaire., Up to 2 years after study start|Blood serotonin levels, Blood serotonin levels will be compared in the 2 groups., Up to 2 years after study start|Response rate (RR), Response rate (RR) will be assessed per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, in patients receiving telotristat ethyl (Group 1)., Up to 2 years after study start|Median overall survival (MOS), Median overall survival (MOS) will be measured using the Kaplan-Meier method., Up to 2 years after study start|Duration of response, Duration of response will be estimated from time of documentation of response to time of progression and will be evaluated by computed tomography/magnetic resonance imaging scans of the organ(s) with the target lesion(s) based on RECIST criteria., Up to 2 years after study start | Emory University | National Cancer Institute (NCI)|Lexicon Pharmaceuticals | ALL | ADULT, OLDER_ADULT | PHASE2 | 22 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IRB00105292|NCI-2018-01977|Winship4441-18 | 2019-04-17 | 2023-10-26 | 2024-10-01 | 2019-04-10 | 2023-08-29 | Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Emory Saint Joseph’s Hospital, Atlanta, Georgia, 30342, United States | ||||
| NCT03908996 | the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer | https://clinicaltrials.gov/study/NCT03908996 | The primary purpose of this study is to evaluate the effectiveness of a 12-month comprehensive weight management program on weight change in overweight/obese patients following treatment for endometrial cancer. During the study period, subjects will be monitored for recurrence during routine clinic visits A secondary exploratory purpose of this study will be to evaluate the gut microbiome in this intervention group and the changes that may occur while participating in a weight loss and weight management program. | NO | Endometrial Cancer|Overweight | BEHAVIORAL: Profile by Sanford weight management plan | Determine weight change from baseline to 6 months., All enrolled subjects will be weighed in pounds and the difference from baseline to 6 months will be recorded., 6 months after starting weight management program|Determine weight change from baseline to 12 months., All enrolled subjects will be weighed in pounds and the difference from baseline to 12 months will be recorded., 12 months after starting weight management program | Sanford Health | FEMALE | ADULT, OLDER_ADULT | NA | 25 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | SH Profile II | 2019-02-11 | 2021-01-11 | 2021-01-11 | 2019-04-09 | 2021-03-18 | Roger Maris Cancer Center, Fargo, North Dakota, 58102, United States|Sanford Gynecological Oncology clinic, Sioux Falls, South Dakota, 57104, United States | ||||||
| NCT03880422 | Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors | https://clinicaltrials.gov/study/NCT03880422 | This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood. | NO | Cancer Survivor|Obesity|Overweight|Prostate Adenocarcinoma|Stage A Prostate Cancer|Stage B Prostate Cancer|Stage C Prostate Cancer|Stage D Prostate Cancer|Stage I Prostate Cancer|Stage II Prostate Cancer|Stage IIA Prostate Cancer|Stage IIB Prostate Cancer|Stage IIC Prostate Cancer|Stage III Prostate Cancer|Stage IIIA Prostate Cancer|Stage IIIB Prostate Cancer|Stage IIIC Prostate Cancer|Stage IV Prostate Cancer|Stage IVA Prostate Cancer|Stage IVB Prostate Cancer | DIETARY_SUPPLEMENT: Dietary Intervention|OTHER: Educational Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Quality-of-Life Assessment|OTHER: Survey Administration | Changes in body composition, Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat., Baseline up to 6 months | Changes in muscle strength, Will be assessed by chest press, leg press, grip strength,6-minute walk test, timed-up-and-go, agility, Berg balance scale, short physical performance battery (SPPB)., Baseline up to 6 months|Changes in functional capacity muscle strength, Improvement of muscle strenght, Baseline up to 6 months|Change in body composition, All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition, Baseline up to 6 months|myokines concentration, Will be assessed by serum biomarker levels., Baseline up to 6 months|cytokines concentration, Will be assessed by serum biomarker levels., Baseline up to 6 months|Health related quality of life Short Form, Will be used to assess quality of life . The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 – 100, Lower scores = more disability, higher scores = less disability, Up to 6 months|Changes in dietary intake, Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey., Baseline up to 6 months|Changes in physical activity, Will be assessed by Godin Leisure Time survey and Fitbit activity report. Will be summarized by time point using the observed sample size, mean, and standard deviation. Will be evaluated using a two-sided permutation paired t-test. Additionally, the mean change in each outcome will be estimated using a 95% confidence interval. As exploratory analyses, the association between the change in each outcome and demographic/clinical factors may be evaluated using general linear models. The change in outcome will be modeled as a function of baseline levels and each demographic/clinical factor in a one-at-a-time manner., Baseline up to 6 months|Change in fatigue, Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey., Baseline up to 6 months|Change in Respiratory Muscle Strength, Mouth pressure device, Baseline up to 6 months | Serum prostate specific antigen (PSA) and androgen levels, Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels., Up to 6 months|Adherence to nutrition and exercise advice, Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics., Up to 6 months | Roswell Park Cancer Institute | MALE | ADULT, OLDER_ADULT | NA | 50 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | I 72118|NCI-2019-00341|I 72118 | 2019-05-02 | 2029-05-02 | 2029-05-02 | 2019-03-19 | 2024-09-26 | Roswell Park Cancer Institute, Buffalo, New York, 14263, United States | ||||
| NCT03851133 | Florida Pancreas Collaborative Next Generation Biobank | https://clinicaltrials.gov/study/NCT03851133 | The goal of this study is to partner with individuals known or suspected to have pancreatic cancer to build a biobank dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a resource that involves collection, processing and storage of blood, other bodily fluids, and tissue. | NO | Pancreatic Cancer|Cancer Cachexia | OTHER: Blood Sample Collection|OTHER: Tumor Sample collection|OTHER: Data Collection | Evidence of Precachexia, Cases will be evaluated for precachexia using the following guidelines: Anorexia with \<5% weight loss over past 6 months along with metabolic changes that together indicate precachexia., Up to 12 months|Evidence of Cachexia, Cases will be evaluated for cachexia using the following guidelines: Anorexia with \>5% weight loss over past 6 months, along with metabolic changes that together indicate cachexia., Up to 12 months|Evidence of Refractory Cachexia, Cases will be evaluated for refractory cachexia using the following guidelines: Anorexia \>5% weight loss over 6 months along with specific metabolic changes that together indicate refractory cachexia., Up to 12 months|Presence of Myopenia, Measures of skeletal muscle index (SMI) and psoas muscle index (PMI) for will be used for myopenia assessment., Up to 12 months|Presence of Visceral Adiposity, Using CT scans at the axial L2-L3 level, the following radiologic measures of abdominal adiposity will be obtained: visceral fat area (VFA), subcutaneous fat area (SFA), total abdominal fat (TAF) area, and the VFA to SFA ratio (V/S). The VFA to SFA ratio (V/S) will be calculated with V/S \> 0.4 defined as viscerally obese., Up to 12 months | Overall Survival, Overall Survival will be defined as time from surgery to death from any cause, Up to 24 months|Progression Free Survival, Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death., Up to 24 months | H. Lee Moffitt Cancer Center and Research Institute | ALL | ADULT, OLDER_ADULT | 500 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | MCC-19717|8JK02 | 2019-03-04 | 2022-08-06 | 2025-07-05 | 2019-02-22 | 2024-11-29 | Lee Memorial Hospital Regional Cancer Center, Fort Myers, Florida, 33905, United States|University of Florida – Gainesville, Gainesville, Florida, 32610-0109, United States|Palmetto General Hospital, Hialeah, Florida, 33016, United States|University of Florida – Jacksonville, Jacksonville, Florida, 32209, United States|Lakeland Regional Health, Lakeland, Florida, 33805, United States|Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States|Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital, Miami, Florida, 33136, United States|Advent Health – Orlando, Orlando, Florida, 32804, United States|University of Florida – Orlando, Orlando, Florida, 32806, United States|St Anthony’s Baycare/Bay Surgical Specialists, Saint Petersburg, Florida, 33705, United States|Sarasota Memorial Hospital, Sarasota, Florida, 34239, United States|Tallahassee Memorial Healthcare, Tallahassee, Florida, 32308, United States|University of South Florida/Tampa General Hospital, Tampa, Florida, 33606, United States|H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, 33612, United States | ||||||
| NCT03840928 | PatientSpot Formerly Known as ArthritisPower | https://clinicaltrials.gov/study/NCT03840928 | Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions. | NO | Rheumatoid Arthritis|Ankylosing Spondylitis|Fibromyalgia|Gout|Crohn Disease|Juvenile Idiopathic Arthritis|Lupus Erythematosus|Myositis|Osteoarthritis|Osteoporosis|Psoriasis|Psoriatic Arthritis|Scleroderma|Dermatomyositis|Inflammatory Bowel Diseases|Polymyositis|Axial Spondyloarthritis|Diffuse Idiopathic Skeletal Hyperostosis|Polymyalgia Rheumatica|Giant Cell Arteritis|Temporal Arteritis|Wegener|Relapsing Polychondritis|Undifferentiated Connective Tissue Disease|Spinal Cord Injuries|Alzheimer Disease|Amyotrophic Lateral Sclerosis|Ataxia|Bell Palsy|Brain Tumor|Cerebral Aneurysm|Epilepsy|Guillain-Barre Syndrome|Headache|Head Injury|Hydrocephalus|Lumbar Disc Disease|Meningitis|Multiple Sclerosis|Muscular Dystrophy|Neurocutaneous Syndromes|Parkinson Disease|Stroke|Cluster Headache|Tension-Type Headache|Chronic Obstructive Pulmonary Disease|Asthma|Lung Cancer|Cystic Fibrosis|Sleep Apnea|Eczema|Alopecia|Chronic Inflammation|Unstable Angina|Heart Attack|Heart Failure|Arrythmia|Valve Heart Disease|High Blood Pressure|Congenital Heart Disease|Peripheral Arterial Disease|Diabetes|Chronic Liver Disease|Obesity | Pain Interference (PROMIS), 7 days|Fatigue (PROMIS), 7 days|Sleep Disturbance (PROMIS), 7 days|Physical Function (PROMIS), 7 days|RAPID-3 (MD-HAQ with visual analogue scale for pain and patient global measure for overall health), 7 days | Global Healthy Living Foundation | University of Alabama at Birmingham | ALL | ADULT, OLDER_ADULT | 40000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | GlobalHealthyLivingF | 2015-04-01 | 2025-03-01 | 2025-03-01 | 2019-02-15 | 2023-12-13 | Global Healthy Living Foundation, Upper Nyack, New York, 10960, United States | |||||||
| NCT03836300 | Parent and Infant Inter(X)Action Intervention (PIXI) | https://clinicaltrials.gov/study/NCT03836300 | The objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed diagnosis of a neurogenetic disorder with associated developmental delays or intellectual and developmental disabilities. The proposed project will capitalize and expand upon existing empirically based interventions designed to improve outcomes for infants with suspected developmental delays. Participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) within the first year of life and their parents/caregivers. The intervention, called the Parent and Infant Inter(X)action Intervention (PIXI) is a comprehensive program inclusive of parent education about early infant development and the neurogenetic disorder for which they were diagnosed, direct parent coaching around parent-child interaction, and family/parent well-being support. The protocol includes repeated comprehensive assessments of family and child functioning, along with an examination of feasibility and acceptability of the program. | NO | Fragile X Syndrome|Angelman Syndrome|Prader-Willi Syndrome|Dup15Q Syndrome|Duchenne Muscular Dystrophy|Phelan-McDermid Syndrome|Rett Syndrome|Smith Magenis Syndrome|Williams Syndrome|Turner Syndrome|Klinefelter Syndrome|Chromosome 22q11.2 Deletion Syndrome|Tuberous Sclerosis|Down Syndrome | BEHAVIORAL: Parent-Infant Inter(X)action Intervention (PIXI) | Social Validity and Acceptability, A social validity measure will be completed to better understand to inquire about family satisfaction with aspects of the intervention including curriculum, timing, goals targeted, and perceived effects of the intervention., Completion of Phase 1 (approximately six months of age)|Social Validity and Acceptability, A social validity measure will be completed to better understand to inquire about family satisfaction with aspects of the intervention including curriculum, timing, goals targeted, and perceived effects of the intervention. Qualitative interviewing will be also be conducted to examine parent perceptions of feasibility and acceptability., Completion of Phase 2 (approximately twelve months of age)|Fidelity, Overall intervention fidelity will be measured by determining if the following goals were achieved: Enrollment target of 10-15 families 80% retention rate with at least 75% completing the 20 sessions across Phase 1 and Phase 2, Completion of Phase 1 (approximately six months of age)|Fidelity, Overall intervention fidelity will be measured by determining if the following goals were achieved: Enrollment target of 10-15 families 80% retention rate with at least 75% completing the 20 sessions across Phase 1 and Phase 2, Completion of Phase 2 (approximately twelve months of age) | Parent Implementation and Engagement, Internal parent implementation and engagement forms will be used to measure parent participation across both intervention phases. These components include parent readiness for the session, attention to materials, participation in topic discussion, appropriateness of intervention activity practice, and general presentation with their child., Across phase 1 and phase 2 engagement (approximately ages 6-months through 1-year of age)|Early Developmental Outcomes, Descriptive statistics around early learning, motor, communication skills, interpersonal, and adaptive skills in the sample will be derived from the Vineland Adaptive Behavior Scales, Third Edition: Parent/Caregiver Report (Vineland-3). Subdomain v-Scaled scores range from 1-24 with higher numbers indicating greater performance; while domain scores are presented in standard score formats with a range of 20-140 with higher scores indicating greater performance., Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)|Autism Symptoms, A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Communication and Symbolic Behavior Scale (CSBS). The parent report developmental profile is a standardized measure is completed to evaluate language and social communication predictors. A total of 57 points are available with age corresponding cutoff scores for clinical concern., Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)|Autism Symptoms, A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Modified Checklist for Autism in Toddlers (MCHAT). The Modified Checklist for Autism in Toddlers is a scientifically validated tool for screening children between 16 and 30 months of age that assesses risk for autism spectrum disorder (ASD).Scores range from 0-20 with corresponding ranges for cutoff scores warranting further follow-up., Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)|Autism Symptoms, A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). The ADOS-2 is a semi-structured, standardized assessment of communication, social interaction, play, and restricted and repetitive behaviors. It is directly administered to the participant and behaviors are scored. Total scores range based on age of participant/module administered. Scores are calculated and compared against cutoff scores for autism spectrum and autism., Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)|Autism Symptoms, A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the TELE-ASD-PEDS. The TELE-ASD-PEDS was developed by researchers at Vanderbilt University to assess remotely autism symptomology. The TELE-ASD-PEDS measures communication, social interaction, play, and restricted and repetitive behaviors. It is administered via telehealth and behaviors are scored. Total scores range based on age of participant/module administered. Scores are calculated and compared against cutoff scores for autism spectrum and autism., Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)|Autism Symptoms, A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Repetitive Behavior Scales (RBS). The RBS-EC is a questionnaire measure of restricted and repetitive behaviors designed for use in children from infancy through early school age. It is intended to capture individual differences across a broad range of behaviors associated with the repetitive behavior domain. Total scores range from 0-136 with a higher score indicating greater need/presence of behaviors., Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age) | RTI International | University of North Carolina, Chapel Hill | ALL | CHILD, ADULT, OLDER_ADULT | NA | 120 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 18-2079 | 2018-11-30 | 2024-12-31 | 2025-06-30 | 2019-02-11 | 2024-05-01 | RTI International, Research Triangle Park, North Carolina, 27709, United States | ||||
| NCT03827343 | Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer | https://clinicaltrials.gov/study/NCT03827343 | Immunotherapy is changing the landscape of cancer therapy. Particularly unique to immunotherapy is the toxicity profile, which differs from chemotherapy-based strategies and can be associated with inflammatory responses and/or autoimmune type reactions resulting from activation of the immune system. Referred to as immune related adverse events (irAEs), these adverse events may require systemic immunosuppression or have other consequences and present unique management challenges. Specific to CAR T-cell and other adoptive cell therapies is the constellation of symptoms referred to as cytokine release syndrome (CRS), which can range in severity from mild to severe, and can require both cytokine directed blockade and/or systemic immunosuppression to ameliorate the side effects. While side effects may be unique to each individual immunotherapy, and may also be patient specific, cumulative experience will help to inform toxicity profiles and improve management of side effects and overall outcomes. Given the number of immunotherapeutic approaches at the NCI, the primary goal of this protocol is to facilitate retrospective chart review of various immunotherapy trials at the NCI used in the treatment of cancer to comprehensively study toxicity profiles. This study will not involve the use of specimens or participant contact. All data that is needed has already been collected on the individual treatment protocols and is available in CRIS records or protocol specific databases. Data will only be collected from treatment protocols where the PI has given permission for use of the data on the trial the subject was enrolled on. This protocol will be amended to incorporate new research objectives and new protocols as necessary…. | NO | Macrophage Activation Syndrome|Primary Hemophagocytic Lymphohistiocytosis | To develop a retrospective study to allow for comparison of immunotherapy related toxicity profiles and risk factors across a set of protocols in the NCI., Summary of immunotherapy related toxicity profiles and risk factors across a set of protocols in the NCI., 2 years | Evaluate infectious complications and their risk factors in patients who receive CAR-T cell therapy for cancer, Summary of infectious complications and their risk factors in patients who receive CAR-T cell therapy for cancer, 2 years|Evaluate the incidence, risk factors for, and treatment of HLH/MAS (now renamed IEC-HS) in patients who receive CAR-T cell therapy., Incidence and treatment of HLH/MAS (now renamed IEC-HS) in patients who receive CAR-T cell therapy, 2 years|Incidence and time to resolution, Incidence of and time to resolution of grade 3 and 4 cytopenias post-CAR T-cell therapy in those who achieve a complete remission., 2 years|Overall and relapse free survival, Summary of overall and relapse free survival and transplant associated toxicities for patients undergoing HSCT following CAR-T cell therapy, 2 years|Incidence of end organ toxicities, Incidence of grade 3 and 4 end organ toxicities experienced within the first 30 days of CAR T-cell therapy and includes associations between pre-CAR organ function as well as post-CAR response to such toxicities as well as validate the CAR-Comorbidity Index as predictive model of CRS severity, 2 years|Evaluate response and toxicity profile of second CAR T-cell infusions, Summary of factors associated with response to second CAR T-cell infusion, 2 years|Evaluate impact of race/ethnicity and obesity on CAR T-cell outcomes, Summary of response and toxicity profiles in patients based on race/ethnicity and also in those who are obese compared to those who are not., 2 years|Evaluate impact of cryopreservation on outcomes following CAR T-cell infusion, Summary of cryopreservation and patients’ outcomes following CAR T-cell infusion, 2 years|Evaluate outcomes for patients with ALL and Down Syndrome following CAR T-cell therapy, Summary of outcomes of patients with ALL and Down Syndrome who have received CAR T-cell therapy, 2 years|Evaluate absolute lymphocyte count following lymphodepleting chemotherapy, Summary of absolute lymphocyte count across lymphodepleting regimens, 2 years|Evaluate relationship between clinical variable and apheresis and manufacturing products, Summary of clinical variables and apheresis and manufacturing products, 2 years|Evaluate incidence of hypertension, identify risk factors for development of hypertension, summarize medical management in CAR setting, and identify complications, Summary of incidence of hypertension, risk factors, medical management and complications, 2 years|Describe baseline demographics, prior treatment characteristics and outcomes based on patients who are referred to CAR T-cell program, Summary of demographics, prior treatment and outcomes for patients referred to CAR T-cell program, 2 years|Incidence of pre-infusion BCA and use of BCA as a prognostic marker for CAR T-cell associated toxicity and efficacy, Incidence of BCA pre-infusion and use as a prognostic marker for CAR T-cell associated toxicity and efficacy, 2 years|Presence and durability of CD72 expression in both B-ALL and normal B-ALL/hematogones, Summary of CD72 expression in both B-ALL and normal B-ALL/hematogones and evaluate use as prognostic marker for CAR T-cell associated toxicity and efficacy, 2 years|Evaluate interventions, documentation of care goals, and use of palliative care consultation or other symptom management, Summary of interventions, documentation of care goals, and use of palliative care consultation or other symptom management for patients treated with CAR T-cell therapy, 2 years|Evaluate long-term outcomes of survivors who received CAR T-cell therapy, Summary of long-term outcomes of survivors who received CAR T-cell therapy, 2 years|Evaluate cross compare responses and outcomes based on NGS MRD and FC MRD, Summary of cross compare responses and outcomes based on NGS MRD and FC MRD, 2 Years|Evaluate the role of manufacturing changes on CAR T-cell outcomes, Summary of the role of manufacturing changes on CAR T-cell outcomes, 2 Years|Evaluate the impact of clonal hematopoiesis on CAR T-cell outcomes, Summary of the impact of clonal hematopoiesis on CAR T-cell outcomes, 2 Years|Evaluate CAR T-cell related coagulopathies, Summary of CAR T-cell related coagulopathies, 2 Years|Evaluate the use of anti-cytokine therapy to treat toxicities after CAR T-cell infusion, Summary of the use of anti-cytokine therapy to treat toxicities after CAR T-cell infusion, 2 Years|Evaluate outcomes of CAR T-cells in patients with extramedullary disease, Summary of outcomes of CAR T-cells in patients with extramedullary disease, 2 Years | National Cancer Institute (NCI) | ALL | CHILD, ADULT, OLDER_ADULT | 500 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999919044|19-C-N044 | 2019-01-23 | 2025-12-31 | 2025-12-31 | 2019-02-01 | 2025-01-14 | National Cancer Institute (NCI), Bethesda, Maryland, 20892, United States | |||||||
| NCT03824145 | Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer | https://clinicaltrials.gov/study/NCT03824145 | EDC | This multi-site study is being conducted to examine dietary and activity patterns, body composition, blood and quality of life in breast cancer patients. The study will recruit 176 women with MBC in Milwaukee (n=88) and Chicago (n=88). | NO | Metastatic Breast Cancer | BEHAVIORAL: Lifestyle Intervention|BEHAVIORAL: Attention Control | Intervention adherence, Number of lifestyle coaching sessions completed out of a possible total of 16 sessions, 4 months|Intervention retention, Number of women who complete the 4-month data collection, 4 months|Intervention retention, Number of women who complete the 8-month data collection, 8 months|Change in Quality of Life, Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better., Change from baseline to 4 months|Change in Quality of Life, Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better., change from baseline to 8 months|Body composition, Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable., change from baseline to 4 months|Body composition, Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable., change from baseline to 8 months | Serum Biomarker Inflammation – C-Reactive Protein, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month|Serum Biomarker Insulin Resistance – Insulin, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month|Serum Biomarker Insulin Resistance- Glucose, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month|Serum Biomarker Inflammation – Tumor Necrosis Factor – alpha, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month|Serum Biomarker Insulin Resistance- C-Peptide, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month|Serum Biomarker Adipokine Dysregulation – Adiponectin, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month|Serum Biomarker Adipokine Dysregulation – Leptin, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month|Serum Biomarker Inflammation – Interleukin 6, Analyzed by EVE technologies using standard ELISA kits, Change from baseline to 4 month | nRNA and Metabolomics – exploratory, MTo explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention. analyzed using a Seahorse Bioscience extracellular flux analyzer., Baseline to 3 months | Medical College of Wisconsin | Loyola University Chicago | FEMALE | ADULT, OLDER_ADULT | NA | 176 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 27600 | 2022-11-01 | 2027-02-01 | 2027-02-01 | 2019-01-31 | 2024-04-30 | Loyola University, Maywood, Illinois, 60153, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States | ||
| NCT03820024 | MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback | https://clinicaltrials.gov/study/NCT03820024 | MOVES | Overweight and obese endometrial cancer (EC) survivors at the University of North Carolina (UNC) at Chapel Hill will be approached for tailored feedback fitness intervention. The investigators plan to enroll 36 women (18 in each arm) to evaluate if receipt of weekly tailored feedback messages can improve physical activity in EC survivors. It is hypothesized that women receiving the feedback message intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-intervention arm. | YES | Endometrial Cancer | BEHAVIORAL: Tailored Feedback Messages | Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention, Steps recorded on a fitness tracker at week 1 and week 13, 13 weeks | UNC Lineberger Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 39 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION | LCCC 1614 | 2018-09-28 | 2019-12-23 | 2020-12-23 | 2019-01-29 | 2021-07-29 | 2021-07-29 | North Carolina Cancer Hospital, Chapel Hill, North Carolina, 27599, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/24/NCT03820024/Prot_SAP_000.pdf | |||
| NCT03817840 | Novel Mediators of the Lipodystrophy and Metabolic Consequences of Cushing’s Disease | https://clinicaltrials.gov/study/NCT03817840 | This proposal will evaluate the glucocorticoid mediated changes in body fat distribution and metabolism that occur in patients with Cushing’s disease. The objective is to identify the mechanisms that influence both the accumulation of lipodystrophic fat and also the changes in energy expenditure and metabolism that accompany them. The study is designed to determine if the high cortisol and AgRP levels in the blood of people living with Cushing’s syndrome, either from taking steroid medications or from tumors, impact body fat and metabolism by turning off brown fat, which is a type of fat that increases one’s metabolism. | NO | Cushing’s Syndrome | PROCEDURE: Treatment of Cushing’s | Energy Expenditure, Resting energy expenditure (REE) will be measured by whole room indirect calorimetry prior to and following cure of Cushing’s Disease (CD)., Change from baseline REE at 3 months post-treatment | Total body adipose tissue volume, Whole body MRI will be utilized to measure total body adipose tissue volume, Change in total body adipose tissue volume from baseline at 3 months post-treatment | Columbia University | New York Obesity and Nutrition Research Center | ALL | ADULT, OLDER_ADULT | 8 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | AAAR7901 | 2018-07-16 | 2021-07-01 | 2021-07-01 | 2019-01-28 | 2024-06-04 | Columbia University Neuroendocrine Unit, New York, New York, 10032, United States | |||||
| NCT03805516 | Central Obesity and Cancer Prevention for Chinese American Women | https://clinicaltrials.gov/study/NCT03805516 | This project examines the feasibility of a smartphone-based intervention to reduce obesity and breast cancer risk among Chinese American women in San Francisco. The proposed intervention is to use the mobile application and an activity tracker device to promote a healthier lifestyle and physical activity. Ultimately, the findings will advance the NIH mission of enhancing health promotion and disease prevention. | NO | Obesity, Abdominal|Cancer Prevention | BEHAVIORAL: SCOPP-CW|BEHAVIORAL: Control | waist circumference, waist measured in centimeters by NIH waist circumference measurement protocol, Change from baseline waist measurement at 3 months and 6 months|breast cancer knowledge and attitudes, 13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening, Change from baseline breast cancer screening knowledge score at 3 months and 6 months | body mass index, Weight and height (weight \[kg\]/height \[m\]), change from baseline BMI at 3 months and 6 months|self-efficacy, 28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity, Change from baseline self-efficacy questionnaire score at 3 months and 6 months|food intake, Chinese food frequency questionnaire (FFQ) includes 118 food items, Change from baseline food frequency at 3 months and 6 months|physical activity, Daily tracking 10 hours awake time with a Fitbit device, Change from baseline daily physical activity at 3 months and 6 months|blood pressure, Systolic and diastolic blood pressure measured in mmHg, Change from baseline blood pressure at 3 months and 6 months|Hemoglobin A1C, Glycated hemoglobin to measure average level of blood sugar, Change from baseline hemoglobin A1C at 6 months|Lipid panel, A blood test that measures the level of different types of fat (lipid molecules) in the blood, Change from baseline lipid panel at 6 months|C-reactive protein, A blood test that measure the presence of inflammation in the body, Change from baseline lipid panel at 6 months | Number of uses of the tracking app, Weekly number of uses of the tracking app, at 6 months|Frequency of accessing the 12 educational modules, Weekly number of accessing the educational modules, at 6 months | San Francisco State University | University of California, San Francisco | FEMALE | ADULT, OLDER_ADULT | NA | 18 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 20429001 | 2019-10-16 | 2021-08-31 | 2021-08-31 | 2019-01-15 | 2023-11-30 | San Francisco State University, San Francisco, California, 94132, United States | |||
| NCT03779867 | Acute Exercise Intervention in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT03779867 | ACE | This trial studies how a 45-minute bout of acute exercise in women with a history of breast cancer can affect factors associated with breast cancer and help doctors learn more about how exercise can help prevent breast cancer. In an earlier part of the study, investigators looked at the effects of the same intervention in women without a history of cancer. | NO | Breast Carcinoma | BEHAVIORAL: Exercise Intervention|OTHER: Resting|OTHER: Biomarker Analysis|OTHER: Questionnaire Administration | Mean change in homeostatic model assessment of insulin resistance (HOMA-IR), Will compare the average changes in HOMA-IR from baseline to 45 minutes between the exercisers and controls., Baseline up to 45 minutes|Mean change in HOMA-IR, Will compare the average changes in HOMA-IR from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes|Change in insulin level, Will compare changes in insulin level from baseline to 45 minutes between the exercisers and controls., Baseline up to 45 minutes|Change in insulin level, Will compare changes in insulin level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes|Change in glucose level, Will compare changes in glucose level from baseline to 45 minutes between the exercisers and controls., Baseline up to 45 minutes|Change in glucose level, Will compare changes in glucose level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes|Change in Vascular Endothelial Growth Factor (VEGF) level, Will compare changes in VEGF level from baseline to 45 minutes between the exercisers and controls., Baseline up to 45 minutes|Change in VEGF level, Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes|Change in Irisin level, Will compare changes in Irisin level from baseline to 45 minutes between the exercisers and controls., Baseline up to 45 minutes|Change in Irisin level, Will compare changes in Irisin level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes|Change in Plasminogen activator inhibitor type-1 (PAI-1) level, Will compare changes in PAI-1 level from baseline to 45 minutes between the exercisers and controls., Baseline up to 45 minutes|Change in PAI-1 level, Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes | Effects of exercise on HOMA-IR in normal-weight participants, Will use the generalized estimating equations (GEE) model including the potential effect modification of weight category (normal weight versus \[vs\] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women., At 45 minutes|Effects of exercise on HOMA-IR in overweight/obese participants, Will use the GEE model including the potential effect modification of weight category (normal weight versus \[vs.\] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women., At 45 minutes|Change in C-reactive protein (CRP), Will compare changes in CRP level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes|Change in Interleukin (IL)-6, Will compare changes in IL-6 level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes|Change in Monocyte chemotactic protein (MCP)-1, Will compare changes in MCP-1 level from baseline to 105 minutes between the exercisers and controls., Baseline up to 105 minutes | Fred Hutchinson Cancer Center | Breast Cancer Research Foundation | FEMALE | ADULT, OLDER_ADULT | NA | 114 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | RG1003977|NCI-2018-02831|8766 | 2019-03-25 | 2024-12-31 | 2024-12-31 | 2018-12-19 | 2024-08-14 | Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States | |||
| NCT03751449 | Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT03751449 | This trial studies how well exercise and nutrition education work in improving physical function and quality of life in older breast cancer survivors. Exercise and nutrition education may help to improve the level of fitness, cardiovascular health, and quality of life in breast cancer survivors. | NO | Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage IA Breast Cancer AJCC v8|Anatomic Stage IB Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage IIA Breast Cancer AJCC v8|Anatomic Stage IIB Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IIIA Breast Cancer AJCC v8|Anatomic Stage IIIB Breast Cancer AJCC v8|Anatomic Stage IIIC Breast Cancer AJCC v8|Cancer Survivor|Inactivity|Obesity|Overweight|Prognostic Stage I Breast Cancer AJCC v8|Prognostic Stage IA Breast Cancer AJCC v8|Prognostic Stage IB Breast Cancer AJCC v8|Prognostic Stage II Breast Cancer AJCC v8|Prognostic Stage IIA Breast Cancer AJCC v8|Prognostic Stage IIB Breast Cancer AJCC v8|Prognostic Stage III Breast Cancer AJCC v8|Prognostic Stage IIIA Breast Cancer AJCC v8|Prognostic Stage IIIB Breast Cancer AJCC v8|Prognostic Stage IIIC Breast Cancer AJCC v8 | OTHER: Educational Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log., Will measure the effect on physical function (6-minute walk test). Activity levels for all participants will be collected using the Fitbit applications and/or a weekly activity log., Up to 2 years|Quality of life as assessed by the Self Geriatric Assessment Measure (GA-Self Assessment), Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on quality of life., Up to 2 years | Diet quality as assessed by the ASA24 website, Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality., Up to 2 years|Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI), The PSQI measures the quality and pattern of sleeps in adults. There are 19 items. Each item is weighted on a 0-3 interval scale., Up to 2 years|Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention, Will measure anxiety as assessed by the State Trait Anxiety Inventory (STAI-Y1)e STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety, Up to 2 years|motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2), A 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me), Up to 2 years|Centers for Epidemiologic Studies Depression Scale (CESD-R), A self reported 20 item scale that measures depressive symptoms. A higher score denotes greater depressive symptoms., Up to 2 years | Roswell Park Cancer Institute | ALL | OLDER_ADULT | NA | 10 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | i 67518|NCI-2018-01704|i 67518 | 2019-03-25 | 2021-05-01 | 2021-05-21 | 2018-11-23 | 2022-06-06 | Roswell Park Cancer Institute, Buffalo, New York, 14263, United States | |||||
| NCT03734653 | Testosterone Therapy in Castration Resistant Prostate Cancer | https://clinicaltrials.gov/study/NCT03734653 | This is an open-labeled, single-arm, interventional pilot study. It is being done to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide, as well as the safety and efficacy. | NO | Prostate Cancer|Castration-Resistant Prostate Cancer | DRUG: Transdermal Testosterone|DRUG: Standard of Care, Enzalutamide | Feasibility of the Administration of Transdermal Testosterone Alternating with Enzalutamide, This study will be considered feasible if at least 50% of patients approached for participation enroll and if at least 50% of patients that initiate therapy do not withdraw consent for participation., Study start date to study end date, up to 12 months, or until patient death | Safety of the Administration of Transdermal Testosterone Alternating with Enzalutamide, Safety will be assessed based on the Common Terminology Criteria of Adverse Events (CTCAE) v5.0 criteria, in which rates of Grade 1-5 AE will be assessed, with a prticular attention to grade 3-5 events, Study start date to study end date, up to 12 months, or until patient death|Prostate Specific Antigen (PSA) Response Rate, PSA response rates as measured by serum PSA at designated study visits. Response will be defined as a decline in the serum PSA of 50% from baseline value at start of study., Study start date to study end date, up to 12 months, or until patient death|Time to Radiographic Progression, Time to radiographic progression as measured by Response Evaluation Criteria in Solid Tumors (RECIST)., Study start date to study end date, up to 12 months, or until patient death|Time to Radiographic Progression, Time to radiographic progression as measured by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) imaging criteria., Study start date to study end date, up to 12 months, or until patient death|Time to PSA Progression, This will be defined by the PCWG3., Study start date to study end date, every four weeks, up to 12 months, or until patient death|Maximum Decrease in PSA, PSA will be assessed at baseline and every four weeks. Maximum decrease assessed through these measurements., Study start date to study end date, up to 12 months, or until patient death|Physical Function Change, Assessed through handgrip exercises., Study start date to study end date, up to 12 months, or until patient death|Physical Function Change, Assessed through chair rise exercises., Study start date to study end date, up to 12 months, or until patient death|Patient Activation, Assessed using the Self-Efficacy for Physical Activity Scale (SEPA), which uses a 5 point Likert scale., Study start date to study end date, up to 12 months, or until patient death|Reported Fatigue, Measured by the Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue 13)., Study start date to study end date, up to 12 months, or until patient death|Patient Mood and Depression Evaluation, Measured through the Center for Epidemiologic Studies-Depression Scale (CES-D), which uses a point system based on responses ranging from “not at all” to “all the time.”, Study start date to study end date, up to 12 months, or until patient death|Bone Health, Standard bone densometry assessment will be used to calculate T and Z score to determine normal, osteopenic, or osteoporotic bone mineral density., Study start date to study end date, up to 12 months, or until patient death|Body Composition, Measured by a DXA scanner. Free fat mass and lean body mass will be assessed to determine sarcopenic obesity., Study start date to study end date, up to 12 months, or until patient death|Quality of Life Assessment, Measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)., Study start date to study end date, up to 12 months, or until patient death|Change in Hormones, Change in testosterone, estrogen, and sex hormone binding globulin., Study start date to study end date, up to 12 months, or until patient death|Self-Reported Physical Function, Measured by the PROMIS-PA., Study start date to study end date, up to 12 months, or until patient death|Energy Expenditure, Measured by hood assessment., Study start date to study end date, up to 12 months, or until patient death|Change in Max Repetition, Measured by subject’s maximal leg press over time in the energy-balance laboratory., Study start date to study end date, up to 12 months, or until patient death|Change in Spontaneous Physical Activity and Sedentary Time, Measured through accelerometry. Patients will wear an accelerometer for one week at initiation and again one month later., Study start date to study end date, up to 12 months, or until patient death|PSA Response in this Cohort of Patients vs Historical Cohorts, Assessed through IM testosterone historical data., Study start date to study end date, up to 12 months, or until patient death | University of Colorado, Denver | Cancer League of Colorado | MALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 30 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 18-0821.cc | 2019-01-18 | 2024-08-14 | 2025-08 | 2018-11-08 | 2024-09-23 | University of Colorado Hospital, Aurora, Colorado, 80045, United States | ||||
| NCT03722030 | Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors | https://clinicaltrials.gov/study/NCT03722030 | This 2-arm pilot trial will enroll 40 participants to test the feasibility, adherence, and benefits of a home-based strength training intervention for endometrial cancer survivors relative to a wait-listed control group. | YES | Endometrial Cancer | OTHER: Baseline Measures|BEHAVIORAL: Strength-Training|OTHER: Mid-point Measures|OTHER: Post-Study Measures | Feasibility – Number of Participants Recruited, The feasibility of recruiting endometrial cancer survivors to a home-based resistance training; 2 sessions per week of 20-40 minutes of exercise. This will be measured by the number of participants recruited. The goal is 40 participants., up to 2 years|Number of Participants Who Completed 100% of the Prescribed Exercises, Compliance/adherence will be measured via detailed exercise logs. A participant needs to complete at least 50% of the prescribed exercises in a session to be considered adherent to the session., up to 20 weeks from beginning of intervention|Number of Participants With Adverse Events, The primary safety endpoint will be total number of adverse events over the duration of the intervention., up to 20 weeks | Number of Participants Reporting “Very” or “Extremely” Satisfied With Intervention, Participants will complete semi-structured qualitative interviews with the study coordinator. Interviews will be recorded, transcribed and coded to identify content themes. These interviews will be used to collect qualitative information and overall satisfaction with the intervention, as well as areas to improve with future interventions and barriers to participation., At final visit – up to 20 weeks|Change in Hemoglobin A1c From Baseline, Baseline and post-study blood biomarkers to assess Hemoglobin A1c will be collected and reported in a table as a change from baseline., baseline and 10 weeks|Change in C-Reactive Protein From Baseline, Baseline and post-study blood biomarkers to assess c-reactive protein will be collected and reported in a table as a change from baseline., baseline and 10 weeks|Change in Lean Muscle Mass From Baseline, Baseline and post-study lean muscle mass will be assessed using dual-energy absorptiometry (DXA) using the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline., baseline and 10 weeks|Change in Fat Mass From Baseline, Baseline and post-study fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline., baseline and 10 weeks|Change in Visceral Fat Mass From Baseline, Baseline and post-study visceral fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline., up to 20 weeks|Change in Total Percent Body Fat From Baseline, Baseline and post-study % body fat will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline., baseline and 10 weeks|Change in Number of Arm Curls Performed From Baseline, Arm curls are part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. These tests will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 30 second arm curl assesses the strength of the upper body, where participants hold a 5 pound dumbbell in a seated position, and they will have 30 seconds to curl their arm and extend it as many times as possible within the time frame., baseline and 10 weeks|Change in Number of Sit to Stand Repetitions Performed From Baseline, The 30 second chair stand is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 30 second chair stand assesses the strength of the lower body. Each person will have 30 seconds to stand up and sit down from a chair as many times as possible within the time frame., baseline and 10 weeks|Change in Handgrip Weight From Baseline, Handgrip is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. \[can you describe this test? I do not see it in the protocol\], baseline and 10 weeks|Change in Sit and Reach Distance From Baseline, The chair sit and reach test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The chair sit and reach assesses lower body flexibility where the participant will sit in a chair, extend one leg in front of them and flex at the waist, reaching toward their toes, the measure is the distance between their toes and fingers., baseline and 10 weeks|Change in Back Scratch Distance From Baseline, The back scratch test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The back scratch test assesses the upper body flexibility, where the person is seated and one arm will be flexed behind the head, and the other arm will be extended behind the shoulder. The assessment measures the distance between the finger tips of both hands., baseline and 10 weeks|Change in 6-minute Walk Distance From Baseline, The 6-minute walk test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 6 minute walk test measures the total distance that a person can quickly walk on a flat hard surface within a period of 6 minutes, using a 100ft length of distance., baseline and 10 weeks|Change in 8 Foot Up and Go Time From Baseline, The 8-foot-up and go test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 8-foot-up and go is an assessment of speed agility and balance. The participant begins in a seated position and will be timed for the duration it takes to rise from the chair, walk as quickly as possible around a cone 8 feet away from the chair, and return to a seated position., baseline and 10 weeks|FACT Scores, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such., baseline, 5 weeks, 10 weeks|Changes in FACT From Baseline, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such., baseline and 10 weeks|FACT-En Scores, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements., baseline, 5 Weeks,10 weeks|Changes in FACT-En From Baseline, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements., baseline and 10 weeks|FACT Physical Subscale Scores, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements., baseline, 5 weeks, 10 weeks|FACT Social Subscale Scores, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements., baseline, 5 weeks, 10 weeks|FACT Emotional Subscale Scores, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements., baseline, 5 weeks, 10 weeks|FACT Functional Subscale Scores, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements., baseline, 5 weeks, 10 weeks|Changes in FACT Subscales From Baseline, Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements., baseline and 10 weeks|Changes in Mental Well-being From Baseline, Changes in mental well-being from baseline, mid-point, and post-study (including anxiety, depression, and fatigue) will be assessed using standardized NIH-provided Patient-Reported Outcome Measurement Information System (PROMIS) measures. The fatigue assessment asks about self-reported systems of fatigue and tiredness, all the way up to exhaustion overall, and ask about fatigue over the past seven days. The depression assessment asks about depressive symptoms over the past seven days. The anxiety assessment asks about symptoms adjacent-to and including anxiety over the past seven days. For each of these three instruments (which comprise the mental well-being assessments) the data will be reported as change over time, specifically using the T-score (standardized mean) and the standard error. Each is standardized to a mean of 50 and a range of 0-100; a higher scores indicate a higher “level” of that construct, whether it’s higher levels of depression, fatigue or anxiety., baseline and Week 10|Changes in Self-Efficacy From Baseline, Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training. This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time., Baseline and 10 weeks|Self-Efficacy Scores, Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training. This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time., Baseline, 5 weeks, 10 weeks|Changes in Accelerometer-Measured Physical Activity From Baseline, Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period. Light intensity is Moderate intensity is Vigorous intensity is, baseline and Week 10|Change in Steps Per Day From Baseline, Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period., baseline and Week 10 | University of Wisconsin, Madison | National Cancer Institute (NCI)|American Cancer Society, Inc. | FEMALE | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | UW18013|P30CA014520|NCI-2018-02257|2018-0953|1R03CA230965-01A1|A176000|EDUC/KINESIOLOGY | 2018-12-05 | 2020-03-14 | 2020-03-14 | 2018-10-26 | 2020-08-11 | 2021-08-13 | University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, 53706, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/30/NCT03722030/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/30/NCT03722030/ICF_001.pdf | ||
| NCT03717935 | Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS | https://clinicaltrials.gov/study/NCT03717935 | ORANGE | The Investigators will measure hepatic glucose and fat metabolism in obese girls with Polycystic Ovarian Syndrome (PCOS) and hepatic steatosis (HS) after taking 4 weeks of an essential amino acid (EAA) supplement or placebo and test whether the EAA supplement can improve hepatic glucose metabolism in these girls. | NO | Polycystic Ovarian Syndrome|Obesity|Hepatic Steatosis | DIETARY_SUPPLEMENT: Essential Amino Acid (EAA) Supplement|OTHER: Placebo | Change in Hepatic Fat Fraction, Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%., 4 weeks after completing the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention) | Change in Rate of De Novo Lipogenesis, Change from baseline of the rate of overnight de novo lipogenesis will be measured utilizing stable isotope methods with deuterated water, and expressed as the rate of newly synthesized lipids in the serum triglyceride fraction., 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Evaluation of Mitochondrial function via change in ratios of direct to indirect hepatic carbon flux in newly synthesized triglycerides, OSTT with UC13 glycerol after each intervention, 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change in the hepatic phosphate profile, hepatic phosphate profile via 31 Phosphorus MR spectroscopy after each intervention, 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change in Whole Body Insulin Sensitivity, Participants will undergo a 75 gram oral glucose tolerance test, and the change from baseline in whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model., 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change in Adipose Insulin Sensitivity, Change from baseline of adipose insulin sensitivity will be calculated as the percent suppression of free fatty acids during the oral glucose tolerance test., 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change in Sleep duration, Sleep duration will be assessed after each intervention using home actigraphy, 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change in Apnea Hypopnea Index (AHI), Apnea Hypopnea Index (AHI) will be measured using WatchPAT after each intervention. In children and adolescents the scale that will be used is AHI\>5 is considered mild sleep apnea. The higher the AHI, indicates more severe sleep apnea., 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change in Amino Acid Metabolomics: glutamate, valine, leucine, alanine, Targeted amino acid metabolomics will be performed after each intervention, 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change in Lipid Metabolomics: 16n1, Targeted lipid metabolomics will be performed after each intervention to look at changes in lipid profiles, 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention)|Change Bile Acid Metabolomics: sphingosine-1-phospate, Targeted bile acid metabolomics will be performed after each intervention, 4 weeks after the first intervention, and approximately 8 weeks later (4 weeks washout and 4 weeks of second intervention) | University of Colorado, Denver | FEMALE | CHILD, ADULT | NA | 27 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 18-0803 | 2018-10-08 | 2022-01-14 | 2022-01-14 | 2018-10-24 | 2022-03-08 | University of Colorado, Anschutz Medical Campus, Aurora, Colorado, 80045, United States | ||||
| NCT03712813 | Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT03712813 | The purpose of this study is to compare the effect of low intensity vibration (LIV) delivered for 10 minutes twice daily for 12 months on skeletal muscle function, in terms of energetic capacity measured by power generation on a stationary bicycle, among patients with early stage breast cancer planned to initiate aromatase inhibitor therapy who do not currently participate in regular exercise, compared to a wait- listed control. | NO | Breast Cancer | DEVICE: Macrodyne LivMD plate | Mean change in energetic capacity measured by peak power generation on a stationary bicycle, Peak power will be measured using the Power Protocol-B, Baseline, 6 months, and 12 months | Change in muscle contractile properties including peak power, fatigue resistance, and time to recovery measured by isokinetic knee extension, A Biodex 4 system will be used to measure each subject’s muscle contractile properties, Baseline, 6 months, and 12 months|Change in lean body mass, Lean mass, total adiposity measured by DXA scan, Baseline, 6 months, and 12 months|Change in bone mineral density of the lumbar spine by T score, Bone mineral density (T score) measured by DXA scan, Baseline, 6 months, and 12 months|Change in trabecular and cortical volumetric bone mineral density, By high resolution peripheral quantitative CT of the distal and diaphyseal tibia and radius, Baseline and 12 months|Change in serologic bone markers of bone turnover (TGF-beta and NTX) by quantitative measurements using ELISA, TGF-beta and NTX by quantitative measurements using ELISA, Baseline and 12 months|Patient reported fatigue measured by the Basic Fatigue Inventory score, Average of all 9 items ranging in a score of 0-10 (total possible score of 11) scores range from 1( no fatigue/does not interfere) to 10 (as bad as you can imagine/completely interferes), Baseline, 6 months, and 12 months|Patient reported aching muscles and joint pain measured by NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events score, Average of 2 scale items for aching muscles and joint pain on a 5-point Likert scale (ranging in severity) with a total possible score of 5 (i.e. very severe/ almost constantly), Baseline, 6 months, and 12 months|Feasibility of low intensity vibration defined by patient compliance, Patients will be asked by the study nurse how they are doing with their LIV therapy, Once monthly from Baseline to 12 months | Indiana University | ALL | ADULT, OLDER_ADULT | NA | 72 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IUSCC-0680 | 2019-10-02 | 2026-03 | 2026-03 | 2018-10-19 | 2024-09-19 | Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States | |||||
| NCT03697577 | CDK and Body Composition Study | https://clinicaltrials.gov/study/NCT03697577 | The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib). | NO | Breast Cancer | DIAGNOSTIC_TEST: CT scans|DIAGNOSTIC_TEST: DEXA scan | Total adipose tissue (TAT), Total Adipose tissue (TAT) is defined as the sum of intramuscular adipose tissue (IMAT), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) obtained from L3 cross section from CT scans., Baseline and 6 months after CDK 4/6 inhibitor therapy | Body Fat Mass (BFM) using Dual-energy X-ray Absorptiometry (DEXA), Body Fat Mass will be obtained from dual-energy x-ray absorptiometry (DEXA). The DEXA scan calculates the ratio of soft tissue attenuation at different X-ray energies. Results are measured and reported in kilograms (kg). DEXA will be performed only if available., Baseline and 6 months after CDK 4/6 inhibitor therapy|Body Lean Mass (BLM) using Dual-energy X-ray Absorptiometry (DEXA), Body Lean Mass (BLM) will be obtained from dual-energy x-ray absorptiometry (DEXA). The DEXA scan calculates the ratio of soft tissue attenuation at different X-ray energies. Results are measured and reported in kilograms (kg). DEXA will be performed only if available., Baseline and 6 months after CDK 4/6 inhibitor therapy|Skeletal muscle index (SMI), Skeletal muscle index (SMI) will be obtained by dual-energy x-ray absorptiometry (DEXA). The DEXA scan will be used to measure the amount of lean muscle in the body. SMI is defined as muscle area at L3 cross section from CT scans in cm\^2 divided by height in meters squared. DEXA will be performed only if available., Baseline and 6 months after CDK 4/6 inhibitor therapy|Adipose Serum Biomarkers – Fasting Glucose, Fasting glucose levels in blood sera will be measured using a glucose blood sugar test. Normal ranges vary based on the health of the individual however standard glucose concentrations are between 70 mg/dL (3.9 mmol/L) -100 mg/dL (5.6 mmol/L). Glucose levels between 100-125 mg/dL (5.6-6.9 mmol/L) may be indicative of prediabetes. Fasting glucose levels \>126 mg/dL on successive tests is correlated with diabetes. Results will be summarized and reported., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy|Adipose Serum Biomarkers – Lipid Panel (Total Cholesterol and LDL cholesterol, HDL cholesterol, and Triglycerides), A lipid panel will be used to assess Total cholesterol, LDL Cholesterol, HDL Cholesterol, and triglyceride levels in blood sera samples. Each parameter has unique ranges and can vary by age, weight, and sex; however, High concentrations of Total cholesterol and LDL cholesterol increases the risk of coronary heart disease and atherosclerosis. HDL cholesterol (“good cholesterol”) removes excess cholesterol from the body. High triglyceride levels also increase the risk of cardiovascular disease. Results for each parameter will be summarized and reported in mg/dL., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy|Adipose Serum Biomarkers – Dehydroepiandrosterone Sulphate (DHEAS), DHEAS levels in blood sera will be measured using a DHEA-sulfate (DHEAS) blood test. This test can be used to check the function of the adrenal glands. Normal ranges vary based on age, gender and laboratory; however, high concentrations could be indicative of adrenal tumors, Cushing’s disease, polycystic ovary syndrome (PCOS), or adrenal hyperplasia. Results will be summarized and reported in ug/dL., Baseline and 3 months and 6 months after CDK 4/6 therapy|Adipose Serum Biomarkers – Insulin, Insulin levels in blood sera will be measured using an insulin blood test. Insulin is a hormone that regulates glucose absorption. Normal ranges vary based on the type of test administered and the health of the individual; however, standard fasting insulin concentrations are usually \<25 mIU/L. Higher concentrations can be indicative of insulin resistance. Results will be summarized and reported., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy|Adipose Serum Biomarkers - Leptin, Leptin will be assessed using a leptin blood test that measures the concentration of leptin in blood sera. Leptin is a hormone that helps regulate appetite and energy levels. Standard ranges vary based on age, gender, body mass index, and other variables; however, ranges are generally between 0.5-15.2 ng/mL for females and 0.5-12.5 ng/mL for males. Results will be summarized and reported., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy|Adipose Serum Biomarkers - Free Leptin Index (FLI), FLI will be assessed by blood test and calculated as the ratio of total leptin and soluble leptin receptor (sOB-R) concentrations. FLI is a biomarker of leptin resistance and the status of leptin action. High FLI is a risk factor for obesity and is associated with several chronic diseases. Results will be summarized and reported., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy|Adipose Serum Biomarkers - Adiponectin, Adiponectin will be assessed using an adiponectin test that measures the concentration of adiponectin in the blood. Adiponectin is a protein hormone produced by fat cells that helps regulate blood sugar and fat metabolism. Lower levels of adiponectin in blood sera are often linked to conditions like obesity, type 2 diabetes, and heart disease. A normal adiponectin blood test result is generally 5-30 ug/mL but can vary depending on age and body mass index (BMI). Results will be summarized and reported., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy|Adipose Serum Biomarkers - High-sensitivity C-reactive protein (hsCRP), hsCRP will be measured and reported by blood test. hsCRP measures the concentration of C-reactive protein (CRP) in blood. CRP is a protein that increases in response to inflammation and is correlated with adverse cardiovascular and cerebrovascular outcomes. Normal results are generally risk stratified with concentrations \<1.0 mg/dL indicating a low risk of cardiovascular disease; concentrations between 1.0-3.0 mg/dL indicating an average risk of cardiovascular disease; and concentrations \>3.0 mg/dL indicating a high risk of cardiovascular disease. Results will be summarized and reported., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy|Body Fat Mass (BFM) using Bioimpedance spectroscopy (BIS), BFM will be measured with the use of bioimpedance spectroscopy (BIS). BIS is a non-invasive method that takes measurements at 256 different frequencies and uses mathematical modeling to calculate electrical resistance throughout the body. Fat tissue has significantly higher resistance compared to lean muscle tissue. The total weight of body fat estimated by the BIS analysis will be expressed in kilograms and summarized for the group., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy, and every 3 months thereafter up to 24 months|Body Fat-Free Mass (FFM), FFM will be derived based on the BFM readout obtained from the BIS analysis. The “fat-free mass” will be calculated by subtracting the total body weight minus the estimated BFM obtained by BIS analysis, based on electrical resistance through the body. This result will be expressed in kilograms and summarized for the group., Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy, and every 3 months thereafter up to 24 months|Anthropometric measurements – Body Mass Index (BMI), BMI will be determined by obtaining height and body weight measurements. It is calculated by dividing body weight in kilograms (kg) by height in meters squared (m\^2). A BMI of 30 kg/m\^2 or higher has been used to define obesity in most reports, including those showing an association between obesity and increased risk of cancers, cancer mortality, and mortality from all causes. Group results will be summarized and reported., Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months|Anthropometric measurements – Skin fold thickness (biceps, triceps, subscapular, and suprailiac), Skin fold thickness will be measured with the use of calipers. Skin fold thickness measurements will be obtained for the biceps, triceps, subscapular, and suprailiac sites. Calipers will be used to pinch the skin and lift it away from the muscle at each site and measure the thickness of skin folds at each location. Values will be summarized in millimeters (mm) for the group and reported. Skin fold thickness measurements provide an overall picture of subcutaneous fat distribution., Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months|Anthropometric measurements – Abdominal circumference, Abdominal circumference is a measurement of the horizontal distance around the abdomen. Abdominal circumference will be assessed by determining the midpoint between the lower rib margin and the iliac crest and measuring the circumference at the midpoint, in centimeters, with measuring tape while breathing normally. Group results will be summarized. An enlarged abdominal circumference can be a sign of obesity and a risk factor for disease., Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months|Anthropometric measurements – Waist-to-hip ratio, Waist-to-hip ratio will be measured with measuring tape by measuring the narrowest part of the waist followed by the widest part of the hips and dividing the waist measurement by the hip measurement. While normal values can vary, a healthy waist-to-hip ratio is generally considered to be below 0.9 for men and 0.85 for women, according to the World Health Organization (WHO). Group results will be summarized., Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months | Montefiore Medical Center | ALL | ADULT, OLDER_ADULT | 30 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2018-9567 | 2019-01-08 | 2026-12 | 2026-12 | 2018-10-05 | 2025-01-17 | Montefiore Medical Center, Bronx, New York, 10461, United States | ||||||
| NCT03694834 | Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer | https://clinicaltrials.gov/study/NCT03694834 | Programmed cell death 1 (PD-1) inhibitor treatment may benefit patients with endometrial cancer (EC) based on the following observations: 1) an overwhelming presence of PD-1 in ECs; 2) the well-known effect of obesity which activates pro-inflammatory white blood cells and promotes the development of ECs; and 3) the high prevalence of a specific gene pattern (ie, microsatellite instability hypermutated \[MSI high\]) among ECs that may be particularly sensitive to this class of drugs. To identify potential biomarkers of response to PD-1 inhibitors in EC, we will conduct a window of opportunity study of pembrolizumab in 20 patients with clinical stage 1, grade 3 EC, encompassing endometrioid, serous and clear cell histologies. Eligible patients will undergo a research biopsy for collection of fresh tissue at the time of enrollment, in addition to the routinely performed endometrial biopsy that led to the diagnosis of their cancer. Patients will receive a single dose of pembrolizumab (200 mg IV) prior to undergoing their scheduled hysterectomy with surgical staging three weeks later. As per standard of care, adjuvant chemotherapy with paclitaxel and carboplatin will be recommended after hysterectomy/surgical staging for women with endometrioid tumors and stage III disease or women with serous/clear cell tumors at all stages of disease. However, in this study pembrolizumab will be added to adjuvant paclitaxel and carboplatin for EC. Pre-treatment endometrial biopsy specimens (fresh frozen tissue and formalin-fixed paraffin embedded (FFPE)) and a post-treatment hysterectomy specimen (fresh frozen tissue and FFPE) will be collected for translational studies. Blood, fecal and vaginal samples will be collected pre-treatment, at the time of surgery and following 3 cycles of adjuvant pembrolizumab/paclitaxel/carboplatin treatment. | NO | Endometrial Cancer|Uterine Cancer | DRUG: Pembrolizumab|PROCEDURE: Hysterectomy | Change in the number of Tumor Infiltrating Lymphocytes, Change in number of tumor-infiltrating lymphocytes in response to single dose of pembrolizumab will be determined by performing histopathologic analysis of H\&E-stained tumor sections collected at baseline and at the time of surgery., 3 weeks | Number of patients who experience Adverse Events after one dose of Pembrolizumab, The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE., 3 weeks|Change in number of Tumor Infiltrating Lymphocytes by endometrial cancer sub-types, Count and compare associations of (1) pre-treatment Tumor Infiltrating Lymphocyte (TIL) numbers (2) clonality of TILs and (3) change in number and phenotype of TILs with pembrolizumab treatment between Microsatellite Instability (MSI) and DNA Polymerase ε Endometrial Cancers (EC) versus MSI low/stable ECs versus Copy Number High ECs., 3 weeks|Correlation of Programmed Cell Death-1 (PD-1) Expression with TILs, Compare possible associations of PD-1, Programmed Death Ligand 1 (PD-L1) and Programmed Death Ligand 2 (PD-L2) messenger Ribonucleic Acid (mRNA) expression with (1) pre-treatment TIL numbers (2) clonality of TILs and (3) change in number and phenotype of TILs., 3 weeks|Correlation of Immune and Obesity/Inflammation EC Signatures with TILs, Compare possible associations of immune and obesity/inflammation EC signatures with (1) Body Mass Index (BMI) (2) pre-treatment TIL numbers (3) clonality of TILs and (4) change in number and phenotype of TILs., 3 weeks|Correlation of Microbiota Profiles with TILs, Compare possible associations of gut, vaginal and uterine microbiota profiles with (1) BMI (2) pre-treatment TIL numbers (3) clonality of TILs and (4) change in number and phenotype of TILs., 3 weeks|Overall Response Rate of Pembrolizumab with Paclitaxel and Carboplatin, Calculate the overall response rate of pembrolizumab in combination with paclitaxel and carboplatin following hysterectomy and surgical staging in (1) stage I/II, serous/clear cell EC and (2) stage III, Grade 3 (serous, clear cell or endometrioid histologies) EC. Response is measured as: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis \<10mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters., 3 weeks | UNC Lineberger Comprehensive Cancer Center | Merck Sharp & Dohme LLC | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 3 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | LCCC 1739 | 2019-03-29 | 2023-10-23 | 2023-10-23 | 2018-10-03 | 2023-11-28 | Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States | ||||
| NCT03677362 | Weight Loss Intervention in Women With PCOS | https://clinicaltrials.gov/study/NCT03677362 | The proposed single arm 6 mo. trial will assess the impact of weight loss and fat loss due to a multicomponent remotely-delivered lifestyle intervention on ovulation rates and time-to-ovulation in overweight and obese women with anovulatory infertility caused by PCOS. | NO | Polycystic Ovary Syndrome|Overweight and Obesity | BEHAVIORAL: Weight loss intervention | Ovulation, Ovulation will be assessed weekly during the 6 mo. intervention by ovulation monitoring kit and the OvuSense device., 6 months | Fertility related quality of life, The fertility quality of life (FertiQoL) tool (questionnaire), Baseline and 6 months|Body composition, A dual energy x-ray absorptiometry scan will determine percent body fat., Baseline and 6 months | University of Kansas Medical Center | FEMALE | ADULT | NA | 12 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 142744 | 2018-09-10 | 2020-02-22 | 2020-02-22 | 2018-09-19 | 2020-09-01 | University of Kansas Medical Center, Kansas City, Kansas, 66160, United States | |||||
| NCT03655223 | Early Check: Expanded Screening in Newborns | https://clinicaltrials.gov/study/NCT03655223 | Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health conditions in addition to providing important data on the implementation of this model program. Early diagnosis may result in health and development benefits for the newborns. Infants who have newborn screening in North Carolina will be eligible to participate, equating to over 120,000 eligible infants a year. Over 95% of participants are expected to screen negative. Newborns who screen positive and their parents are invited to additional research activities and services. Parents can enroll eligible newborns on the Early Check electronic Research Portal. Screening tests are conducted on residual blood from existing newborn screening dried blood spots. Confirmatory testing is provided free-of-charge for infants who screen positive, and carrier testing is provided to mothers of infants with fragile X. Affected newborns have a physical and developmental evaluation. Their parents have genetic counseling and are invited to participate in surveys and interviews. Ongoing evaluation of the program includes additional parent interviews. | NO | Spinal Muscular Atrophy|Fragile X Syndrome|Fragile X – Premutation|Duchenne Muscular Dystrophy|Hyperinsulinemic Hypoglycemia, Familial 1|Diabetes Mellitus|Adrenoleukodystrophy, Neonatal|Medium-chain Acyl-CoA Dehydrogenase Deficiency|Very Long Chain Acyl Coa Dehydrogenase Deficiency|Beta-ketothiolase Deficiency|Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency|Primary Hyperoxaluria Type 1|Congenital Bile Acid Synthesis Defect Type 2|Pyridoxine-Dependent Epilepsy|Hereditary Fructose Intolerance|Hypophosphatasia|Hyperargininemia|Mucopolysaccharidosis Type 6|Argininosuccinic Aciduria|Citrullinemia, Type I|Wilson Disease|Maple Syrup Urine Disease, Type 1A|Maple Syrup Urine Disease, Type 1B|Biotinidase Deficiency|Neonatal Severe Primary Hyperparathyroidism|Intrinsic Factor Deficiency|Usher Syndrome Type 1D/F Digenic (Diagnosis)|Cystic Fibrosis|Stickler Syndrome Type 2|Stickler Syndrome Type 1|Alport Syndrome, Autosomal Recessive|Alport Syndrome, X-Linked|Carbamoyl Phosphate Synthetase I Deficiency Disease|Carnitine Palmitoyl Transferase 1A Deficiency|Carnitine Palmitoyltransferase II Deficiency|Cystinosis|Chronic Granulomatous Disease|Cerebrotendinous Xanthomatoses|Maple Syrup Urine Disease, Type 2|Severe Combined Immunodeficiency Due to DCLRE1C Deficiency|Thyroid Dyshormonogenesis 6|Thyroid Dyshormonogenesis 5|Supravalvar Aortic Stenosis|Factor X Deficiency|Hemophilia A|Hemophilia B|Tyrosinemia, Type I|Fructose 1,6 Bisphosphatase Deficiency|Glycogen Storage Disease Type I|G6PD Deficiency|Glycogen Storage Disease II|Galactokinase Deficiency|Mucopolysaccharidosis Type IV A|Galactosemias|Guanidinoacetate Methyltransferase Deficiency|Agat Deficiency|Glutaryl-CoA Dehydrogenase Deficiency|Gtp Cyclohydrolase I Deficiency|Hyperinsulinism-Hyperammonemia Syndrome|Primary Hyperoxaluria Type 2|3-Hydroxyacyl-CoA Dehydrogenase Deficiency|Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency|Mitochondrial Trifunctional Protein Deficiency|Sickle Cell Disease|Beta-Thalassemia|Holocarboxylase Synthetase Deficiency|3-Hydroxy-3-Methylglutaric Aciduria|Primary Hyperoxaluria Type 3|Hermansky-Pudlak Syndrome 1|Hermansky-Pudlak Syndrome 4|Apparent Mineralocorticoid Excess|HSDB|CBAS1|Mucopolysaccharidosis Type 2|Mucopolysaccharidosis Type 1|Severe Combined Immunodeficiency, X Linked|Severe Combined Immunodeficiency Due to IL-7Ralpha Deficiency|Diabetes Mellitus, Permanent Neonatal|Isovaleric Acidemia|Severe Combined Immunodeficiency T-Cell Negative B-Cell Positive Due to Janus Kinase-3 Deficiency (Disorder)|Jervell and Lange-Nielsen Syndrome 2|Hyperinsulinemic Hypoglycemia, Familial, 2|Diabetes Mellitus, Permanent Neonatal, With Neurologic Features|Jervell and Lange-Nielsen Syndrome 1|Lysosomal Acid Lipase Deficiency|CblF|3-Methylcrotonyl CoA Carboxylase 1 Deficiency|3-Methylcrotonyl CoA Carboxylase 2 Deficiency|Waardenburg Syndrome Type 2A|Methylmalonic Aciduria cblA Type|Methylmalonic Aciduria cblB Type|Methylmalonic Aciduria and Homocystinuria Type cblC|MAHCD|Methylmalonic Aciduria Due to Methylmalonyl-CoA Mutase Deficiency|Congenital Disorder of Glycosylation Type 1B|Mthfr Deficiency|Methylcobalamin Deficiency Type Cbl G (Disorder)|Methylcobalamin Deficiency Type cblE|Usher Syndrome, Type 1B|N-acetylglutamate Synthase Deficiency|Ornithine Transcarbamylase Deficiency|Phenylketonurias|Waardenburg Syndrome Type 1|Congenital Hypothyroidism|Propionic Acidemia|Usher Syndrome, Type 1F|Pancreatic Agenesis 1|Hereditary Hypophosphatemic Rickets|Glycogen Storage Disease IXB|Glycogen Storage Disease IXC|MOWS|Epilepsy, Early-Onset, Vitamin B6-Dependent|Pyridoxal Phosphate-Responsive Seizures|Pituitary Hormone Deficiency, Combined, 1|Ptsd|Dihydropteridine Reductase Deficiency|Severe Combined Immunodeficiency Due to RAG1 Deficiency|Severe Combined Immunodeficiency Due to RAG2 Deficiency|Retinoblastoma|Multiple Endocrine Neoplasia Type 2B|Pseudohypoaldosteronism, Type I|Liddle Syndrome|Biotin-Responsive Basal Ganglia Disease|SCD|DIAR1|GSD1C|Acrodermatitis Enteropathica|Thyroid Dyshormonogenesis 1|Riboflavin Transporter Deficiency|Waardenburg Syndrome, Type 2E|SRD|Congenital Lipoid Adrenal Hyperplasia Due to STAR Deficiency|Barth Syndrome|Adrenocorticotropic Hormone Deficiency|Transcobalamin II Deficiency|Thyroid Dyshormonogenesis 3|Segawa Syndrome, Autosomal Recessive|Autosomal Recessive Nonsyndromic Hearing Loss|Thyroid Dyshormonogenesis 2A|Congenital Isolated Thyroid Stimulating Hormone Deficiency|Hypothyroidism Due to TSH Receptor Mutations|Usher Syndrome Type 1C|Usher Syndrome Type 1G (Diagnosis)|Von Willebrand Disease, Type 3|Combined Immunodeficiency Due to ZAP70 Deficiency|Adenine Phosphoribosyltransferase Deficiency|Metachromatic Leukodystrophy|Canavan Disease|Menkes Disease|Carbonic Anhydrase VA Deficiency|Developmental and Epileptic Encephalopathy 2|17 Alpha-Hydroxylase Deficiency|Smith-Lemli-Opitz Syndrome|Krabbe Disease|Glutathione Synthetase Deficiency|Mucopolysaccharidosis Type 7|Rett Syndrome|Molybdenum Cofactor Deficiency, Type A|Niemann-Pick Disease, Type C1|Niemann-Pick Disease Type C2|Ornithine Aminotransferase Deficiency|3-Phosphoglycerate Dehydrogenase Deficiency|Leber Congenital Amaurosis 2|Dravet Syndrome|Mucopolysaccharidosis Type 3 A|Ornithine Translocase Deficiency|Carnitine-acylcarnitine Translocase Deficiency|Glucose Transporter Type 1 Deficiency Syndrome|Creatine Transporter Deficiency|Niemann-Pick Disease Type A|Pitt Hopkins Syndrome|Tuberous Sclerosis 1|Tuberous Sclerosis 2|Ataxia With Isolated Vitamin E Deficiency|Angelman Syndrome|Prader-Willi Syndrome|Homocystinuria|Permanent Neonatal Diabetes Mellitus|Transient Neonatal Diabetes Mellitus|Factor VII Deficiency|Glycogen Storage Disease Type IXA1|Glycogen Storage Disease, Type IXA2|Glycogen Storage Disease IC|Glycogen Storage Disease Type IB|Central Hypoventilation Syndrome With or Without Hirschsprung Disease | DIAGNOSTIC_TEST: Confirmatory Testing | Incidence Rates: Number of newborns who screen positive comparative to the whole sample, Incidence rates of infants who screen positive for conditions on the Early Check panel., Every 6 months for approximately three years | Impact of Screening: Semi-structured parent interviews., Each project year, we will recruit mothers whose newborns screen negative and mothers whose newborns screen positive to participate in an approximately 30-minute, semi-structured telephone interview about their perceptions of Early Check and the impact of screening results., Measured within 6 months of participant screening results | RTI International | University of North Carolina, Chapel Hill|The John Merck Fund|Duke University|Wake Forest University|North Carolina Department of Health and Human Services|National Center for Advancing Translational Sciences (NCATS)|Cure SMA|The National Fragile X Foundation|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Asuragen, Inc.|Sarepta Therapeutics, Inc.|Muscular Dystrophy Association|The Leona M. and Harry B. Helmsley Charitable Trust|Juvenile Diabetes Research Foundation|Janssen Pharmaceuticals|GeneDx|Illumina, Inc. | ALL | CHILD | 30000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 18-0009|U01TR001792-01|HHSN27500003 | 2018-10-15 | 2024-11-30 | 2025-12-31 | 2018-08-31 | 2024-03-27 | RTI International, Research Triangle Park, North Carolina, 27709, United States | |||||
| NCT03644524 | Heat Therapy and Cardiometabolic Health in Obese Women | https://clinicaltrials.gov/study/NCT03644524 | CMH | Traditional medical treatments are often based on research done exclusively in males, and recent research efforts in the physiology community have highlighted critical sex differences in disease presentation and progression. For example, the relative risk of fatal heart disease is 50% greater in obese, diabetic women as compared to their male counterparts, and women appear to respond differently to lifestyle interventions such as exercise compared with men. Chronic passive heat exposure (hot tub use) provides alternative or supplemental therapeutic potential for improving cardiovascular and metabolic health in obese women. In addition, passive heat exposure may offer specific cellular protection from stresses like a lack of blood flow (ischemia), which is the primary cause of fatal coronary heart disease. This study is investigating the possible cardiovascular and metabolic health benefits of chronic passive heat exposure, and whether regular hot tub use (3-4 days per week for 8-10 weeks) may reduce obese womens’ cardiometabolic risk. The investigators are examining cardiovascular health through blood pressure, blood vessel stiffness, sympathetic (‘fight or flight’) activity, and responsiveness to stresses like increased or decreased blood flow. The investigators are also examining metabolic health through an oral glucose tolerance test and a subcutaneous fat biopsy. The goal of this research is to develop a therapy targeted toward the specific health needs and complications of obese women, in an effort to improve cardiovascular and metabolic health and provide therapeutic alternatives in this high-risk population. | NO | Obesity|Polycystic Ovary Syndrome|Prehypertension|PreDiabetes|Cardiovascular Risk Factor|Metabolic Syndrome | BEHAVIORAL: Heat therapy | systolic blood pressure, Resting supine blood pressure, measured in triplicate with median recorded, through study completion, an average of 10 weeks|diastolic blood pressure, Resting supine blood pressure, measured in triplicate with median recorded, through study completion, an average of 10 weeks|oral glucose tolerance test, glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast, through study completion, an average of 10 weeks | muscle sympathetic nerve activity burst frequency, recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute, through study completion, an average of 10 weeks|arterial wall thickness (carotid), intimal thickness of common carotid artery assessed using doppler ultrasonography, through study completion, an average of 10 weeks|arterial wall thickness (femoral), intimal thickness of superficial femoral artery assessed using doppler ultrasonography, through study completion, an average of 10 weeks|dynamic arterial compliance (carotid), arterial compliance of common carotid artery measured using ultrasonography, through study completion, an average of 10 weeks|dynamic arterial compliance (femoral), arterial compliance of superficial femoral artery measured using ultrasonography, through study completion, an average of 10 weeks|flow mediated dilation, flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function., through study completion, an average of 10 weeks|flow mediated dilation after ischemia-reperfusion, flow-mediated dilation of brachial artery, expressed as % change in diameter, following 20 minute ischemia-20 minute reperfusion. A measure of vascular tolerance to ischemia-reperfusion stress., through study completion, an average of 10 weeks|Abdominal subcutaneous fat biopsy, Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression, through study completion, an average of 10 weeks | C-reactive protein, serum measurement of high-sensitivity C-reactive protein, global inflammatory marker, through study completion, an average of 10 weeks|Cholesterol panel, serum measurement of cholesterol, through study completion, an average of 10 weeks | University of Oregon | American Heart Association | FEMALE | ADULT | NA | 20 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 08282015.026 | 2015-09-08 | 2018-04-30 | 2018-07-01 | 2018-08-23 | 2018-08-23 | University of Oregon, Eugene, Oregon, 97403, United States | ||
| NCT03600909 | A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia | https://clinicaltrials.gov/study/NCT03600909 | The goal of this study is to see if the study therapy can decrease the chemotherapy-related side effects while maximizing the effectiveness of disease control. The physicians will also be studying the effect of removing T-cells from the donor”s stem cells before transplant. T-cells are a type of white blood cell that may help cause a serious side effect of transplant called Graft versus Host Disease (GVHD). The way it removes the T-cells from the donor stem cells is actually by selecting only the stem cells (called CD34 cells) by using a device called CliniMACS. This process is called CD34 selection. The CliniMACS® device is currently under the supervision of the FDA . | YES | Fanconi Anemia|Myelodysplastic Syndrome (MDS)|Acute Myelogenous Leukemia (AML) | DRUG: Busulfan|DRUG: Fludarabine|DRUG: Cyclophosphamide|DRUG: Anti-Thymocyte Globulin (Rabbit)|DEVICE: The CliniMACS device|DRUG: G-CSF | Graft Failure or Rejection, Primary non-engraftment is diagnosed when the patient fails to achieve an ANC ≥500/µl at any time in the first 28 days post-transplant. If (1) after achievement of an ANC ≥500/mm\^3, the ANC declines to \<500/mm\^3 for more than 3 consecutive days in the absence of relapse, or, (2) there is absence of donor cells in the marrow and/or blood as demonstrated by chimerism assay in the absence of relapse, a diagnosis of secondary graft failure is made. The patient is not evaluable for graft failure or rejection if recurrence of host MDS is detected concurrently., 5 years | Memorial Sloan Kettering Cancer Center | Pediatric Brain Tumor Consortium | ALL | CHILD, ADULT, OLDER_ADULT | PHASE2 | 3 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 17-498 | 2018-05-15 | 2021-04-09 | 2021-04-09 | 2018-07-26 | 2022-04-12 | 2022-04-12 | Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/09/NCT03600909/Prot_SAP_000.pdf | |||
| NCT03575624 | Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT03575624 | The purpose of this project was to test the efficacy of partnering with a community-led wellness program to reduce disease risk and increase wellness among breast cancer survivors. Information gathered will serve the dual purpose of testing intervention effectiveness and providing the community organization data to be used to secure sustainability funding | NO | Breast Cancer Female|Survivorship | BEHAVIORAL: Nutritional and goal-setting education, yoga | Change in central adiposity, circumferential measurement of waist, 20 weeks | Independent yoga posture series, participant independently demonstrates series of 6 postures, 20 weeks|Change in body weight, weight in pounds, 20 weeks|Change in balance, Time in seconds in single-leg stance, 20 weeks|independent healthy meal preparation, participant brings dish prepared from intervention recipe focusing on nutrition, Post intervention, after 20 weeks|Goal setting, Participant independently writes SMART (specific, measureable,attainable , reasonable, timely), 20 weeks | Mount Mary University | FEMALE | ADULT, OLDER_ADULT | NA | 17 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 20170126 | 2017-01-26 | 2017-06-15 | 2017-06-15 | 2018-07-02 | 2018-07-02 | Mount Mary University, Milwaukee, Wisconsin, 53222, United States | |||||
| NCT03557710 | Devaluing Foods to Change Eating Behavior | https://clinicaltrials.gov/study/NCT03557710 | Excessive eating of energy-dense foods and obesity are risk factors for a range of cancers. There are programs to reduce intake of these foods and weight loss, but the effects of the programs rarely last. This project tests whether altering the value of cancer-risk foods can create lasting change, and uses neuroimaging to compare the efficacy of two programs to engage the valuation system on a neural level. Results will establish the pathways through which the programs work and suggest specific treatments for individuals based on a personalized profile. | NO | Overweight and Obesity|Cancer | BEHAVIORAL: Devaluing energy-dense foods for cancer-control | Change from Baseline Food Intake at 1 month using dietary assessment tool, Assessed with the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool The National Cancer Institutes’s standard self-assessment instrument to comprehensively measure food intake., baseline, 1 month|Change from Baseline Food Intake at 1 month, Self-Report Questionnaire, Food-Frequency Questionnaire modified to include cancer risk foods, baseline, 1 month | Change from Baseline Body Fat Percent at 1 month, Assessed with a BodPod (body pod) air displacement system, baseline, 1 month|Change from Baseline Body Mass Index at 1 month, Index of body composition based on height and weight, baseline, 1 month|Change from Baseline Waist-to-Hip Ratio at 1 month, Index of body morphology based on external measurements, baseline, 1 month|Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 2, Barratt Impulsivity self-report questionnaire, measuring the construct of impulsivity. There are three subscales: Attentional impulsivity (8 items), motor impulsivity (10 items) non-planning impulsivity (12 items). Participants respond to each item on a 1-to-4 Likert scale and scores are averaged within subscales (yielding three 1-to-4 average scores) then averaged across the three subscales to yield one 1-to-4 overall score. Higher scores indicate higher impulsivity, which is a worse outcome., baseline, 1 month|Change from Baseline Food Approach and Avoidance Behavior at 1 month, Self-Report Questionnaire 3, Restraint Scale self-report questionnaire. This questionnaire measures the construct of dietary restraint. There are 2 subscales: concern for dieting and weight fluctuations. Participants answer 6 questions about concern for dieting (1-to-5) that are averaged to create a 1-to-5 score on dieting concern. Dieting concern is expected to be u-shaped in terms of better or worse, where no concern or extreme concern is worse and moderate concern is better. Participants answer 4 questions about weight fluctuations (1-to-5) that are averaged to create a 1-to-5 score for weight fluctuation. Great fluctuation is a worse outcome., baseline, 1 month|Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 1, Need for Cognition self-report questionnaire, which measures the construct of cognitive engagement and enjoyment of thinking. Participants complete 18 items on a 9-point Likert scale (-4 to +4) and scores are averaged across all items to create a single score that ranges from -4 to +4. Higher scores indicate a better outcome, indicating more enjoyment of thinking processes., baseline, 1 month|Change from Baseline Cognitive Tendencies at 1 month, Self-Report Questionnaire 2, Craving Regulation Scale self-report questionnaire, which measures the construct of self-regulation of food cravings. There are 24 items total, with 4 items within each of 6 subscales: avoidance of temptation, controlling temptations, distraction, suppression, goal/rule setting, and goal deliberation. Responses are on a 1-to-5 Likert scale and averaged within subscales to create 6 1-to-5 average ratings. Those six averages are also averaged to create an overall score. Greater scores indicate better self-regulation of craving, which is a desired outcome., baseline, 1 month|Change from Baseline Food-related Habitual Behavior at 1 month, Self-report Questionnaire 1, Food version of the Self-Report Habit Index self-report questionnaire. This measures the construct of habitual eating of healthy and unhealthy foods. The scale contains two subscales: healthy foods and unhealthy foods. Each subscale contains 12 items, and responses are on a 1-to-5 Likert scale. Responses are averaged within each subscale to create 1-to-5 average ratings for habitual eating of healthy and unhealthy foods, respectively. The subscales are reported separately and not combined. Greater numbers indicate more habitual eating, so lower averages on the unhealthy subscale and higher averages on the healthy subscale indicate a better outcome., baseline, 1 month|Change from Baseline Cancer Risk and Healthy Food Craving and Valuation at 1 month, Self-report Questionnaire 2, Food Craving Inventory self-report questionnaire measuring craving and valuation in dollars per serving of cancer risk and healthy foods. There are 28 items on each subscale (one for craving and one for valuation), and the items are averaged within each subscale. The range of the craving scale is 1-5 (i.e., average of 28 1-to-5 Likert ratings) and the range of the valuation scale is 1-4 (i.e., average of 28 1-to-4 Likert ratings). The subscales are reported separately and not combined. Greater numbers indicate more craving / value of the unhealthy foods, so lower numbers indicate a better outcome., baseline, 1 month|Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Behavioral marker, Task 1, Performance on a standard inhibitory control task (Stop-Signal) with personal risk cues, baseline, 1 month|Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Behavioral marker, Task 2, Performance on a standard inhibitory control task (Go/No-Go) with personal risk cues, baseline, 1 month|Change from Baseline Cognitive Reappraisal of Food at 1 month, Behavioral marker, Performance on a Regulation of Craving Task for Food, baseline, 1 month|Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Behavioral marker, Performance on Willingness-to-Pay Task – Food, baseline, 1 month|Change from Baseline Habitual Response to Food at 1 month, Behavioral marker, Performance on Speeded Cue-Behavior Association Task, baseline, 1 month|Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 1, Premotor, basal ganglia, dorsal cingulate, and Thalamus Activity during standard inhibitory control task (Stop-Signal) with personal risk cues, baseline, 1 month|Change from Baseline Behavioral Response Biases Toward and Away from Cancer Risk and Healthy Foods at 1 month, Neural marker, Task 2, Premotor, basal ganglia, dorsal cingulate, and Thalamus Activity during standard inhibitory control task (Go/No-Go) with personal risk cues, baseline, 1 month|Change from Baseline Cognitive Reappraisal of Food at 1 month, Neural marker, Dorsolateral Prefrontal Cortex and ventrolateral Prefrontal Cortex activity during Regulation of Craving Task for Food, baseline, 1 month|Change from Baseline Habitual Response to Food at 1 month, Neural marker, Shift from ventral to dorsal striatum activity during Speeded Cue-Behavior Association Task, baseline, 1 month|Change from Baseline Valuation of Subjective Value of Various Foods at 1 month, Neural marker, Ventromedial prefrontal cortex activity during the Willingness-to-Pay Task – Food, baseline, 1 month | University of Oregon | ALL | ADULT | NA | 253 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT | EPCS24327 | 2018-05-01 | 2023-05-01 | 2023-06-30 | 2018-06-15 | 2023-08-14 | University of Oregon, Lewis Integrative Sciences Building, Eugene, Oregon, 97403, United States | |||||
| NCT03548948 | Obesity, Iron Regulation and Colorectal Cancer Risk | https://clinicaltrials.gov/study/NCT03548948 | Obesity is an independent risk factor for colorectal cancer (CRC) although the underlying mechanisms have not been elucidated. Dietary nutrients play a key role in both the prevention and promotion of CRC. While iron is an essential nutrient, excess iron is associated with carcinogenesis. Unlike the systemic compartment, the intestinal lumen lacks an efficient system to regulate iron. In conditions when dietary iron malabsorption and intestinal inflammation co-exist, greater luminal iron is associated with increased intestinal inflammation and a shift in the gut microbiota to more pro-inflammatory strains. However, treatments designed to reduce luminal, including diet restriction and chelation, are associated with lower intestinal inflammation and the colonization of protective gut microbes. Obesity is associated with inflammation-induced, hepcidin-mediated, iron metabolism dysfunction characterized by iron deficiency and dietary iron malabsorption. Obesity is also linked to intestinal inflammation. Currently, there is a fundamental gap in understanding how altered iron metabolism impacts CRC risk in obesity. The investigator’s objective is to conduct a crossover controlled feeding trial of: 1) a “Typical American” diet with “high” heme/non-heme iron”, 2) a “Typical American” diet with “low” iron, and 3) a Mediterranean diet with “high” non heme iron and examine effects on colonic and systemic inflammation and the gut microbiome. | NO | Colon Inflammation|Iron Malabsorption|Obesity|Diet Modification | OTHER: High heme iron diet|OTHER: Low iron diet|OTHER: Plant-based high non-heme iron diet | Change in colonic inflammation, Fecal calprotectin, a proxy for colon tissue inflammation, will be measured from stool an calprotectin immunoassay, Baseline and post-diet (day 22) for each of the three 3-week diets | Change in systemic inflammation, Circulating C-reactive protein, Interleukin-6 (IL-6) and Tumor necrosis factor-alpha (TNF-a) will be measured from serum using immunoassays., Baseline and post-diet (day 22) for each of the three 3-week diets|Change in stool microbial community profile at the phylum and genus level, Stool samples to analyze the composition of the microbiota, extracted bacterial genomic DNA will be used as a template for polymerase chain reactions targeting the V4 variable regions of the 16S ribosomal ribonucleic acid gene. Amplicons generated from polymerase chain reaction will be run on the Illumina MiSeq sequencing platform to profile microbial communities at the phylum and genus level., Baseline and post-diet (day 22) for each of the three 3-week diets|Change in serum hepcidin, Serum hepcidin will be measured using an immunoassay, Baseline and post-diet (day 22) for each of the three 3-week diets | University of Illinois at Chicago | American Cancer Society, Inc. | FEMALE | ADULT, OLDER_ADULT | NA | 17 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER | 2014-0721 | 2015-07-15 | 2018-11 | 2019-06-30 | 2018-06-07 | 2019-09-27 | University of Illinois at Chicago, Chicago, Illinois, 60608, United States | ||||
| NCT03546972 | Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants | https://clinicaltrials.gov/study/NCT03546972 | This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers. | NO | Deleterious BRCA1 Gene Mutation|Deleterious BRCA2 Gene Mutation|Ductal Breast Carcinoma In Situ|Obesity|Overweight|Premalignant Lesion | OTHER: Behavioral, Psychological or Informational Intervention|OTHER: Behavioral, Psychological or Informational Intervention|OTHER: Questionnaire Administration | Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate, Measured by percentage of participants who enroll in the study., Up to 2 years|Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates, Measured by percentage of participants who leave the study., Up to 2 years|Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates, Measured by percentage of participants who complete the study., Up to 2 years | Changes in weight loss, Will use linear regression to study the effects of participant characteristics (i.e., weight history) and their interactions with the treatment groups., Baseline to 2 years|Changes in metabolic and breast cancer risk biomarkers, Biomarkers will be assessed through blood draws., Baseline to 2 years|Changes in proposed behavioral mediators through survey, Eating patterns will be assessed through survey ASA24 (Automated Self-assessment)., At baseline and at 16 weeks | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 51 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2017-0507|NCI-2018-01275|2017-0507|R21CA215415 | 2017-12-17 | 2026-11-30 | 2026-11-30 | 2018-06-06 | 2024-10-02 | M D Anderson Cancer Center, Houston, Texas, 77030, United States | ||||
| NCT03547453 | Ovarian Ultrasonography for the Clinical Evaluation of Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT03547453 | The investigators would like to determine how aspects of adiposity and age influence ultrasound features of the ovaries which are used to diagnose polycystic ovarian syndrome (PCOS). The study will also compare anti-Müllerian hormone (AMH) levels against ultrasound features of the ovary to predict PCOS. | NO | Polycystic Ovary Syndrome (PCOS)|Menstrual Irregularity|Overweight and Obesity | Follicle number per ovary, The number of follicles in each ovary will be assessed by ultrasonography, 1 day | Follicle number per cross section, The number all follicles in a single cross sectional plane of each ovary will be assessed by ultrasonography, 1 day|Ovarian volume, The size of each ovary will be determined by ultrasonography for each participant and compared across groups., 1 day|Stromal echogenicity on ultrasound, The brightness of the ovarian stroma in a single cross section will be determined by ultrasonography for each participant and compared across groups., 1 day|Ovarian area-stromal area ratio, The ratio of the stromal area to the total ovarian area of the ovary in a single cross section will be determined by ultrasonography for each participant and compared across groups., 1 day|Follicle distribution pattern, The follicle distribution pattern will be assessed by ultrasonography for each participant and compared across groups., 1 day|Anti-Müllerian hormone, Circulating AMH levels in the serum will be determined for each participant and compared across groups., 1 day|LH-FSH ratio, The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups, 1 day|Hirsutism Score, Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups, 1 day|Androgen concentrations, Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups., 1 day|Menstrual Cycle Length, Average menstrual cycle length as determined by self-reported history will be determined and compared across groups, 1 day|Body mass index, The ratio of weight to height will be determined and compared across groups., 1 day|Waist-to-hip ratio, The ratio of waist circumference to hip circumference will be determined and compared across groups., 1 day | Cornell University | University of Rochester | FEMALE | ADULT, OLDER_ADULT | 240 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 00070269 | 2018-06-04 | 2022-12-31 | 2022-12-31 | 2018-06-06 | 2023-02-13 | Strong Fertility Center, Rochester, New York, 14623, United States | ||||||
| NCT03542604 | Cancer, Obesity/Overweight and Insomnia Study | https://clinicaltrials.gov/study/NCT03542604 | COIN | This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program. | NO | Breast Cancer|Overweight and Obesity|Insomnia | BEHAVIORAL: Cognitive Behavioral Therapy for Insomnia|BEHAVIORAL: Sleep Education | Percent Weight loss, The primary outcome will be percent (%) weight loss. All subjects who are randomized will be included in the analysis of the primary outcome. Weight will be measured according to standardized BMI and anthropometric procedures (hip/waist ratio). For the primary aim, comparing the effects of CBT-I+BWL and EDU+BWL on % weight loss at 3 and 6 months, we will model outcomes (at 3 months \& 6 mos.) as a function of baseline level, treatment assignment, time, and their interaction. The interaction term represents the between-group difference in change over time on the outcome., Change from Baseline, 8 weeks, 3 months and 6 months | Sleep continuity as measured by wake after sleep onset (WASO), WASO will be measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months. For this aim, evaluating the extent to which short-term sleep continuity improvements (8 wk and 3 mo) are associated with improvements in daily physical activity and dietary quality/quantity and determining their association with 3- and 6-month weight changes, we will model between-group differences in the short-term trajectory of change for the primary sleep continuity measures, actigraphy TST and WASO., Change from Baseline, 8 weeks, 3 months and 6 months|Sleep continuity as measured by total sleep time (TST), TST will be measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months. For this aim, evaluating the extent to which short-term sleep continuity improvements (8 wk and 3 mo) are associated with improvements in daily physical activity and dietary quality/quantity and determining their association with 3- and 6-month weight changes, we will model between-group differences in the short-term trajectory of change for the primary sleep continuity measures, actigraphy TST and WASO., Change from Baseline, 8 weeks, 3 months and 6 months|Sleep continuity as measured by sleep efficiency (SE), Sleep efficiency is measured as the ratio of total sleep time (TST) compared to the total time spent in bed (TST / time in bed). This is measured in percent of total time spent in bed, asleep. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months., Change from Baseline, 8 weeks, 3 months and 6 months|Sleep continuity as measured by sleep latency (SL), Sleep latency is the time it takes to transition from full wakefulness to sleep. This is measured in minutes. Sleep continuity will be measured using actigraphs and sleep diaries at baseline, 8 weeks, 3 months, and 6 months., Change from Baseline, 8 weeks, 3 months and 6 months | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Under Armour | FEMALE | ADULT, OLDER_ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER | J17120|IRB00132883 | 2018-06-12 | 2020-11-30 | 2020-11-30 | 2018-05-31 | 2020-12-16 | Johns Hopkins University, Bayview Medical Campus, Baltimore, Maryland, 21224, United States | |||
| NCT03538665 | The DETECT Study: Discovery and Evaluation of Testing for Endometrial and Ovarian Cancer in Tampons | https://clinicaltrials.gov/study/NCT03538665 | DETECT | BACKGROUND: Endometrial cancer is a common and deadly cancer for women. It is getting more common and deadly because risk factors like age and obesity are increasing. Also, this cancer is becoming more common and deadly for black women than white women. Researchers want to find better ways to take samples and test them for this cancer. They want to study this for a racially diverse population. One way to take samples might be from a tampon. If identified early, endometrial cancer can be highly curable; however, the earliest stages may be asymptomatic, and clinical symptoms are often missed. Combining sensitive molecular testing approaches with non-invasive sampling techniques may to lead to the development of novel endometrial cancer early detection approaches with the potential to overcome disparities in access to care and time to diagnosis and treatment. In contrast to endometrial cancer, ovarian cancer is typically detected at advanced stages with poor survival since symptoms manifest only late in the disease process and are very unspecific. Racial disparities in ovarian cancer incidence and mortality are also much less pronounced. Racial disparities can manifest particularly when screening, symptom appraisal and early detection, and effective treatment interventions have important roles in determining outcomes of cancers. OBJECTIVES: The purpose of this study is to see if it is possible and acceptable for individuals to have an endometrial or ovarian sample collected by using a tampon placed in the vagina. The investigators will look at DNA in these samples. DNA is the genetic information participants inherited from their parents. The investigators want to see whether the investigators can find changes in DNA and proteins related to endometrial or ovarian cancer from tampon samples. Tests on the samples from tampons will help to understand endometrial and ovarian cancer. The samples collected during this study will be used for research related to both endometrial and ovarian cancer and non-cancer conditions. ELIGIBILITY: Women at least ≥18 years undergoing clinically-indicated hysterectomy and/or bilateral salpingo-oophorectomy for endometrial or ovarian cancer, cancer precursors, or benign conditions. DESIGN: 1. Participants will put a tampon in their vagina at least 30 minutes before their surgery. 2. Participants will take a short survey. 3. The tampon will be collected during the surgery. 4. A small piece of tissue will be collected from the uterus +/- ovary that is removed in surgery. 5. Participants will give a blood sample. 6. Before or after surgery, participants will answer questions. These will be about their medical history and basic data such as age and race. 7. Researchers will follow participants medical records for up to 5 years after the study. Additional blood may be taken from patient if patient agrees. 8. Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples. | NO | Endometrial Cancer|Endometrial Cancer Precursors|Ovarian Cancer|Complex Atypical Endometrial Hyperplasia | Endometrial Cancer, Women with histologically confirmed diagnosis of endometrial or ovarian cancer, Enrollment or at time of surgery|Endometrial cancer precursors, Women with histologically confirmed diagnosis of precursors (e.g., atypical hyperplasia), Enrollment or at time of surgery|Non-malignant uterus, Women with fibroids, polyps, endometrial hyperplasia without atypia, adenomyosis, normal endometrium, or other benign conditions determined by histology and/or clinical imaging., Enrollment or at time of surgery | Acceptability of tampon sampling, Women will be given a 10 question survey to assess acceptability of tampon sampling, Prior to surgery|Feasibility of tampon sampling, The feasibility of tampon sampling will be determined by successful tampon insertion according to protocol prior to surgery and sufficient DNA yield (e.g., 1-2 microgram) from the tampon sample., During and immediately after surgery | University of Alabama at Birmingham | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | 1500 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999918106|Z01CP010124-21 | 2019-07-01 | 2025-08-11 | 2025-08-11 | 2018-05-29 | 2024-09-05 | University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States | |||||
| NCT03480022 | Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS | https://clinicaltrials.gov/study/NCT03480022 | SAXAPCOS | There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and weight loss is essential but difficult to achieve, it is important to study if the effect on body weight reported in other studies can be confirmed in a selected population of hyperandrogenic patients, especially with medications currently approved for weight reduction. High dose liraglutide alone results in significant weight reduction in obese women without PCOS. There is limited data on weight loss with high dose liraglutide in non-diabetic females with PCOS treated with this agent . Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and androgen excess in obese women diagnosed with PCOS are lacking. The investigators aim to elucidate the most efficacious weight reduction regime in obese PCOS women. The investigators further hope to determine which treatment(s) addressing the multifaceted disturbances of this disorder in patients with PCOS and obesity emerges as the preferable therapy. | YES | Pre Diabetes|Polycystic Ovary Syndrome|Obesity Android | DRUG: Liraglutide Pen Injector [Saxenda]|DRUG: Placebo Liraglutide Pen Injector | Absolute Body Weight (BW), Treatment impact on change in body weight after 32 weeks of treatment., 32 weeks of treatment|Free Androgen Index (FAI), Drug treatment effect on free androgen levels as calculated as FAI= total testosterone (T) concentrations divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome (more androgenic)., 32 weeks of treatment | Body Mass Index (BMI), Treatment effect in reducing body mass, 32 weeks of treatment|Change in Percent Body Weight, Treatment effect on reducing body weight expressed as percent body weight loss from baseline, Change from baseline (time 0) to study end (32 weeks)|5% Weight Loss From Baseline, Frequency of patients achieving 5% weight loss from baseline with treatment, 32 weeks of treatment|10% Body Weight Loss From Baseline, Frequency of patients with at least 10% reduction in body weight from baseline, 32 weeks of treatment|Abdominal Adiposity (Waist Circumference [WC], Treatment effect on loss of WC (abdominal adiposity) with drug treatment, 32 weeks of treatment|Waist-to-Hip Ratio, Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat., 32 weeks of treatment|Waist-to Height Ratio [WHtR]), Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity., 32 weeks of treatment|Total Fat Mass Evaluated by DEXA, Treatment effect on reduction of fat mass (kg), 32 weeks of treatment|Total Body Fat (%) by DXA, Treatment effect on reduction of percent body fat by DXA, 32 weeks of treatment|Android-Gynoid Ratio (AGR) by DXA, Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity., 32 weeks of treatment|Trunk/Leg Fat Ratio (TLR) by DXA, Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat., 32 weeks of treatment|Menstrual Cycle Frequency, Drug treatment impact on normalization of cycle frequency (cycle every 28-30 days). All cycle data is expressed as number of menses annualized to one year., 32 weeks of treatment|Total Testosterone Concentrations (T), Drug treatment effect on total testosterone concentrations, 32 weeks of treatment|Adrenal Dehydroepiandrosterone Sulfate (DHEAS), Treatment efficacy in reducing adrenal hyperandrogenism, 32 weeks of treatment|Fasting Blood Glucose (FG), Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT), 32 weeks of treatment|OGTT Mean Blood Glucose (MBG), Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia., 32 weeks of treatment|Fasting Insulin Sensitivity (HOMA-IR), Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant., 32 weeks of treatment|Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT), The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity, 32 weeks of treatment|Corrected First Phase Insulin Secretion (IGI/HOMA-IR), Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose., 32 weeks of treatment|Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI), Treatment effect on an estimation of Beta cell compensatory function, the IS-SI is derived by applying the concept of the disposition index to measurements obtained during the 2 hour OGTT and calculated as the index of insulin secretion factored by insulin sensitivity. A higher score shows improved pancreatic beta cell function relative to insulin sensitivity., 32 weeks of treatment|Total Cholesterol Levels, Treatment impact on improving total cholesterol levels, 32 weeks of treatment|High Density Lipoprotein Cholesterol (HDL-C), Impact of treatment on HDL levels after 32 weeks of treatment, 32 weeks of treatment|Triglyceride Levels (TRG), Drug effect of TRG levels after treatment, 32 weeks of treatment|Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C), Treatment impact on TRG/HDL-C ratio which is a simple measure to estimate insulin action. A decrease in ratio indicates improvement in insulin sensitivity., 32 weeks of treatment|Triglyceride and Glucose Index (TyG), Treatment impact on the TyG index which estimates insulin resistance. A reduction in TyG indicates an improvement in insulin action., 32 weeks of treatment|Systolic Blood Pressure, Treatment impact on systolic blood pressure, 32 weeks of treatment|Diastolic Blood Pressure (BP), Treatment impact on reducing diastolic blood pressure, 32 weeks of treatment | Woman’s | Novo Nordisk A/S | FEMALE | ADULT | PHASE3 | 88 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | U1111-1198-4126 | 2018-09-26 | 2021-02-22 | 2021-05-19 | 2018-03-27 | 2021-06-07 | 2021-06-07 | Woman’s Hospital, Baton Rouge, Louisiana, 70817, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/22/NCT03480022/Prot_SAP_001.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/22/NCT03480022/ICF_000.pdf | |
| NCT03463941 | Peer Support Dyads in Churches | https://clinicaltrials.gov/study/NCT03463941 | The purpose of this study is to explore how working with a partner can influence participation in a church wellness program. There are many different types of church wellness programs. Church members are more likely to participate and achieve goals in these programs when they have peer support. The researcher would like to know what African American men and women think about working with a support partner. This information will help researchers design better church wellness programs. The participants are being asked to take part in this research because the investigators believe that it is helpful to share feelings and thoughts about experiences working with a partner to achieve health goals. This knowledge will be used to create church wellness programs that will help African American men and women prevent disease and live healthier lives. | YES | Peer Support and Chronic Disease|Obesity|Type II Diabetes|Cardiovascular Disease|Cancer | BEHAVIORAL: Peer Support Dyad Intervention | Feasibility as Measured by Retention, Retention will be calculated from the number of participants who continue to Phase II out of the number who complete Phase I (\>50% attendance), and the attrition rate., Baseline to week 18|Number of Participants Who Agreed That Program Component Was Acceptable, Measured by ten item feasibility survey, scored based on 5-point Likert scale administered at week 18, the last week of the program. Feasibility was measured on a scale of 1-5, where 1=strongly disagree that program component was acceptable or feasible, and 5=strongly agree that program component was acceptable or feasible), Measured at Week 18|Health Educators’ Perceptions of Feasibility as Measured by Semi-structured Interviews, Reported as number of health educators who found the program to be feasible., Measured at Week 18 | Goal Attainment as Measured by BMI (Body Mass Index), Mixed models will be used to assess changes in participant BMI pre and post intervention., Week 18|Goal Attainment as Measured by Weight in Pounds, A mixed model using intraclass correlation will be used used to assess changes in participant weight pre and post intervention., Week 18|Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day, A mixed model using intraclass correlation will be used to assess changes in participant fruit and vegetable intake pre and post intervention., Week 18|Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More, A mixed model using intraclass correlation will be used to assess changes in physical activity at weeks 1 and 18 pre and post intervention., Week 18 | Duke University | National Institute of Nursing Research (NINR) | ALL | ADULT, OLDER_ADULT | NA | 80 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | Pro00091547|1F31NR017813-01 | 2019-01-05 | 2019-07-31 | 2019-07-31 | 2018-03-13 | 2020-09-02 | 2020-09-02 | Faithful Families Program, Raleigh, North Carolina, 27695, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/41/NCT03463941/Prot_SAP_000.pdf | ||
| NCT03443635 | Cooking for Health Optimization With Patients | https://clinicaltrials.gov/study/NCT03443635 | CHOP | Cooking for Health Optimization with Patients (CHOP) is the first known multi-site prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive cardiology field of culinary medicine. It is also the first known longitudinal study to assess the impact of hands-on cooking and nutrition education on patient outcomes, with those classes taught by medical students and other future and current medical professionals who have first been trained in those classes on how to integrate diet and lifestyle counseling of patients with their respective scopes of clinical practice. CHOP is the primary research study of the world’s first known medical school based teaching kitchen, The Goldring Center for Culinary Medicine at Tulane University School of Medicine. Medical trainees and professionals are followed in this study long-term to understand how the classes impact their competencies in patient counseling, attitudes about the counseling, and their own diets. Patients who consent to being randomized to these classes compared to standard of care are studied within the nested Bayesian adaptive randomized trial to understand how the classes impact their health outcomes, clinical and food costs, and the costs of health systems caring for these patient populations. CHOP is designed as a pragmatic population health trial to hopefully improve healthcare effectiveness, equity, and cost by establishing an evidence-based, scalable, sustainable model of healthcare intervention targeting the social determinants of health, while complementing the pharmacological and/or surgical management of patients. | YES | Cardiovascular Diseases|Cardiovascular Risk Factor|Nutrition Disorders|Diabetes|Hypertension|Cancer|Depression|Obesity|Physical Activity | BEHAVIORAL: Treatment | High or Medium (Versus Low) Mediterranean Diet Adherence, Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers), 6 months | Hospital Readmissions, Re-presenting to the hospital for similar presenting diagnosis (for patients), 30 days|Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event, (For patients), 6 months|Competencies, Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees), 6 months|Healthcare Costs, Direct and indirect (for patients), 6 months|Healthcare Costs, Direct and indirect (for health systems caring for the patients in the trial), 6 months|Food Costs, Grocery and restaurant costs (for patients), 6 months | Tulane University | ALL | CHILD, ADULT, OLDER_ADULT | PHASE1|PHASE2 | 7192 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | CHOP | 2018-02-01 | 2020-12-18 | 2020-12-18 | 2018-02-23 | 2022-02-25 | 2022-04-29 | The Goldring Center for Culinary Medicine at Tulane University School of Medicine, New Orleans, Louisiana, 70119, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/35/NCT03443635/Prot_SAP_000.pdf | ||
| NCT03422731 | Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy | https://clinicaltrials.gov/study/NCT03422731 | This clinical trial investigates multi-modality imaging and collection of biospecimen samples in understanding bone marrow changes in patients with acute myeloid leukemia undergoing total body irradiation (TBI) and chemotherapy. Using multi-modality imaging and collecting biospecimen samples may help doctors know more about how TBI and chemotherapy can change the bone marrow. | NO | Acute Lymphoblastic Leukemia|Acute Myeloid Leukemia | PROCEDURE: Biospecimen Collection|PROCEDURE: Dual-Energy Computed Tomography|DRUG: Fluorothymidine F-18|OTHER: Laboratory Biomarker Analysis|PROCEDURE: Magnetic Resonance Imaging|PROCEDURE: Positron Emission Tomography | Change over time in cellularity and adiposity, A non-parametric smoothing plot will be produced in the first step to view changes in the trend. Measurements will be summarized by mean +/- standard deviation (SD) at each time point. Exploratory within subjects’ correlation will be examined using Pearson correlation between adjacent time points. A random-effects model will also be used to investigate whether there is significant time trend. Will use a two-sample t-test for comparing bone marrow cellularity percentage at pre-HCT and 1-year post-HCT between the total marrow and lymphoid irradiation (TMLI) group and total body irradiation (TBI) group (all cohorts). A paired t-test will also be carried out to examine if there is significant difference in changes of cellularity between these two groups., Up to 1 year post-hematopoietic stem cell transplant (HCT)|Change over time of red marrow (cellularity) and yellow marrow (adipocyte), A non-parametric smoothing plot will be produced in the first step to view changes in the trend. Measurements will be summarized by mean +/- SD at each time point. Exploratory within subjects’ correlation will be examined using Pearson correlation between adjacent time points. A random-effects model will also be used to investigate whether there is significant time trend. In addition, bone marrow/peripheral blood measurements will be correlated with survival outcome (relapse)., Up to 2 years|Number of hematopoietic stem cell (HSC) colony forming units (sub-analysis), Will be assessed by HSCs from marrow aspirate., Up to 2 years|Ratio of HSC sub-populations (sub-analysis), Long-term, short-term, multi-potent progenitor, common myeloid progenitor, and granulocyte macrophage progenitor will all be assessed by HSCs marrow aspirate., Up to 2 years|Hematopoietic stem cell density in bone marrow biopsy samples (sub-analysis), Will be assessed by CD34 staining., Up to 2 years|Microvascular density in bone marrow biopsy samples (sub-analysis), Will be assessed by CD31 staining., Up to 2 years | Standardized uptake value (SUV) distribution at different skeletal sites, Changes in standardized uptake value (SUV) from fluorothymidine F-18 (FLT) positron emission tomography (PET) imaging uptake will be described. The distribution or heterogeneity will be first estimated using medians, ranges, interquartile ranges, means and standard deviations. Kolmogorov-Smirnov test (K-S) test will be performed to examine whether the distribution is the same for different skeletal sites. Also as a side product, sensitivity and specificity of the imaging will be estimated., Baseline|SUV distribution and presence of focal hot spot, Changes in SUV from FLT-PET imaging uptake will be described. The distribution or heterogeneity will be first estimated using medians, ranges, interquartile ranges, means and standard deviations. K-S test will be performed to examine whether the distribution is the same for different skeletal sites. Also as a side product, sensitivity and specificity of the imaging will be estimated., Baseline|Change in FLT PET activity, Baseline up to 2 years|SUVmax at site of biopsy, SUVmax: the maximum SUV within the region of interest. SUVmin: the minimum SUV within the region of interest. SUVmean: the average SUV within the region of interest. As a primary goal we will be using SUVmax. Other parameters are secondary parameters. Sites: site of bone marrow biopsy is iliac crest. Image analysis is done at the different locations – iliac crest, Lumber spine, and femur., At time of biopsy|SUVmean at site of biopsy, SUVmax: the maximum SUV within the region of interest. SUVmin: the minimum SUV within the region of interest. SUVmean: the average SUV within the region of interest. As a primary goal we will be using SUVmax. Other parameters are secondary parameters. Sites: site of bone marrow biopsy is iliac crest. Image analysis is done at the different locations – iliac crest, Lumber spine, and femur., At time of biopsy|Blast counts, Will be assessed by bone marrow aspirate smears., Up to 2 years|SUVmax at iliac crest, lumber spine, and femur, For each location SUV measurement, software provides SUVmax, SUVmin and SUVmean. These are not separate measurements. Once region (volume) is defined, software will calculate SUV in the form of SUVmax, SUVmean and SUVmin. For simplicity, we will report SUVmax only as primary parameter. SUVmean and SUVmin will be secondary SUV parameters., Up to 2 years|SUVmean at iliac crest, lumber spine, and femur, For each location SUV measurement, software provides SUVmax, SUVmin and SUVmean. These are not separate measurements. Once region (volume) is defined, software will calculate SUV in the form of SUVmax, SUVmean and SUVmin. For simplicity, we will report SUVmax only as primary parameter. SUVmean and SUVmin will be secondary SUV parameters., Up to 2 years | City of Hope Medical Center | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | EARLY_PHASE1 | 74 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC | 17222|NCI-2017-01778|17222|P30CA033572 | 2018-02-15 | 2025-11-06 | 2025-11-06 | 2018-02-06 | 2024-11-12 | City of Hope Medical Center, Duarte, California, 91010, United States | ||||
| NCT03382886 | Nivolumab and Bevacizumab in Patients With Advanced and or Metastatic Hepatocellular Carcinoma | https://clinicaltrials.gov/study/NCT03382886 | NUANCE | This is an open label, phase I study to test for maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of the combination of nivolumab and bevacizumab. The study will use a 3+3 phase I study design using a fixed dose of nivolumab (240mg) and escalating doses of bevacizumab (1-10mg). | NO | Hepatocellular Carcinoma | DRUG: Nivolumab|DRUG: Bevacizumab | Adverse Events that occur, Investigate the safety and tolerability of 14-day cycles of nivolumab plus bevacizumab. Adverse events will be collected for each subject that received the study treatment combination., Every 14 day cycle for up to 2 years – Patients are expected to be on treatment for an average of 6 months|Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D). Dose Limiting Toxicities (DLT) will define subsequent subject accrual and dose escalation, The DLT period will begin at Cycle 1 Day 1 and continue through Cycle 1 Day 28 for each patient | Progression Free Survival (PFS), To examine the effect of the study treatment combination on the rate of progression-free survival (PFS). Subjects will have regular imaging scans to measure disease status and response will be defined by RECIST1.1., 3 years after treatment stops|Overall Survival, To examine the effect of the study treatment combination on the rate of overall survival., 3 years after treatment stops | University of Utah | Bristol-Myers Squibb | ALL | ADULT, OLDER_ADULT | PHASE1 | 1 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | HCI103945 | 2018-04-11 | 2018-07-26 | 2019-07-02 | 2017-12-26 | 2019-12-12 | Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States | |||
| NCT03364803 | Collecting Information About Treatment Results for Patients With Cushing’s Syndrome | https://clinicaltrials.gov/study/NCT03364803 | The purpose of this study is to follow participants with Cushing’s syndrome during the course of their routine care and to form a data registry to study long term participant outcomes. | NO | Cushing’s Disease|Cushing Syndrome|Cushing Disease | OTHER: Cushing’s QoL (Quality of Life Questionnaire)|OTHER: Nottingham Health Profile (NHP)|OTHER: Hospital Anxiety and Depression Scale (HADS)|OTHER: Perceived Stress Scale (PSS)|OTHER: Barratt’s Impulsivity Scale (BIS)|OTHER: Beck Depression Inventory (BDI)|OTHER: State-Trait Anxiety Inventory (STAI)|OTHER: State Food Craving Questionnaire-State (FCQ-S)|OTHER: Trait Food Craving Questionnaire-Trait (FCQ-T)|OTHER: Visual Analogue Scale (VAS)|OTHER: Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant | Collection of data on Cushing’s Syndrome participants before and over time after surgical, medication, and/or radiation therapy., up to 10 years after treatment | Memorial Sloan Kettering Cancer Center | ALL | CHILD, ADULT, OLDER_ADULT | 200 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 17-592 | 2017-11-28 | 2025-11-28 | 2025-11-28 | 2017-12-07 | 2024-12-31 | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States | |||||||
| NCT03361020 | Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation | https://clinicaltrials.gov/study/NCT03361020 | While thoracic radiation therapy (TRT) has been a primary component in successful treatment of Hodgkin lymphoma, exposure to this treatment has been associated with significant cardiovascular, cerebrovascular, and pulmonary morbidity in long-term survivors. Survivors of Hodgkin lymphoma (HL) are also at risk for fatigue and excessive daytime sleepiness. Insufficient sleep is recognized as an important public health concern, and is associated with cardiovascular disease, diabetes, obesity, neurocognitive problems, and reduced quality of life and productivity. Survivors of HL, who are already at risk for cardiac and neurologic morbidity due to their treatment exposures, could face catastrophic cardiovascular and cerebrovascular events with the added risk associated with obstructive sleep apnea (OSA). The investigators propose to examine indices of sleep quality using polysomnography, and associated neurocognitive performance, brain MRI, and structure and strength of neck muscles in 220 long-term adult survivors of Hodgkin lymphoma treated with thoracic radiation. OBJECTIVES: 1. To estimate the prevalence of OSA in adult survivors of HL treated with thoracic radiation, and compare the frequency to community controls matched on age, gender, race and body mass index. 2. To identify specific therapeutic factors associated with OSA in adult survivors of HL treated with thoracic radiation. 3. To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation. 4. To examine associations between OSA and cardiac morbidity and brain integrity in the adult survivors of HL treated with thoracic radiation. | NO | Obstructive Sleep Apnea|Hodgkin Lymphoma | Number of participants with obstructive sleep apnea (OSA) compared between groups, The comparison will be between the Hodgkin lymphoma survivors and race, age, sex, body mass index (BMI) matched control group on frequency of OSA. OSA will be deemed present if either of two conditions is met: (1) polysomnography reveals an apnea hypopnea index (AHI) ≥ 15, or (2) polysomnography reveals an AHI ≥ 5 and the participant presents with clinical symptoms., Once, at enrollment | St. Jude Children’s Research Hospital | National Cancer Institute (NCI)|University of California, San Diego | ALL | ADULT, OLDER_ADULT | 434 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | APNEA|R01CA215405 | 2018-01-23 | 2023-07-31 | 2028-07-10 | 2017-12-04 | 2025-01-10 | St. Jude Children’s Research Hospital, Memphis, Tennessee, 38105, United States | |||||||
| NCT03337230 | Feasibility of a Social Media-based Weight Loss Program for Low Socioeconomic Status Individuals | https://clinicaltrials.gov/study/NCT03337230 | The purpose of this study is to see if it is practical to use social media-based and traditional online weight loss intervention components among low socioeconomic status participants using the Facebook social media (SM) and Fitbit self-monitoring platforms. Also, the study will test the effectiveness of recruiting participants via social media and at community events and locations. The results of this study will be used to inform future research studies. | NO | Obesity | BEHAVIORAL: Physical Activity|BEHAVIORAL: Diet|BEHAVIORAL: Social Support | Ratio or participants screened to patients completing 12-week measures, This is a measure of feasibility, Up to 12 weeks|Average score of adapted INSHAPE computer-based questionnaire, Computer-based questionnaires will be self-administered via the Qualtrics Survey platform. INSHAPE questionnaire is a 14 question survey gauging acceptability of the program, Up to 12 weeks | Number of eligible participants, This is a measure of feasibility, Up to 12 weeks|Number of consented participants, This is a measure of feasibility, Up to 12 weeks|Average change in Fitbit activity, This is a measure of physical activity, From baseline to 12 weeks|Average change in International physical activity questionnaire (IPAQ) score, This is a measure of physical activity, From baseline to 12 weeks|Average change in score of the National Cancer Institute’s Automated Self-Administered 24-Hour (ASA24) dietary assessment web-based assessment tool, This is a measure of dietary intake, From baseline to 12 weeks|Change in weight, Trained study staff will determine weight at baseline and 12 weeks of the study, From baseline to 12 weeks|Change in waist circumference, Trained study staff will determine waist circumference at baseline and 12 weeks of the study, From baseline to 12 weeks|Average change in social support score, This is a 31 question, multiple choice survey adapted from Gruber and Sallis, From baseline to 12 weeks|Average change in weight loss self-efficacy score, Multiple choice questions and short answer survey which can be scored to gauge weight-loss self-efficacy. Adapted from Wilson, From baseline to 12 weeks|Average change in dietary knowledge, Multiple choice questions and short answer survey which can be scored to gauge dietary knowledge. Adapted from Jones, From baseline to 12 weeks | Case Comprehensive Cancer Center | ALL | ADULT, OLDER_ADULT | NA | 55 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | CASE17Z17 | 2017-10-31 | 2018-06-01 | 2018-06-01 | 2017-11-08 | 2021-03-16 | Case Western Reserve Univeristy, Cleveland, Ohio, 44106, United States | |||||
| NCT03295279 | WTC Chest CT Imaging Archive | https://clinicaltrials.gov/study/NCT03295279 | Dr. Rafael E de la Hoz and colleagues have performed standardized and computer-assisted readings of all chest CT scans received by WTC workers and volunteers at the Mount Sinai Medical Center between 2003 and 2016. The clinical team sought to assess all findings suggestive of airway, interstitial, and neoplastic disease in a systematic way, and correlate those findings with clinical, functional, and exposure indicators. The study team’s research will also involve analyses of longitudinal imaging and functional trends, and characterization of the WTC related lower airway diseases and their risk factors, with a focus on obesity-related imaging markers. The study team also plans to characterize the transitions into chronic obstructive pulmonary disease (COPD) among these workers. | NO | Chronic Airway Disease|Interstitial Lung Disease|Lung Cancer | Accelerated longitudinal FEV1 decline, The clinical team selects spirometries of acceptable quality, and subjects with at least 3 spirometries spanning at least 5 years, to calculate FEV1 slope, which can then be modeled quantitatively. For categorical analyses, the clinical team defines rapid FEV1 decliners and contrast them to normal-and-stable FEV1 subjects, defined as those having an FEV1 above the lower limit of normal at baseline, no bronchodilator response, and FEV1 not changing by more than 25 ml/year on average in either direction., 5 years | Number of physician diagnosis of incident asthma, Physician diagnosis of asthma with onset after WTC occupational exposures., 5 years | Icahn School of Medicine at Mount Sinai | University of Pittsburgh|Brigham and Women’s Hospital|National Jewish Health|University of New Mexico | ALL | ADULT, OLDER_ADULT | 1722 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | GCO 12-0751|U01OH010401|U01OH011697|GCO 17-2598 | 2012-09-01 | 2026-08 | 2026-08 | 2017-09-27 | 2024-02-28 | Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States | ||||||
| NCT03286699 | Lifestyle Change for Better Health | https://clinicaltrials.gov/study/NCT03286699 | LCBH | The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention. | NO | Bladder Cancer|Telomere Shortening|Colorectal Adenoma | BEHAVIORAL: Dietary Intervention|BEHAVIORAL: Physical Activity Intervention | Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates), LTL will be measured in blood samples from participants, Blood samples will be collected as part of the 6 month assessment | Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates), LTL will be measured in blood samples from participants, Blood samples will be collected as part of the 3 month assessment|Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates), LTL will be measured in blood samples from participants, Blood samples will be collected as part of the 12 month assessment (as feasible)|Telomerase level at 3 months (controlling for appropriate covariates), Telomerase will be measured in blood samples from participants, Blood samples will be collected as part of the 3 month assessment|Telomerase level at 6 months (controlling for appropriate covariates), Telomerase will be measured in blood samples from participants, Blood samples will be collected as part of the 6 month assessment|Telomerase level at 12 months (controlling for appropriate covariates), Telomerase will be measured in blood samples from participants, Blood samples will be collected as part of the 12 month assessment (as feasible)|8-OHdG level at 3 months (controlling for appropriate covariates), 8-OHdG will be measured in samples from participants, Samples will be collected as part of the 3 month assessment|8-OHdG level at 6 months (controlling for appropriate covariates), 8-OHdG will be measured in samples from participants, Samples will be collected as part of the 6 month assessment|Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates), SOD1 will be measured in samples from participants, Samples will be collected as part of the 3 month assessment|Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates), SOD1 will be measured in samples from participants, Samples will be collected as part of the 6 month assessment|Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates), SOD2 will be measured in samples from participants, Samples will be collected as part of the 3 month assessment|Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates), SOD2 will be measured in samples from participants, Samples will be collected as part of the 6 month assessment|Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates), Gpx will be measured in samples from participants, Samples will be collected as part of the 3 month assessment|Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates), Gpx will be measured in samples from participants, Samples will be collected as part of the 6 month assessment|Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates), SIR will be measured in samples from participants, Samples will be collected as part of the 3 month assessment|Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates), SIR will be measured in samples from participants, Samples will be collected as part of the 6 month assessment | Body Mass Index (BMI) at 3 months (controlling for appropriate covariates), BMI will be calculated from height and weight measurements, Measurements will be collected as part of the 3 month assessment|Body Mass Index (BMI) at 6 months (controlling for appropriate covariates), BMI will be calculated from height and weight measurements, Measurements will be collected as part of the 6 month assessment|Body composition at 3 months (controlling for appropriate covariates), Body composition will be measured by dual-energy x-ray absorptiometry (DXA), Measurements will be collected as part of the 3 month assessment|Body composition at 6 months (controlling for appropriate covariates), Body composition will be measured by dual-energy x-ray absorptiometry (DXA), Measurements will be collected as part of the 6 month assessment|Regional adiposity (DXA) at 3 months (controlling for appropriate covariates), Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA), Measurements will be collected as part of the 3 month assessment|Regional adiposity (DXA) at 6 months (controlling for appropriate covariates), Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA), Measurements will be collected as part of the 6 month assessment|Waist-to-hip ratio at 3 months (controlling for appropriate covariates), Waist-to-hip ratio will be calculated from waist and hip measurements, Measurements will be collected as part of the 3 month assessment|Waist-to-hip ratio at 6 months (controlling for appropriate covariates), Waist-to-hip ratio will be calculated from waist and hip measurements, Measurements will be collected as part of the 6 month assessment|Objective physical activity level at 3 months (controlling for appropriate covariates), Physical Activity will be objectively measured with SenseWear BodyMedia, Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment|Objective physical activity level at 6 months (controlling for appropriate covariates), Physical Activity will be objectively measured with SenseWear BodyMedia, Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment|Self-reported physical activity level at 3 months (controlling for appropriate covariates), The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity, Self-reports will be obtained as part of the 3 month assessment|Self-reported physical activity level at 6 months (controlling for appropriate covariates), The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity, Self-reports will be obtained as part of the 6 month assessment|Cardiorespiratory fitness at 3 months (controlling for appropriate covariates), Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test, Measurements will be collected as part of the 3 month assessment|Cardiorespiratory fitness at 6 months (controlling for appropriate covariates), Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test, Measurements will be collected as part of the 6 month assessment|Depressive symptoms at 3 months (controlling for appropriate covariates), The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms, Questionnaires will be completed as part of the 3 month assessment|Depressive symptoms at 6 months (controlling for appropriate covariates), The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms, Questionnaires will be completed as part of the 6 month assessment|Symptoms of anxiety at 3 months (controlling for appropriate covariates), The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety, Questionnaires will be completed as part of the 3 month assessment|Symptoms of anxiety at 6 months (controlling for appropriate covariates), The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety, Questionnaires will be completed as part of the 6 month assessment|Perceived stress at 3 months (controlling for appropriate covariates), The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress, Questionnaires will be completed as part of the 3 month assessment|Perceived stress at 6 months (controlling for appropriate covariates), The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress, Questionnaires will be completed as part of the 6 month assessment|Sleep quality at 3 months (controlling for appropriate covariates), The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality, Questionnaires will be completed as part of the 3 month assessment|Sleep quality at 6 months (controlling for appropriate covariates), The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality, Questionnaires will be completed as part of the 6 month assessment|Quality of life at 3 months (controlling for appropriate covariates), The Functional Assessment of Cancer Therapy – Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life, Questionnaires will be completed as part of the 3 month assessment|Quality of life at 6 months (controlling for appropriate covariates), The Functional Assessment of Cancer Therapy – Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life, Questionnaires will be completed as part of the 6 month assessment | University of Pittsburgh | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 8 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | STUDY19070303|R21CA212628 | 2017-06-01 | 2020-12-31 | 2024-10-01 | 2017-09-18 | 2025-01-10 | UPMC Shadyside, Pittsburgh, Pennsylvania, 15232, United States | ||
| NCT03284346 | Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors | https://clinicaltrials.gov/study/NCT03284346 | This randomized pilot clinical trial studies how well circuit, interval-based aerobic and resistance exercise works in targeting metabolic dysregulation in stage I-III breast or prostate cancer survivors. Circuit, interval-based aerobic and resistance exercise may help to improve cardiovascular fitness, weight loss, healthy lifestyle behaviors, and muscle strength in breast or prostate cancer survivors. | NO | Cancer Survivor|No Evidence of Disease|Obesity|Overweight|Prostate Carcinoma|Sedentary Lifestyle|Stage I Breast Cancer|Stage IA Breast Cancer|Stage IB Breast Cancer|Stage II Breast Cancer|Stage IIA Breast Cancer|Stage IIB Breast Cancer|Stage III Breast Cancer|Stage IIIA Breast Cancer|Stage IIIB Breast Cancer|Stage IIIC Breast Cancer | BEHAVIORAL: Exercise Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Laboratory Biomarker Analysis|DEVICE: Monitoring Device|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Change in insulin resistance, Homeostasis Model Assessment (HOMA) will be used to estimate insulin resistance using fasting plasma levels of glucose and insulin., Baseline up to week 34|Change in metabolic syndrome (Blood Pressure), Blood pressure will be measured using an automated device with an appropriate sized cuff (Omron BP 786, Lake Forest, IL) after the participant has sat quietly for 5 minutes while resting his/her arm on a table so the brachial artery is level with the heart., Baseline up to week 34|Change in metabolic syndrome (Waist Circumference), A tape measure will be used to obtain waist circumference defined as the distance around the waist using the umbilicus as the reference point., Baseline up to week 34|Change in metabolic syndrome (Fasting Plasma Levels of Glucose), The investigators will assess fasting plasma levels of glucose at baseline, weeks 9, 18 and 34., Baseline up to week 34|Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol), The investigators will assess high-density lipoprotein-cholesterol levels at baseline, weeks 9, 18 and 34., Baseline up to week 34|Change in metabolic syndrome (Triglycerides), The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34., Baseline up to week 34 | University of Southern California | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 23 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 0S-17-5|NCI-2017-01426|0S-17-5|P30CA014089 | 2017-08-17 | 2019-07-15 | 2019-07-15 | 2017-09-15 | 2020-05-12 | USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States | |||||
| NCT03285152 | A Study of Ketogenic Diet in Newly Diagnosed Overweight or Obese Endometrial Cancer Patients | https://clinicaltrials.gov/study/NCT03285152 | The purpose of this study is to test any good and bad effects of an experimental diet, called a ketogenic diet, in endometrial cancer. A ketogenic diet is one that is very low in carbohydrates (simple and complex sugars). The goal of this diet is for the body to go into a state of ketosis. Ketosis is when the body does not have enough sugar for energy so it burns stored fats which create acids called ketones, which can be used for energy. Researchers hope to learn whether or not a ketogenic diet is well-tolerated and safe to eat before surgery in endometrial cancer patients. | NO | Endometrial Cancer | OTHER: Ketogenic Diet (KD)|OTHER: Standard Diet (SD) | number of patients that complete the study, 2 years | Memorial Sloan Kettering Cancer Center | Weill Medical College of Cornell University|New York University | FEMALE | ADULT, OLDER_ADULT | NA | 19 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 17-396 | 2018-02-19 | 2025-08-11 | 2025-08-11 | 2017-09-15 | 2024-10-21 | Memorial Sloan Kettering Basking Ridge (Consent and Follow up), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Consent and follow-up only), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (Consent and Follow up), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (Consent & Follow Up), Harrison, New York, 10604, United States|New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (Consent and Follow-up), Rockville Centre, New York, 11570, United States | |||||
| NCT03270111 | High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women | https://clinicaltrials.gov/study/NCT03270111 | The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction. | NO | Breast Cancer Female | BEHAVIORAL: Supervised Exercise|BEHAVIORAL: Home-based Exercise|BEHAVIORAL: Reduced Energy Diet|BEHAVIORAL: Group Phone Calls | Adherence to supervised exercise sessions, Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant., Week 12 | Percent participants meeting physical activity goal, Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear., Week 12 | Carol Fabian, MD | FEMALE | ADULT, OLDER_ADULT | NA | 11 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | STUDY00141301 | 2017-09-25 | 2018-07-24 | 2018-07-24 | 2017-09-01 | 2024-12-18 | University of Kansas Medical Center, Kansas City, Kansas, 66160, United States | |||||
| NCT03261271 | Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy | https://clinicaltrials.gov/study/NCT03261271 | WARRIOR | The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer. | NO | Obesity|Prostate Cancer | BEHAVIORAL: Weight Loss Program|BEHAVIORAL: Standardized educational flyer|BEHAVIORAL: Weight Maintenance Program | Impact of weight loss before and weight maintenance after Prostate Cancer (PCa) surgery on immunosuppressive factors, Impact will be measured by changes in specific blood immune biomarker biomarkers., Change from Baseline to Month 6 | Impact of weight loss before and weight maintenance after PCa surgery on inflammation factors, Impact will be measured by changes in specific blood inflammation biomarkers., Change from Baseline to Month 6|Change in weight, Body weight will be measured at participant study visits., Change from Baseline to Month 6|Change in body composition, Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA)., Change from Baseline to Prior to Surgery, from 4 to 16 weeks|Change in Quality of Life, Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life., Change from Baseline to Month 6 | University of Kansas Medical Center | American Cancer Society, Inc. | MALE | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | STUDY00141060|RSG-17-050-01-NEC | 2017-08-28 | 2023-11-28 | 2025-02-28 | 2017-08-24 | 2024-09-19 | University of Kansas Medical Center, Kansas City, Kansas, 66160, United States | |||
| NCT03229408 | Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction | https://clinicaltrials.gov/study/NCT03229408 | TIN-PCOS-AOD | Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovaries. Insulin resistance (IR) is a common feature of PCOS, and the resultant hyperinsulinemia is theorized to promote hyperandrogenism in the disorder. However, 30-50% of women with PCOS who are lean do not have insulin resistance. Women with PCOS also exhibit chronic low-grade inflammation. In PCOS, glucose ingestion activates nuclear factor ĸB (NFĸB), the cardinal signal of inflammation culminating in upregulation of the inflammation pathway within mononuclear cells (MNC). This phenomenon is independent of excess adiposity and is highly correlated with circulating androgens. In addition, in vitro exposure to proinflammatory stimuli is capable of directly stimulating ovarian theca cell androgen production. Nonacetylated salicylates suppress NFĸB activation and are well tolerated in humans. The proposed research is a randomized double-blind placebo-controlled study of 90 women with PCOS. Forty-five subjects with PCOS (15 lean without IR), 15 lean with IR and 15 obese) receiving salsalate, a nonacetylated salicylate, at an oral dose of 3-4 gm daily for 12 weeks will be compared with 45 age- and body-composition-matched control women with PCOS receiving placebo. The overarching hypothesis is that inflammation contributes to ovarian dysfunction, independent of excess adiposity or IR. The specific aims are, I: To examine the effect of salsalate administration on the ovarian capacity to secrete androgen and on insulin sensitivity in PCOS. II: To examine the effect of salsalate administration on the inflammatory response of mononuclear cells induced by lipid ingestion and glucose infusion in PCOS. The approach involves evaluation of ovarian androgen secretion in response to human chorionic gonadotropin (HCG) administration and insulin sensitivity during the euglycemic phase of a two-step pancreatic clamp along with ovulation monitoring before and after salsalate administration. The inflammatory response of MNC to lipid ingestion and the hyperglycemic phase of the two-step clamp will also be evaluated during treatment by measuring reactive oxygen species, the mRNA and protein content of inflammation markers, NFĸB activation and cytokine release in culture. The investigators expect that women with PCOS receiving salsalate will exhibit decreased ovarian androgen secretion and reduced inflammation regardless of adiposity or IR status. These results will be significant if they show a causal contribution of inflammation to ovarian dysfunction in PCOS, thus improving our understanding of the pathogenesis of PCOS, opening previously unexplored therapeutic avenues that are not necessarily dependent on improving IR, and guiding the design of future studies aimed at determining what interventions will optimally attenuate inflammation in PCOS to reduce medical disease and enhance fertility. | NO | Polycystic Ovary Syndrome | DRUG: Salsalate|OTHER: Placebo | Aim 1: Area under the curve (AUC) for circulating testosterone from serial measurements during HCG stimulation test, Serum ovarian androgen measurement, Change from pre-treatment baseline after 12 weeks of salsalate administration|Aim 2: Maximum lipid-stimulated mononuclear cell nuclear factor ĸB activation during cream challenge test, Transcription factor that is the cardinal signal of inflammation, Change from pre-treatment baseline after 12 weeks of salsalate administration | Aim1: Fractional glucose disappearance / insulin concentration unit during insulin-modified frequently-sampled intravenous tolerance test adjusted for hepatic and peripheral insulin clearance, Peripheral insulin sensitivity measurement, Change from pre-treatment baseline after 12 weeks of salsalate administration | University of Illinois at Chicago | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | FEMALE | ADULT | PHASE2 | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE | 2017-0476|R01DK107605-01 | 2018-12-05 | 2024-02-14 | 2024-02-28 | 2017-07-25 | 2024-06-25 | Frank González, Chicago, Illinois, 60612, United States | |||
| NCT03194516 | Ketogenic Diet and Prostate Cancer Surveillance Pilot | https://clinicaltrials.gov/study/NCT03194516 | GCC 1717 | Men with indolent forms of prostate cancer are managed expectantly using active surveillance, with a goal of delaying treatment and its deleterious side effects. However, almost 50% of men experience progression with this approach and require treatment. Elevated body mass index (BMI) is associated with a dramatically increased risk of progression to higher grade prostate cancer. The goal of the proposed research is to gather preliminary data evaluating the effects of a promising dietary strategy to delay cancer progression in overweight and obese prostate cancer patients undergoing active surveillance. The investigators hypothesize that a ketogenic diet intervention may reduce BMI and favorably alter the prostate microenvironment. | NO | Prostate Cancer | OTHER: Surveillance | Weight loss, 8 weeks | Changes in Testosterone Level, 8 weeks|Changes in Estrogen Level, 8 weeks|Changes in TNF-Alpha Level, 8 weeks|Changes in C-Reactive Protein Level, 8 weeks|Changes in PSA Level, 8 weeks|Changes in High Density Lipoprotein (HDL), 8 weeks|Changes in Low Density Lipoprotein (LDL), 8 weeks|Changes in Triglyceride Level, 8 weeks|Changes in Total Cholesterol Level, 8 weeks|Changes in Fasting Glucose Level, 8 weeks|Changes in Leptin Level, 8 weeks|Changes in Fasting Insulin Level, 8 weeks|Changes in Prostate Tissue Metabolomic Profile, 8 weeks|Changes in Prostate Tissue DNA Methylation, 8 weeks | University of Maryland, Baltimore | MALE | ADULT, OLDER_ADULT | 12 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | HP-00072961 | 2017-06-12 | 2019-01-09 | 2019-11-13 | 2017-06-21 | 2021-04-05 | University of Maryland GCCC, Baltimore, Maryland, 21201, United States | |||||
| NCT03169023 | Scale Down for Endometrial Cancer | https://clinicaltrials.gov/study/NCT03169023 | This proposal will pilot a weight management program for patients with endometrial cancer, the cancer most associated with obesity. If successful, this pilot could be expanded to include obese women with other gynecologic cancers (ovarian and cervical) and could be expanded and adapted for use not only upon completion of treatment, but during chemotherapy or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for obese women as a practical cancer prevention strategy for obesity-associated cancers. | NO | Endometrial Cancer|Cancer of the Endometrium | BEHAVIORAL: ScaleDown|BEHAVIORAL: Enhanced Usual Care Packets|OTHER: 12-Item Short Form Health Survey|OTHER: International Physical Activity Questionnaire short form|OTHER: Multidimensional Body Self Relations Questionnaire – Appearance Subscales|OTHER: Cancer-Related Body Image Scale|OTHER: Patient Health Questionnaire 9-Item Version|BEHAVIORAL: iOTA | Mean weight loss compared between the two arms, -The purpose will be to obtain estimates for the size of an effect achievable by the experimental intervention in order to power and justify a full-scale trial of a weight management program in women with endometrial cancer., Up to 12 months | Washington University School of Medicine | ScaleDown | FEMALE | ADULT, OLDER_ADULT | NA | 155 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 201701098 | 2017-02-21 | 2019-02-03 | 2019-02-03 | 2017-05-30 | 2019-02-28 | Washington University School of Medicine, Saint Louis, Missouri, 63110, United States | |||||
| NCT03157323 | Low GI Diet in Children and Adolescents With ALL | https://clinicaltrials.gov/study/NCT03157323 | The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia. | NO | Acute Lymphoblastic Leukemia, Pediatric|Obesity, Pediatric | BEHAVIORAL: Low Glycemic Index Diet | Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL., Feasibility will be measured by compliance to a low glycemic index diet, which will be measured via 24 dietary recall, using the Automated Self-Administered 24-Hour Dietary Assessment Tool. A dietary recall will be taken at 7 timepoints from diagnosis to end of treatment; each recall will be defined categorically as high compliance (GI score \<55), moderate compliance (GI score 56-69) and low compliance (GI score \>70). Change in glycemic index score will show compliance., 6 months | Columbia University | American Cancer Society, Inc.|Gabrielle’s Angel Foundation | ALL | CHILD, ADULT | NA | 88 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | AAAQ9790 | 2017-06-01 | 2023-06-01 | 2026-06 | 2017-05-17 | 2024-02-15 | Connecticut Children’s Medical Center, Hartford, Connecticut, 06106, United States|Children’s National Hospital, Washington, District of Columbia, 20010, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|Columbia University, New York, New York, 10032, United States|Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States | |||||
| NCT03152591 | Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT03152591 | PCOS | The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women. | YES | Polycystic Ovary Syndrome | DRUG: LIK066|DRUG: Placebo | Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline, Baseline, Day 15 | Change From Baseline in Luteinizing Hormone (LH) at Day 15, Baseline, Day 15|Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15, Baseline, Day 15|Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15, Baseline, Day 15|Change From Baseline in Androstenedione at Day 15, Baseline, Day 15|Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15, Baseline, Day 15|Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15, Baseline, Day 15|Change From Baseline in Total Testosterone, at Day 15, Baseline, Day 15|Change From Baseline in Free Androgen Index (FAI), at Day 15, Free Androgen Index (FAI) is a ratio used to determine abnormal androgen status in humans. The ratio is the total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by 100. FAI has no units., Baseline, Day 15 | Novartis Pharmaceuticals | FEMALE | ADULT | PHASE2 | 29 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE | CLIK066X2205|2017-001373-16 | 2017-07-24 | 2018-06-25 | 2018-06-25 | 2017-05-15 | 2019-05-09 | 2021-01-05 | Novartis Investigative Site, Springfield, Missouri, 65802, United States|Novartis Investigative Site, Philadelphia, Pennsylvania, 19104, United States|Novartis Investigative Site, Berlin, 10117, Germany|Novartis Investigative Site, Essen, 45147, Germany|Novartis Investigative Site, Freiburg, 79106, Germany | Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/91/NCT03152591/SAP_000.pdf|Study Protocol, https://cdn.clinicaltrials.gov/large-docs/91/NCT03152591/Prot_001.pdf | ||
| NCT03150381 | Promoting Weight-Loss in African American Cancer Survivors in the Deep South | https://clinicaltrials.gov/study/NCT03150381 | DSNCARES | This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama. | NO | Weight Loss|Cancer | BEHAVIORAL: Weight Loss Only|BEHAVIORAL: Weight Loss Plus|BEHAVIORAL: Control | Weight, Measured weight (nearest kg), Baseline to 6 months | Waist Circumference, Measured circumference (nearest cm), Baseline to 24 months|Lipids, Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL), Baseline to 24 months|Blood Pressure, Measured blood pressure (mmHG) – systolic and diastolic, Baseline to 24 months|Weight, Measured weight (nearest kg), Baseline to 12 months|Weight, Measured weight (nearest kg), Baseline to 24 months|Social Support for Diet and Exercise Behaviors, self report measure of social support (family, friend) in performing diet and exercise behaviors, Baseline to 6 months|Social Support for Diet and Exercise Behaviors, self report measure of social support (family, friend) in performing diet and exercise behaviors, Baseline to 12 months|Social Support for Diet and Exercise Behaviors, self report measure of social support (family, friend) in performing diet and exercise behaviors, Baseline to 24 months|Self Efficacy for Diet and Exercise Behaviors, self report measure of confidence in performing diet and exercise behaviors, Baseline to 6 months|Self Efficacy for Diet and Exercise Behaviors, self report measure of confidence in performing diet and exercise behaviors, Baseline to 12 months|Self Efficacy for Diet and Exercise Behaviors, self report measure of confidence in performing diet and exercise behaviors, Baseline to 24 months|Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24), self report measure of dietary intake, Baseline to 6 months|Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24), self report measure of dietary intake, Baseline to 12 months|Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24), self report measure of dietary intake, Baseline to 24 months | University of Alabama at Birmingham | ALL | ADULT, OLDER_ADULT | NA | 369 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | X120329018 | 2012-05-01 | 2018-03-31 | 2018-03-31 | 2017-05-12 | 2018-05-16 | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States | ||||
| NCT03120390 | Physical Activity in Reducing Metabolic Dysregulation (MetD) in Obese Latina Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT03120390 | This randomized phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast cancer. | NO | Cancer Survivor|Central Obesity|No Evidence of Disease | OTHER: Best Practice|BEHAVIORAL: Exercise Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Laboratory Biomarker Analysis|DEVICE: Monitoring Device|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Change in MetD, Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline., From week 25 to week 49 | Change in cardiorespiratory fitness, Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake., Baseline to week 49|Change in functional capacity, 1). Hand grip strength: Grip strength will be measured using a hand-held dynamometer on the participant’s dominant hand. The subject will be asked to grip the handle of the dynamometer with one hand using as much grip pressure as possible while holding for 2 seconds; 2). Y Balance Test: All subjects will be required to complete the Y Balance by standing on a single limb and reach as far as possible with the opposite limb; 3). Modified Margaria-Kalamen Step Test will be used to test leg muscle power. Subjects will climb a flight of 10 stairs as quickly as possible, without missing a stair and will be evaluated based on time-to-completion and accuracy of completing all steps, given a total of 3 chances to complete the test as quickly as possible., Baseline to week 49|Change in muscle strength, The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention., Baseline to week 49 | University of Southern California | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 1B-15-6|NCI-2017-00532|1B-15-6|P30CA014089 | 2019-03-08 | 2019-07-31 | 2019-07-31 | 2017-04-19 | 2020-12-17 | USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States | ||||
| NCT03111680 | Healthy Families to Change Obesity in Public Housing Residents | https://clinicaltrials.gov/study/NCT03111680 | This is a cluster randomized study of an environmental level intervention to improve nutrition and physical activity, among public housing residents. Followup was one year post baseline | NO | Breast Cancer | OTHER: environmental intervention | healthy eating, fruit and vegetable servings per day, in the last three months|healthy physical activity, time spent doing moderate physcial activity, in the last three months | University of Washington | Boston University | FEMALE | ADULT, OLDER_ADULT | NA | 211 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION | U48DP001922 | 2014-01 | 2015-01 | 2016-01 | 2017-04-13 | 2017-04-14 | University of Washington, Seattle, Washington, 98195, United States | |||||
| NCT03091842 | Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer | https://clinicaltrials.gov/study/NCT03091842 | This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese. | NO | Cancer Survivor|Central Obesity|Estrogen Receptor Positive|Postmenopausal|Progesterone Receptor Positive|Stage I Breast Cancer|Stage IA Breast Cancer|Stage IB Breast Cancer|Stage II Breast Cancer|Stage IIA Breast Cancer|Stage IIB Breast Cancer|Stage III Breast Cancer|Stage IIIA Breast Cancer|Stage IIIB Breast Cancer|Stage IIIC Breast Cancer | BEHAVIORAL: Exercise Intervention|BEHAVIORAL: Exercise Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Informational Intervention|OTHER: Laboratory Biomarker Analysis|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Reduction of adipose tissue inflammation assessed by measuring M1 and M2 adipose tissue macrophages, crown-like structures, and adipose tissue secretion levels of inflammatory cytokines secreted, Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes. Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period. Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month). The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes., Up to 16 weeks | Distant DFS defined as events that are either lethal (death from any cause) or a direct threat to patient survival (distant recurrence or second primary invasive cancer), Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group)., Up to 8 years|Overall survival, Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group)., From randomization to death from any cause, assessed up to 8 years|Recurrence-free interval defined as events directly attributable to the original breast cancer including invasive ipsilateral breast tumor recurrence; local, regional or distant recurrence; and death from breast cancer, A competing risks analysis will be conducted, with death modeled as a competing event, using the Fine-Gray proportional hazards model. Analyses will be presented unadjusted, as well as adjusted for prognostic variables (age, estrogen receptor (ER)/HER2 status, tumor size, presence/number of positive nodes, and surgery (mastectomy vs. breast-sparing)., Up to 8 years|Sarcopenic obesity assessed using dual energy X-ray absorptiometry, Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes. Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period. Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month). The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes., Up to 8 months | Disease free survival (DFS), Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group. Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group). Ancillary analyses will assess associations of inflammation measures with DFS. Results will be presented as hazard ratios, with 95% confidence intervals. Unadjusted and adjusted survival curves will be presented by treatment group., From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years | University of Southern California | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 1B-16-11|NCI-2017-00070|1B-16-11|P30CA014089 | 2019-07-29 | 2024-07-29 | 2025-07-29 | 2017-03-27 | 2019-10-24 | USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States | |||
| NCT03089151 | Denver Garden Environment and Microbiome Study Disease | https://clinicaltrials.gov/study/NCT03089151 | DGEM | An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers. | NO | Diet Modification|Physical Activity|Weight Gain|Chronic Disease|Lifestyle, Sedentary|Health Behavior | BEHAVIORAL: Community Garden Intervention | Change in fruit and vegetable intake from baseline at 20 weeks, 6 24-hour diet recalls will be collected at random, Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)|Change in sedentary time behavior from baseline at 20 weeks, Accelerometers will be adhered to thigh and collect data for 7 days, 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)|Change in bacterial load from baseline at 20 weeks, Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples, Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)|Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks, Accelerometers will be adhered to thigh and collect data for 7 days, 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)|Change in weight (kg) from baseline at 20 weeks, Objective measurements of weight will be collected, 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)|Change in waist circumference from baseline at 20 weeks, Objective measurement of waist circumference, 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)|Change in pathogenic taxa from baseline at 20 weeks, Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples, Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)|Change in taxonomic diversity from baseline at 20 weeks, Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples, Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)|Change in relative dominance from baseline at 20 weeks, Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples, Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)|Change in indicator taxa from baseline at 20 weeks, Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples, Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)|Change in Inflammatory biomarkers from baseline at 20 weeks, Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10, 20 weeks | Change in HbA1C from baseline at 20 weeks, 20 weeks|Change in blood pressure from baseline at 20 weeks, 20 weeks|Change in lipid profile from baseline at 20 weeks, Including LDL, HDL, total cholesterol, triglycerides, 20 weeks | University of Colorado, Boulder | ALL | ADULT, OLDER_ADULT | NA | 16 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 16-0138, 16-0424 | 2016-06-02 | 2017-12-15 | 2017-12-30 | 2017-03-24 | 2021-05-07 | University of Colorado Boulder, Boulder, Colorado, 80303, United States | ||||
| NCT03089177 | Community Activation for Prevention (CAPs): A Study of Community Gardening | https://clinicaltrials.gov/study/NCT03089177 | CAPs | The investigators previous studies show that community gardening is associated with reduction of key health behaviors for cancer prevention in diverse populations. Community gardeners eat more fruits and vegetables per day, are more physically active, and are more likely to avoid age-associated increase in body mass index (BMI). The effect is partially explained by the finding that gardeners are more socially involved, and feel more social support than non-gardeners. The investigators propose a randomized controlled trial to determine whether community gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult population and elucidate the pathways that shape cancer-preventive behaviors. A randomized controlled trial is needed to demonstrate that the observed behavioral differences are due to the effect of gardening as an intervention rather than self-selection by gardeners. | NO | Cancer|Obesity|Lifestyle, Sedentary|Physical Activity|Health Behavior|Chronic Disease|Diet Modification | BEHAVIORAL: Community Garden Intervention | Change in fruit and vegetable intake from baseline at 20 weeks and 52 weeks, 9 24-hour diet recalls will be collected randomly, Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)|Change in sedentary time from baseline at 20 weeks and 48 weeks, Accelerometers will be adhered to thigh and collect data for 7 days, 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)|Change in fiber Intake from baseline at 20 weeks and 52 weeks, 9 24-hour diet recalls will be collected randomly, Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)|Change in Healthy Eating Index (HEI) from baseline at 20 weeks and 52 weeks, 9 24-hour diet recalls will be collected randomly, Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)|Change in moderate-to-vigorous physical activity (MVPA) from baseline to 20 weeks, Accelerometers will be adhered to thigh and collect data for 7 days, 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)|Change in waist circumference from baseline to 20 weeks and 52 weeks, Measurement of waist circumference (cm), 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)|Change in weight (kg) from baseline to 20 weeks and 52 weeks, Objective measurement of weight will be collected, 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52) | Change in Perceived Stress from baseline to 20 weeks and 52 weeks, Validated scale of perceived stress will be completed, 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52) | University of Colorado, Boulder | Michigan State University|Colorado School of Public Health|University of South Carolina|Colorado State University|Denver Urban Gardens | ALL | ADULT, OLDER_ADULT | NA | 296 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 16-0644 | 2017-01-01 | 2020-07-30 | 2021-06-30 | 2017-03-24 | 2021-05-07 | University of Colorado Boulder, Boulder, Colorado, 80303, United States | |||
| NCT03082157 | Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities | https://clinicaltrials.gov/study/NCT03082157 | Mighty Men is a 6-month faith-based weight-loss intervention for obese African American men 35-74 years old being conducted in Nashville, TN. | NO | Weight Loss | BEHAVIORAL: Mighty Men Intervention | Weight Loss, The Primary outcome is change in weight loss at 6-months post-baseline., 6 months post-baseline | Dietary patterns, Dietary patterns will be assessed using tools to measure fruit and vegetable intake and fat intake. Fruit and vegetable intake will be assessed using servings of fruits and vegetables consumed per day assessed with two brief frequency measures., 6 months post-baseline | Vanderbilt University | American Cancer Society, Inc. | MALE | ADULT, OLDER_ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 191252 | 2017-10-27 | 2021-06-30 | 2021-06-30 | 2017-03-17 | 2021-04-23 | Vanderbilt University, Nashville, Tennessee, 37232, United States | ||||
| NCT03049462 | The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists | https://clinicaltrials.gov/study/NCT03049462 | Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages 18-40 with a body mass index between 18 and 40 Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Dietitian interview Participants will have an overnight baseline visit. This includes: Repeats of screening tests Exercise test Scans. For one scan, a radioactive substance is injected into the arm. FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other. Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature. Optional fat biopsy: A small piece of tissue is removed with a needle. Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo. All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests. Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests. Participants will keep food and medication diaries. Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests. | NO | Polycystic Ovary Syndrome | DRUG: Mirabegron|OTHER: B Complex Plus Vitamin C Tablets | Cohorts 1 and 2: Change in BAT metabolic activity, Change in brown adipose tissue (BAT) metabolic activity as measured by 18FFDG PET/CT, 4 weeks|Cohort 3: Change in insulin sensitivity, Change in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp, 4 weeks | Identify changes in metabolic health arising from BAT activation and/or prolonged treatment with mirabegron, Change in metabolic health parameters including body weight, fat mass, glucose tolerance, changes in levels of hormones, and improved liver function, 4 weeks|Cohort 3: Changes in BAT metabolic activity, Change in brown adipose tissue (BAT) metabolic activity as measured by 18FFDG PET/CT, 4 weeks|Cohorts 1 and 2: Changes in insulin sensitivity, Changes in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp, 4 weeks | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ALL | ADULT | PHASE1 | 100 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE | 170054|17-DK-0054 | 2017-03-13 | 2026-09-30 | 2026-09-30 | 2017-02-10 | 2024-12-27 | National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States | |||||
| NCT03042897 | Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer | https://clinicaltrials.gov/study/NCT03042897 | This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer. | NO | Estrogen Receptor Positive|Obesity|Progesterone Receptor Positive|Stage I Uterine Corpus Cancer|Stage IA Uterine Corpus Cancer|Stage IB Uterine Corpus Cancer | DIETARY_SUPPLEMENT: Dietary Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Laboratory Biomarker Analysis|OTHER: Quality-of-Life Assessment | Cardiorespiratory Fitness (CRF), Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake., Up to 34 weeks|Cardiovascular (CV) health outcomes, Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound. The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques., Up to 34 weeks|Depression measured by Center for Epidemiologic Studies Depression scale, Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21)., Up to 34 weeks|Fatigue measured by the Brief Fatigue Inventory, Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21)., Up to 34 weeks|Muscle strength, The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention., Up to 34 weeks|Percent weight loss at the completion of the intervention, Each of the 25 women will be classified as having achieve the 10% weight-loss or not. Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated. The mean percent weight loss, as well as the range and quartiles will be calculated. In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g. inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.). This information will guide the design (or redesign of the weight loss program as well as the follow-up studies., At 16 weeks|Quality of Life (QOL), The SF-36 short-form health survey with 36 items will be used to assess physical and mental health. The FACT-En questionnaire will also be used. This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants., Up to 34 weeks | University of Southern California | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 5U-16-1|NCI-2016-01684|5U-16-1|P30CA014089 | 2017-09-08 | 2019-07-31 | 2019-07-31 | 2017-02-03 | 2020-12-17 | USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States | |||||
| NCT03041129 | Post-Prandial Liver Glucose Metabolism in PCOS | https://clinicaltrials.gov/study/NCT03041129 | PLUM | The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS. | YES | Polycystic Ovarian Syndrome|Obesity|Hepatic Steatosis | DIAGNOSTIC_TEST: oral glucose tolerance test|DIAGNOSTIC_TEST: MRI of liver | Hepatic Fat Fraction, Amount of fat in the liver measured by MRI and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver., Measured up to 4 months from enrollment | Hepatic Metabolism Ratios, Percent indirect glucose at 360 minutes following an oral sugar tolerance test (OGTT) with an isotope labeled oral glycerol tracer., Measured up to 4 months from enrollment|Whole Body Insulin Sensitivity, Participants will undergo a 75 gram oral glucose tolerance test, and whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model., Measured up to 4 months from enrollment|Sleep Duration, Sleep duration will be assessed using home actigraphy using the Philips Actigraph wrist-worn watch, and collects 7 days of data., Measured up to 4 months from enrollment|Sleep Quality, Apnea Hypopnea Index (AHI) will be measured using WatchPAT. The higher the AHI, indicates more severe sleep apnea. The AHI is the number of times you have apnea or hypopnea during one night, divided by the hours of sleep. Normal sleep: An AHI of fewer than five events, on average, per hour Mild sleep apnea: An AHI of five to 14 events per hour Moderate sleep apnea: An AHI of 15 to 29 events per hour Severe sleep apnea: An AHI of 30 or more events per hour, Measured up to 4 months from enrollment|Hepatic Phosphate Concentrations, 31 phosphorus spectroscopy will be utilized to measure hepatic Phosphodiesterase (PDE)/Total phosphate concentration. This is measured in the MRI using a phosphorus coil., Measured up to 4 months from enrollment | University of Colorado, Denver | FEMALE | CHILD, ADULT | 19 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 16-2399 | 2017-04-14 | 2018-08-29 | 2018-09-29 | 2017-02-02 | 2024-04-17 | 2024-04-17 | University of Colorado Anshutz Medical Campus/Children’s Hospital Colorado, Aurora, Colorado, 80045, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/29/NCT03041129/Prot_SAP_000.pdf | |||
| NCT03029182 | Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility | https://clinicaltrials.gov/study/NCT03029182 | The study will evaluate the utility of hypoxic exercise training to improve cardiovascular and metabolic health among obese breast cancer survivors. While participants exercise, a lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which is believed to support exercise tolerance. Participants are randomized to either the treatment (walking+simulated-altitude) or control (walking under normoxic conditions). | NO | Obesity|Breast Cancer | OTHER: Walking+simulated-altitude|BEHAVIORAL: Walking (control) | Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on retention., number of participants completing the 8 week session, baseline to 8 weeks|Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on adherence to exercise compliance., mean compliance among all participantswith exercise prescription, baseline to 8 weeks|Determine the feasibility of an 8 week exercise intervention comparing walking+simulated-altitude to walking (control) based on number of adverse events., Number of adverse events in each group, baseline to 8 weeks | The effect sizes for walking+simulated-altitude and walking (control) as measured by a 6 minute walk., 6 minute walk test, a valid and reliable tool in cancer survivors will be used to evaluate cardiovascular health and mobility. Total distance (in meters) covered over the duration of 6 minutes will be recorded., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by the cardiorespiratory fitness., Cardiorespiratory fitness, will be measured by indirect calorimetry during a graded walking test on a treadmill to estimate peak aerobic capacity., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by arterial elasticity., Arterial elasticity, will be measured by local pulse contour analyses (HDI/Pulse Wave), A non-invasive procedure based on a modified Windkessel model which permits the evaluation of vascular health., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by resting heart rate variability., Heart rate variability, will be determined by R-to-R interval variations in heart rate, used to index sympatho-vagal balance., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by the fasting glucose., Typically, a “normal” blood sugar level is identified by experts as anything less than 100 mg/dL after a period of fasting., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by C-reactive protein (mg/L) serum assays., Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by tumor-necrosis factor-alpha (pg/mL) assays., Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-6 (pg/mL) serum assays., Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by interleukin-10 (pg/mL) serum assays., Serum assays, will be measured following an overnight to evaluate metabolic and cardiovascular health. Standards practices will be implemented., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by body composition (% body fat)., Body composition, will be measured by dual-energy X-ray absorptiometry during which participants will be scanned while lying supine in light clothing with their arms at their sides., baseline to 8 weeks|The effect sizes for walking+simulated-altitude and walking (control) as measured by free-living physical activity., Free-living physical activity, will be measured by a triaxial accelerometer (e.g., Actigraph GT3X). Participants will wear the accelerometer on the hip of their non-dominant side during waking periods and around the wrist when sleeping according to a previously published protocol., baseline to 8 weeks | University of Alabama at Birmingham | FEMALE | ADULT, OLDER_ADULT | NA | 15 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | F160215001 | 2016-10 | 2018-03 | 2018-04 | 2017-01-24 | 2018-05-14 | University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States | |||||
| NCT02969291 | A Home-Based Study to Enhance Activity in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT02969291 | There is a well-documented association between physical activity \& risk for breast cancer development and recurrence. It is known that exercise interventions have been effective at increasing physical activity levels in breast cancer survivors. Knowing that breast cancer survivors are less active than non-cancer patients, a less active lifestyle places them at risk of obesity and poor overall health, which in turn also increases risk of cancer and cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known that hormones and other inflammatory markers play a role. This study has three goals: 1. To investigate the feasibility of a home intervention designed to reduce sedentary behavior. 2. Describe the effects of the intervention on levels of sedentary behavior, physical activity, and symptoms. 3. Assess cost of the intervention. | NO | Breast Cancer | BEHAVIORAL: Reduced Sedentary Time Intervention (RSTI) | Sedentary Time, Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention., 8 weeks | Activity Level, Change in Activity level as recorded by Actigraph monitor in all 25 participants, 8 weeks|Glucose, Change in fasting glucose ( mmol/L)in all 25 participants, 8 weeks|Insulin, Change in insulin (pmol/L) in all 25 participants, 8 weeks|Total cholesterol, Change in total cholesterol (mmol) in all 25 participants, 8 weeks|High density lipoprotien cholesterol, Change in high density lipoprotein cholesterol (mmol) in all 25 participants, 8 weeks|Triglyceride, Change in triglycerides (mmol) in all 25 participants, 8 weeks|Body Mass Index, Change in Body Mass Index (kg/m2) in all 25 participants, 8 weeks|Waist Circumference, Change in waist circumference in cm in all 25 participants, 8 weeks|Systolic Blood pressure, Change in systolic blood pressure measured in mmHg in all 25 participants, 8 weeks|Diastolic Blood pressure, Change in diastolic blood pressure measured in mmHg in all 25 participants, 8 weeks|Cancer-related fatigue measured by change in PROMIS short form 8a in all 25 participants, 8 weeks|Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants, 8 weeks|Sedentary behavior self -efficacy, Change in Sedentary Behavior Self-Efficacy Scale (modified from BARSE) in all 25 participants, 8 weeks|Change in EORTC-QLQ-C30 scores in all 25 participants, 8 weeks|Assessment of Intervention, Change in Assessment of Intervention questions on a scale of 1-5 in all 25 participants, 8 weeks | Baystate Medical Center | University of Massachusetts, Amherst | FEMALE | ADULT, OLDER_ADULT | NA | 13 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 776553-5 | 2016-10 | 2018-10 | 2018-10 | 2016-11-21 | 2019-07-17 | Baystate Medical Center, Springfield, Massachusetts, 01109, United States | ||||
| NCT02960542 | HELP Prevent Cancer Pilot Study | https://clinicaltrials.gov/study/NCT02960542 | HELP PC | This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer. | NO | Obesity|Cancer | BEHAVIORAL: HELP Prevent Cancer Intervention | Recruitment of 20 eligible study participants, Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled), 6 months|Retention of study participants, Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention), 6 months|Attendance at group sessions, Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance), 6 months | Blood Pressure, Estimate the means and standard deviations at baseline and 6 months., 6 months|Weight, Estimate the means and standard deviations at baseline and 6 months., 6 months|Glucose, Estimate the means and standard deviations at baseline and 6 months., 6 months|Insulin, Estimate the means and standard deviations at baseline and 6 months., 6 months|Cholesterol, Estimate the means and standard deviations at baseline and 6 months., 6 months | Wake Forest University Health Sciences | Virginia Polytechnic Institute and State University|Danville Regional Medical Center | ALL | ADULT, OLDER_ADULT | NA | 21 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | IRB00039102 | 2017-06-26 | 2018-04-04 | 2018-04-04 | 2016-11-09 | 2020-06-19 | Danville Regional Medical Center, Danville, Virginia, 24541, United States | |||
| NCT02940470 | Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT02940470 | The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence. | NO | Breast Cancer|Obesity|Overweight | OTHER: Calorie restricted diet plus exercise|OTHER: Weight management classes | Change in body weight, 0, 6, 12, 18 weeks | USDA Grand Forks Human Nutrition Research Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 22 | FED | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER | UMN999|U54CA116849|CPRC#2008NTLS107 | 2009-01 | 2010-01 | 2010-08 | 2016-10-21 | 2018-08-03 | University of Minnesota, Minneapolis, Minnesota, 55455, United States | |||||
| NCT02938780 | Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT02938780 | Preventing or reducing obesity is one factor that has been hailed as a way to improve quality of life, reduce recurrence, and increase survival rates among breast cancer survivors. An experienced team of multi-disciplinary researchers has developed an innovative and unique approach to encourage enhanced nutrition and exercise behaviors in this population using principles of behavioral economics. In particular, the use of social norms or exemplars has been shown in other applications to be effective, and if successful in this population could be inexpensively scaled up for widespread adoption. The proposed pilot study develops a system of text messages for social/mobile media that will provide ongoing reinforcement of desired behavior in breast cancer survivors. These messages would focus on achieving compliance with the expert-developed nutrition and exercise recommendations of the American Cancer Society. In the main study, 310 breast cancer survivors will be randomly placed in intervention and control groups for the 12 week study. Behavior change will be measured using established measures of self-reported behavior. In a sub-study, 60 of the breast cancer survivor participants will also provide blood and urine samples so changes in biomarkers can be assessed. The impact of the study will be measured by biomarkers and self-reported survey responses. | NO | Breast Cancer Female | OTHER: placebo text message|OTHER: nutrition physical activity text message | Urinary levels of 8-OHdG, To measure oxidative stress DNA damage. ug/mmol creatinine, 3 months | physical activity, Use physical activity survey, 3 months|Intake of fruit and vegetable behavior, Use food intake record, 3 months|Self-efficacy, Use Self-efficacy survey, 3 months|Serum total antioxidant capacity, To measure total antioxidant concentration (mM), 3 months | Texas Tech University Health Sciences Center | Texas Tech University | FEMALE | ADULT, OLDER_ADULT | NA | 310 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | L15-178 | 2015-06 | 2019-09 | 2019-12 | 2016-10-19 | 2020-01-18 | Texas Tech University Health Sciences Center, Lubbock, Texas, 79430, United States | ||||
| NCT02938312 | Journey to Better Health | https://clinicaltrials.gov/study/NCT02938312 | JTBH | This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study. | NO | Weight Loss | BEHAVIORAL: Weight Loss Only|BEHAVIORAL: Weight Loss Plus | Weight, Measured weight (nearest kg), baseline to 6-months | Waist Circumference, Measured circumference (nearest cm), baseline to 6-months|Blood Pressure, Measured blood pressure (mmHG) – systolic and diastolic, baseline to 6-months|Lipids, Measured lipids – total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio, baseline to 6-months|Weight, Measured weight (nearest kg), baseline to 12-months|Weight, Measured weight (nearest kg), baseline to 24-months|Social Support for Healthy Eating and Exercise, Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated., baseline to 6-months|Social Support for Healthy Eating and Exercise, Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated., baseline to 12-months|Social Support Healthy Eating and Exercise, Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise. Composite and subscale scores are calculated., baseline to 24-months|Self Efficacy for Healthy Eating and Exercise, Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated., baseline to 6-months|Self Efficacy for Healthy Eating and Exercise, Self-report, baseline to 12-months|Self Efficacy for Healthy Eating and Exercise, Self-report questionnaire about confidence in ability to eat healthy and exercise. Composite and subscale scores are calculated., baseline to 24-months|Dietary Intake, 24 hour recall, baseline to 6-months|Dietary Intake, 24 hour recall, baseline to 12-months|Dietary Intake, 24 hour recall, baseline to 24-months|Perceived Stress Scale, Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses., baseline to 6-months|Perceived Stress Scale, Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses., baseline to 12-months|Perceived Stress Scale, Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses., baseline to 24-months | University of Alabama at Birmingham | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 409 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | F100708003|1U54CA153719 | 2010-08 | 2015-04 | 2015-08 | 2016-10-19 | 2016-10-24 | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States | |||
| NCT02935478 | Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation | https://clinicaltrials.gov/study/NCT02935478 | Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not candidates for liver transplantation, depriving them of the best option for cure from HCC. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with cirrhosis and HCC who are not transplant candidates due to morbid obesity, leads to clinically significant weight loss with eligibility for liver transplantation. | NO | Obesity|Weight Loss|Body Weight|Hepatocellular Carcinoma|HCC|Hepatitis C|Cirrhosis | DEVICE: Embospheres Microspheres | Weight, Total body weight loss \> 10 % in 12 months, 12 months | Clinical parameter- Abdominal circumference, Improvement in abdominal circumference measured in centimeters (cm), 12 months|Clinical parameter-Blood pressure, Improvement in blood pressure measured in mmHg, 12 months|Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY), Reduction in serum Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY) measured in pg/mL, 12 months|Laboratory parameter-serum glucose, Reduction in serum glucose levels measured as mg/dL, 12 months|Laboratory parameters- HbA1c, Reduction in HbA1c measures as percentage(%), 12 months|Laboratory parameters-Lipid profile, Improvement in lipid profile measured as mg/dL, 12 months|Number of patients with clinical adverse events, Symptoms: pain, nausea, vomiting ;Adverse effects: Expected and unexpected, 12 months|Number of patients with abnormal endoscopies, Photos and clinical reports analyzed for ulcers, 12 months|Eligibility for liver transplant, Weight loss to lower BMI\< 35 kg/m2 to be eligible for transplant or receive a new liver transplant. Proportion of patients that achieved appropriate weight reduction to be listed for transplantation., 12 months | St. Louis University | ALL | ADULT, OLDER_ADULT | NA | 8 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 27420- HCC | 2017-10-18 | 2024-12 | 2024-12 | 2016-10-17 | 2024-01-22 | Saint Louis University, Saint Louis, Missouri, 63110, United States | |||||
| NCT02923401 | High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer | https://clinicaltrials.gov/study/NCT02923401 | The goal of this research study is to learn if there is a level of exercise training that is more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers are found in the blood/tissue and may be related to your reaction to exercise. This is an investigational study. Up to 72 participants will be enrolled in this study. All will take part at MD Anderson. | NO | Disorders of Breast | OTHER: Exercise|BEHAVIORAL: Questionnaires|BEHAVIORAL: Motivational Session|BEHAVIORAL: Phone Call|OTHER: Printed Materials | Feasibility of High-Intensity Interval Exercise to Offset the Tumor Promoting Effects of Obesity in High-Risk Breast Cancer Participants, Trials judged feasible if: At least 45% of screened patients meet inclusion criteria, 2. At least 50% of patients who meet the inclusion criteria consent, 3. Adherence in HIIT and MICT is larger than 80%, and 4. Retention rate is larger than 80%., 12 weeks | M.D. Anderson Cancer Center | FEMALE | ADULT | NA | 39 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2016-0442|NCI-2016-01938 | 2016-09-30 | 2022-01-05 | 2022-01-05 | 2016-10-04 | 2022-02-28 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | ||||||
| NCT02890030 | The Platinum Study Comparison Group | https://clinicaltrials.gov/study/NCT02890030 | The patients enrolled on this new study will serve as an appropriate comparison group consisting of patients with the diagnosis of germ cell testicular cancer who were cured with surgical resection and did not receive cisplatin-based chemotherapy with a group of patients from another study who did receive cisplatin-based chemotherapy. | NO | Testicular Neoplasms | BEHAVIORAL: Questionnaire | Proportion of patients with ototoxicity, The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study., 1 year after surgery|Proportion of patients with neurotoxicity, The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study., 1 year after surgery | Proportion of patients with obesity, The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study., 1 year after surgery|Proportion of patients with hypertension, The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study., 1 year after surgery|Proportion of patients who use antidepressants/anxiolytics, The proportion of patients from this study will be compared to the proportion of patients with The Platinum Study., 1 year after surgery | Lawrence Einhorn | MALE | ADULT | 102 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IRB No. 1604502652 | 2015-05 | 2017-06-14 | 2017-06-14 | 2016-09-07 | 2020-04-08 | Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States | ||||||
| NCT02871388 | Addressing Modifiable Breast Cancer Risk Factors With Project CONECT | https://clinicaltrials.gov/study/NCT02871388 | The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change. | NO | Weight Loss|Breast Cancer Risk Factors | BEHAVIORAL: CONECT | feasibility-participant engagement and retention, recruitment of 30 participants with 70% retention at 12 weeks, 12 weeks|feasibility-intervention adherence, Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions, 12 weeks | Change in autonomous motivation, Motivation assessment and feedback., 12 weeks and 24 weeks|Steps per day, participants will be asked to use the Fitbit Heart Rate (HR) Physical Activity Monitor to track daily steps and minutes of physical activity., 12 and 24 weeks|Total minutes of weekly physical activity, assessed by 7 day Physical Activity Recall Scale (PAR), 12 and 24 weeks|Daily caloric goals, assessed by Automated Self-Administered (ASA) 24, 12 and 24 weeks | change in waist circumference, waist circumference measured at 12 and 24 weeks., 12 and 24 weeks|weight loss, percent weight loss at 12 weeks, 12 weeks|weight maintenance, for intervention group only, percent weight loss at 24 weeks, 24 weeks | Virginia Commonwealth University | FEMALE | ADULT, OLDER_ADULT | NA | 14 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | MCC-16-12892|HM20008111 | 2017-05-30 | 2019-02-28 | 2019-02-28 | 2016-08-18 | 2019-07-09 | Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, 23298, United States | ||||
| NCT02849743 | Intranasal Oxytocin in Hypothalamic Obesity | https://clinicaltrials.gov/study/NCT02849743 | This research study will test if oxytocin, delivered by nasal spray, will promote weight loss in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The study is divided into two parts. During the first part, subjects will receive either oxytocin or placebo. In the second part, subjects will “cross-over” to receive the other treatment – either oxytocin or placebo. During study visits participants will do blood tests, physical exams, metabolic testing, a MRI scan, and some surveys and questionnaires. | YES | Craniopharyngioma|Hypothalamic Obesity | DRUG: Syntocinon|DRUG: Placebo (for Syntocinon) | Weight Loss, The primary objective of this study is to determine whether treatment with 8 weeks of intranasal OXT (relative to 8 weeks of placebo) will promote weight loss in children and adolescents with brain tumors and hypothalamic obesity syndrome ages 10 to 35 years. Specifically, the primary outcome will be: the difference of the post-treatment weight between the two periods (treatment vs. placebo); the statistical model will include the difference of the baseline weight between the two periods and the sequence (OXT-PBO versus PBO-OXT)., Assessed at the beginning and end of each Intervention Period (Intervention 1: Visit 1 to Visit 4 = 8 Weeks, Intervention 2: Visit 5 to Visit 8 = 8 Weeks) | Peripheral Oxytocin Area Under the Curve (AUC), We will determine the immediate peripheral pharmacokinetics of intranasal oxytocin (versus placebo/endogenous oxytocin). In order to minimize participant burden, each participant had the assessment at one time point with either the low or high dose of oxytocin. And at one point during the placebo block. For this exploratory outcome, visits representing lower dose and higher dose oxytocin were Combined versus lower and higher dose placebo., Assessed during each treatment block: at either initial lower dose at baseline (week 0 & week 12) or increased dose at 2 weeks (week 2 & week 15); 50% of participants at each set. | Cognitive Restraint at Test Meal Attributable to Oxytocin vs Placebo, Cognitive Restraint at Test Meal Attributable to Oxytocin vs Placebo measured using stop-signal task, stop signal reaction time (SSRT). For this exploratory outcome, in order to minimize participant burden, each participant had the assessment at one time point with either the low or high dose of oxytocin. And at one point during the placebo block for comparison., Intervention 1: Week 2 (Low Dose) or Week 4 (High Dose) and Intervention 2: Week 14 (Low Dose) or Week 16 (High Dose)|Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 1 (Week 0 & Week 12), as a % of kcal Offered., Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 1 (Week 0 \& Week 12). Total number of calories consumed during the standardized test meal., Assessed during Intervention 1: Week 0 (Dose 1) and Intervention 2: Week 12 (Dose 1)|Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 2 (Week 2 & Week 14), as a % of kcal Offered., Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 2 (Week 2 \& Week 14). Total number of calories consumed during the standardized test meal., Assessed during Intervention 1: Week 2 (Dose 2) and Intervention 2: Week 14 (Dose 2).|Within Participant Difference After Oxytocin vs After Placebo in Resting Energy Expenditure (kcal/kg Lean Body Mass/Day), Within Participant Difference After Oxytocin vs After Placebo in Resting Energy Expenditure (kcal/kg lean body mass/day). Resting Energy Expenditure (REE) with output of kcal/kg lean body mass/day measured using indirect calorimetry., Assessed at the end of each treatment block: Week 8 & Week 20.|Respiratory Quotient (VCO2/VO2), Within Participant Difference After Oxytocin vs Placebo in Respiratory Quotient (RQ) measured using indirect calorimetry., Assessed at the end of each treatment block: week 8 & week 20.|Within Participant Difference After Oxytocin vs Placebo in % Body Fat, Total % Body Fat measured using dual energy x-ray absorptiometry (DXA)., Assessed at the end of each treatment block: week 8 & week 20.|Skeletal Muscle Oxidative Phosphorylation (OXPHOS) Capacity, Measured using MRI-based post-exercise Creatine Chemical Exchange Saturation Transfer (CrCEST) decline exponential time constant., Assessed at the end of each treatment block.|Within Participant Change in Hyperphagia (Total Score) Attributable to Oxytocin vs Placebo, Measured using the Dykens Hyperphagia Questionnaire. The Dykens Hyperphagia Questionnaire is a 11-item questionnaire with responses on a scale of 1 to 5. 1 = Not a Problem, 5 = Severe or Frequent Problem. The scale includes three domains: hyperphagic behavior, hyperphagic drive, and hyperphagic severity. There is also a total or overall score which is calculated by combining the scores from each domain. Maximum Possible Score: 55, Minimum Possible Score: 11. Higher scores indicated more severe and/or frequent Hyperphagia., Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20).|Within Participant Change in Disinhibition of Eating Attributable to Oxytocin vs Placebo, Within Participant Change in Disinhibition of Eating Attributable to Oxytocin vs Placebo. Measured using the Eating Inventory questionnaire. The Eating Inventory consists of 36 statements where participants respond true or false, 14 questions where participants select a response from 1 (least severe: rarely or not at all) to 4 (most severe: always or very much), one final question askes participants to rate their level of restraint in eating from 1 (no restraint) to 6 (constantly limiting food). The scores are assessed in 3 dimensions: Dietary Restraint (Max Score: 21), Disinhibition (Max Score: 16), and Hunger (Max Score: 14). Within Participant Change in Scores from the Disinhibition of Eating dimension are reported., Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20).|Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo, The National Institute of Neurological Disorders and Stroke (NINDS) quality of life in neurological disorders (Neuro-QoL) scale is a set of self-reported measures to assess health-related quality of life of adults and children. Individuals rate domains on a scale from 1 (Never/Not at all) to 5 (Always/Very Often). Each response is assigned a value. Values are combined for a total raw score, then converted to a T-Scores (cohort-specific mean 50, SD 10). Higher scores on the sub-scale domains indicate more of the entity. Adult and child scores were combined in analyses., Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20)|Within Participant Change in Family Assessment Device-General Function Scale (FAD-GFS) Attributable to Oxytocin vs Placebo, Within Participant Change in Family Assessment Device-General Function Scale (FAD-GFS) Attributable to Oxytocin vs Placebo. The Family Assessment Device (FAD-GFS) includes 12 statements where individuals select from a scale of 4 responses ranging from Strongly Agree (SA) to Strongly Disagree (SD). Each response has a score ranging from 1 to 4, some of the items are reverse scored (i.e. 1 = 4, 2 = 3, 3 = 2, 4 = 1). Minimum Total Score: 12, Maximum Total Score: 48. The scores for each question are added and then divided by the total number of questions. The Minimum Overall Score: 1, Maximum Overall Score: 4. A score of 2 or above is considered dysfunction., Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20).|Within Participant Change in Voluntary Physical Activity Attributable to Oxytocin vs Placebo, Measured using the Bone Mineral Density in Childhood Study (BMDCS) physical activity questionnaire. The Bone Mineral Density in Childhood Study (BMDCS) questionnaire captures the amount of time spent in physical activity. The assessment asks participants to record the number of hours spent in different categories of physical activity (Min: 0 hours per week, Max: 11+ hours per week)., Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20)|Eye-Tracking Task, Amount of time spent viewing socially relevant versus socially irrelevant stimuli during eye-tracking., Assessed at the end of each treatment block.|EEG Task, N170 EEG signal during eye-tracking, Assessed at the end of each treatment block. | Shana McCormack, MD | ALL | CHILD, ADULT | PHASE2 | 18 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | 16-012730 | 2016-10 | 2021-04 | 2022-05 | 2016-07-29 | 2022-10-05 | 2022-10-05 | Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/43/NCT02849743/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/43/NCT02849743/SAP_001.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/43/NCT02849743/ICF_002.pdf | ||
| NCT02843425 | The Beans to Enrich the Gut Microbiome Vs. Obesity’s Negative Effects (BE GONE) Trial | https://clinicaltrials.gov/study/NCT02843425 | You are being asked to take part in this study because either you are a survivor who has a previous history of colorectal cancer or an MD Anderson patient who had a precancerous colorectal polyp or you have a previous history of colorectal cancer, and you have a current adult body mass index (BMI) score of 25 or higher. The BMI score is used as an indicator of the level of body fat, based on height and weight. The goal of this clinical research study is to learn if eating canned, pre-cooked beans can help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk. This is an investigational study. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson. | NO | Colorectal Cancer Prevention | OTHER: Regular Diet|OTHER: Navy Beans (Canned) | Changes in Stool 16S rRNA Gene Profiles, The primary outcome measures will be intra- and inter-individual changes in stool 16S rRNA gene profiles at baseline, week 4 and week 8 for each cross-over period., Baseline to week 8|Changes in Blood Markers and Metabolites, The primary outcome measures will be intra- and inter-individual changes in blood makers and metabolites at baseline, week 8 for each cross-over period., Baseline to week 8 | M.D. Anderson Cancer Center | ALL | ADULT, OLDER_ADULT | NA | 71 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION | 2016-0365|NCI-2016-01191 | 2016-07-25 | 2025-07-31 | 2025-07-31 | 2016-07-25 | 2024-10-16 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | ||||||
| NCT02829554 | Differential Influences of Integral and Incidental Emotion on Cancer-related Judgments and Decision Making | https://clinicaltrials.gov/study/NCT02829554 | Background: Researchers are testing new methods for research projects. They want to see how people respond to different types of communication, including videos. They also want to learn how people respond to life events and how they pay attention to computer tasks. They want to learn about how various risks and threats affect the way people make decisions. Objectives: To learn how different stimuli and events affect the way people make decisions. Eligibility: Adults ages 18 and older with a U.S. computer address Design: Participants will be recruited online. Participants will take one of three studies online. Each study will take about a half hour. Participants in Study 1 will watch a short video from a popular movie then answer questions. They will also complete 2 questionnaires. One will be about how likely they think it is that they will experience different risks and threats. The other will be about goals for behavior change. Participants in Study 2 will write in detail about a life event. Then they will answer questions. They will also complete the same 2 questionnaires as Study 1. Participants in Study 3 will pay close attention to words and images on a computer. They will answer questions about attitudes toward different behaviors, products, and experiences. … | NO | Cancer|Overweight|Obesity | Risk perceptions, Perceived susceptibility to cancer and other threats (self-report), End of protocol|Intentions, Intentions to engage in cancer and other threat-preventive behavior (self-report), End of protocol | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | 6242 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999916142|16-C-N142 | 2016-07-08 | 2016-08-29 | 2020-05-15 | 2016-07-12 | 2020-05-20 | National Cancer Institute (NCI), Bethesda, Maryland, 20892, United States | ||||||||
| NCT02815982 | Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors | https://clinicaltrials.gov/study/NCT02815982 | NOURISH-T | This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care). | YES | Obesity|Cancer | BEHAVIORAL: NOURISH-T|BEHAVIORAL: Enhanced Usual Care | Satisfaction and Exit Survey Composite Scale Score — ONLY CAREGIVERS COMPLETED THIS MEASURE, At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating., 6 weeks | Automated Self-administered 24-Hour Dietary Recall (ASA 24) — CAREGIVERS ONLY MEASURE, A 24-hour recall was completed by caregivers using the Automated Self-administered 24-Hour Dietary Recall-2011 (adult version) at pre-intervention, post-intervention (6-weeks) and at 4 months follow-up. The outcome was measured as the number of calories consumed over 1-day. Caregivers reported detailed information on the foods consumed and quantity including the method used for preparation, portion sizes, and where the food was purchased using visual cues in the previous day through the ASA24 website (https://asa24.nci.nih.gov/). The website reported the total number of calories consumed based on the data input., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Child BMI Percentile — ONLY Pediatric Cancer Survivors (PCS), Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score — ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure, This 8-item questionnaire was completed by the pediatric cancer survivor and assessed child intake of sugar sweetened beverages, breakfast and dinner habits, as well as frequency of fast food intake. The sum score represents the total number of sugary beverages consumed and the number of times consuming fast food in the prior week. Higher scores indicate greater consumption of sugary beverages and fast food in the prior week. The sum score could range from 0 and has no upper limit., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Child Feeding Questionnaire Sum Score — ONLY CAREGIVERS COMPLETED THIS MEASURE, This 31-item questionnaire assesses parental approaches to and attitudes about feeding their children. Sub-scales include concerns about child weight, monitoring, restriction, and pressure to eat. The sum score of the Likert items ranged from 31 to 155 with higher scores indicating greater perceived concern, monitoring, restriction and pressure to eat., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Number of Daily Steps Averaged Over a Week — ONLY Pediatric Cancer Survivors (PCS) Assessed, PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Child Waist to Hip Ratio — ONLY Pediatric Cancer Survivors (PCS) ASSESSED, Measured at the clinic via standardized equipment., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Parent BMI Score — CAREGIVER MEASURE, Measured at the clinic via standardized equipment., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Parent Waist to Hip Ratio — CAREGIVER MEASURE, Measured at the clinic via standardized equipment, Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)|Number of Daily Steps Averaged Over a Week for Caregivers — CAREGIVER MEASURE, PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week., Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) | University of South Florida | University of Pittsburgh|Johns Hopkins All Children’s Hospital | ALL | CHILD | NA | 106 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 5R21CA167259-02 | 2013-12 | 2016-06 | 2016-12 | 2016-06-28 | 2018-09-20 | 2018-09-20 | Johns Hopkins All Children’s Hospital, Saint Petersburg, Florida, 33701, United States|Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States | ||
| NCT02811809 | Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer | https://clinicaltrials.gov/study/NCT02811809 | This study is open to men who have biochemical recurrence (BCR, increased PSA) following local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low levels of red blood cells that can make people feel tired and weak), diabetes (low blood sugar), heart disease, metabolic syndromes (sometimes called “pre-diabetes” and includes obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood), and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given “breaks” from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug. Apalutamide is an investigational drug, which means it has not been approved by the Food and Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study is to determine the ability of Apalutamide to extend the time between the first two injections of leuprolide and improve quality of life. This study will also look at the safety of Apalutamide and the effects that Apalutamide has on prostate cancer. Men will be randomized (like flipping a coin) to receive: * Group A: Leuprolide + Apalutamide or * Group B: Leuprolide only (until second leuprolide injection), then leuprolide + Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken by mouth (4 tablets) daily. Each cycle is 4 weeks long. Intermittent treatment with Apalutamide + leuprolide will continue until continuous leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above undetectable level unless leuprolide is given without pause, every 3 months). | NO | Prostate Cancer | DRUG: Apalutamide|DRUG: IHT | Time to second injection, Time to second injection, 48 months | Time to prostate-specific antigen (PSA) nadir, Time to prostate-specific antigen (PSA) nadir, 48 months|Duration of PSA nadir, Duration of PSA nadir, 48 months|Time to testosterone recovery to >50 ng/dl, Time to testosterone recovery to \>50 ng/dl, 48 months|Duration of testosterone recovery, Duration of testosterone recovery, 48 months|Circulating tumor cell (CTC) enumeration, Circulating tumor cell (CTC) enumeration, 48 months|Time until BCR after discontinuation of Apalutamide and ADT, Time until BCR after discontinuation of Apalutamide and ADT, 48 months|Quality of life as determined by FACT-P survey, Quality of life as determined by FACT-P survey, 48 months|Number of Adverse Events, Number of Adverse Events, 48 months | The University of Texas Health Science Center, Houston | Janssen Scientific Affairs, LLC | MALE | ADULT, OLDER_ADULT | PHASE2 | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT | GU-15-105|HSC-MS-16-0477 | 2020-12 | 2024-12 | 2025-12 | 2016-06-23 | 2020-02-27 | UTHealth Memorial Hermann Cancer Center, Houston, Texas, 77030, United States | ||||
| NCT02774759 | Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers | https://clinicaltrials.gov/study/NCT02774759 | The goal of this research study is to learn if a home-based physical activity program is feasible and can help endometrial cancer survivors lose weight. | NO | Malignant Neoplasms of Female Genital Organs | DEVICE: Accelerometer|BEHAVIORAL: Questionnaires|BEHAVIORAL: Fitness Test|BEHAVIORAL: Resistance Training|BEHAVIORAL: Aerobic Exercise|BEHAVIORAL: Telephone Coaching/Phone Calls|BEHAVIORAL: Video Chat Sessions | Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors, Study considered feasible if consent rate is larger than 40%., 6 months|Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors, Study considered feasible if retention rate is larger than 70%., 6 Months|Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors, Study considered feasible if adherence in NEXT Steps- Aerobic exercise and Resistance Training (NS-ART) and NEXT Steps- Aerobic exercise (NS-A) is larger than 65%., 6 months|Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors, Study considered feasible if the mean overall satisfaction with the program is larger than 3.5 in a 5-level scale., 6 months | Changes in Lean Body Mass, Changes in lean body mass measured by dual-energy x-ray absorptiometry (DXA)., 6 months | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 15 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2015-1076|NCI-2016-00904|5T32CA101642 | 2016-10-17 | 2026-12-31 | 2026-12-31 | 2016-05-17 | 2024-09-19 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | ||||
| NCT02767362 | A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium | https://clinicaltrials.gov/study/NCT02767362 | This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese women who are to undergo surgical staging for endometrial cancer. | NO | Endometrial Cancer | DRUG: Atorvastatin | Absolute difference score, Measurement of the change in tumor proliferation as measured by Ki67 immunohistochemical staining after 2-4 weeks of treatment with atorvastatin. For visual comparisons of pre- and post-treatment measures, informative plots will be generated. For statistical comparisons of pre- and post-treatment measures absolute difference scores will be created. An absolute difference score is the subtraction of a post-treatment measurement from a pre-treatment measurement. The nonparametric Wilcoxon signed-rank tests will be used to examine the significance of the absolute difference scores for each measure of interest., Two Years | UNC Lineberger Comprehensive Cancer Center | Wilma Williams Education and Clinical Research for Endometrial Cancer Award | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 24 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | LCCC 1514 | 2015-11 | 2019-09-26 | 2019-09-26 | 2016-05-10 | 2020-07-07 | University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States | |||||
| NCT02755636 | Pro-Change Population Health Solution | https://clinicaltrials.gov/study/NCT02755636 | PCPHS | Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools designed to assist patients and primary care providers (PCPs) in applying evidence-based principles of health behavior change to reduce four cancer risk behaviors-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-and depression among at-risk patients. The intervention is based on the Transtheoretical Model of Behavior Change (TTM, the “stage model”) and includes computer-tailored interventions and text messages for patients and a clinical dashboard for providers. The efficacy of the intervention will be assessed in a cluster-randomized trial involving 780 patients recruited from 12 federally qualified health centers randomly assigned to intervention or usual care. | NO | Risk Behavior | BEHAVIORAL: PCPHC|OTHER: Usual care | Change in number of cancer risk behaviors, Change in number of cancer risk behaviors will be computed by taking the difference in the count of the four cancer risk behaviors (cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity) from baseline to 12 months follow-up. At each time point, the index will range from 0 to 4, with each risk behavior scored a “1” if present, and “0” if not present (Prochaska, Prochaska, \& Prochaska, 2014)., Baseline, 12 months | Change in consumer engagement, Change in consumer engagement will be computed by taking the difference in scores on the Altarum Consumer Engagement Measure (Duke, Lynch, Smith, \& Winstanley, 2015) from baseline to 12 months follow-up. The measure assesses four dimensions of engagement in healthcare: 1) commitment, 2) informed choice, 3) navigation, and 4) ownership., Baseline, 12 months|Adherence with cancer screenings, Adherence with cancer screenings be the percentage of age- and gender-based U.S. Preventive Services Task Force-recommended screenings received during follow-up., 12 months|Change in satisfaction with medical care, Change in patient satisfaction will be computed by taking the difference in participant scores on a 1-item global rating of satisfaction with care scale from baseline to 12 months follow-up. The scale is taken from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey (Agency for Healthcare Policy and Research, 1999; Hargraves, Hays, \& Cleary, 2003)., Baseline, 12 months|Change in well-being, Change in well-being will be computed by taking the difference in the Cantril Self-Anchoring Scale (Cantril, 1965) from baseline to 12 months follow-up. The measure asks participants to imagine a ladder with steps numbered from zero to ten, with the top representing the best possible life and the bottom representing the worst possible life, and to indicate where they feel their life falls currently and where it will be in five years., Baseline, 12 months|Change in health-related quality of life, Change in well-being will be computed by taking the difference in the Centers for Disease Control and Prevention Healthy Days (2000) Core Measures from baseline to 12 months follow-up. The measures assess overall self-rated health, recent physical symptoms, recent mental and emotional distress, and recent activity limitations., Baseline, 12 months | Change in number of cigarettes smoked per day, Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance), Baseline, 12 months|Progress to the Action stage for smoking cessation, Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance), 12 months|Change in number of alcoholic drinks per week, Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance), Baseline, 12 months|Progress to the Action stage for drinking within recommended limits, Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance), 12 months|Change in level of leisure-time exercise, Will be assessed using Godin’s Leisure-Time Exercise Questionnaire (Godin \& Shephard, 1985) only among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance), Baseline, 12 months|Progress to the Action stage for meeting national guidelines for physical activity, Will only be assessed among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance), 6 months, 12 months|Change in body mass index (BMI), Will be calculated using height and weight only among patients who are overweight (BMI of 25 kg/m2 or higher) at baseline (exploratory analysis; study is not powered to find significance), Baseline, 12 months|Progress to the Action stage for engaging in four key behaviors for healthy weight management, Progress to the Action stage for 1) reducing daily calorie intake by 500 calories/day, 2) limiting saturated and trans fat intake, 3) managing emotional distress, and 4) meeting national guidelines for physical activity will only be assessed among patients who are overweight (BMI of 25 kg/m2 or higher) at baseline (exploratory analysis; study is not powered to find significance), 6 months, 12 months|Change in level of depression, Will be assessed using the Patient Health Questionnaire (PHQ-8) (Kroenke, Strine, Spritzer, Williams, Berry, \& Mokdad, 2009) only among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance), Baseline, 12 months|Progress to the Action stage for managing depression, Will only be assessed among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance), 6 months, 12 months | Pro-Change Behavior Systems | Community Health Center, Inc. | ALL | ADULT, OLDER_ADULT | PHASE2 | 780 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | HHSN261201500015C | 2016-05 | 2017-07 | 2017-07 | 2016-04-29 | 2016-06-02 | Connecticut Health Center, Inc., Middletown, Connecticut, 06457, United States|Pro-Change Behavior Systems, Inc., South Kingstown, Rhode Island, 02879, United States | ||
| NCT02750826 | Breast Cancer WEight Loss Study (BWEL Study) | https://clinicaltrials.gov/study/NCT02750826 | This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment. | NO | Breast Carcinoma | OTHER: Health Education Program|OTHER: Weight Loss Intervention | Invasive disease-free survival, Up to 10 years | Overall survival, Up to 10 years|Distant disease-free survival, Up to 10 years|Change in weight (defined as % change), At baseline, 6, 12, 24 and 60 months|Measures of physical activity (self report and objective), Up to 10 years|Dietary intake (total calorie consumption), Up to 10 years|Occurrence of insulin resistance syndrome complications (diabetes, hospitalizations for cardiovascular disease), Up to 10 years|Changes in biomarker (insulin) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (glucose) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (HOMA) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (leptin) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (adiponectin) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (IGF-1) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (IGFBP3) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (IL-6) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (CRP) associated with breast cancer risk and outcomes, Up to 10 years|Changes in biomarker (TNF-a) associated with breast cancer risk and outcomes, Up to 10 years|Patient reported outcomes – physical functioning, Up to 10 years|Patient reported outcomes – fatigue, Up to 10 years|Patient reported outcomes – depression and anxiety, Up to 10 years|Patient reported outcomes – sleep disturbance, Up to 10 years|Patient reported outcomes – incidence of breast cancer treatment related symptoms, Up to 10 years|Patient reported outcomes – body image, Up to 10 years | Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI)|Division of Cancer Control|NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP)|Canadian Cancer Trials Group | FEMALE | ADULT, OLDER_ADULT | PHASE3 | 3177 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | A011401|NCI-2015-01918|U10CA180821 | 2016-09-16 | 2030-05-30 | 2030-05-30 | 2016-04-26 | 2025-01-13 | Southern Cancer Center PC-Daphne, Daphne, Alabama, 36526, United States|Southern Cancer Center PC-Mobile, Mobile, Alabama, 36607, United States|Southern Cancer Center PC-Providence, Mobile, Alabama, 36608, United States|Southern Cancer Center PC-Springhill, Mobile, Alabama, 36608, United States|Anchorage Associates in Radiation Medicine, Anchorage, Alaska, 98508, United States|Anchorage Radiation Therapy Center, Anchorage, Alaska, 99504, United States|Alaska Breast Care and Surgery LLC, Anchorage, Alaska, 99508, United States|Alaska Oncology and Hematology LLC, Anchorage, Alaska, 99508, United States|Alaska Women’s Cancer Care, Anchorage, Alaska, 99508, United States|Anchorage Oncology Centre, Anchorage, Alaska, 99508, United States|Katmai Oncology Group, Anchorage, Alaska, 99508, United States|Providence Alaska Medical Center, Anchorage, Alaska, 99508, United States|Fairbanks Memorial Hospital, Fairbanks, Alaska, 99701, United States|Kingman Regional Medical Center, Kingman, Arizona, 86401, United States|Cancer Center at Saint Joseph’s, Phoenix, Arizona, 85004, United States|Mayo Clinic Hospital in Arizona, Phoenix, Arizona, 85054, United States|Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States|University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, 85704, United States|Banner University Medical Center – Tucson, Tucson, Arizona, 85719, United States|University of Arizona Cancer Center-North Campus, Tucson, Arizona, 85719, United States|Mercy Hospital Fort Smith, Ft. Smith, Arkansas, 72903, United States|CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, 71913, United States|Baptist Memorial Hospital and Fowler Family Cancer Center – Jonesboro, Jonesboro, Arkansas, 72401, United States|Kaiser Permanente-Anaheim, Anaheim, California, 92806, United States|Kaiser Permanente-Deer Valley Medical Center, Antioch, California, 94531, United States|Mission Hope Medical Oncology – Arroyo Grande, Arroyo Grande, California, 93420, United States|PCR Oncology, Arroyo Grande, California, 93420, United States|Sutter Auburn Faith Hospital, Auburn, California, 95602, United States|Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, 95603, United States|AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, California, 93301, United States|Kaiser Permanente-Baldwin Park, Baldwin Park, California, 91706, United States|Kaiser Permanente-Bellflower, Bellflower, California, 90706, United States|Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, 94704, United States|Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, 91505, United States|Mills-Peninsula Medical Center, Burlingame, California, 94010, United States|Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, 95682, United States|Mercy San Juan Medical Center, Carmichael, California, 95608, United States|Eden Hospital Medical Center, Castro Valley, California, 94546, United States|Enloe Medical Center, Chico, California, 95926, United States|Adventist Health Cancer Care Center Chico, Chico, California, 95973, United States|Sutter Davis Hospital, Davis, California, 95616, United States|City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States|Epic Care-Dublin, Dublin, California, 94568, United States|Kaiser Permanente Dublin, Dublin, California, 94568, United States|Mercy Cancer Center – Elk Grove, Elk Grove, California, 95758, United States|Bay Area Breast Surgeons Inc, Emeryville, California, 94608, United States|Epic Care Partners in Cancer Care, Emeryville, California, 94608, United States|Kaiser Permanente-Fontana, Fontana, California, 92335, United States|Kaiser Permanente-Fremont, Fremont, California, 94538, United States|Palo Alto Medical Foundation-Fremont, Fremont, California, 94538, United States|Kaiser Permanente-Fresno, Fresno, California, 93720, United States|Kaiser Permanente – Harbor City, Harbor City, California, 90710, United States|Kaiser Permanente-Irvine, Irvine, California, 92618, United States|UC San Diego Moores Cancer Center, La Jolla, California, 92093, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Kaiser Permanente-Cadillac, Los Angeles, California, 90034, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|Contra Costa Regional Medical Center, Martinez, California, 94553-3156, United States|Fremont – Rideout Cancer Center, Marysville, California, 95901, United States|Memorial Medical Center, Modesto, California, 95355, United States|Kaiser Permanente-Modesto, Modesto, California, 95356, United States|Palo Alto Medical Foundation-Camino Division, Mountain View, California, 94040, United States|Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040, United States|Sutter Cancer Research Consortium, Novato, California, 94945, United States|Alta Bates Summit Medical Center – Summit Campus, Oakland, California, 94609, United States|Bay Area Tumor Institute, Oakland, California, 94609, United States|Kaiser Permanente-Oakland, Oakland, California, 94611, United States|Kaiser Permanente-Ontario, Ontario, California, 91761, United States|Saint Joseph Hospital – Orange, Orange, California, 92868, United States|Desert Regional Medical Center, Palm Springs, California, 92262, United States|Palo Alto Medical Foundation Health Care, Palo Alto, California, 94301, United States|Kaiser Permanente – Panorama City, Panorama City, California, 91402, United States|Huntington Memorial Hospital, Pasadena, California, 91105, United States|Pomona Valley Hospital Medical Center, Pomona, California, 91767, United States|Eisenhower Medical Center, Rancho Mirage, California, 92270, United States|Mercy Regional Cancer Center, Redding, California, 96001, United States|Mercy Oncology Center, Redding, California, 96002, United States|Kaiser Permanente-Redwood City, Redwood City, California, 94063, United States|Kaiser Permanente-Richmond, Richmond, California, 94801, United States|Kaiser Permanente-Riverside, Riverside, California, 92505, United States|Mercy Cancer Center – Rocklin, Rocklin, California, 95765, United States|Kaiser Permanente-Roseville, Roseville, California, 95661, United States|Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, 95661, United States|Sutter Roseville Medical Center, Roseville, California, 95661, United States|Kaiser Permanente Downtown Commons, Sacramento, California, 95814, United States|Mercy Cancer Center – Sacramento, Sacramento, California, 95816, United States|Sutter Medical Center Sacramento, Sacramento, California, 95816, United States|University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States|Kaiser Permanente-South Sacramento, Sacramento, California, 95823, United States|Kaiser Permanente – Sacramento, Sacramento, California, 95825, United States|Saint Helena Hospital, Saint Helena, California, 94574, United States|Kaiser Permanente-San Diego Mission, San Diego, California, 92108, United States|Kaiser Permanente-San Diego Zion, San Diego, California, 92120, United States|Sharp Memorial Hospital, San Diego, California, 92123, United States|Naval Medical Center -San Diego, San Diego, California, 92134, United States|California Pacific Medical Center-Pacific Campus, San Francisco, California, 94115, United States|Kaiser Permanente-San Francisco, San Francisco, California, 94115, United States|UCSF Medical Center-Mount Zion, San Francisco, California, 94115, United States|UCSF Medical Center-Mission Bay, San Francisco, California, 94158, United States|Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, 95119, United States|Kaiser Permanente San Leandro, San Leandro, California, 94577, United States|Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo, California, 93401, United States|Kaiser Permanente-San Marcos, San Marcos, California, 92078, United States|Mills Health Center, San Mateo, California, 94401, United States|Kaiser Permanente-San Rafael, San Rafael, California, 94903, United States|Kaiser San Rafael-Gallinas, San Rafael, California, 94903, United States|Kaiser Permanente Medical Center – Santa Clara, Santa Clara, California, 95051, United States|Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, 95065, United States|Mission Hope Medical Oncology – Santa Maria, Santa Maria, California, 93444, United States|Kaiser Permanente-Santa Rosa, Santa Rosa, California, 95403, United States|Saint Joseph Heritage Healthcare-Santa Rosa, Santa Rosa, California, 95403, United States|Sutter Pacific Medical Foundation, Santa Rosa, California, 95403, United States|City of Hope South Pasadena, South Pasadena, California, 91030, United States|Kaiser Permanente-South San Francisco, South San Francisco, California, 94080, United States|Kaiser Permanente-Stockton, Stockton, California, 95210, United States|Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, 94086, United States|Torrance Memorial Physician Network – Cancer Care, Torrance, California, 90505, United States|Torrance Memorial Medical Center, Torrance, California, 90509, United States|Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee, California, 96161, United States|City of Hope Upland, Upland, California, 91786, United States|Northbay Cancer Center, Vacaville, California, 95687, United States|Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, 95687, United States|Kaiser Permanente Medical Center-Vacaville, Vacaville, California, 95688, United States|Kaiser Permanente-Vallejo, Vallejo, California, 94589, United States|Sutter Solano Medical Center/Cancer Center, Vallejo, California, 94589, United States|Kaiser Permanente-Walnut Creek, Walnut Creek, California, 94596, United States|Epic Care Cyberknife Center, Walnut Creek, California, 94597, United States|Presbyterian Intercommunity Hospital, Whittier, California, 90602, United States|Kaiser Permanente-Woodland Hills, Woodland Hills, California, 91367, United States|Woodland Memorial Hospital, Woodland, California, 95695, United States|Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, 80012, United States|The Medical Center of Aurora, Aurora, Colorado, 80012, United States|University of Colorado Hospital, Aurora, Colorado, 80045, United States|Boulder Community Hospital, Boulder, Colorado, 80301, United States|Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, 80304, United States|Rocky Mountain Cancer Centers – Centennial, Centennial, Colorado, 80112, United States|Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, 80907, United States|Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, 80907, United States|UCHealth Memorial Hospital Central, Colorado Springs, Colorado, 80909, United States|Memorial Hospital North, Colorado Springs, Colorado, 80920, United States|Cancer Center of Colorado at Sloan’s Lake, Denver, Colorado, 80204, United States|Denver Health Medical Center, Denver, Colorado, 80204, United States|Kaiser Permanente-Franklin, Denver, Colorado, 80205, United States|National Jewish Health-Main Campus, Denver, Colorado, 80206, United States|The Women’s Imaging Center, Denver, Colorado, 80209, United States|Porter Adventist Hospital, Denver, Colorado, 80210, United States|Colorado Blood Cancer Institute, Denver, Colorado, 80218, United States|Presbyterian – Saint Lukes Medical Center – Health One, Denver, Colorado, 80218, United States|Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, 80218, United States|SCL Health Saint Joseph Hospital, Denver, Colorado, 80218, United States|Rocky Mountain Cancer Centers-Rose, Denver, Colorado, 80220, United States|Rose Medical Center, Denver, Colorado, 80220, United States|Mercy Medical Center, Durango, Colorado, 81301, United States|Southwest Oncology PC, Durango, Colorado, 81301, United States|Shaw Cancer Center, Edwards, Colorado, 81632, United States|Mountain Blue Cancer Care Center – Swedish, Englewood, Colorado, 80113, United States|Swedish Medical Center, Englewood, Colorado, 80113, United States|Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States|Cancer Care and Hematology-Fort Collins, Fort Collins, Colorado, 80528, United States|Valley View Hospital Cancer Center, Glenwood Springs, Colorado, 81601, United States|Mountain Blue Cancer Care Center, Golden, Colorado, 80401, United States|National Jewish Health-Western Hematology Oncology, Golden, Colorado, 80401, United States|Saint Mary’s Hospital and Regional Medical Center, Grand Junction, Colorado, 81501, United States|Grand Valley Oncology, Grand Junction, Colorado, 81505, United States|North Colorado Medical Center, Greeley, Colorado, 80631, United States|UCHealth Greeley Hospital, Greeley, Colorado, 80631, United States|Rocky Mountain Cancer Centers-Greenwood Village, Greenwood Village, Colorado, 80111, United States|UCHealth Highlands Ranch Hospital, Highlands Ranch, Colorado, 80129, United States|Good Samaritan Medical Center, Lafayette, Colorado, 80026, United States|Kaiser Permanente-Rock Creek, Lafayette, Colorado, 80026, United States|Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, 80228, United States|Saint Anthony Hospital, Lakewood, Colorado, 80228, United States|Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, 80120, United States|Littleton Adventist Hospital, Littleton, Colorado, 80122, United States|Kaiser Permanente-Lone Tree, Lone Tree, Colorado, 80124, United States|Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, 80124, United States|Sky Ridge Medical Center, Lone Tree, Colorado, 80124, United States|UCHealth Lone Tree Health Center, Lone Tree, Colorado, 80124, United States|Longmont United Hospital, Longmont, Colorado, 80501, United States|Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, 80501, United States|Medical Center of the Rockies, Loveland, Colorado, 80538, United States|McKee Medical Center, Loveland, Colorado, 80539, United States|Parker Adventist Hospital, Parker, Colorado, 80138, United States|Rocky Mountain Cancer Centers-Parker, Parker, Colorado, 80138, United States|Saint Mary Corwin Medical Center, Pueblo, Colorado, 81004, United States|Rocky Mountain Cancer Centers – Pueblo, Pueblo, Colorado, 81008, United States|National Jewish Health-Northern Hematology Oncology, Thornton, Colorado, 80260, United States|Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, 80260, United States|SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, 80033, United States|Danbury Hospital, Danbury, Connecticut, 06810, United States|Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, 06418, United States|Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, 06824, United States|Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury, Connecticut, 06033, United States|Greenwich Hospital, Greenwich, Connecticut, 06830, United States|Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, 06830, United States|Smilow Cancer Hospital Care Center – Guiford, Guilford, Connecticut, 06437, United States|Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, 06105, United States|Middlesex Hospital, Middletown, Connecticut, 06457, United States|Yale University, New Haven, Connecticut, 06520, United States|Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, 06473, United States|Norwalk Hospital, Norwalk, Connecticut, 06856, United States|Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, 06477, United States|Stamford Hospital/Bennett Cancer Center, Stamford, Connecticut, 06904, United States|Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, 06790, United States|Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, 06611, United States|Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, 06708, United States|Smilow Cancer Hospital Care Center – Waterford, Waterford, Connecticut, 06385, United States|Bayhealth Hospital Kent Campus, Dover, Delaware, 19901, United States|Beebe South Coastal Health Campus, Frankford, Delaware, 19945, United States|Beebe Medical Center, Lewes, Delaware, 19958, United States|Bayhealth Hospital Sussex Campus, Milford, Delaware, 19963, United States|Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, 19713, United States|Helen F Graham Cancer Center, Newark, Delaware, 19713, United States|Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States|Christiana Care Health System-Christiana Hospital, Newark, Delaware, 19718, United States|Beebe Health Campus, Rehoboth Beach, Delaware, 19971, United States|TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, 19973, United States|Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, 19801, United States|Kaiser Permanente-Capitol Hill Medical Center, Washington, District of Columbia, 20002, United States|MedStar Georgetown University Hospital, Washington, District of Columbia, 20007, United States|MedStar Washington Hospital Center, Washington, District of Columbia, 20010, United States|Sibley Memorial Hospital, Washington, District of Columbia, 20016, United States|George Washington University Medical Center, Washington, District of Columbia, 20037, United States|John Fitzgerald Kennedy Medical Center, Atlantis, Florida, 33462, United States|Mount Sinai Comprehensive Cancer Center at Aventura, Aventura, Florida, 33180, United States|Boca Raton Regional Hospital, Boca Raton, Florida, 33486, United States|Morton Plant Hospital, Clearwater, Florida, 33756, United States|Halifax Health Medical Center-Centers for Oncology, Daytona Beach, Florida, 32114, United States|Florida Hospital Memorial Medical Center, Daytona Beach, Florida, 32117, United States|Broward Health North, Deerfield Beach, Florida, 33064, United States|Holy Cross Hospital, Fort Lauderdale, Florida, 33308, United States|Broward Health Medical Center, Fort Lauderdale, Florida, 33316, United States|University of Florida Health Science Center – Gainesville, Gainesville, Florida, 32610, United States|Baptist MD Anderson Cancer Center, Jacksonville, Florida, 32207, United States|Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States|Lakeland Regional Health Hollis Cancer Center, Lakeland, Florida, 33805, United States|The Watson Clinic, Lakeland, Florida, 33805, United States|Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States|Orlando Health Cancer Institute, Orlando, Florida, 32806, United States|Halifax Health Center for Oncology – Ormond Beach, Ormond Beach, Florida, 32174, United States|Sacred Heart Hospital, Pensacola, Florida, 32504, United States|South Florida Baptist Hospital, Plant City, Florida, 33563, United States|Halifax Health Center for Oncology – Port Orange, Port Orange, Florida, 32127, United States|Tallahassee Memorial HealthCare, Tallahassee, Florida, 32308, United States|Saint Joseph’s Hospital/Children’s Hospital-Tampa, Tampa, Florida, 33607, United States|Indian River Medical Center, Vero Beach, Florida, 32960, United States|Winter Haven Hospital, Winter Haven, Florida, 33881, United States|Phoebe Putney Memorial Hospital, Albany, Georgia, 31701, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Kaiser Permanente-Glenlake Medical Center, Atlanta, Georgia, 30328, United States|Emory Saint Joseph’s Hospital, Atlanta, Georgia, 30342, United States|Northside Hospital, Atlanta, Georgia, 30342, United States|Augusta Oncology Associates PC-D’Antignac, Augusta, Georgia, 30901, United States|Augusta Oncology Associates PC-Wheeler, Augusta, Georgia, 30909, United States|Augusta University Medical Center, Augusta, Georgia, 30912, United States|John B Amos Cancer Center, Columbus, Georgia, 31904, United States|Northside Hospital-Forsyth, Cumming, Georgia, 30041, United States|Dekalb Medical Center, Decatur, Georgia, 30033, United States|Kaiser Permanente-Gwinnett Medical Center, Duluth, Georgia, 30096, United States|Northside Hospital – Duluth, Duluth, Georgia, 30096, United States|Kaiser Permanente Southwood, Jonesboro, Georgia, 30236, United States|Kaiser Permanente TownPark Comprehensive Medical Center, Kennesaw, Georgia, 30144, United States|Northside Hospital – Gwinnett, Lawrenceville, Georgia, 30046, United States|Central Georgia Gynecologic Oncology, Macon, Georgia, 31201, United States|Medical Center of Central Georgia, Macon, Georgia, 31201, United States|Southern Regional Medical Center, Riverdale, Georgia, 30274, United States|Harbin Clinic Medical Oncology and Clinical Research, Rome, Georgia, 30165, United States|Memorial Health University Medical Center, Savannah, Georgia, 31404, United States|Summit Cancer Care-Memorial, Savannah, Georgia, 31404, United States|Lewis Cancer and Research Pavilion at Saint Joseph’s/Candler, Savannah, Georgia, 31405, United States|Low Country Cancer Care Associates PC, Savannah, Georgia, 31405, United States|Summit Cancer Care-Candler, Savannah, Georgia, 31405, United States|Suburban Hematology Oncology Associates – Snellville, Snellville, Georgia, 30078, United States|Hawaii Cancer Care – Savio, Aiea, Hawaii, 96701, United States|Pali Momi Medical Center, Aiea, Hawaii, 96701, United States|Queen’s Cancer Center – Pearlridge, Aiea, Hawaii, 96701, United States|The Cancer Center of Hawaii-Pali Momi, Aiea, Hawaii, 96701, United States|Hawaii Cancer Care Inc – Waterfront Plaza, Honolulu, Hawaii, 96813, United States|Island Urology, Honolulu, Hawaii, 96813, United States|Queen’s Cancer Cenrer – POB I, Honolulu, Hawaii, 96813, United States|Queen’s Medical Center, Honolulu, Hawaii, 96813, United States|Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States|University of Hawaii Cancer Center, Honolulu, Hawaii, 96813, United States|Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, 96817, United States|Kuakini Medical Center, Honolulu, Hawaii, 96817, United States|Queen’s Cancer Center – Kuakini, Honolulu, Hawaii, 96817, United States|The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, 96817, United States|Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, 96819, United States|Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States|Tripler Army Medical Center, Honolulu, Hawaii, 96859, United States|Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, 96766, United States|Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, 83706, United States|Saint Luke’s Cancer Institute – Boise, Boise, Idaho, 83712, United States|Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, 83605, United States|Kootenai Medical Center, Coeur D’Alene, Idaho, 83814, United States|Walter Knox Memorial Hospital, Emmett, Idaho, 83617, United States|Saint Luke’s Cancer Institute – Fruitland, Fruitland, Idaho, 83619, United States|Saint Joseph Regional Medical Center, Lewiston, Idaho, 83501, United States|Idaho Urologic Institute-Meridian, Meridian, Idaho, 83642, United States|Saint Luke’s Cancer Institute – Meridian, Meridian, Idaho, 83642, United States|Saint Alphonsus Medical Center-Nampa, Nampa, Idaho, 83686, United States|Saint Luke’s Cancer Institute – Nampa, Nampa, Idaho, 83686, United States|Kootenai Cancer Center, Post Falls, Idaho, 83854, United States|Kootenai Cancer Clinic, Sandpoint, Idaho, 83864, United States|Saint Luke’s Cancer Institute – Twin Falls, Twin Falls, Idaho, 83301, United States|Northwest Community Hospital, Arlington Heights, Illinois, 60005, United States|Rush – Copley Medical Center, Aurora, Illinois, 60504, United States|Mac Neal Hospital, Berwyn, Illinois, 60402, United States|Saint Joseph Medical Center, Bloomington, Illinois, 61701, United States|Illinois CancerCare-Bloomington, Bloomington, Illinois, 61704, United States|Illinois CancerCare-Canton, Canton, Illinois, 61520, United States|Memorial Hospital of Carbondale, Carbondale, Illinois, 62902, United States|SIH Cancer Institute, Carterville, Illinois, 62918, United States|Illinois CancerCare-Carthage, Carthage, Illinois, 62321, United States|Centralia Oncology Clinic, Centralia, Illinois, 62801, United States|Northwestern University, Chicago, Illinois, 60611, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|University of Illinois, Chicago, Illinois, 60612, United States|Presence Resurrection Medical Center, Chicago, Illinois, 60631, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States|Weiss Memorial Hospital, Chicago, Illinois, 60640, United States|Advocate Illinois Masonic Medical Center, Chicago, Illinois, 60657, United States|Carle on Vermilion, Danville, Illinois, 61832, United States|Hematology Oncology Consultants Limited-Darien, Darien, Illinois, 60561, United States|Cancer Care Specialists of Illinois – Decatur, Decatur, Illinois, 62526, United States|Decatur Memorial Hospital, Decatur, Illinois, 62526, United States|Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, 60115, United States|Illinois CancerCare-Dixon, Dixon, Illinois, 61021, United States|Advocate Good Samaritan Hospital, Downers Grove, Illinois, 60515, United States|Carle Physician Group-Effingham, Effingham, Illinois, 62401, United States|Crossroads Cancer Center, Effingham, Illinois, 62401, United States|Advocate Sherman Hospital, Elgin, Illinois, 60123, United States|AMITA Health Alexian Brothers Medical Center, Elk Grove Village, Illinois, 60007, United States|Elmhurst Memorial Hospital, Elmhurst, Illinois, 60126, United States|Illinois CancerCare-Eureka, Eureka, Illinois, 61530, United States|NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, 60201, United States|Little Company of Mary Hospital, Evergreen Park, Illinois, 60805, United States|Illinois CancerCare-Galesburg, Galesburg, Illinois, 61401, United States|Western Illinois Cancer Treatment Center, Galesburg, Illinois, 61401, United States|Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, 60134, United States|NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, 60026, United States|Ingalls Memorial Hospital, Harvey, Illinois, 60426, United States|NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, 60035, United States|AMITA Health Cancer Institute and Outpatient Center, Hinsdale, Illinois, 60521, United States|Presence Saint Mary’s Hospital, Kankakee, Illinois, 60901, United States|Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, 61443, United States|Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, 60045, United States|Condell Memorial Hospital, Libertyville, Illinois, 60048, United States|Illinois CancerCare-Macomb, Macomb, Illinois, 61455, United States|Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, 61938, United States|Loyola University Medical Center, Maywood, Illinois, 60153, United States|Good Samaritan Regional Health Center, Mount Vernon, Illinois, 62864, United States|Edward Hospital/Cancer Center, Naperville, Illinois, 60540, United States|UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, 60451, United States|Cancer Care Center of O’Fallon, O’Fallon, Illinois, 62269, United States|Advocate Christ Medical Center, Oak Lawn, Illinois, 60453-2699, United States|University of Chicago Medicine-Orland Park, Orland Park, Illinois, 60462, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350, United States|Advocate Lutheran General Hospital, Park Ridge, Illinois, 60068, United States|Illinois CancerCare-Pekin, Pekin, Illinois, 61554, United States|OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, 61554, United States|Illinois CancerCare-Peoria, Peoria, Illinois, 61615, United States|OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, 61615, United States|Methodist Medical Center of Illinois, Peoria, Illinois, 61636, United States|OSF Saint Francis Medical Center, Peoria, Illinois, 61637, United States|Illinois CancerCare-Peru, Peru, Illinois, 61354, United States|Valley Radiation Oncology, Peru, Illinois, 61354, United States|Edward Hospital/Cancer Center?Plainfield, Plainfield, Illinois, 60585, United States|Illinois CancerCare-Princeton, Princeton, Illinois, 61356, United States|Quincy Medical Group-Clinic, Quincy, Illinois, 62301, United States|West Suburban Medical Center, River Forest, Illinois, 60305, United States|SwedishAmerican Regional Cancer Center/ACT, Rockford, Illinois, 61114, United States|Genesis Cancer Center – Silvis, Silvis, Illinois, 61282, United States|North Shore Medical Center, Skokie, Illinois, 60076, United States|Central Illinois Hematology Oncology Center, Springfield, Illinois, 62702, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States|Springfield Clinic, Springfield, Illinois, 62702, United States|Memorial Medical Center, Springfield, Illinois, 62781, United States|Southwest Illinois Health Services LLP, Swansea, Illinois, 62226, United States|Carle Cancer Center, Urbana, Illinois, 61801, United States|The Carle Foundation Hospital, Urbana, Illinois, 61801, United States|Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, 60555, United States|Rush-Copley Healthcare Center, Yorkville, Illinois, 60560, United States|Saint Vincent Anderson Regional Hospital/Cancer Center, Anderson, Indiana, 46016, United States|IU Health Bloomington, Bloomington, Indiana, 47403, United States|IU Health North Hospital, Carmel, Indiana, 46032, United States|Deaconess Clinic Downtown, Evansville, Indiana, 47713, United States|Radiation Oncology Associates PC, Fort Wayne, Indiana, 46804, United States|Parkview Hospital Randallia, Fort Wayne, Indiana, 46805, United States|Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, 46845, United States|Parkview Regional Medical Center, Fort Wayne, Indiana, 46845, United States|Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States|Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, 46202, United States|Franciscan Health Indianapolis, Indianapolis, Indiana, 46237, United States|Springmill Medical Center, Indianapolis, Indiana, 46290, United States|Franciscan Saint Elizabeth Health – Lafayette East, Lafayette, Indiana, 47905, United States|Woodland Cancer Care Center, Michigan City, Indiana, 46360, United States|Memorial Regional Cancer Center Day Road, Mishawaka, Indiana, 46545, United States|Franciscan Health Mooresville, Mooresville, Indiana, 46158, United States|IU Health Ball Memorial Hospital, Muncie, Indiana, 47303, United States|The Community Hospital, Munster, Indiana, 46321, United States|Chancellor Center for Oncology, Newburgh, Indiana, 47630, United States|Reid Health, Richmond, Indiana, 47374, United States|Memorial Hospital of South Bend, South Bend, Indiana, 46601, United States|Union Hospital, Terre Haute, Indiana, 47804, United States|Mary Greeley Medical Center, Ames, Iowa, 50010, United States|McFarland Clinic PC – Ames, Ames, Iowa, 50010, United States|University of Iowa Healthcare Cancer Services Quad Cities, Bettendorf, Iowa, 52722, United States|McFarland Clinic PC-Boone, Boone, Iowa, 50036, United States|Physicians’ Clinic of Iowa PC, Cedar Rapids, Iowa, 52402, United States|Mercy Hospital, Cedar Rapids, Iowa, 52403, United States|Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, 52403, United States|Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, 50325, United States|Mercy Cancer Center-West Lakes, Clive, Iowa, 50325, United States|Alegent Health Mercy Hospital, Council Bluffs, Iowa, 51503, United States|Greater Regional Medical Center, Creston, Iowa, 50801, United States|Genesis Medical Center – East Campus, Davenport, Iowa, 52803, United States|Genesis Cancer Care Institute, Davenport, Iowa, 52804, United States|Iowa Cancer Specialists, Davenport, Iowa, 52807, United States|Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States|Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, 50309, United States|Broadlawns Medical Center, Des Moines, Iowa, 50314, United States|Medical Oncology and | ||||
| NCT02722668 | UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep | https://clinicaltrials.gov/study/NCT02722668 | This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen with modifications based on factors including diagnosis, disease status, and prior treatment. Single or double unit selected according to current University of Minnesota umbilical cord blood graft selection algorithm. | NO | Acute Leukemia|Acute Myeloid Leukemia|Acute Lymphoblastic Leukemia/Lymphoma|Burkitt’s Lymphoma|Natural Killer Cell Malignancies|Chronic Myelogenous Leukemia|Myelodysplastic Syndrome|Large-cell Lymphoma|Hodgkin Lymphoma|Multiple Myeloma|Relapsed Chronic Lymphocytic Leukemia|Relapsed Small Lymphocytic Lymphoma|Marginal Zone B-cell Lymphoma|Follicular Lymphoma|Lymphoplasmacytic Lymphoma|Mantle-cell Lymphoma|Prolymphocytic Leukemia|Bone Marrow Failure Syndromes|Myeloproliferative Neoplasms/Myelofibrosis|Biphenotypic/Undifferentiated/Prolymphocytic Leukemias|MRD Positive Leukemia|Leukemia or MDS in Aplasia|Relapsed T-Cell Lymphoma|Relapsed Multiple Myeloma|Plasma Cell Leukemia | DRUG: Fludarabine|DRUG: Cyclophosphamide|DRUG: MMF|DRUG: Sirolimus|RADIATION: TBI|BIOLOGICAL: Umbilical cord blood cell infusion|BIOLOGICAL: ATG | Probability of Acute Graft Versus Host Disease (GVHD), Simple proportions will be used to estimate the probability of grade II-IV actue GVHD., Day 100 | Incidence of Acute GVHD, Percentage of patients with grade III-IV acute GVHD., Day 100|Transplant related mortality, 6 months post transplant|Chimerism, Percentage of subjects with donor chimerism., Day 21|Chimerism, Percentage of subjects with donor chimerism., Day 100|Chimerism, Percentage of subjects with donor chimerism., Day 180|Chimerism, Percentage of subjects with donor chimerism., 1 year post transplant|Neutrophil Engraftment, Percentage of subjects with neutrophil engraftment., Day 42 | Masonic Cancer Center, University of Minnesota | ALL | CHILD, ADULT, OLDER_ADULT | PHASE2 | 16 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 2015LS149|MT2015-17 | 2017-05-15 | 2023-02-22 | 2029-12 | 2016-03-30 | 2023-02-24 | Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, 55455, United States | |||||
| NCT02708108 | Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL) | https://clinicaltrials.gov/study/NCT02708108 | This study tests the ability of a focused dietary, exercise, and activity intervention to reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to improve disease response and reduce toxicity. | YES | B Precursor Type Acute Leukemia | BEHAVIORAL: Dietary Intervention|BEHAVIORAL: Activity and Exercise Intervention | Fat Mass, Assessment of change in fat before and after the induction chemotherapy phase (first 28 days of chemotherapy) as measured dual-energy x-ray absorptiometry (DXA) in comparison to fat gain in a recent historical cohort. Calculated as (Day 28 Fat Mass – Diagnosis Fat Mass)/Diagnosis Fat Mass, Diagnosis and 28-35 days | Percentage of Participants With Minimal Residual Disease >=0.01%, Compare the rate of minimal residual disease “positivity” (defined as \>=0.01%) in the bone marrow by flow cytometry after the induction phase of chemotherapy as compared to a recent historical cohort, 28-35 days from diagnosis|Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist, Assess feasibility of incorporating the intervention into induction chemotherapy as defined by \>80% of overall scheduled study visits successfully completed. The expected number of overall visits is equal to the sum of total visits scheduled with the physiotherapist (PT) or the registered dietitian (RD). The measure was calculated as the total # expected visits/completed visits., 28 days|Percentage of Overall Adherence to the IDEAL Intervention, Overall adherence to the study intervention was calculated as the mean of dietary adherence (average of percent consumed calories/prescribed calories for each food group) and activity (self-reported % adherence to prescribed days)., 28 days | Children’s Hospital Los Angeles | Gabrielle’s Angel Foundation | ALL | CHILD, ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CCI-14-00073 | 2016-05 | 2019-04 | 2019-12-30 | 2016-03-15 | 2023-03-28 | 2023-03-28 | Childrens Hospital Los Angeles, Los Angeles, California, 90027, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/08/NCT02708108/Prot_SAP_000.pdf | ||
| NCT02697734 | Efficacy and Safety Evaluation of Osilodrostat in Cushing’s Disease | https://clinicaltrials.gov/study/NCT02697734 | LINC-4 | The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing’s disease who are candidates for medical therapy. | YES | Cushing’s Disease | DRUG: osilodrostat|DRUG: osilodrostat Placebo | Percentage of Randomized Participants With a Complete Response, A complete responder at week 12 is defined as a participant who had a mean urine free cortisol ≤ upper limit of normal (mUFC ≤ ULN) at Week 12. Participants who had a missing mUFC assessment at Week 12 were counted as non-responders for the primary endpoint., at Week 12 | Percentage of Participants With mUFC ≤ ULN at Week 36, The complete response rate in both arms combined at Week 36. A complete responder at Week 36 is defined as a participant who had mean urine free cortisol \<= upper limit of normal (mUFC \<= ULN) at Week 36. Participants with missing mUFC at Week 36 were counted as non-responders., At Week 36|Change From Baseline in mUFC, To assess the change in mean urinary free cortisol (mUFC) from baseline by treatment arm., Baseline, weeks 2,5,8,12,14,17,20,23,26,29,32,36,40,48,60,72,84,96|Time-to-first Control of mUFC - Number (%) of Participants With mUFC <=ULN, To assess time-to-first control of mUFC, (in days) from randomization to the first mUFC collection that was ≤ ULN before completion/discontinuation of placebo-controlled period. Participants who did not achieve post-baseline mUFC control were censored at discontinuation or completion of placebo-controlled period, whichever was earlier., up to 12 weeks|Time-to-first Control of mUFC – Median Time to First Controlled mUFC Response, To assess time-to-first control of mUFC, (in days) from randomization to the first mUFC collection that was ≤ ULN before completion/discontinuation of placebo-controlled period. Participants who did not achieve post-baseline mUFC control were censored at discontinuation or completion of placebo-controlled period, whichever was earlier. The median time-to-first control and corresponding two-sided 95% Confidence Interval were calculated using Kaplan-Meier methodology of Brookmeyer and Crowley (1982)., up to 12 weeks|Time-to-first Control of mUFC – % Event Probability Estimates, To assess time-to-first control of mUFC, (in days) from randomization to the first mUFC collection that was ≤ ULN before completion/discontinuation of placebo-controlled period. Participants who did not achieve post-baseline mUFC control were censored at discontinuation or completion of placebo-controlled period, whichever was earlier. % Event probability estimate is the estimated probability that a participant will have an event prior to the specified time point. % Event probability estimates are obtained from the Kaplan-Meier survival estimates for all treatment groups; Greenwood formula is used for Confidence Interval (CI) of Kaplan-Meier (KM) estimates., up to 12 weeks|Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN – Number (%) of Participants, To assess time-to-escape from the first collection of normal mUFC (≤ ULN) to the first mUFC \> 1.3 x ULN on two consecutive visits on the highest tolerated dose of osilodrostat and not related to a dose interruption or dose reduction due to safety reasons. Escape will not be assessed for participants during the first 26 weeks., up to 48 weeks|Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN – Median Time to Escape From Normal mUFC, To assess time-to-escape from the first collection of normal mUFC (≤ ULN) to the first mUFC \> 1.3 x ULN on two consecutive visits on the highest tolerated dose of osilodrostat and not related to a dose interruption or dose reduction due to safety reasons. Escape will not be assessed for participants during the first 26 weeks. The median time-to-escape and corresponding two-sided 95% Confidence Interval were calculated using Kaplan-Meier methodology of Brookmeyer and Crowley (1982)., from week 26 to week 48|Time-to-escape During Osilodrostat Treatment From Collection of Normal mUFC (≤ ULN) to the First mUFC > 1.3 x ULN – % Event Probability Estimates, Escape is defined as the first loss of control of urinary free cortisol (UFC) that meets all of the following criteria: 1. prior normalization of UFC has occurred (median urinary free cortisol (mUFC)≤ upper limit of normal (ULN)); 2. patient reached the highest tolerated dose of osilodrostat; 3. 2 consecutive mUFC (collected at scheduled visits) were above 1.3x ULN; 4. the loss of control of UFC is not related to a dose interruption or dose reduction due to safety reasons; 5. happened beyond Week 26 when the patients have a chance to be treated with doses as high as 30 mg bid. * Event probability estimate is the estimated probability that a participant will have an event prior to the specified time point. * Event probability estimates are obtained from the Kaplan-Meier survival estimates for all treatment groups; Greenwood formula is used for CI of KM estimates., week 26 and week 36|Change From Baseline in Bone Mineral Density (BMD) by Dual-energy X-ray Absorptiometry (DXA) Scan at the Femoral Neck, Hip and Spinal Cord – QC Corrected, The change from baseline in bone mineral density at the femoral neck, hip and spinal cord at Week 48 by treatment arm – QC corrected. An increase in bone mineral density is indicative of an improvement., Baseline, week 48|Change From Baseline in Bone Mineral Density (BMD) T-score by Dual-energy X-ray Absorptiometry (DXA) Scan at the Femoral Neck, Hip and Spinal Cord – QC Corrected, The change from baseline in bone mineral density at the femoral neck, hip and spinal cord at Week 48 by treatment arm – QC corrected. An increase in bone mineral density is indicative of an improvement. T-score is the number of standard deviations above or below the mean for a healthy 30-year-old adult of the same sex and ethnicity as the patient. The WHO criteria are: Normal is a T-score of -1.0 or higher”, Baseline, week 48|Patients With a Complete Response (mUFC ≤ ULN) or a Partial Response (mUFC Decrease ≥ 50% From Baseline and >ULN) at Week 12, 36 and 48, Overall response rate defined as percentage of complete responders (mUFC ≤ ULN) plus partial responders (≥ 50% reduction in mUFC from baseline and \>ULN) at week 12, 36, 48 by treatment arms for all patients., baseline, week 12, 36 and 48|Change in Fasting Plasma Glucose, Change from baseline in fasting plasma glucose at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Hemoglobin A1C, Change from baseline in Hemoglobin A1C (%) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Cholesterol, Change from baseline in Cholesterol (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in LDL Cholesterol, Change from baseline in LDL Cholesterol (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in HDL Cholesterol, Change from baseline in HDL Cholesterol (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Triglyceride, Change from baseline in Triglyceride (mmol/L) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Standing Systolic Blood Pressure, Change from baseline in Standing Systolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Supine Systolic Blood Pressure, Change from baseline in Supine Systolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Standing Diastolic Blood Pressure, Change from baseline in Standing Diastolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Supine Diastolic Blood Pressure, Change from baseline in Supine Diastolic Blood Pressure (mmHg) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Weight, Change from baseline in Weight (kg) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change in Waist Circumference, Change from baseline in Waist Circumference (cm) at Week 12, Week 36, and Week 48 by treatment arm, Baseline, weeks 12, 36, and 48|Change From Baseline to Week 12, Week 36, and Week 48 in Clinical Signs of Cushing’s Disease, Change from baseline to Week 12, Week 36, and Week 48 in each of the following clinical signs of Cushing’s disease, captured by: a semi-quantitative Likert scale for facial rubor, striae, supraclavicular fat pad, dorsal fat pad, proximal muscle wasting (atrophy), central (abdominal) obesity, and ecchymoses (bruises) by randomized treatment arm. The number/proportion of participants with an improvement or no change compared to baseline are reported, baseline, Week 12, Week 36 and Week 48|Change From Baseline in Standardized Health Related Quality of Life Score, Using Cushing Disease-specific Quality of Life Patient Reported Outcome (PRO) Assessment, The CushingQoL is a valid and reliable disease-specific QoL questionnaire which assesses health-related quality of life (HRQoL) in patients with Cushing’s syndrome and has been validated in patients with Cushing’s disease. The CushingQoL consists of questions reflecting dimensions of HRQoL related to physical aspects (e.g. ‘I bruise easily’), psychological aspects (e.g. ‘I am more irritable, I have sudden mood swings and angry outbursts’), and social aspects (e.g. ‘I have had to give up my social or leisure activities due to my illness’). The questionnaire consists of 12 items measured on a five point Likert-type scale assessing how often or how much each item has been related to the patient’s Cushing’s disease in the previous week. The raw score is calculated by summing the individual item scores prior to being standardized so that the total score ranges from 0 to 100. Increases from baseline are indicative of an improvement., Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48.|Change From Baseline in Standardized Psychosocial Issues Score, Using Cushing Disease-specific Quality of Life Patient Reported Outcome (PRO) Assessment, The CushingQoL is a valid and reliable disease-specific QoL questionnaire which assesses health-related quality of life (HRQoL) in patients with Cushing’s syndrome and has been validated in patients with Cushing’s disease. The CushingQoL consists of questions reflecting dimensions of HRQoL related to physical aspects (e.g. ‘I bruise easily’), psychological aspects (e.g. ‘I am more irritable, I have sudden mood swings and angry outbursts’), and social aspects (e.g. ‘I have had to give up my social or leisure activities due to my illness’). The questionnaire consists of 12 items measured on a five point Likert-type scale assessing how often or how much each item has been related to the patient’s Cushing’s disease in the previous week. The raw score is calculated by summing the individual item scores prior to being standardized so that the total score ranges from 0 to 100. Increases from baseline are indicative of an improvement., Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48.|Change From Baseline in Standardized Physical Problems Score, Using Cushing Disease-specific Quality of Life Patient Reported Outcome (PRO) Assessment, The CushingQoL is a valid and reliable disease-specific QoL questionnaire which assesses health-related quality of life (HRQoL) in patients with Cushing’s syndrome and has been validated in patients with Cushing’s disease. The CushingQoL consists of questions reflecting dimensions of HRQoL related to physical aspects (e.g. ‘I bruise easily’), psychological aspects (e.g. ‘I am more irritable, I have sudden mood swings and angry outbursts’), and social aspects (e.g. ‘I have had to give up my social or leisure activities due to my illness’). The questionnaire consists of 12 items measured on a five point Likert-type scale assessing how often or how much each item has been related to the patient’s Cushing’s disease in the previous week. The raw score is calculated by summing the individual item scores prior to being standardized so that the total score ranges from 0 to 100. Increases from baseline are indicative of an improvement., Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48.|Change From Baseline in EQ-5D-5L Utility Index, EQ-5D-5L Utility Index: The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an “unconscious” health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement., Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48.|Change From Baseline in EQ-5D VAS, The EQ-5D-5L also includes a 20 cm vertical, VAS (visual analogue scale) with a scale of 0-100, with endpoints labeled 100=’the best health you can imagine’ and 0=’the worst health you can imagine’. A single index value is analyzed for the EQ-5D-5L VAS score. An increase from baseline in the EQ-ED-5L VAS is indicative of an improvement., Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48.|Change From Baseline in Beck Depression Inventory-II – Total Score Derived, The Beck Depression Inventory II (BDI-II) is a patient reported instrument that consists of 21 items designed to assess the intensity of depression in clinical and normal patients in the preceding two weeks. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. A global score ranges from 0 to 63 and is calculated with a higher score representing a greater level of depression. The following scoring guidelines for interpretation of BDI-II have been suggested (Smarr, 2011): Minimal range =0-13, Mild depression =14-19, Moderate depression =20-28 and Severe depression = 29-63. A reduction from baseline in BDI-II is indicative of an improvement., Baseline to Week 12 and 48, Week 12 to Week 36, Week 36 to Week 48.|Change From Baseline in Serum Cortisol, Change from baseline in serum cortisol, Baseline, Week 12, Week 36, Week 48|Change From Baseline in Late Night Saliva Cortisol, Change from baseline in late night saliva cortisol (nmol/L), Baseline, Week 12, Week 36, Week 48|Change From Baseline in Morning Saliva Cortisol, Change from baseline in morning saliva cortisol (nmol/L), Baseline, Week 12, Week 36, Week 48|Change From Baseline in Hair Cortisol Levels, Change from baseline in hair cortisol levels, Baseline, Week 26, Week 48|Plasma Osilodrostat Concentrations (ng/mL), Plasma osilodrostat concentrations (ng/mL), pre-dose and 1-2hrs post dose at weeks 1, 2, 5, 8, 12, 14, 20, 26 | Novartis Pharmaceuticals | ALL | ADULT, OLDER_ADULT | PHASE3 | 73 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT | CLCI699C2302 | 2016-10-03 | 2019-06-19 | 2020-12-31 | 2016-03-03 | 2021-10-19 | 2021-11-01 | University of Colorado Endocrinology Clinical Trials Unit, Aurora, Colorado, 80045, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States|Columbia University Medical Center New York Presbyterian Neuroendocrine Unit, New York, New York, 10032, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Oregon Health and Science University SC LCI699C2301, Portland, Oregon, 97239, United States|University of Pennsylvania Medical Center University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Novartis Investigative Site, Leuven, 3000, Belgium|Novartis Investigative Site, Fortaleza, CE, 60430-275, Brazil|Novartis Investigative Site, Rio de Janeiro, RJ, 21941-590, Brazil|Novartis Investigative Site, Sao Paulo, SP, 04039 004, Brazil|Novartis Investigative Site, Sao Paulo, SP, 05403 000, Brazil|Novartis Investigative Site, Halifax, Nova Scotia, B3H 1V7, Canada|Novartis Investigative Site, Montreal, Quebec, H2W 1T8, Canada|Novartis Investigative Site, Sherbrooke, Quebec, J1H 5N4, Canada|Novartis Investigative Site, Chengdu, Sichuan, 610041, China|Novartis Investigative Site, Beijing, 100034, China|Novartis Investigative Site, Beijing, 100730, China|Novartis Investigative Site, Guang Zhou, 510080, China|Novartis Investigative Site, San Pedro, San Jose, Costa Rica, 1406 1200, Costa Rica|Novartis Investigative Site, Athens, 106 76, Greece|Novartis Investigative Site, Warszawa, Mazowieckie, 04-305, Poland|Novartis Investigative Site, Krakow, 31-501, Poland|Novartis Investigative Site, Warszawa, 03 242, Poland|Novartis Investigative Site, Porto, 4200-319, Portugal|Novartis Investigative Site, Moscow, 117036, Russian Federation|Novartis Investigative Site, Malaga, Andalucia, 29009, Spain|Novartis Investigative Site, Sevilla, Andalucia, 41013, Spain|Novartis Investigative Site, Alzira, Comunidad Valenciana, 46600, Spain|Novartis Investigative Site, Valencia, Comunidad Valenciana, 46026, Spain|Novartis Investigative Site, La Coruna, Galicia, 15006, Spain|Novartis Investigative Site, Madrid, 28009, Spain|Novartis Investigative Site, Luzern, 6000, Switzerland|Novartis Investigative Site, Bangkok, THA, 10330, Thailand|Novartis Investigative Site, Bangkok, 10700, Thailand|Novartis Investigative Site, Istanbul, 34890, Turkey|Novartis Investigative Site, Kocaeli, 41380, Turkey | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/34/NCT02697734/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/34/NCT02697734/SAP_001.pdf | ||
| NCT02681965 | A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT02681965 | LEAN3 | Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study). | NO | Breast Cancer Survivorship|Obesity | BEHAVIORAL: LEAN book/videos | Body weight (kg), A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg)., 6 Months | Body weight (kg), A standard digital scale will be used to measure participants at baseline. Body weight will be collected in kilograms (kg)., Baseline|Body weight (kg), A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg)., 12 Months|Quality of Life (QOL), QOL will be self-reported and collected at the baseline and 6-months. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire will be administered to assess overall quality of life. The FACT-B measures physical, emotional, social, and functional well-being as well as quality of life issues specific to breast cancer survivors. The overall score will be used for assessment., Baseline|Quality of Life (QOL), QOL will be self-reported and collected at the baseline and 6-months. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire will be administered to assess overall quality of life. The FACT-B measures physical, emotional, social, and functional well-being as well as quality of life issues specific to breast cancer survivors. The overall score will be used for assessment., 6 months|Dietary Intake, The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women’s Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake., Baseline|Dietary Intake, The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women’s Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake., 6 months|Dietary Intake, The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women’s Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake., 12 months|Physical Activity (Moderate), Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity., Baseline|Physical Activity (Moderate), Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity., 6 months|Physical Activity (Moderate), Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity., 12 months|Physical Activity (Vigorous), Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity., Baseline|Physical Activity (Vigorous), Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity., 6 months|Physical Activity (Vigorous), Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity., 12 months | Yale University | FEMALE | ADULT, OLDER_ADULT | NA | 205 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 1410014716 | 2016-03 | 2018-04-01 | 2018-04-01 | 2016-02-15 | 2018-06-29 | Yale University, New Haven, Connecticut, 06511, United States | ||||
| NCT02681120 | Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer | https://clinicaltrials.gov/study/NCT02681120 | This is a pilot, non-randomized, single institution, observational study investigating the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Twelve months after bariatric surgery, 50% of excess weight is generally expected. Eligible women at elevated risk for breast cancer who are already planning to undergo bariatric surgery will be consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and fasting blood draw prior to bariatric surgery, approximately 14 days after bariatric surgery, and approximately 1 year after bariatric surgery. In parallel we will also be assessing 40 normal breast tissue specimens as well as blood samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI, elevated risk control group for our study. The KTB samples will be matched for general risk of breast cancer (\>20%), age, race and menopausal status. | NO | Breast Neoplasms|Obesity | PROCEDURE: Biopsy|PROCEDURE: Blood draw|PROCEDURE: Mammogram|PROCEDURE: MRI | Change in breast density via MRI from baseline, Categorical measures will be reported numerically: 1-increased, 2-decreased, 3-no change, 1 year post-bariatric surgery|Change in breast density via mammography from baseline, Categorical measures will be reported numerically: 1-increased, 2-decreased, 3-no change, 1 year post-bariatric surgery | Comparison of number of crown-like structures in obese breast tissue and normal breast tissue, Numerical measures, 14 days post-bariatric surgery|Comparison of number of crown-like structures in obese breast tissue and normal breast tissue, Numerical measures, 1 year post-bariatric surgery|Change in aromatase expression markers in obese tissue from baseline, Numerical measures, 14 days post-bariatric surgery|Comparison of aromatase expression markers in normal weight breast tissue with obese breast tissue, Numerical measures, 14 days post-bariatric surgery|Change in aromatase expression markers in obese tissue from baseline, Numerical measures, 1 year post-bariatric surgery|Comparison of aromatase expression markers in normal weight breast tissue with obese breast tissue, Numerical measures, 1 year post-bariatric surgery|Change in other correlative blood markers (inflammatory, insulin, hormonal) from baseline, Numerical measures, 14 days post-bariatric surgery|Change in other correlative blood markers (inflammatory, insulin, hormonal) from baseline, Numerical measures, 1 year post-bariatric surgery | Tarah J Ballinger, MD | FEMALE | ADULT, OLDER_ADULT | 3 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IUSCC-0556|1511957605 | 2016-10-07 | 2020-01-30 | 2020-01-30 | 2016-02-12 | 2021-10-14 | Indiana University Health North Hospital, Carmel, Indiana, 46032, United States|Indiana University Health Hospital, Indianapolis, Indiana, 46202, United States|Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States | ||||||
| NCT02677857 | Developing a Healthy Lifestyle in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT02677857 | At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center’s (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I \[\> 1 cm\], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in \> 8 hours a day of SB) and inactive (engage in \< 100 min/wk MVPA) to one of three, 3-month conditions: 1. lifestyle intervention (Lifestyle) (increase MVPA to \> 200 min/wk); 2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to \> 200 min/wk and reduce SB by 2 hrs/day); or 3. weight management education materials provided via mailed newsletter (Newsletter). Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie \[1200-1500 kcal/day\], low-fat \[\<30% calories from fat\]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness. | NO | Breast Cancer|Sedentary Lifestyle | BEHAVIORAL: Common intervention components for Lifestyle | Measures of activity by Armband, Participants will wear the SenseWear Armband (SWA) for data collection of time spent engaging in physical activity per day., change from baseline to 12 weeks|Weight, Weight will be assessed by an electronic scale., change from baseline to 12 weeks|Measures of diet, Diet will be assessed by 3-day food records (2 weekdays and 1 weekend day). Each record will be completed using the Nutrition Data System Software for Research (NDS-R) developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota., change from baseline to 12 weeks|Fitness (The 6 Minute Walk Test (6MWT)), The 6 Minute Walk Test (6MWT) is well tolerated by participants who are obese. Participants will walk as quickly as possible, without jogging or running, around two cones placed 60 m apart for 6 min. The primary measure will be distance walked. The 6MWT has been significantly correlated to peak oxygen uptake (VO2) values from a cycle ergometer test (r = .73, p \< 0.001). The 6MWT has been shown to measure enhanced physical performance beyond that which occurs from weight loss itself in participants with obesity. Standard safety protocols will be used for participants that Dr. Bell considers appropriate for testing., change from baseline to 12 weeks|Physical activity by Questionnaire, Participants will complete the Past-day Adults' Sedentary Time (PAST), a seven-item questionnaire that asks questions about sedentary behaviors that have occurred during the previous day., change from baseline to 12 weeks|Insulin, Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures., change from baseline to 12 weeks|Glucose, Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures., change from baseline to 12 weeks|Leptin, Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures., change from baseline to 12 weeks|C-Reactive Protein, Blood samples will be obtained from over-night fasted participants who have not engaged in MVPA and analyzed at UTMC using standard procedures., change from baseline to 12 weeks|Height, Height will be assessed using a stadiometer at baseline, baseline|BMI, BMI (kg/m2) will be calculated from height and weight measurements., change from baseline to 12 weeks|Waist circumference, waist measurement, change from baseline to 12 weeks|Percent body fat, Percent body fat will be assessed by bioelectrical impedance analysis (BIA), using the foot to foot pressure contact electrode BIA technique (Tanita TBF-300A model) following standard protocol, change from baseline to 12 weeks | Completion of self-monitoring records, Number of weekly records of self-monitoring of diet and activity completed and turned in., 12 weeks | The University of Tennessee, Knoxville | FEMALE | ADULT, OLDER_ADULT | NA | 7 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | UTKIRB-15-02602-FB | 2016-01 | 2016-12 | 2016-12 | 2016-02-09 | 2018-04-05 | Healthy Eating and Activity Laboratory, Knoxville, Tennessee, 37996, United States | |||||
| NCT02665962 | Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer | https://clinicaltrials.gov/study/NCT02665962 | 80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data have shown that caloric restriction (CR) protects against organ injury and decreases perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed endometrial cancer patients. The intervention will provide individualized CR program, meal replacement products and nutritional counselling sessions. | NO | Obese|Endometrial Cancer | OTHER: Perioperative Caloric Restriction Program | Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients, 2 years | Abramson Cancer Center at Penn Medicine | FEMALE | ADULT, OLDER_ADULT | NA | 8 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | UPCC 09815 | 2015-07 | 2018-07 | 2018-07 | 2016-01-28 | 2020-03-10 | Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States | ||||||
| NCT02664441 | Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity | https://clinicaltrials.gov/study/NCT02664441 | ECHO | The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic parameters in a double-blind, placebo-controlled 36 week randomized trial with an 18 week open label extension. Following baseline testing, 48 patients will be randomly assigned with equal allocation to ExQW or matching placebo injection for 36 weeks, followed by an 18 week open label extension during which all patients receive ExQW. Changes of weight status, body composition, free-living total daily energy expenditure (EE) by doubly labeled water (DLW), activity by acetimetry, energy intake (questionnaires and food diary), as well as glucose tolerance and hormonal parameters of energy homeostasis and insulin resistance will be assessed before treatment and at the end of the placebo-controlled phase (week 36). Activity, metabolic outcomes, energy intake will be also assessed at study week 18 (mid treatment of randomized study), as well as week 54 (end of open label treatment). | YES | Hypothalamic Obesity | DRUG: Exenatide|DRUG: placebo | Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters²., Percent change of body mass index (BMI), as calculated by the formula: body weight in kg divided by height in meters², between baseline and the end of the 36-week randomized drug treatment phase., From baseline to 36 weeks | Changes in Body Composition as Assessed by Body Fat Mass Using Dual Energy X-ray Absorptiometry (DEXA), Body composition change between baseline and the end of the 36-week randomized drug treatment phase assessed by dual energy x-ray absorptiometry (DEXA) and expressed as the change in adipose tissue mass., At baseline and 36 weeks|Changes in Fat and Total Calorie Intake Assessed by Free Buffet Meal Analysis., Changes in fat and total calorie intake during free buffet meals assessed at baseline and after 36-weeks of study drug treatment. The buffet meal is an objective measure of satiety as it assesses food intake and choice after a caloric preload. A standardized test meal preload provided 20% of estimated daily caloric requirements,based on the Schofield-HW equation. The purpose of the test meal is to ensure that study participants are in an equally fed state. Ninety minutes later, an ad libitum buffet meal was served consisting of a wide variety of food items and more than the child’s estimated daily calorie requirements will be offered (5,000 kcal). Children had access to the buffet for 30 min, after which calorie intake and composition of consumed foods was measured by weighing back uneaten food., From baseline to 36 weeks|Changes in Fasting Glucose, Change in fasting blood glucose between baseline and the end of the 36-week randomized drug treatment phase., From baseline to 36 weeks|Changes in HDL Cholesterol and Triglycerides Assessed by Fasting Lipids, Change in fasting HDL cholesterol and triglycerides between baseline and the end of the 36-week randomized drug treatment phase., From baseline to 36 weeks|Changes in Inflammation Assessed by C-reactive Protein (CRP), Change in C-reactive protein (CRP) between baseline and the end of the 36-week randomized drug treatment phase., From baseline to 36 weeks|Changes of Insulin Resistance Assessed by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Changes of insulin resistance estimated by the homeostasis model assessment of insulin resistance (HOMA-IR) using the formula HOMA-IR = insulin \[mU/l\] x glucose \[mmol/l\]) / 22.5 where both insulin and glucose values are obtained from a fasting blood sample., From baseline to 36 weeks|Changes of Circulating Leptin Levels, Change in circulating leptin between baseline and the end of the 36-week randomized drug treatment phase., From baseline to 36 weeks|Changes of Energy Expenditure Assessed by Doubly Labeled Water Analysis, Total energy expenditure in the free-living environment was measured using doubly labeled water which estimates carbon dioxide production by measuring the elimination of the tracers deuterium (²H) and oxygen-18 (¹⁸O) from the body. These measures are used to determine the average daily rate of carbon dioxide production which is then used to calculate total energy expenditure using an equation from Weir and an assumed food quotient (0.85)., Baseline and 36 weeks|Changes of Energy Intake Assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids), Self-reported daily energy intake was assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids, http://appliedresearch.cancer.gov/tools/instruments/asa24/), a web-based diet assessment tool that allows 24-hour diet recall using branded food items., Baseline and 36 weeks|Changes in Glucose 120 Minutes Following an Oral Glucose Tolerance Test, Change in blood glucose measures 120 minutes post-glucose bolus during an oral glucose tolerance test between baseline and the end of the 36-week randomized drug treatment phase., From baseline to 36 weeks | Seattle Children’s Hospital | Children’s Hospitals and Clinics of Minnesota|Vanderbilt University | ALL | CHILD, ADULT | PHASE3 | 42 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | R01DK104936-01A1 | 2016-03 | 2020-03-16 | 2020-07-31 | 2016-01-27 | 2022-05-05 | 2022-05-05 | Children’s Hospitals adn Clinics of Minnesota, Minneapolis, Minnesota, 55404, United States|Vanderbilt University School of Medicine, Nashville, Tennessee, 37235, United States|Seattle Childrens, Seattle, Washington, 98105, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/41/NCT02664441/Prot_SAP_000.pdf | |
| NCT02661035 | Allo HSCT Using RIC for Hematological Diseases | https://clinicaltrials.gov/study/NCT02661035 | This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies. | NO | Acute Myelogenous Leukemia|Acute Lymphocytic Leukemia|Chronic Myelogenous Leukemia|Plasma Cell Leukemia|Myelodysplastic Syndromes|Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma|B-Cell Lymphoma|Follicular Lymphoma|Lymphoplasmacytic Lymphoma|Mantle-Cell Lymphoma|Prolymphocytic Leukemia|Lymphoblastic Lymphoma|Burkitt’s Lymphoma|Non-Hodgkin’s Lymphoma|Multiple Myeloma|Myeloproliferative Syndromes|Hematological Diseases | DRUG: Allopurinol|DRUG: Fludarabine|DRUG: Cyclophosphamide|DRUG: ATG|RADIATION: TBI|DRUG: Tacrolimus|DRUG: MMF|BIOLOGICAL: Peripheral Blood Stem Cells|BIOLOGICAL: Related or Unrelated Bone Marrow Cells | Evaluate rates of acute graft-versus-host disease (GVHD) II-IV, Percent of subjects with grade II-IV acute GVHD, Day 100 post transplant | Evaluate rates of chronic GVHD, Percent of subjects with chronic GVHD, 1 year post transplant|Evaluate neutrophil engraftment without ATG (in siblings), Percent of subjects with neutrophil engraftment without ATG (in siblings), Day 42 post transplant|Evaluate neutrophil engraftment with ATG (in unrelated donors), Percent of subjects with neutrophil engraftment with ATG (in unrelated donors), Day 42 post transplant|Evaluate neutrophil engraftment without ATG (in unrelated donors), Percent of subjects with neutrophil engraftment without ATG (in unrelated donors), Day 42 post transplant|Evaluate relapse without ATG (in siblings) – 1 year, Percent of subjects who relapsed without ATG (in siblings), 1 year post transplant|Evaluate relapse without ATG (in siblings) – 2 years, Percent of subjects who relapsed without ATG (in siblings), 2 years post transplant|Evaluate relapse with ATG (in unrelated donors) – 1 year, Percent of subjects who relapsed with ATG (in unrelated donors), 1 year post transplant|Evaluate relapse with ATG (in unrelated donors) – 2 years, Percent of subjects who relapsed with ATG (in unrelated donors), 2 years post transplant|Evaluate relapse without ATG (in unrelated donors) – 1 year, Percent of subjects who relapsed without ATG (in unrelated donors), 1 year post transplant|Evaluate relapse without ATG (in unrelated donors) – 2 years, Percent of subjects who relapsed without ATG (in unrelated donors), 2 years post transplant|Overall survival, Percent of surviving subjects, Day 100 post transplant|Overall survival, Percent of surviving subjects, 1 year post transplant|Overall survival, Percent of surviving subjects, 3 years post transplant|Transplant related mortality (TRM), Percent of subjects with TRM, Day 100 post transplant|Transplant related mortality (TRM), Percent of subjects with TRM, 1 year post transplant | Masonic Cancer Center, University of Minnesota | ALL | CHILD, ADULT, OLDER_ADULT | PHASE2 | 156 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2015LS152 | 2017-03-09 | 2023-04-17 | 2023-05-29 | 2016-01-21 | 2023-09-21 | Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, 55455, United States | |||||
| NCT02658565 | Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation | https://clinicaltrials.gov/study/NCT02658565 | Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient’s cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy. | NO | Endometrial Cancer | PROCEDURE: Lymphadenectomy | Recurrence-free survival, Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)., 24 months | Progression-free survival, Progression-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC), 5 years|Disease-specific Survival, Disease-specific survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC), 5 years|Overall patient survival, Overall survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC), 5 years|Concordance between IOC and final pathology Incidence, 5 years|Perioperative morbidity and mortality, Perioperative morbidity and mortality outcome will be assessed as the number of participants with Adverse Events/death which are related to treatment/surgery ., 5 years | Frederick R. Ueland, M.D. | FEMALE | ADULT, OLDER_ADULT | NA | 401 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | MCC-15-GYN-150 | 2016-01-29 | 2023-12-08 | 2026-11 | 2016-01-20 | 2025-01-06 | University of Kentucky, Lexington, Kentucky, 40506, United States | |||||
| NCT02635386 | EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS) | https://clinicaltrials.gov/study/NCT02635386 | This is a randomized, single-blind, parallel 5 treatment group 24-week trial designed to directly compare the therapeutic effects of exenatide once weekly (EQW), dapagliflozin (DAPA), EQW plus DAPA, combined DAPA/metformin extended release (XR) and the weight loss medication, phentermine/topiramate extended release (PHEN/TPM ER) on metabolic and endocrinological parameters in overweight/obese non-diabetic women with PCOS. In this study, we will examine the efficacy of these therapies on metabolic parameters, body weight and body composition, anthropometric measurements, and reproductive function in a well-defined group of pre-menopausal overweight/obese, non-diabetic women with PCOS, focusing on their relationship to insulin resistance and obesity. We hope to determine which treatment(s) addressing the multifaceted disturbances of individual subgroups emerge as the preferable therapy. | YES | Polycystic Ovary Syndrome|Obesity | DRUG: Exenatide once weekly (EQW )|DRUG: Dapagliflozin (DAPA)|DRUG: EQW plus DAPA|DRUG: Dapagliflozin plus Glucophage (MET ER)|DRUG: Phentermine /Topiramate (PHEN/ TPM) ER | Oral Disposition (Insulin Sensitivity-insulin Secretion) Index, An estimation of β-cell compensatory function, the insulin secretion-sensitivity index (IS-SI) will be derived by applying the concept of the oral disposition index to measurements obtained during the 2-h OGTT and calculated as the index of insulin secretion factored by insulin sensitivity (ΔINS/ΔPG 30 x Matsuda SIOGTT) from the OGTT. A higher score shows improved pancreatic insulin responsiveness relative to resistance., 24 weeks of treatment | Absolute Body Weight, Treatment effect on body weight at 24 weeks of treatment, 24 weeks of treatment|Body Mass Index (BMI), Treatment efficacy in reducing body mass at 24 weeks of treatment, 24 weeks of treatment|Change in Percent Body Weight, Treatment effect on change in percent body weight from baseline, Change from baseline (time 0) to study end (24 weeks)|Central Adiposity (Waist Circumference), Treatment effect on loss of central adiposity after 24 weeks, 24 weeks of treatment|Waist-to-Hip Ratio (WHR), Treatment impact on central adiposity after 24 weeks, 24 weeks of treatment|Waist-to-Height Ratio (WHtR), Treatment impact on WHtR which is a measure of central adiposity, 24 weeks of treatment|Total Fat Mass (kg) Evaluated by DEXA, Treatment impact on total fat mass by DEXA, 24 weeks of treatment|Total Body Fat (%) by DEXA, Treatment impact on percent total body fat by DEXA, 24 weeks of treatment|Android-Gynoid Ratio (AGR) as Determined by DEXA, treatment impact on measure of central adiposity as determined by android/gynoid ratio, 24 weeks of treatment|Trunk/Leg Fat Ratio by DEXA, Treatment impact on trunk/limb ratio (measure of central adiposity) by DEXA, 24 weeks of treatment|Fasting Blood Glucose, Treatment impact on fasting concentration of glucose in the blood, 24 weeks of treatment|OGTT Mean Blood Glucose (MBG), Treatment effect on MBG measured during the oral glucose tolerance test, 24 weeks of treatment|Fasting Insulin Sensitivity (HOMA-IR), Treatment effect on the ratio HOMA-IR which is insulin resistance measure derived from fasting blood glucose and insulin and is calculated by insulin (mU/ml)\*glucose (mmol/L)/22,5. The higher thenumber the more insulin resistant., 24 weeks of treatment|Matsuda Sensitivity Index Derived From the OGTT(SI OGTT), The SI IOGTT is a measure of peripheral insulin sensitivity derived from the values of Insulin (microunits per milliliter) and Glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values. SI (OGTT) = 10,000/ \[(G fasting x I fasting) x (G OGTTmean x I OGTTmean)\], where fasting glucose and insulin data are taken from time 0 of the OGTT and mean data represent the average glucose and insulin values obtained during the entire OGTT. The square root is used to correct for nonlinear distribution of insulin, and 10,000 is a scaling factor in the equation. The higher value, the more sensitive to insulin., 24 weeks of treatment|Corrected First Phase Insulin Secretion (IGI/HOMA-IR), Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose, 24 weeks of treatment|Total Cholesterol Levels, Treatment effect on blood concentrations of total cholesterol, 24 weeks of treatment|Triglyceride (TRG) Levels, Treatment effect on blood concentrations of triglycerides, 24 weeks of treatment|Total Testosterone Concentrations, Treatment effect on blood concentrations of total testosterone, 24 weeks of treatment|Dehydroepiandrosterone Sulfate (DHEA-S) Levels, Treatment effect on blood concentrations of DHEA-S, 24 weeks of treatment|Free Androgen Index (FAI), Treatment effect on FAI calculated from total testosterone divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome., 24 weeks of treatment|Systolic Blood Pressure (SBP), Treatment effect on SBP after 24 weeks of treatment, 24 weeks treatment|Diastolic Blood Pressure (DBP), Treatment effect on DBP after 24 weeks, 24 weeks of treatment | Woman’s | AstraZeneca | FEMALE | ADULT | PHASE3 | 119 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT | RP15-008|AZ ESR-14-10725 | 2016-03-22 | 2020-07-22 | 2020-10-09 | 2015-12-18 | 2021-01-29 | 2021-01-29 | Woman’s Hospital, Baton Rouge, Louisiana, 70817, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/86/NCT02635386/ICF_000.pdf|Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/86/NCT02635386/Prot_SAP_002.pdf | ||
| NCT02614859 | Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients | https://clinicaltrials.gov/study/NCT02614859 | BIMET-1 | Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an elevated insulin level in the blood is associated with a shorter median time to cancer progression and median overall survival in patients with an elevated PSA after prior treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used in this patient population,with no proven benefit, which may increase mortality and morbidity.This study evaluates how metformin in combination with bicalutamide affects prostate cancer. | YES | Cancer of Prostate | DRUG: Observation and Bicalutamide|DRUG: Metformin and Bicalutamide | Biochemical Response Rate Based on PSA, Participants with undetectable PSA after 32 weeks, 32 weeks | PSA Decline ≥ 85% at 32 Weeks, Number of patients with PSA decline ≥ 85% after 32 weeks, 32 Weeks|PSA Decline, Number of patients with PSA decline after 8 weeks (observation vs metformin), 8 Weeks|Median PSA Decline, Median PSA decline after 8 weeks % (range), 8 weeks|BMI Decline After 32 Weeks, Number of patients with BMI decline after 32 weeks, 32 Weeks | Fox Chase Cancer Center | MALE | ADULT, OLDER_ADULT | PHASE2 | 29 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | GU-079|15-1015 | 2015-12-01 | 2020-01-24 | 2020-01-24 | 2015-11-25 | 2022-03-29 | 2022-03-29 | National Cancer Institute, Bethesda, Maryland, 20892-9760, United States|Fox Chase Cancer Center – Philadelphia, Philadelphia, Pennsylvania, 19111-2497, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/59/NCT02614859/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/59/NCT02614859/ICF_001.pdf | ||
| NCT02611128 | Urinary DENND1A.V2 as a Predictor of Pubertal Hyperandrogenemia | https://clinicaltrials.gov/study/NCT02611128 | DENND1A | Polycystic ovary syndrome (PCOS) is a common disorder marked by hyperandrogenism, oligo-/anovulation, and subfertility. The precise causes of PCOS are unclear, but the pathophysiology involves complex genetic and environmental influences. Importantly, not all girls with obesity have HA, and free testosterone (T) concentrations are highly variable in this group. Luteinizing hormone (LH) and insulin concentrations are significant but only partial predictors of free T in girls with obesity; significant unexplained variability in free T suggests that additional factors contribute to HA in this population. Abnormalities of ovarian and adrenal steroidogenesis are likely contributors in this regard, but such abnormalities are difficult to quantify. Recent Genome Wide Association Studies have identified DENND1A as a PCOS susceptibility gene candidate. Preliminary in vitro data strongly implicate a DENND1A splice variant called DENND1A Variant 2 (DENND1A.V2) as a contributor to excessive theca cell androgen production in PCOS. The investigators’ primary goal with the proposed pilot study is to determine the relationship between urinary exosomal DENND1A.V2 mRNA and free T concentrations in peripubertal girls. The investigators hypothesize that urinary exosomal DENND1A.V2 mRNA quantity is a significant and independent predictor of peripubertal hyperandrogenemia. In this study, the investigators will carefully phenotype peripubertal girls with and without hyperandrogenemia (primarily in the form of hormonal, maturational, and anthropometric measurements) in addition to measuring urinary exosomal DENND1A.V2 mRNA. As a primary analysis, the investigators will examine the relationship between morning free testosterone and urinary exosomal DENND1A.V2, controlling for previously-described partial predictors of free testosterone (LH, insulin) in addition to potential confounders (BMI z-score, bone age). These studies will provide important information regarding the etiology of HA in peripubertal girls. Ultimately, these data may lead to a non-invasive test of ovarian/adrenal steroidogenic activity and support the development of a diagnostic test for PCOS in high-risk peripubertal girls (e.g., those with obesity). | NO | Polycystic Ovary Syndrome|Hyperandrogenism|Puberty | OTHER: Phenotype/genotype assessment | Urinary exosomal DENND1A.V2, Urinary exosomal DENND1A.V2, Day 1 of study (the study involves one outpatient visit)|Serum free testosterone, Calculated free testosterone, Day 1 of study (the study involves one outpatient visit) | Bone age, A measure of maturational stage, Day 1 of study (the study involves one outpatient visit)|BMI z-score, Body mass index normalized for age and gender, Day 1 of study (the study involves one outpatient visit)|Morning luteinizing hormone, Serum luteinizing hormone (LH) measured at same time as free testosterone and fasting insulin, Day 1 of study (the study involves one outpatient visit)|Fasting insulin, Serum insulin measured at same time as free testosterone and morning LH, Day 1 of study (the study involves one outpatient visit) | University of Virginia | Penn State University|Virginia Commonwealth University|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | CHILD | 65 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 17633|P50HD028934 | 2015-05-29 | 2024-12 | 2024-12 | 2015-11-20 | 2023-11-02 | Center for Research in Reproduction, Charlottesville, Virginia, 22908, United States | ||||
| NCT02575872 | Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors | https://clinicaltrials.gov/study/NCT02575872 | This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors. | NO | Stage IA Uterine Corpus Cancer|Stage IB Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage IIIA Uterine Corpus Cancer|Stage IIIB Uterine Corpus Cancer|Stage IIIC Uterine Corpus Cancer|Stage IVA Uterine Corpus Cancer|Stage IVB Uterine Corpus Cancer | BEHAVIORAL: Exercise Intervention | Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS), Data will be analyzed using Pearson Chi-square test., 12 weeks | Barrier avoidance/coping, measured using 5 point Likert scales, Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders., Up to 12 weeks|BMI, Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests., Up to 12 weeks|Change in ability to perform activities of daily living, assessed with the YPAS, Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests., Baseline to 12 weeks|Change in sedentary time, assessed with the YPAS, Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests., Baseline to 12 weeks|Exercise efficacy, measured using 5 point Likert scales, Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders., Up to 12 weeks|Fatigue, assessed by the FACT-Fatigue, Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests., Up to 12 weeks|Outcome expectations, measured using 5 point Likert scales, Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders., Up to 12 weeks|Physical function score, Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests., Up to 12 weeks|Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer, Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests., Up to 12 weeks|Self-regulation, measured using 5 point Likert scales, Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders., Up to 12 weeks|Social support, measured using 5 point Likert scales, Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders., Up to 12 weeks|Waist circumference, Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests., Up to 12 weeks | Albert Einstein College of Medicine | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 30 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE | 2013-2167|NCI-2014-01510|2013-2167|P30CA013330 | 2013-10 | 2018-04 | 2018-06 | 2015-10-15 | 2019-09-16 | Albert Einstein College of Medicine, Bronx, New York, 10461, United States | ||||
| NCT02574507 | Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners | https://clinicaltrials.gov/study/NCT02574507 | The objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team’s prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate. | NO | Breast Cancer | BEHAVIORAL: Couples-Based Behavioral Weight and Symptom Management | Change in Weight, Participants will be weighed at each assessment and each session., baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in steps per day, Participants will wear wireless activity trackers (Fitbits) to measure daily activity (e.g., steps taken). Participants will be provided with the activity trackers by study staff and begin to use the trackers following the pre-treatment assessment. Participants will continue to use the trackers throughout treatment. Participants will return the Fitbits to the study staff upon completion of the study., Through study completion (an average of 31 weeks)|Change in 6 minute walk ability score, The 6-minute walk test is a self-paced, timed test of the total distance in meters that a patient is able to walk over a six-minute period and assesses the ability to exert effort during activity., baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in 6 minute walk pain score, The degree of pain experienced during the 6-minute walk test will also be assessed., baseline, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in Stanford Leisure-Time Activity Categorical Item (L-Cat), The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active., baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in Eating Behavior, Participants will also be asked to complete the Dietary Instrument for Nutrition Education (DINE). The DINE is a brief assessment of the amount of fat and dietary fiber in an individual’s usual diet. Participants are provided with a list of food items and asked about the frequency with which they have eaten the items per week when considering the last month., baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in The Brief Pain Inventory (BPI), The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents “no pain” and 10 represents “pain as bad as you can imagine.” Participants also rate their level of interference from pain., baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in Promis Fatigue Scale, The Promis Fatigue Scale is a 6-item self-report measure of fatigue in the last week, pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in Profile of Mood States (POMS), The POMS will be used to assess psychological distress. Each item is rated on a scale from 0 (not at all) to 4 (extremely) as being self-descriptive for the last seven days., baseline , post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in Physical Activity based on the International Physical Activity Questionnaire, Participants will also complete the International Physical Activity Questionnaire (IPAQ). This seven-item questionnaire assesses the amount of time participants have spent doing moderate and vigorous physical activities in the last seven days., pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in eating behavior using the Three Factor Eating Questionnaire, Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating., pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks) | Change in Fasting insulin, Fasting insulin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments., baseline and 3 months post-treatment (approximately 30-32 weeks)|Change in IL-6, The pro-inflammatory cytokine IL-6 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments., baseline and 3 months post-treatment (approximately 30-32 weeks)|Change in IL-8, The pro-inflammatory cytokine IL-8 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments., baseline and 3 months post-treatment (approximately 30-32 weeks)|Change in TNF-alpha, The pro-inflammatory cytokine TNF-alpha will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments., baseline and 3 months post-treatment (approximately 30-32 weeks)|Change in Adiponectin, The anti-inflammatory cytokine adiponectin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments., baseline and 3 months post-treatment (approximately 30-32 weeks)|Change in Heart Rate, Heart rate will be assessed via the wireless activity trackers (Fitbit) worn by participants throughout the study., Through study completion (an average of 31 weeks)|Treatment Acceptability Questionnaire (TAQ), The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 “very unacceptable” to 7 “very acceptable)., post-treatment (approximately 30-32 weeks)|Change in Session attendance rate, Treatment feasibility will be assessed by measuring the session attendance rate for each participant and each day., week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18|Change in Use of intervention strategies, Participants’ use of intervention strategies will be assessed using a measure developed for components of the present study. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session in the past week or past month depending on the timing of the questionnaire. A scale ranging from 0 “not at all” to 5 “2 or more times a day” will be used., week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18|Change in partner support for eating and exercise, Partner support for eating and exercise will be assessed using a modified version of the Social Support for Diet and Exercise questionnaires. Participants will be asked to provide information about the amount of encouragement and discouragement they have received from their partner over the last three months regarding healthy eating and exercise. Items are rated on a 5 point scale from 1 “none” to 5 “very often.”, pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks)|Change in Self-Efficacy for Weight, The Weight Efficacy Lifestyle Questionnaire is an 8-item measure of eating self-efficacy. Participants are asked to provide information about how certain they are that they can resist overeating in difficult situation (e.g., over the weekend, when tired, etc.). Response choices range from 0= “not at all confident” to 10= “very confident.”, pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18)|Change in self-efficacy for managing chronic disease, The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale that asks participants to rate their confidence in doing certain activities (e.g., keep emotional distress from interfering with the things you want to do) on a scale from 1= “not at all confident” to 10= “totally confident.” The wording of items was slightly altered to better match the sample intended for the present study., pre-treatment, post-treatment (approximately 18-20 weeks), 3 months post-treatment (approximately 30-32 weeks); at each intervention session (week 1, week 2, week 3, week 4, week 5, week 6, week 8, week 10, week 12, week 14, week 16, week 18) | Duke University | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 52 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | Pro00063328|1F32CA200091-01 | 2015-10 | 2018-12 | 2018-12 | 2015-10-14 | 2020-05-06 | Duke Cancer Institute, Durham, North Carolina, 27710, United States | ||||
| NCT02565706 | Online WIC Nutrition Education to Promote Farmers’ Market Fruit and Vegetable Purchases and Consumption | https://clinicaltrials.gov/study/NCT02565706 | This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote farmers’ market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). | YES | Cardiovascular Diseases|Cancer|Type 2 Diabetes|Obesity | BEHAVIORAL: WIC Fresh Start Program|BEHAVIORAL: Existing Online Health Education | Number of Participants Who Redeemed FMNP Vouchers, The state WIC agency is providing data on FMNP voucher redemption., 6 months (2015 farmers’ market season [June to November 2015])|Frequency of Fruit and Vegetable Intake, Times per day fruits and vegetable are consumed as assessed by a validated food frequency questionnaire., Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up|Quantity of Fruit and Vegetable Intake, Cups per day consumed of fruits and vegetables as assessed by a validated fruit and vegetable screener., Pretest, posttest, and 3- and 6-month follow-up | Number of Participants Who Redeemed Cash Value Vouchers at Farmers’ Markets, The state WIC agency is providing data on cash value voucher redemption., 6 months (2015 farmers’ market season [June to November 2015])|Response to Survey Items Assessing Knowledge of the WIC Farmers’ Market Nutrition Program Using a True/False Format., Index of Knowledge of the FMNP Score range: 0-6 Higher scores indicates greater knowledge, Pretest, posttest, and 3- and 6-month follow-up|Response to an Item Assessing Knowledge of WIC-authorized Farmers’ Markets Using a Yes/no Format., Knowledge of a farmers’ market with farmers approved by WIC to accept WIC farmers’ Market Nutrition Program and Cash Value vouchers Scores: No (0) and yes (1). Higher scores (yes responses) indicate that the respondent knows of a farmers’ market with farmers approved by WIC to accept WIC farmers’ Market Nutrition Program and Cash Value vouchers. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (knowledge of such markets) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm., Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Attitudes Towards Farmers’ Market Fruits and Vegetables Using 7-point Likert Rating Scales., Attitudes towards Farmers’ Market Fruits and Vegetables Score range: 6-42 Higher scores indicate more favorable attitudes, Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Awareness of Locally Grown, Seasonal Fruits and Vegetables Using a Yes/no Format., Familiarity with Locally Grown Seasonal Items Score range: 0-3 Higher scores indicate greater familiarity, Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Fruit and Vegetable Food Safety Skills Using 7-point Likert Rating Scales., Fruit and Vegetable Food Safety Skills Score range: 19-85 Higher scores indicate greater skills, Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Farmers’ Market Asking Skills Using a Yes/no Format., Farmers’ Market Asking Skills Score range: 0-3 Higher scores indicate greater skills, Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Positive Outcome Expectations for Consuming Locally Grown Fruits and Vegetables Using a Yes/no Format., Positive Outcome Expectations for Consuming Locally Grown Fruit and Vegetables Score range:0-3 Higher scores indicate more favorable ratings, Pretest, posttest, and 3- and 6-month follow-up|Response to an Item Assessing Whether the Participant Ever Purchased Fruits and Vegetables at a Farmers’ Market Using a Yes/no Format., Lifetime Farmers’ Market Fruit and Vegetable Purchases Scores: No (0), Yes (1). Higher scores (yes responses) indicate indicate that the respondent has ever purchased fruits and vegetables at a farmers’ market. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having ever purchased fruits and vegetables at a farmers’ market) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm., Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Farmers’ Market Fruit and Vegetable Preparation Skills Using 7-point Likert Rating Scales., Farmers’ Market Fruit and Vegetable Preparation Skills Score range:12-84 Higher scores indicate greater skills, 2 weeks|Response to an Item Assessing Whether the Participant Purchased Fruits and Vegetables at a Farmers’ Market in the Past Two Weeks Using a Yes/no Format., Recent Farmers’ Market Fruit and Vegetable Purchases Scores: No (0), Yes (1). Higher scores (yes responses) indicate that the respondent purchased fruits and vegetables at a farmers’ market in the past two weeks. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having purchased fruits and vegetables at a farmers’ market in the past two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm., Pretest, posttest, and 3- and 6-month follow-up|Response to an Item Assessing Behavioral Intentions to Purchase Fruits and Vegetables at a Farmers’ Market in the Next Two Weeks Using a Yes/no Format., Intentions to Purchase Fruits and Vegetables at a Farmers’ Market Scores: no (0), Yes (1). Higher scores (yes responses) indicate that the respondent intends to purchase fruits and vegetables at a farmers’ market in the next two weeks. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (intending to purchase fruits and vegetables at a farmers’ market in the next two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm., Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Knowledge of Locally Grown Seasonal Fruits and Vegetables Found at Farmers’ Markets in July Using a Yes/no Format., Knowledge of Locally Grown Seasonal Fruits and Vegetables found at Farmers’ Markets in July Score range:0-9 Higher scores indicate greater knowledge, Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format, Food-specific Knowledge Score range: 2-13 Higher scores indicate greater knowledge, Pretest, posttest, and 3- and 6-month follow-up|Response to Survey Items Assessing Knowledge of Area Farmers’ Markets, Farmers’ Market-specific Knowledge Score range:0-2 Higher scores indicate greater knowledge, Pretest, posttest, and 3- and 6-month follow-up | William Paterson University of New Jersey | USDA Food and Nutrition Service | FEMALE | CHILD, ADULT, OLDER_ADULT | NA | 744 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | WIC NEI-12-TX | 2014-07 | 2016-06 | 2016-06 | 2015-10-01 | 2019-10-30 | 2019-10-30 | Saint Joseph’s WIC Program, Paterson, New Jersey, 07524, United States | |||
| NCT02539355 | Diet and Metabolic Inflammation | https://clinicaltrials.gov/study/NCT02539355 | Obesity is a risk factor for several common cancers, including those of the breast, colon, liver, and pancreas. Proposed molecular links between obesity and these types of cancer include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic inflammatory processes in expanded adipose tissue. The objective of this proposal is to test the hypothesis that adipose tissue inflammation can be reduced by the foods we eat. | NO | Insulin Resistance|Diabetes|Cancer|Obesity|Inflammation | OTHER: Diet A|OTHER: Diet B | Change in adipose tissue macrophage cell surface expression of metabolic activation marker CD36 as measured by relative mean fluorescence intensity, As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in adipose tissue macrophage cell surface expression of metabolic activation marker ABCA1 as measured by relative mean fluorescence intensity (rMFI), As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages, Change between beginning (day 1) and end (week 12) of the study diet period. | Change in adipose tissue expression of the key pro-inflammatory cytokine, tumor necrosis factor α (TNFα) assessed by qPCR, Assessed by qPCR on whole abdominal subcutaneous adipose tissue, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-6 (IL-6) assessed by qPCR, Assessed by qPCR on whole abdominal subcutaneous adipose tissue, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-1 beta (IL-1beta) assessed by qPCR, Assessed by qPCR on whole abdominal subcutaneous adipose tissue, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in adipose tissue expression of the key anti-inflammatory adipokine, adiponectin assessed by qPCR, Assessed by qPCR on whole abdominal subcutaneous adipose tissue, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in systemic insulin sensitivity assessed by the Matsuda-DeFronzo Insulin Sensitivity Index, Assessed by the Matsuda-DeFronzo Insulin Sensitivity Index (ISI) based on a 3-hour frequently sampled oral glucose tolerance test (FS-OGTT), Change between beginning (day 1) and end (week 12) of the study diet period.|Change in oral glucose tolerance assessed by measuring total area under the curve glucose in the FS-OGTT, Assessed by measuring total area under the curve glucose in the FS-OGTT, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in fasting plasma C-reactive protein assessed by immunonephelometry, Assessed by immunonephelometry, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in fasting plasma IL-6 assessed by high-sensitivity ELISA, Assessed by high-sensitivity ELISA, Change between beginning (day 1) and end (week 12) of the study diet period.|Change in fasting plasma total adiponectin assessed by ELISA, Assessed by ELISA, Change between beginning (day 1) and end (week 12) of the study diet period. | Dietary adherence to prescribed 12-week diet assessed by dietary compliance score, Assessed by dietary compliance score, based on data from repeated 4-day dietary records, Assessed at the end of the study (week 12).|Changes in gut microbiota assessed by stool sample analysis, Assessed by stool sample analysis, Change between beginning (day 1) and end (week 12) of the study diet period. | Fred Hutchinson Cancer Center | ALL | ADULT, OLDER_ADULT | NA | 16 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | NCI2P30CA015704|CCSG Y39 Pilot: Kratz, M | 2015-08 | 2016-09 | 2016-09 | 2015-09-03 | 2016-10-24 | Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States | ||||
| NCT02538484 | Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects | https://clinicaltrials.gov/study/NCT02538484 | Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients. | NO | Breast Cancer | DRUG: Letrozole|DIETARY_SUPPLEMENT: Fish Oil | Change in levels of aromatase target gene., 30 Days|Change in serum levels of PGE2 (prostaglandin E2)., 30 Days | The University of Texas Health Science Center at San Antonio | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 24 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | CTMS# 15-2100|HSC20150602H | 2016-04 | 2020-03-11 | 2020-03-26 | 2015-09-02 | 2023-07-17 | Houston Methodist Cancer Center at Texas Medical Center, Houston, Texas, 77030, United States|Mays Cancer Center, UT Health San Antonio, San Antonio, Texas, 78229, United States | ||||||
| NCT02513407 | Eat, Move, Live Intervention in Reducing Chronic Disease Risk in Medically Vulnerable Communities | https://clinicaltrials.gov/study/NCT02513407 | This randomized pilot research trial studies how well Eat, Move, Live (EML) works in reducing chronic disease risk in medically vulnerable communities. Obesity, unhealthy diet, and physical inactivity are linked to increased cancer risk, especially hormone-related cancer (example, breast cancer). Improving healthy lifestyle practices, namely increasing physical activity and encouraging healthy eating behaviors may reduce the risk of getting cancer and chronic disease. | NO | Healthy Subject | BEHAVIORAL: Behavioral Dietary Intervention|OTHER: Educational Intervention|BEHAVIORAL: Exercise Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Laboratory Biomarker Analysis|OTHER: Questionnaire Administration | Changes in plasma glucose level measured using point of care glucometer OneTouch Ultra® 2, Will convert plasma glucose into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures., Baseline to up to 3 months|Changes in hemoglobin A1c level measured using a point of care device A1CNow®, Will convert hemoglobin A1c into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures., Baseline to up to 3 months|Changes in level of self reported 5-9 servings of fruits and vegetables using self evaluation and the daily food diary, Chi-square test and Logistic regression analysis will be used to determine whether the intervention significantly motivated participants to consume 7-8 servings of fruits/vegetables per day, adjusting for significant confounders (e.g., age, baseline BMI). Additionally, the Cochran Q test will be used to evaluate changes on barriers to fruit/vegetable consumption at the baseline and follow-up time points., Baseline to up to 3 months|Changes in reduction in barriers to exercise using self-report evaluation based on historical EML program using Likert-type scale items, Compliance to exercise at baseline and follow-up will be assessed using Logistic regression analysis. Additionally, the Cochran Q test will be used to evaluate changes on barriers to exercise at the baseline and follow-up time points., Baseline to up to 3 months|Changes in self-reports of activity tracker readings, Will compare baseline and follow-up exercise levels between the intervention and control groups in an independent t-tests, and compare the pre- to post-intervention change in activity tracker readings between groups with repeated measure analysis of covariance with age and baseline body mass index (BMI) as confounders., Up to 3 months|Reduction in barriers to fruit and vegetable consumption using self-evaluation based on historical EML program using Likert-type scale, Cochran Q test will be used to assess participants’ barriers to fruit and vegetable consumption at different follow up period., Baseline to up to 3 months | City of Hope Medical Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 15160|NCI-2015-01220|15160 | 2016-04-06 | 2016-10-15 | 2025-05-15 | 2015-07-31 | 2025-01-03 | City of Hope Medical Center, Duarte, California, 91010, United States | |||||
| NCT02501460 | Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors | https://clinicaltrials.gov/study/NCT02501460 | This study is being conducted because low lean muscle mass is prevalent among childhood cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the body’s lean body mass. Low lean muscle mass is associated with loss of overall body strength, declining mobility and eventually, loss of independence. Among childhood cancer survivors, low lean muscle mass may contribute to reduced physical functioning and a sense of fatigue with exertion, limiting ability to participate in adequate physical activity. Loss of strength and a sense of fatigue with repeated movement make it difficult to participate in daily activities. Although there have not been exercise intervention studies among childhood cancer survivors specifically designed to evaluate the effects of resistance training on muscle mass, studies among individuals with chronic disease, including survivors of adult onset cancers, indicate that resistance exercise improves muscle mass, muscle strength, mobility, vitality and physical activity levels. Resistance training (weight lifting) is a form of physical activity that is designed to improve muscular fitness by exercising a muscle or a muscle group against external resistance. The purpose of the study is to evaluate the effects of resistance training combined with either a protein supplement or a sports drink on changes in lean muscle mass in young adults who were treated for childhood cancer. The sports drink, for this study, is considered a placebo. | NO | Cancer | OTHER: Educational handouts|OTHER: Resistance training|DIETARY_SUPPLEMENT: Supplementation|OTHER: Placebo | Change in lean muscle mass by arm, Dual x-ray absorptiometry (DEXA) will be used to determine lean muscle mass. Fat free mass will be measured in the total body scanning mode., Baseline and at 24 weeks|Change in handgrip by arm, Handgrip strength will be evaluated with a hand held dynamometer., Baseline and at 24 weeks|Change in knee extension by arm, Knee extension strength will be evaluated with the Biodex System IV dynamometer., Baseline and at 24 weeks|Change in ankle dorsiflexion by arm, Ankle dorsiflexion strength will be evaluated with the Biodex System IV dynamometer., Baseline and at 24 weeks|Change in walking speed by arm, Usual walking speed will be evaluated by having participants complete a timed 10 meter walk test., Baseline and at 24 weeks|Change in endurance by arm, Endurance will be evaluated by having participants complete the six minute walk test in a level of corridor as outlined by the American Thoracic Society., Baseline and at 24 weeks|Change in activity level by arm, Participants will complete the physical activity monitor (PAM) component of the most recent release of the National Health and Nutrition Examination Survey to measure activity levels. The PAM collects information on intensity and duration of common activities like walking and jogging for seven consecutive days. Participants will receive an accelerometer with written instructions, programmed to begin recording 12:01 a.m. on the day after the baseline assessment (the week before they begin training) and the day after their final training appointment., Baseline and at 24 weeks|Change in blood pressure by arm, Blood pressure will be evaluated with a sphygmomanometer., Baseline and at 24 weeks|Change in high density lipoprotein by arm, High density lipoprotein will be evaluated from fasting blood samples as part of a standard lipid panel., Baseline and at 24 weeks|Change in triglycerides by arm, Triglycerides will be evaluated from fasting blood samples as part of a standard lipid panel., Baseline and at 24 weeks|Change in abdominal obesity by arm, Abdominal obesity will be evaluated by measuring waist circumference with a Gulick tape measure to the nearest mm., Baseline and at 24 weeks|Change in fasting glucose by arm, Glucose level will be measured from fasting blood samples., Baseline and at 24 weeks|Change in fasting insulin by arm, Insulin level will be measure from fasting blood samples., Baseline and at 24 weeks|Change in C-reactive protein by arm, Highly sensitive C-reactive protein will be measured from fasting blood samples., Baseline and at 24 weeks|Change in self-reported exhaustion by arm, Measured using the vitality subscale of the Medical Outcomes Survey Short Form-36 (SF-36), version 2., Baseline and at 24 weeks | St. Jude Children’s Research Hospital | ATC Fitness|American Institute for Cancer Research | ALL | ADULT | NA | 130 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | REPS|AICR FDN YR 1|NCI-2015-01152 | 2015-08-17 | 2018-01-30 | 2018-01-30 | 2015-07-17 | 2018-07-17 | St. Jude Children’s Research Hospital, Memphis, Tennessee, 38105, United States | |||||
| NCT02476162 | Assessing Blood Pressure Remotely in Childhood Cancer Survivors | https://clinicaltrials.gov/study/NCT02476162 | Second malignant neoplasms and cardiac late effects are primary drivers of serious non-recurrence morbidity and mortality in long term childhood cancer survivors. Cardiac late effects have been most prominently associated with exposure to high doses of anthracyclines or chest radiation. While increased recognition of late effects has resulted in risk-targeted therapy and reductions in use of high dose radiation and anthracyclines for many patients, these cardiotoxic exposures continue to be essential components of curative childhood cancer therapy. In addition, as survivors age they are increasingly susceptible to other general risk factors for cardiovascular disease recognized in the general population, such as hypertension, obesity, dyslipidemia, and diabetes. This study will evaluate a high blood pressure monitor (HBPM)-based intervention for the early detection of pre-hypertension and prevention of clinical hypertension in survivors of childhood cancer. Eligible and consenting participants will be randomized into one of three groups: GROUP 1: Instructed to measure blood pressure (BP) every day for 3 months. GROUP 2: Instructed to measure BP for 7 consecutive days once a month, for 3 months. GROUP 3: Instructed to measure blood pressure for 3 consecutive days each month, for 3 months. The randomization to the above groups will be done using sequential assignment of newly recruited participants based on a randomly ordered list. PRIMARY OBJECTIVE: * Evaluate the feasibility of High Blood Pressure Monitoring (HBPM) for three consecutive months using a remote blood pressure device provided to participants of the St. Jude Lifetime cohort (SJLIFE) protocol. SECONDARY OBJECTIVES: * Assess compliance with use of HBPM by measurement frequency, evaluating overall and defined minimum use in each of the three different groups. * Assess compliance with use of HBPM by cell phone status, evaluating those with and without a personal cell phone capable of connecting directly to the home blood pressure monitoring device via Wi-Fi or Bluetooth network. | NO | Hypertension | DEVICE: iHealth Wireless Blood Pressure Monitor | Proportion of participants who meet or exceed defined minimum use of HBPM device by group, The proportion of participants who meet or exceed the defined minimum level of compliance with recording of scheduled blood pressure measurements will be reported. Minimum use is defined as: Groups 1 and 2: Successful recording of 12 measurements (maximum 2 per day, one morning and one evening) over any 7 day period in at least 2 of the 3 months of the study. Group 3: Successful recording of two measurements each day (morning and evening) for three consecutive days, at least once in each of the 3 months of the study., From Day 0 through 3 months | Compliance rate for the use of the HBPM device by group measurement frequency, The overall compliance rate for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled., From Day 0 through 3 months|Proportion of participants who comply with the use of HBPM device by cell phone status, Calculations will be done for participants who own a smart phone compatible with the HBPM device compared to those who need to be supplied with an additional device to pair with the HBPM device. The overall compliance for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled., From Day 0 through 3 months|Number of participants who fail to record any blood pressure measurements over the course of a month, From Day 0 through 3 months|Proportion of participants by group who recorded at least 80% of scheduled measurements, From Day 0 through 3 months | St. Jude Children’s Research Hospital | ALL | ADULT, OLDER_ADULT | 60 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | FABRIC|NCI-2015-02265 | 2015-06 | 2016-01 | 2016-01 | 2015-06-19 | 2016-09-15 | St. Jude Children’s Research Hospital, Memphis, Tennessee, 38105, United States | ||||||
| NCT02466061 | TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors | https://clinicaltrials.gov/study/NCT02466061 | This randomized, controlled study evaluates the efficacy of weigh loss interventions in endometrial cancer survivors, using novel technology-based weight loss platforms. This is a multi-site, pilot feasibility study which will provide preliminary data to support a larger NIH funded, mult-center trial. | NO | Endometrial Cancer | BEHAVIORAL: Telemedicine Weight Management plus Wi-Fi Scale (Arm A)|BEHAVIORAL: Text for Diet (Text4Diet) Group (Arm B)|BEHAVIORAL: Enhanced Usual Care Group (Arm C) | Change in Weight (kilograms), Change in weight (in kilograms) of study participants randomized to one of three weight loss intervention programs will be assessed. Measurement of this change will be evaluated from weights taken at baseline (randomization) and six months, the conclusion of the intervention program., Change from Baseline Weight at 6 months|Serum biomarker: Change in levels of Insulin-like growth factor-binding protein 1 (IGFBP-1), in ng/mL, Change in IGFBP-1 (in ng/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline IGFBP-1 at 6 months|Serum biomarker: Change in levels of Adiponectin, in ug/mL, Change in Adiponectin (in ug/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline Adiponectin at 6 months|Serum biomarker: Change in levels of Vascular Endothelial Growth Factor (VEGF), in pg/mL, Change in VEGF (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline VEGF at 6 months|Serum biomarker: Change in Interleukin 1-beta (IL1-beta), in pg/mL, Change in IL1-beta (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline IL1-beta at 6 months|Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL, Change in IL2 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline IL2 at 6 months|Serum biomarker: Change in Interleukin 6 (IL6), in pg/mL, Change in IL6 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline IL6 at 6 months|Serum biomarker: Change in Interleukin 7 (IL7), in pg/mL, Change in IL7 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline IL7 at 6 months|Serum biomarker: Change in Interleukin 8 (IL8), in pg/mL, Change in IL8 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline IL8 at 6 months|Serum biomarker: Change in C reactive protein (CRP), in mg/L, Change in CRP (in mg/L) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program., Change from Baseline CRP at 6 months | Knowledge of the association between obesity and endometrial cancer risk, Participants’ level of knowledge of the association between obesity and the risk of endometrial cancer will be assessed at baseline. Frequencies of categorical responses will be reported. The instrument used to collect this data is a participant completed Endometrial Cancer Questionnaire and was developed by the study investigators., Baseline|Psychosocial measure: Change in Body Image, Change in participants’ self-reported body image will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. Two validated, participant-completed instruments will be utilized to assess this outcome: the Multidimensional Body Self Relations Questionnaire-Appearance Subscales (MBSRQ-AS) and the Cancer-Related Body Image Scale (CRBI)., Change from Baseline Body Image at 6 months|Psychosocial measure: Change in Quality of Life, Change in participants’ self-reported quality of life will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the 12-Item Short Form Health Survey (SF-12)., Change from Baseline in Quality of Life at 6 months|Psychosocial measure: Change in Mood, Change in participants’ self-reported quality of life will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the Patient Health Questionnaire 9-Item Version (PHQ-9)., Change from Baseline in Mood at 6 months|Psychosocial measure: Change in Sexual Functioning, Change in participants’ self-reported sexual functioning will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. Three validated, participant-completed instruments will be utilized to assess this outcome: the Female Sexual Function Index (FSFI), the Dyadic Adjustment Scale (DAS), and the Female Sexual Distress Scale-Revised (FSDS-R)., Change from Baseline in Sexual Functioning at 6 months|Psychosocial measure: Change in Physical Activity, Change in participants’ self-reported physical activity will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the International Physical Activity Questionnaire Short Form (IPAQ)., Change from Baseline Physical Activity at 6 months | Fred Hutchinson Cancer Center | National Cancer Institute (NCI)|University of Pennsylvania|Washington University School of Medicine|Dana-Farber Cancer Institute | FEMALE | ADULT, OLDER_ADULT | NA | 207 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: | TREC 1190|U01CA116850|U54CA155850|U54CA155496|U54CA155626 | 2014-07 | 2016-06 | 2016-06 | 2015-06-09 | 2016-06-02 | Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States|Washington University in St Louis (Siteman Cancer Center), St. Louis, Missouri, 63110, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States | ||||
| NCT02465541 | Gentle Yoga and Dietary Counseling in Improving Physical Function and Quality of Life in Stage I-II Endometrial Cancer Survivors | https://clinicaltrials.gov/study/NCT02465541 | This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle change effects physical function and quality of life of endometrial cancer survivors. Gentle yoga and dietary counseling may help improve physical function and quality of life for stage I-II endometrial cancer survivors. | NO | Obesity|Endometrial Carcinoma | PROCEDURE: Gentle yoga therapy|OTHER: counseling intervention|OTHER: educational intervention|OTHER: quality-of-life assessment|OTHER: questionnaire administration | Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB)., Physical function will be assess using a SPPB walk performance assessment. Quality life will be assessed via the SF-36 and the Functional Assessment of Cancer Therapy-Endometrial FACT-EN., Up to 14 weeks | Examine intervention feasibility using a composite assessment., Descriptive statistics for the feasibility measures will be calculated using recruitment, adherence, and retention rate., Up to 14 weeks | Change from baseline in quality of life as measured by the FACT-G (Functional Assessment of Cancer Therapy: General), Up to 14 weeks|Change from baseline in mindfulness as measured by the 5 Factor mindfulness questionnaires (FFMQ), Up to 14 weeks | Ohio State University Comprehensive Cancer Center | FEMALE | CHILD, ADULT, OLDER_ADULT | NA | 16 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | OSU-13005|NCI-2014-00770 | 2013-07-23 | 2014-06-10 | 2022-04-27 | 2015-06-08 | 2023-09-15 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, 43210, United States | ||||
| NCT02454517 | Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer | https://clinicaltrials.gov/study/NCT02454517 | PALS | This randomized phase III trial studies a diet and exercise program based on the Diabetes Prevention Program to promote weight loss and improve health in men with low-risk or low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that promotes weight loss may influence prostate health. A combined diet and exercise program that is based on the Diabetes Prevention Program may affect markers (or “biomarkers”) of prostate cancer progression. Gathering this information may help doctors understand how obesity affects prostate cancer progression and may help lead to a program that can reduce the risk of prostate cancer progression. | YES | Prostate Adenocarcinoma|Stage I Prostate Cancer AJCC V7|Stage IIA Prostate Cancer AJCC v7 | BEHAVIORAL: Behavioral Dietary Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Informational Intervention|OTHER: Laboratory Biomarker Analysis|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Change From Baseline in Fasting Glucose at 6 Months, Mean and standard deviation of change from baseline., Baseline to 6 months|Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months, Mean and standard deviation of change from baseline., Baseline to 6 months|Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells, Mean and standard deviation of change from baseline., Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization)|Weight at 12 Months, Mean and standard deviation of weight at 12 months, 12 months (6 months after active intervention)|Change From Baseline in Fasting Insulin at 6 Months, Mean and standard deviation of change from baseline., Baseline to 6 months | Health Related Quality of Life (HRQOL) at 6 Months, Mean and standard deviation of Quality of Life measures at 6 months., 6 months | Fred Hutchinson Cancer Center | National Cancer Institute (NCI) | MALE | ADULT, OLDER_ADULT | NA | 117 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 9369|NCI-2015-00686|RG1001233|R01CA184075 | 2016-05-19 | 2021-09-30 | 2021-09-30 | 2015-05-27 | 2022-12-16 | 2023-01-04 | Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/17/NCT02454517/Prot_SAP_000.pdf | |
| NCT02432950 | Pancreatic Nutritional Program for Weight Loss in Overweight/Obese Patients With Stage I-III Breast Cancer | https://clinicaltrials.gov/study/NCT02432950 | This pilot clinical trial studies a pancreatic nutritional program for helping patients with stage I-III breast cancer who are overweight or obese lose weight. When patients have a high level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and other illnesses. Breast cancer patients who are overweight and obese are more likely to have their breast cancer return. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low, and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment. | NO | Obesity|Stage IA Breast Cancer|Stage IB Breast Cancer|Stage IIA Breast Cancer|Stage IIB Breast Cancer|Stage IIIA Breast Cancer|Stage IIIB Breast Cancer|Stage IIIC Breast Cancer | DIETARY_SUPPLEMENT: Dietary Intervention|OTHER: Educational Intervention|OTHER: Laboratory Biomarker Analysis|OTHER: Quality-of-Life Assessment | Change in body weight, Tested using the paired t-test, alpha = 0.05., Baseline to 6 months | Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance), Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing., Baseline to up to 6 months|Change in body composition (BMI), Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing., Baseline to up to 6 months|Change in physical fitness (measured using a handgrip dynamometer), Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing., Baseline to 6 months|Change in quality of life score (FACT-B+4), Baseline to 6 months|Change in serum inflammatory markers (C-reactive protein; cytokines), Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing., Baseline to 6 months|Compliance metrics (days glucometer sensor not utilized; days body weight not recorded; days journal entries not made; days meal cards not created; weekly counseling sessions missed), 12 weeks|DNA repair capacity (comet assay’s mean olive tail moment; number of gamma-H2A histone family, member X foci), Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing., Baseline to 6 months|Incidence of adverse events reported as possibly or definitely related to wearing the glucometer sensor following the PNP diet, Up to 6 months | City of Hope Medical Center | National Cancer Institute (NCI) | FEMALE | CHILD, ADULT, OLDER_ADULT | NA | 21 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 14253|NCI-2015-00654|14253 | 2016-01-07 | 2018-01-15 | 2022-12-19 | 2015-05-04 | 2023-03-21 | City of Hope Medical Center, Duarte, California, 91010, United States | ||||
| NCT02431676 | Survivorship Promotion In Reducing IGF-1 Trial | https://clinicaltrials.gov/study/NCT02431676 | SPIRIT | This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on insulin-like growth factor (IGF)-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors | YES | Breast Cancer|Prostate Cancer|Lung Cancer|Colon Cancer|Melanoma of Skin|Endometrial Cancer|Liver Cancer|Pancreatic Cancer|Rectal Cancer|Kidney Cancer|Other Solid Malignant Tumors | DRUG: Metformin|BEHAVIORAL: Coach Directed Behavioral Weight Loss|BEHAVIORAL: Self-control weight loss | IGF-1 Levels, Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months., 6 months | IGF-1 Levels, IGF-1 at 12 months, 12 months|IGF-1 to IGFBP3 Level Ratio (Molar Ratio), IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months., 6 months | Weight Measured by Scale(Kg), Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months, 6 and 12 months|Body Mass Index Measured by Scale and Tap(kg/m2), Changes in BMI among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|EuroQol Score Assessed by Questionnaire, Changes in EuroQol score among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|Dietary Intake Assessed by Questionnaire, Changes in dietary intake among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|Physical Activity Amount Assessed by Questionnaire, Changes in physical activity amount among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|Fasting Glucose Levels, Changes in fasting glucose among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|Insulin Levels, Changes in insulin among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|Hemoglobin A1C Levels, Changes in Hb-A1C among Metformin arm, or Coach-directed behavioral weight loss arm versus the Self-control weight loss arm at 6 and 12 months., 6 and 12 months|Interleukin (IL)-6 Levels, Changes in IL-6 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|Interleukin 8 Levels, Changes in IL-8 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|C-reactive Protein (CRP) Levels, Changes in CRP among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months|Side Effects Assessed by Side Effect Questionnaire, assessing side effect among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months., 6 and 12 months | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Cigarette Restitution Fund | ALL | ADULT, OLDER_ADULT | PHASE2 | 121 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | J14148|IRB00035653 | 2015-05 | 2018-12 | 2018-12 | 2015-05-01 | 2020-09-16 | 2024-08-28 | Johns Hopkins ProHealth, Baltimore, Maryland, 21207, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/76/NCT02431676/Prot_SAP_000.pdf |
| NCT02399956 | Lactation Outcomes Among Survivors of Pediatric Cancer | https://clinicaltrials.gov/study/NCT02399956 | While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Childhood cancer treatments are known to cause late effects that frequently involve the endocrine system. Because normal lactation is dependent upon interplay of multiple endocrine factors, the investigators anticipate more breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies, thyroid disorders and obesity. In order to more fully inform clinicians and female survivors, the study of the burden of lactation failure is needed to begin to address the impact of pediatric cancer therapy on lactation success/failure and to examine the association of specific endocrine disorders on lactation outcomes. | NO | Cancer|Leukemia | OTHER: Survey | Number of survivors who experience successful breastfeeding outcome by age at diagnosis, Once, at enrollment (Day 1)|Number of survivors who experience successful breastfeeding outcome by years since diagnosis, Years since diagnosis will equal the years since diagnosis prior to first pregnancy resulting in a live birth., Once, at enrollment (Day 1)|Number of survivors who experience successful breastfeeding outcome by therapy with radiation, Once, at enrollment (Day 1)|Number of survivors who experience successful breastfeeding outcome by therapy with surgery, Includes chest and/or brain surgery., Once, at enrollment (Day 1)|Number of survivors who experience successful breastfeeding outcome by diagnosis of growth hormone deficiency, Growth hormone deficiency indicated by low IGF-1, Once, at enrollment (Day 1)|Number of survivors who experience successful breastfeeding outcome by diagnosis of hypothyroidism, Hypothyroidism, primary or central, measured by TSH level., Once, at enrollment (Day 1)|Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus, Once, at enrollment (Day 1)|Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity, Obesity (BMI) prior to pregnancy., Once, at enrollment (Day 1) | Number of survivors who experience successful breastfeeding outcome compared to healthy women, Breastfeeding outcomes (intention, initiation, and duration/weaning) will be determined by self-report, and dichotomized for analysis. Intention is defined as a mother’s specific plan to breastfeed her infant prior to birth (yes/no); initiation is defined as ever having started breastfeeding (yes/no); duration is defined as at least 6 months of breastfeeding (yes/no); and weaning is defined as breastfeeding cessation after 1 year (yes/no). Data from survivors will be compared with a national sample of healthy women (n=2,000) who responded to the Project First survey (2009). The Infant Feeding Practices Survey II (Project First) is a longitudinal study developed by the Food and Drug Administration and the Centers for Disease Control and Prevention., Once, at enrollment (Day 1) | St. Jude Children’s Research Hospital | FEMALE | ADULT, OLDER_ADULT | 471 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | LACOUT | 2015-03 | 2015-12 | 2015-12 | 2015-03-26 | 2015-12-10 | St. Jude Children’s Research Hospital, Memphis, Tennessee, 38105, United States | ||||||
| NCT02370277 | Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer | https://clinicaltrials.gov/study/NCT02370277 | This pilot research trial studies the effects of chemotherapy on intestinal bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in intestinal microbiota may be associated with weight gain in patients treated with chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the types and quantity of bacterial composition in the stool of breast cancer patients treated with chemotherapy may help determine whether body weight and composition are associated with changes in the intestinal microbiota and allow doctors to plan better treatment to prevent weight gain and possibly disease recurrence. | NO | Ductal Breast Carcinoma In Situ|Invasive Breast Carcinoma|Stage I Breast Cancer|Stage IIA Breast Cancer|Stage IIB Breast Cancer|Stage IIIA Breast Cancer | OTHER: Cytology Specimen Collection Procedure|OTHER: Laboratory Biomarker Analysis|OTHER: Questionnaire Administration | Change in intestinal microbiota (composition, abundance, and diversity), Paired sample t-test will be used to determine whether there are significant changes in microbiota diversity (as measured by the number of taxonomic groups) between pre-treatment levels and 1 and 4 months after the final chemotherapy treatment. Mixed-model linear regression on repeated measures will be used to concurrently adjust for physical activity, dietary intakes, and other factors., Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course | Change in body composition based on dual-energy x-ray absorptiometry (DEXA), Analyses of body composition measures will be based on fat mass, lean mass, and bone mineral content (BMC); each will be expressed in kilograms, on arms, legs, and trunk. Mixed effects regression models will be used to compare changes per week between pre-treatment assessment and 1 and 4 months after last chemotherapy. Additional analyses will use BMI group (normal, overweight, obese) for stratification and as a covariate in regression models. The relationship between body composition and gut microbiota before and after chemotherapy will be examined., Baseline to 4 months after last chemotherapy|Baseline estradiol and estrone levels, Changes in the microbiota composition, abundance and diversity will be correlated with baseline estradiol and estrone levels., Baseline|Change in estrogen levels, Correlation analyses of changes in the microbiota with changes in estrogen levels will be performed. Mixed effects regression analysis will be used to model systemic estrogen levels as a function of microbiota abundance and diversity, adjusting for cancer treatment, and baseline tumor and other individual characteristics., Baseline to up to 4 months after last chemotherapy | University of Southern California | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | 36 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1B-14-6|NCI-2014-02611|HS-14-00712|1B-14-6|P30CA014089 | 2014-12-16 | 2016-06-15 | 2018-08-22 | 2015-02-24 | 2019-06-18 | USC Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States | |||||
| NCT02361047 | Let’s Play! Healthy Kids After Cancer | https://clinicaltrials.gov/study/NCT02361047 | This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors. | NO | Childhood Acute Lymphoblastic Leukemia in Remission|Obesity | BEHAVIORAL: Phone Coaching Program | Feasibility: Number of participants who complete 8 of 10 intervention sessions, Measured by intervention session completion rates., 6 months|Retention: Number of participants who complete 6-month outcome assessments, Measured by completion of the 6-month outcome assessment., 6 months|Acceptability: Number of participants who report high satisfaction with the intervention, Measured by parent survey of satisfaction with intervention materials and sessions., 6 months | Change in children’s physical activity, Measured by ActiGraph accelerometers, 6 months|Change in children’s dietary intake, Measured by Nutrition Data System for Research (NDSR) interview, 6 months|Change in children’s BMI, Staff-measured height and weight, 6 months|Change in children’s biomarker outcome measures, Measured by serum blood samples, 6 months|Change in children’s energy level, Measured by questionnaire: PedsQL Multidimensional Fatigue Scale, 6 months | HealthPartners Institute | National Cancer Institute (NCI)|Masonic Cancer Center, University of Minnesota|Children’s Hospitals and Clinics of Minnesota|St. Jude Children’s Research Hospital | ALL | CHILD | NA | 42 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | A13-175|1R21CA182727-01A1 | 2015-02 | 2016-10 | 2016-10 | 2015-02-11 | 2019-06-10 | Children’s Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, 55404, United States|Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, 55455, United States|St. Jude Children’s Research Hospital, Memphis, Tennessee, 38105, United States | ||||
| NCT02342730 | Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia | https://clinicaltrials.gov/study/NCT02342730 | This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or obesity is one of the most common contributors to (causes of) endometrial cancer. Over two-thirds of women who have survived endometrial cancer are obese. Complications of obesity, such as heart disease are often more dangerous than the cancer itself. A weight loss of even 5-10% of excess body weight is associated with improved health. Often, meeting with a doctor or person who is an expert in weight loss (bariatric specialist) is the best way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia who go see a weight loss specialist recommended by their doctor may be able to achieve a healthier body weight. | NO | Complex Endometrial Hyperplasia With Atypia|Stage IA Uterine Corpus Cancer|Stage IB Uterine Corpus Cancer|Stage II Uterine Corpus Cancer | BEHAVIORAL: Weight Loss Specialist|OTHER: Quality-of-Life Assessment|OTHER: Medical Chart Review | Accrual with intervention, defined as number of subjects who agree to participate, Descriptive statistics will be used. Will be compared using chi square or fisher exact tests., Up to 24 months|Compliance with intervention, defined as number of patients who follow up with the obesity referral, Descriptive statistics will be used. Will be compared using chi square or fisher exact tests., Up to 24 months | Weight loss (in kilograms), Descriptive statistics will be used. Will compare groups using a paired t-test., Baseline to 12 months|Weight loss (in kilograms), Descriptive statistics will be used. Will compare groups using a paired t-test., Baseline to 24 months|Compliance with lifestyle changes (based on affirmative response to 3 month follow up when asked if lifestyle changes have been adopted), Will be compared using chi square or fisher exact tests., At 3 months|Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism), Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests., Baseline|Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism), Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests., At 12 months|Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism), Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests., At 24 months|Progression free survival, Descriptive statistics will be used. Will be described with Kaplan Meier curves., Up to 24 months|Overall survival, Descriptive statistics will be used. Will be described with Kaplan Meier curves., Up to 24 months|Recurrence rate, Descriptive statistics will be used to detail cancer related outcomes (cancer recurrence, date and location of recurrence, cancer related death)., Up to 24 months|Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24, Will compare groups using a paired t-test., At 12 months|Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24, Will compare groups using a paired t-test., At 24 months | Case Comprehensive Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 127 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | CASE13813|NCI-2014-02477|CASE13813|P30CA043703 | 2014-12-17 | 2015-05-18 | 2015-05-18 | 2015-01-21 | 2018-11-19 | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, 44195, United States | ||||
| NCT02341235 | Self-monitoring Activity: a Randomized Trial of Game-oriented Applications | https://clinicaltrials.gov/study/NCT02341235 | SMARTGOAL | The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight. | YES | Breast Cancer|Obesity | BEHAVIORAL: Game intervention|BEHAVIORAL: Standard intervention | Change in Minutes Per Day of Physical Activity, Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months., baseline and 6 months | Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test, We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course, baseline to 6 months|Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test’s Chair Stand Measure, We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of chair stands that can be completed within 30 seconds. A higher number indicates better function in this area., baseline to 6 months|Change in Weight From Baseline to 6 Months, We will measure weight using a calibrated scale, baseline to 6 months|Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy – Breast Measure, We will use the Functional Assessment of Cancer Therapy – Breast measure’s physical subscale. This scale has a range of 0-28 and 7 items measured on a 5 point scale (not at all to very much). A higher score indicates greater physical quality of life., baseline to 6 months|Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity, The Behavioral Regulation in Exercise Questionnaire-2 intrinsic regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates higher intrinsic motivation., baseline to 6 months|Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy – Breast Measure’s Social/Family Well-Being Subscale, We will use the Functional Assessment of Cancer Therapy – Breast measure’s social/family subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater social/family quality of life., baseline to 6 months|Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy – Breast Measure’s Emotional Well-Being Subscale, We will use the Functional Assessment of Cancer Therapy – Breast measure’s emotional subscale. This scale has a range of 0-24 and 6 items measured on a 5-point scale (not at all to very much). A higher score indicates greater emotional quality of life, baseline to 6 Months|Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy – Breast Measure’s Functional Well-Being Subscale, We will use the Functional Assessment of Cancer Therapy – Breast measure’s functional subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater functional quality of life, baseline to 6 Months|Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy – Breast Measure’s Breast Cancer Subscale, We will use the Functional Assessment of Cancer Therapy – Breast measure’s breast cancer subscale. This scale has a range of 0-40 and 10 items measured on a 5-point scale (not at all to very much). A higher score indicates greater breast cancer-related quality of life, baseline to 6 Months|Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity, The Behavioral Regulation in Exercise Questionnaire-2 identified regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation., baseline to 6 Months|Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity, We will use items from P.M. Wilson and colleague’s expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation., baseline to 6 Months|Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test’s Arm Curl Measure, We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of arm curls that can be completed within 30 seconds. A higher number indicates better function in this area., baseline to 6 Months|Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test’s Sit and Reach Measure, We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance an individual can reach from their toes when bending forward. A higher number indicates better function in this area., baseline to 6 Months|Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test’s Back Scratch Measure, We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance between an individual’s arms when they reach them behind their back (one higher above the shoulder and one lower). A higher number indicates better function in this area., baseline to 6 Months|Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test’s 8 Foot Up and Go Test, We will use the Senior Fitness Test to measure physical function, specifically in regards to the time in which an individual can sit up, walk 8 feet around a cone, and sit back down. A lower number indicates better function in this area., baseline to 6 Months | Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 6 Minute Walk Test, We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course, baseline to 6 months|Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test, We will use the Senior Fitness Test to measure physical function, with a higher number indicating greater function, baseline to 6 months|Change in Sleep From 6 Months to 1 Year, We will use a computerized PROMIS measure specific to cancer survivors, baseline to 6 months|Change in Weight From 6 Months to 1 Year, Weight will be measured using a calibrated scale, baseline to 6 months|Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols, We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.), 1 year|Number of Participants Who Report Adverse Events, We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed., 1 year|Change in Anxiety From Baseline to 6 Months, We will use a computerized PROMIS measure to investigate anxiety (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 – Anxiety). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less anxiety) than the population., baseline to 6 months|Change in Depression From 6 Months to 1 Year, We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 – Depression), baseline to 6 months|Change in Fatigue From Baseline to 6 Months, We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 Fatigue). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less fatigued) than the population., baseline to 6 months|Change in Quality of Life From 6 Months to 1 Year, We will use the Functional Assessment of Cancer Therapy – Breast measure, baseline to 6 months|Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity, Behavioral Regulation in Exercise Questionnaire-2 will be used, specifically subscales for autonomous motivation (intrinsic, integrated, identified regulation). We will use items from P.M. Wilson and colleague’s expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation., baseline to 6 months|Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps, Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire, baseline to 6 months|Play Experience, Measured Using the Play Experience Questionnaire, Participants will self-report their perceptions of the playfulness of the intervention apps, Measured at 3 months|Change in Exercise Identity From Baseline to 6 Months, We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity, baseline to 6 months|Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale, We will measure the extent to which participants in the narrative group felt narratively engaged in the game’s storyline, Measured at 3 months|Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale, We will measure the extent to which participants in the narrative group felt like they identified with their game character, Measured at 3 months|Change in Depression From Baseline to 6 Months, We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 – Depression). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less depressed) than the population., baseline to 6 months|Change in Fatigue From 6 Months to 1 Year, We will use a computerized PROMIS measure specific to cancer patients/survivors, baseline to 6 months|Change in Sleep From Baseline to 6 Months, We will use a computerized PROMIS measure (Patient Reported Outcomes Measurement Information System PROMIS Bank v1.0 – Sleep-Related Impairment). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower than the population (more/less impairment)., baseline to 6 months|Maintenance of Physical Activity From 6 Months to 1 Year, Minutes of moderate-vigorous physical activity measured over a 7 day period, baseline to 6 months | The University of Texas Medical Branch, Galveston | American Cancer Society, Inc. | FEMALE | ADULT, OLDER_ADULT | NA | 90 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | 14-0376 | 2015-02 | 2020-06-30 | 2021-06-30 | 2015-01-19 | 2024-07-31 | 2024-07-31 | The University of Texas Medical Branch, Galveston, Texas, 77550, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/35/NCT02341235/Prot_SAP_000.pdf |
| NCT02309944 | Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients | https://clinicaltrials.gov/study/NCT02309944 | The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients. | YES | Postoperative Complications|Obesity|Gynecologic Neoplasms | PROCEDURE: Standard Wound Closure|DEVICE: Prevena™ Incision Management System | Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection), one month after surgery | Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies, up to 20 weeks | Masonic Cancer Center, University of Minnesota | ALL | ADULT, OLDER_ADULT | NA | 93 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 2013NTLS073 | 2015-05 | 2020-06 | 2020-06 | 2014-12-05 | 2020-07-27 | 2020-07-27 | University of Minnesota, Minneapolis, Minnesota, 55455, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/44/NCT02309944/Prot_SAP_000.pdf | |||
| NCT02279303 | Rx for Better Breast Health | https://clinicaltrials.gov/study/NCT02279303 | This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing \[MI\] and tailored newsletters) on obese (body mass index \[BMI\] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group. | NO | Breast Cancer | BEHAVIORAL: Dietary Intervention|BEHAVIORAL: Dietary Control | Achieve USDA-recommended dietary intake based on five major food groups, The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score (“yes” vs. “no”) describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values., 12 months|Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up, We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values., 12 months|Comparison of Interleukin (IL) pro-inflammatory biomarkers, We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values., 12 months|Comparison of Interleukin (IL) anti-inflammatory biomarkers, We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values., 12 months|Comparison of C-Reactive Protein (CRP), We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values., 12 months|Comparison of Tumor Necrosis Factor-alpha (TNF-alpha), We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values., 12 months | The University of Texas Health Science Center at San Antonio | Susan G. Komen Breast Cancer Foundation | FEMALE | ADULT, OLDER_ADULT | NA | 153 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION | HSC20140150H | 2013-04 | 2017-12 | 2017-12 | 2014-10-31 | 2018-01-23 | The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States | |||||
| NCT02278185 | Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer | https://clinicaltrials.gov/study/NCT02278185 | This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy. | YES | Adenocarcinoma of the Prostate|Recurrent Prostate Cancer|Stage III Prostate Cancer|Stage IV Prostate Cancer | DRUG: Enzalutamide|DRUG: leuprolide acetate|DRUG: goserelin acetate|DRUG: histrelin acetate|DRUG: triptorelin|DRUG: degarelix | Metabolic Syndrome Incidence, Summarized by the Number of Patients With at Least 3 of the 5 Pre-specified Criteria, Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference \> 102 cm (\> 40 in); serum triglycerides \>= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum high density lipoprotein (HDL) cholesterol \< 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure \>= 130/\>= 85 mmHg or drug treatment for elevated blood pressure; and fasting plasma glucose (FPG) \>= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose., Within the first 12 months of therapy | Metabolic Syndrome Incidence, Summarized by the Proportion of Patients With at Least 3 of the 5 Pre-specified Criteria, Metabolic syndrome will be assessed at the beginning of each course and defined by the presence of 3 of the following five traits: abdominal obesity, defined as a waist circumference \> 102 cm (\> 40 in); serum triglycerides \>= 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides; serum HDL cholesterol \< 40 mg/dL (1 mmol/L) or drug treatment for low HDL; blood pressure \>= 130/\>= 85 mmHg or drug treatment for elevated blood pressure; and FPG \>= 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose., Within the first 6 months of therapy|Change in Bone Turnover Markers, as Measured by Bone-specific Alkaline Phosphatase, Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test will test within an arm as to whether the change from baseline to 12 months is significantly different from zero., Baseline and month 12|Change in Bone Density, We will measure bone density via a DXA scanner, Left Femur and Right femur T scores will be added to a composite score. A paired t-test will test within an arm as to whether the change from baseline to twelve months is significantly different from zero. The T-score is the standard deviation of how much bone density differs from the bone mass of an average healthy 30 year old. A score of 0 indicates no deviation from average. The following ranges are used: * T-score of -1.0 or above = normal bone density * T-score between -1.0 and -2.5 = low bone density, or osteopenia * T-score of -2.5 or lower = osteoporosis, Baseline to 12 months|Change in Free Fat Mass, as Measured by a DXA Scanner, A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero. These data are not able to be reported as the DXA did not measure free fat mass and thus we will be using cross sectional CT analysis., Baseline to up to 12 months|Change in Fat Mass, as Measured by a DXA Scanner, A paired t-test will test within an arm as to whether the change from baseline to each time point is significantly different from zero., Baseline to up to 12 months|Change in Quality of Life (QOL) Scores, as Measured by the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and Sexual Health in Men (SHIM), The FACT-P is the Functional Assessment of Cancer Therapy – Prostate and measures physical/emotional quality of life in prostate cancer patients. NUMBER OF ITEMS:39 PATIENT POPULATION:Prostate cancer patients 18 years and older RECALL PERIOD:Past 7 days RESPONSE SCALE:5 point Likert-type scale SUBSCALE DOMAINS: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), Prostate Cancer Subscale (PCS) SCORING: Scores range from 0-158. In general, the higher the score, the better the quality of life. Sexual Health in Men (SHIM). 5 item measure of erectile function. Total score is 1-25 with a higher score indicating better sexual health. Scores: no ED (SHIM total score, 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe ED (1-7)., Baseline to up to 7 months|Number of Patients With PSA Progression, PSA progression as defined by an increase in \>= 50% from nadir and an absolute increase of at least 2 ng/mL above the nadir, occurring at least 12 weeks after start of therapy that is confirmed by two consecutive increases taken at least 2 weeks apart. Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT., Time from randomization to the earliest objective evidence of PSA progression as defined per protocol, assessed up to 30 days after the last dose of study drug|Time to Radiographic Progression, Log rank test will be used to compare the distributions of above variables between the group treated with enzalutamide to the group on standard ADT., Time from randomization to the earliest objective evidence of radiographic progression as defined per protocol, assessed up to 30 days after the last dose of study drug|Change in Markers of Inflammation, as Measured by Circulating Hs-CRP, Mean change in available samples from baseline to 12 months, presented in mg/dL, Difference between baseline and 12 months.|Incidence of Adverse Events, Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.1, The incidence of adverse events has been reported in the adverse events log for clinicaltrials.gov, Up to 30 days after the last dose of study drug|Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB)., The Short SPPB incorporates 3 validated portions to assess a patient’s balance and mobility. SPPB scores range from zero to 12 possible points. SPPB score of 3-9 points in persons with no mobility disability indicates frailty; SPPB score of 10 or greater for persons with no sarcopenia and no mobility disability indicates robustness. The higher the score, the better the physical function. Will be measured as a continuous outcome., Difference between baseline and 12 months.|Change in Bone Turnover Markers as Measured by N-telopeptide, Will be assessed for each treatment group. Measurements will be taken at day 1 of each course. A paired t-test within an arm as to whether the change from baseline to 12 months is significantly different from zero. N-Telopeptide units – nM Bone Collagen Equivalent (BCE)., Baseline and 12 months | University of Colorado, Denver | MALE | ADULT, OLDER_ADULT | PHASE2 | 19 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 14-0909.cc|NCI-2014-02219 | 2015-11-11 | 2019-04-10 | 2025-04-10 | 2014-10-29 | 2022-04-27 | 2024-05-06 | University of Colorado Cancer Center – Anschutz Cancer Pavilion, Aurora, Colorado, 80045, United States|University of Colorado Health – Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/85/NCT02278185/Prot_SAP_000.pdf | |||
| NCT02273206 | Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women | https://clinicaltrials.gov/study/NCT02273206 | PCM3 | Bronx County, New York is the poorest urban county in the U.S.A., and residents are almost entirely Latino or African American. Cancer is the leading cause of premature death in the Bronx, with morality rates significantly higher than for New York City as a whole. Low-income/minority populations are more likely to be diagnosed with preventable and late-stage cancers than the general population, in part, due to lower screening rates. While research has addressed screening barriers in low-income/minority groups, depression, a common,potentially critical barrier, has received scant attention. Research suggests that depressed women are less likely to engage in cancer screening, especially mammography and Pap testing. The link between mental health and cancer screening is particularly important to address in the Bronx, which has the highest rates of self-reported serious psychological distress (a measure closely related to depression) in New York City. Depression affects almost 1 in 4 minority women, and while minorities often seek help for depression in primary care, primary care depression management often does not meet evidence-based standards. Drawing on the expertise and close collaboration of Bronx medical and social service providers and patient stakeholders, this study will determine whether a collaborative care intervention that addresses both depression and cancer screening needs simultaneously among women ages 50-64 is more effective at improving cancer screening and patient-reported outcomes for women with depression than an existing evidence-based cancer screening intervention alone. To achieve this, the investigators will compare the effectiveness of these two interventions using a randomized controlled trial (RCT). In partnership with six Bronx Federally Qualified Health Centers (FQHCs), the investigators will recruit approximately 800 women ages 50-64 who screen positive for depression and are non-adherent with recommended cervical, breast, and/or colorectal cancer screenings. The investigators specific aims are to: 1) compare the impact of the two interventions on patient-reported outcomes, including cancer screening knowledge and attitudes, self-efficacy, depression-related stigma, provider referrals, participation in mental health care, medication adherence, quality of life, satisfaction with care and treatment decisions, and depression; 2) compare the effectiveness of the two interventions in increasing breast, cervical, and colorectal cancer screening; 3) determine whether reducing depression increases the likelihood that low-income women 50-64 will receive cancer screening; 4) determine whether effectiveness of the two interventions in increasing cancer screening varies according to patient characteristics, such as duration of depression, presence of other chronic conditions, and obesity. This study is designed to increase the investigators understanding of how to enhance primary care systems’ ability to improve a range of outcomes related to cancer screening and depression among low-income minority women, and how to best support this population in making cancer-screening decisions. | YES | Depression|Breast Cancer Screening|Cervical Cancer Screening|Colorectal Cancer Screening | BEHAVIORAL: Prevention Care Management for Depression and Cancer Screening|BEHAVIORAL: Prevention Care Management for Cancer Screening | Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status, Comparison of the proportion of patients who were up to date for colorectal cancer, breast cancer and cervical cancer screenings before and after the intervention. (Chart Review), Baseline – 12 months|Assessment of Colorectal Cancer Screening Up to Date Status After Intervention, Multivariate logistic regression model was used to assess which factors contributed to colorectal cancer screening up to date status., Baseline – 12 months|Assessment of Breast Cancer Screening Up to Date Status After Intervention, Multivariate logistic regression model was used to assess which factors contributed to breast cancer screening up to date status, Baseline – 12 months|Assessment of Cervical Cancer Screening Up to Date Status After Intervention, Multivariate logistic regression model was used to assess which factors contributed to cervical cancer screening up to date status, Baseline – 12 months|Comparison of Change in Patient Health Questionnaire-9 (PHQ9) Score by Intervention Arm, Comparison of change in depression between the CCI and PCM arm before and after intervention. (Self-Report). The Patient Health Questionnaire-9 (PHQ9) is a well-validated measure of Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for screening and diagnosing depressive episode, assessing severity, and monitoring treatment response. The PHQ9 score ranges from the minimum of 0 (no depression) to the maximum of 27 (severe depression). The detailed PHQ9 scores and corresponding level of depression severity are as follow: 0 (no depression), 1-4 (mild depression), 5-9 (medium-mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression) and 20-27 (severe depression). The mean change in PHQ9 score is the mean of the differences between PHQ9 score at baseline and the PHQ9 score at follow up for all cases in the respective intervention arm; the greater the change in PHQ9 score, the greater the improvement in depression severity., Baseline – 12 months|Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 6 Months, The SCL-20 consists of the 20 depression items on a 4-point scale from the SCL-90, and has been shown to be a valid and reliable measure of depression in diverse outpatient and community populations., Baseline – 6 months|Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 12 Months, The SCL-20 consists of the 20 depression items on a 4-point scale from the SCL-90, and has been shown to be a valid and reliable measure of depression in diverse outpatient and community populations., Baseline – 12 months|Changes From Baseline in Number of Participants With Colorectal, Breast, and/or Cervical Cancer Screening, Self-Report: We will ask participants about their participation (yes/no) in specific screening methods: Pap testing (past 3 years), mammography (past 2 years), and colorectal screening (fecal occult blood tests (FOBT)/fecal immunohistochemical tests (FIT)), past year; flexible sigmoidoscopy, the past 5 years; and colonoscopy, past 10 years)., Baseline – 12 months | Mental Health Care Utilization: Assessed by Patient Report, Participants were asked how many times in the past six months they had seen a provider to talk about or to receive medication for feeling sad, nervous, hopeless, or blue. This question was adapted from the NCI’s HINTS survey. Two categories were created using the median as a cut point. The two categories were high utilization and low utilization., Baseline, 6 months and 12 months|Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale, The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker’s values, and behaviorally implemented. This scale has been tailored to healthcare decisions to receive treatment for emotional or mental health and to have cervical, breast, and colon cancer screening.The continuous summary score was converted into two categories using the median as a cut point. The two categories are high satisfaction and low satisfaction., Baseline, 6 months and 12 months|Physician Recommendation of Screening/Mental Health Care, This questionnaire, adopted from National Cancer Institute’s (NCI) Health Information National Trends Survey (HINTS), assesses whether patients report that their primary care physician 1) has recommended cervical, breast, and colon cancer screening and 2) has recommended that the patient make an appointment with a mental health provider and/or take psychotropic medication. Two categories were created according to whether the patient received a physician recommendation (yes/no). The category of “Recommendation” for when they received a recommendation and a category of “No Recommendation” if they did not receive a recommendation, Baseline, 6 months and 12 months|Generalized Anxiety Disorder, This Generalized Anxiety Disorder scale is based on diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) and measures probable anxiety disorder and severity of anxiety symptoms. Patients are asked to rate how often they have been bothered by 7 problems in the last 2 weeks on a 4-point scale. Standard cut points were used for the Generalized Anxiety Disorder measure. Minimal anxiety is (0-4). Mild Anxiety would be count as (5-9). Moderate Anxiety (10-14) and severe anxiety would be (15-21)., Baseline, 6 months and 12 months|Medical Outcomes Study Health Survey-Short Form, The quality of life was measured with the Medical Outcomes Study (MOS) Short Form Health Survey (SF-12) is a general measure of health status that assess the patient’s perceived health status and whether health problems interfere with normal functioning. The SF-12 has demonstrated validity and test-retest reliability in the general population and in patients with chronic health conditions, and has been tested in five languages, including Spanish. It has been used extensively as a quality of life measure in collaborative care studies, including with low-income minority populations. It has also been used frequently in screening studies, for cancer and other conditions. The SF-12 has been validated as an indicator of effects of depression on quality of life in ethnically diverse patients. The continuous summary score was converted into 4 categories using quartiles as cutoff points. The four categories are Best Health, Good health, Fair Health and Worst Health., Baseline, 6 months and 12 months|Breast, Cervical and Colorectal Cancer Screening Attitudes, This measure was adapted from the National Cancer Institute’s HINTS questions for colorectal cancer. The continuous summary score was converted into 4 categories using quartiles as cut points. The categories for screening attitudes were as follows: positive attitudes, moderate attitudes, fair attitudes and negative attitudes., Baseline, 6 months and 12 months|Satisfaction With Decision Scale- Cancer Screening (Data Reported in Outcome Measure #10), The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker’s values, and behaviorally implemented. This scale has been tailored to healthcare decisions to have cervical, breast, and colon cancer screening.The satisfaction with decision scale of cancer screening and its continuous summary score was converted into two categories (high satisfaction and low satisfaction) using the median as the cutoff point., Baseline, 6 months and 12 months|Satisfaction With Decision Scale- Mental Health (Data Reported in Secondary Outcome Measure #10), The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker’s values, and behaviorally implemented. This scale has been tailored to healthcare decisions to have mental health care.The satisfaction with decision scale of mental health and its continuous summary score was converted into two categories (high satisfaction and low satisfaction) using the median as the cutoff point., 12 months|Devaluation-Discrimination Scale, This measure was adapted from the Link’s Devaluation-Discrimination Scale.The continuous summary score was converted into 4 categories using quartiles as cut points. The 4 categories were as follows: Low stigma, minimal stigma, moderate stigma and high stigma., Baseline and 12 months|Ambulatory Care Experiences as Assessed by Ambulatory Care Experiences Survey, The Ambulatory Care Experiences Survey produces 11 summary measures covering 2 broad dimensions of patients’ experiences: quality of physician-patient interactions and organizational features of care. The continuous summary score was converted into 4 categories (High, Moderate, Fair and Low) using quartiles as cut-points., Baseline, 6 months and 12 months|Medication Adherence, In this questionnaire, respondents were asked if they had been prescribed medication for depression and about difficulties taking medication(s) regularly. Standard cut points was used for medical adherence. High adherence- around an 8. Medium adherence – 6-7.99. Low adherence would be anything less than 6., Baseline, 6 months and 12 months|Self-efficacy and Behavior Towards Cancer Screening/Mental Health Utilization, This 5-item scale measures a sense of perceived self-efficacy associated with accessing and paying for the three different types of cancer screening and utilization of needed mental health services. The continuous study score was converted into 4 categories using quartiles as cut points. The 4 categories are high self-efficacy, moderate self- efficacy, minimal self-efficacy and low self-efficacy., Baseline, 6 months and 12 months | Clinical Directors Network | FEMALE | ADULT | NA | 802 | NETWORK | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | IH-12-11-4522 | 2014-01 | 2017-12-31 | 2017-12-31 | 2014-10-23 | 2020-03-12 | 2020-03-12 | Lincoln Ambulatory Care Practice, Bronx, New York, 10451, United States|Morrissania Diagnostic and Treatment Center, Bronx, New York, 10452, United States|Morris Heights Health Center, Bronx, New York, 10453, United States|Segundo Ruiz Belvis Diagnostic and Treatment Center, Bronx, New York, 10454, United States|BronwWorks, Bronx, New York, 10456, United States|Urban Health Plan, Bronx, New York, 10459, United States|Montefiore Family Care Center, Bronx, New York, 10467, United States|Good Shepherd Service, Bronx, New York, 10468, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/06/NCT02273206/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/06/NCT02273206/SAP_001.pdf | ||
| NCT02269631 | Legume Diet Satiety Pilot Study | https://clinicaltrials.gov/study/NCT02269631 | This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger and other indicators of health over the course of eight weeks, compared to a more conventional healthy diet. | YES | Obesity|Colorectal Carcinoma | BEHAVIORAL: Legume diet group|BEHAVIORAL: Control diet group|DEVICE: Smartpill|OTHER: legumes | Change in Weight, Evaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study., Baseline to 8 weeks | Gastric Emptying Time, Compare the effects of the high-legume and control diets on gastric emptying time, 8 weeks|Change in Plasma Insulin Level (Biomarker of Appetite Regulation), Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment., Baseline to 8 weeks|Energy Intake, Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls., Baseline to 8 weeks|Satiety, Use self-reported satiety questionnaire to compare short-term responses to test meals., Time course response at baseline and 8 weeks | Emory University | MALE | ADULT, OLDER_ADULT | NA | 12 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION | IRB00075830 | 2014-12 | 2017-12 | 2017-12 | 2014-10-21 | 2019-01-25 | 2019-01-25 | Morehouse, Atlanta, Georgia, 30310, United States|Emory ACTSI, Atlanta, Georgia, 30322, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/31/NCT02269631/Prot_SAP_000.pdf | |||
| NCT02255240 | LEVEL UP: Video Games for Activity in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT02255240 | LEVEL UP | The purpose of this study is to test an intervention that uses home console video games to encourage increased physical activity among postmenopausal breast cancer survivors. | NO | Breast Cancer|Obesity | BEHAVIORAL: Physical activity intervention | Change in physical activity from baseline to 6 weeks, Minutes of moderate-vigorous physical activity measured over a 7 day period, 6 weeks | Change in physical fitness from baseline to 6 weeks, We will use a six minute walk test to measure fitness, 6 weeks|Change in weight from baseline to 6 weeks, Weight will be measured using a calibrated scale, 6 weeks|Change in motivation from baseline to 6 weeks, We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity, 6 weeks|Change in body function from baseline to 6 weeks, We will use the Senior Fitness Test to measure strength and body function, 6 weeks|Change in quality of life from baseline to 6 weeks, We will use the Functional Assessment of Cancer Therapy – Breast measure to quantify quality of life, 6 weeks | Number of participants who drop out of the study from baseline to 6 weeks, We will investigate the number of participants who drop out of the intervention group in comparison to similar studies, 6 weeks|Acceptability, We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups, 6 weeks|Number of participants who report adverse events, We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed., 6 weeks|Adherence, We will use objective measures to investigate adherence to game play protocols (console logs, automatic postings to the console social network, etc.), 6 weeks | The University of Texas Medical Branch, Galveston | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | 14-0240|1K07CA175141-01A1 | 2014-09 | 2015-01 | 2015-01 | 2014-10-02 | 2015-05-27 | University of Texas Medical Branch, Galveston, Texas, 77555, United States | ||
| NCT02254902 | Physical Activity and Education Program for Somali Women | https://clinicaltrials.gov/study/NCT02254902 | There is a significant need for culturally adapted and effective health education programs to address rising rates of obesity and chronic disease concerns for refugee communities. Physical activity has been identified as an important prevention tool to prevent numerous chronic health conditions. This research tests the feasibility and acceptability of a culturally adapted physical activity intervention for sedentary adult Somali women. Study participants will be randomized to a 3-month physical activity program or a wait-list control group. The primary outcome is increases in physical activity between baseline and the end of the program as measured by pedometer. | NO | Sedentary Lifestyle | BEHAVIORAL: Physical Activity intervention | Change in physical activity as measured by pedometer from baseline to 3 months, Baseline and 3 months | University of California, San Diego | American Cancer Society, Inc. | FEMALE | ADULT, OLDER_ADULT | NA | 27 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | ACS-MRSG-13-069 | 2014-09 | 2015-12 | 2015-12 | 2014-10-02 | 2016-05-13 | University of California San Diego, La Jolla, California, 92093-0725, United States | |||||
| NCT02244411 | Exercise and QUality Diet After Leukemia: The EQUAL Study | https://clinicaltrials.gov/study/NCT02244411 | The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and exercise can help people lose weight and improve other health problems. This two year study will compare two methods of informing participants about ways to lose weight. | NO | Adult Survivors of Childhood Leukemia | BEHAVIORAL: individual diet & physical activity counselor and website through Healthways at Hopkins|BEHAVIORAL: self directed weight loss|BEHAVIORAL: questionnaires|OTHER: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure | Weight loss, Weight loss will be evaluated in an intent-to-treat analysis with a linear mixed effects model with robust standard errors and an unstructured covariance matrix(50) using weight measured at each time points (0, 12 months and 24 months after randomization) as the outcome modeled as a function of time, randomization arm, a history of CRT, gender, age, and race together with interaction terms between time and randomization arm., 24 months | Memorial Sloan Kettering Cancer Center | Johns Hopkins University|St. Jude Children’s Research Hospital | ALL | ADULT, OLDER_ADULT | NA | 358 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 14-164 | 2014-09 | 2025-09 | 2025-09 | 2014-09-19 | 2024-07-15 | Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|St. Jude Children’s Research Hospital, Memphis, Tennessee, United States | |||||
| NCT02224807 | Effects of Diet and Exercise on Ductal Carcinoma in Situ | https://clinicaltrials.gov/study/NCT02224807 | DCIS | This pilot/feasibility trial seeks to explore whether an acute bout of negative energy balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2 study arms: 1) an Attention Control Group that receives instruction on dietary approaches to correct nutritional deficiencies and progressive resistance training (PRT) that targets the arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and guidance to correct nutritional deficiencies plus an intensive intervention to promote a 1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study will explore and contrast changes in body mass index (BMI) observed from enrollment to the time of surgery in the experimental vs. attention control arms, and also monitor changes in energy intake and physical activity. These changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor, Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor tissue and blood will be examined from pre-to-post-intervention, this study will provide exciting new data that can elucidate pathways by which energy balance affects breast cancer progression. Although longer term weight loss is recommended for overweight and obese breast cancer survivors, it is not known whether placing the body in a state of negative energy balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and the host environment occur with short-term, pre-surgical weight loss, this study provides proof of concept that weight loss may offer an acceptable and complementary treatment option that could be combined with standard therapies. | NO | Ductal Carcinoma In Situ|Breast Cancer | BEHAVIORAL: Active Comparator: Progressive Resistance Training (PRT) and a healthy diet|BEHAVIORAL: Experimental: PRT and a healthy diet, plus weight loss | Tumor proliferation, Ki-67 will be used to determine tumor proliferation. Ki-67 is a cancer antigen that is found in growing, dividing cells but is absent in the resting phase of cell growth. This characteristic makes Ki-67 a good tumor marker. This test is done on a sample of tumor tissue, to help predict prognosis. High levels of Ki-67 indicate an aggressive tumor and predict a poor prognosis. High scores mean that the cancer cells are growing and dividing at a rapid pace. The Ki-67 scores will be compared between arms., Baseline to Time of Surgery|Weight, Baseline to Time of Surgery|Feasibility, Enroll 40 subjects within 2-year study, retain \>80% of the sample and completion \>70% of contact sessions., Baseline to Time of Surgery | Body Composition, Via Dual Energy Absorptiometry (DXA), Baseline to Time of Surgery|Waist Circumference, Baseline to Time of Surgery|Tumor markers, Tumor Markers on the CHIEF (Convergence of Hormonal, Inflammatory and Energy-related Factors) Pathway, e.g., Insulin Receptor, Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Nuclear Factor Kappa Beta (NFKB), caspase-3, as well as various phosphoproteins., Baseline to Time of Surgery|Serum Biomarkers, Insulin, leptin, Sex Hormone Binding Globulin, VEGF, TNF-alpha, Baseline to Time of Surgery|Gene expression, Select genes on the CHIEF pathway as well as \~47,231 curated and putative genes and expressed sequence tags (ESTs), Baseline to Time of Surgery|Dietary Intake, 24-hour recalls to assess kcal intake as well as intake of fat, protein, and carbohydrate and diet quality, Baseline to Time of Surgery|Physical Activity, Assessed via accelerometry as well as via questionnaire, Baseline to Time of Surgery|Quality of Life, Using the FACT-B, Baseline to Time of Surgery|Cardiorespiratory Fitness, Sub-maximal testing and a modified version of the Naughton Protocol, Baseline to Time of Surgery | University of Alabama at Birmingham | FEMALE | ADULT, OLDER_ADULT | NA | 32 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | R21CA178359-01A1 | 2014-07 | 2018-07 | 2018-07 | 2014-08-25 | 2018-08-31 | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States | ||||
| NCT02180217 | Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing’s Disease | https://clinicaltrials.gov/study/NCT02180217 | The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing’s disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing’s disease in the US and the EU. This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease. | YES | Cushings Disease | DRUG: osilodrostat|DRUG: LCI699 matching placebo | Percentage of Primary Efficacy Responder at Week 34 by Randomized Treatment and Strata, To compare the complete response rate at the end of the 8-week period of randomized withdrawal between randomized patients.A primary efficacy responder is defined as a randomized patient who has mUFC ≤ ULN at Week 34 and who was neither discontinued (study or RW treatment) nor had osilodrostat dose increase above the level at Week 26 during the RW Period of the study. mUFC: mean urinary free cortisol; ULN: Upper Limit of Normal, Week 34 (8 weeks) | Percentage of Secondary Efficacy Responder at Week 24 (Key Secondary Endpoint), To assess the complete response rate at the end of individual dose-titration and treatment with LCI699 in the initial single-arm, open label period. A Key secondary efficacy responder is defined as a patient in FAS who has mUFC ≤ ULN at Week 24 and the dose of osilodrostat during Study Period 2 (Weeks 13-24) was not increased above the level established at the end of Study Period 1 (Week 12). Patients who had missing mUFC assessment at Week 24 will be counted as non-responders for the key secondary endpoint., Week 24|Time-to-loss of Control of Mean Urinary Free Cortisol (mUFC) by Randomized Treatment Group, Time-to-loss of control of mUFC during the RW Period, defined as the time (in days) from randomization to the first evidence of loss of control (defined as mUFC assessment \>1.5 ULN based on central laboratory result \& at least 2 of the associated individual urine samples showing UFC \>1.5×ULN) within the RW period. A patient without evidence of loss of control was censored at the date of the last assessment with mUFC ≤ 1.5 ULN. If a patient discontinued randomized treatment without having a UFC assessment, they were censored at the date of randomization. The measure type (number) refers to an Event probability estimate 8 weeks after randomization., 8 weeks after randomization|Complete Response Rate (CRR), Complete response rate is defined as percentage of enrolled participants with mUFC ≤ ULN, Week 12, Week 24, Week 48, Week 72, last observed value|Actual Change From Baseline in mUFC, Actual change in mUFC from baseline., Weeks 12, 24, 48, 72, last available assessment|Actual Change From Baseline in Cardiovascular-related Parameter Associated With Cushing’s Disease: Fasting Glucose, Actual change in fasting glucose from baseline., Baseline, Weeks 48, 72, last available assessment|Actual Change From Baseline in Cardiovascular-related Parameter Associated With Cushing’s Disease: Hemoglobin A1C (HbA1C), Actual change in glycosylated hemoglobin (HbA1c) from baseline., Baseline, Weeks 48, 72, last available assessment|Actual Change From Baseline in Cardiovascular-related Parameter Associated With Cushing’s Disease: Cholesterol, LDL Cholesterol, HDL Cholesterol & Triglyceride, Actual change in Cholesterol, LDL Cholesterol, HDL Cholesterol \& Triglyceride from baseline., Baseline, Weeks 48, 72, last available assessment|Actual Change From Baseline in Cardiovascular-related Parameter Associated With Cushing’s Disease: Sitting Systolic Blood Pressure (SBP) & Sitting Diastolic Blood Pressure (DBP), Actual change in sitting SBP \& DBP from baseline., Baseline, Weeks 48, 72, last available assessment|Actual Change From Baseline in Cardiovascular-related Parameter Associated With Cushing’s Disease: Weight, Actual change in weight from baseline., Baseline, Weeks 48, 72, last available assessment|Actual Change From Baseline in Cardiovascular-related Parameter Associated With Cushing’s Disease: Body Mass Index (BMI), Actual change in BMI from baseline., Baseline, Weeks 48, 72, last available assessment|Actual Change From Baseline in Cardiovascular-related Parameter Associated With Cushing’s Disease: Waist Circumference, Actual change in waist circumference from baseline., Baseline, Weeks 48, 72, last available assessment|Actual Change From Baseline in Patient-Reported Outcomes (Cushing’s Health-Related Quality of Life (QoL)) – Total Score, Cushing’s Disease Health-Related Quality of Life Questionnaire was developed to evaluate quality of life in patients with Cushing’s syndrome. It is comprised of 12 items that capture patient responses on 7 concepts: daily activities, healing \& pain, mood \& self-confidence, social concerns, physical appearance, memory \& concern about the future. These items are measured on a 5- point Likert-type scale assessing how often or how much each item has been related to the patient’s Cushing’s disease in the previous 4 weeks. The raw score is calculated by summing the individual item scores prior to being standardized so that the total score ranges from 0 to 100. Content reliability, sensitivity to change \& psychometric properties have been validated in patients with Cushing’s disease. Patients were asked to complete the questionnaire prior to clinical assessments being undertaken. Increases from baseline are indicative of an improvement., Baseline, Week (W) 48, W72, Last available assessment|Actual Change From Baseline in Patient-Reported Outcomes: Beck Depression Inventory-II (BDI-II), BDI-II is a patient-reported instrument developed to measure the severity of depression in adults \& adolescents aged 13 years \& older. It is designed to be completed by the patient on paper \& takes approximately 5 minutes to complete. The BDI-II consists of 21 items designed to assess the intensity of depression in clinical \& normal patients in the preceding 2 weeks. Items are rated on a 4-point severity scale of 0 (‘not at all’) to 3 (‘extreme’ form of each symptom) with differing response options for each item. A global score ranging from 0 to 63 is calculated with a higher score representing a greater level of depression. The following scoring guidelines for interpretation of BDI-II have been suggested (Smarr, 2011): Minimal range =0-13, Mild depression =14-19, Moderate depression =20-28 and Severe depression = 29-63. Patients were asked to complete the questionnaire prior to clinical assessments being undertaken. A reduction from baseline in BDI-II is indicative of an improvement., Baseline, W48, W72, Last available assessment|Actual Change in Patient-Reported Outcomes: EQ-5D-5L Utility Index, The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It is cognitively undemanding, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, \& extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an “unconscious” health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement., Baseline, W48, W72, Last available assessment|Actual Change in Patient-Reported Outcomes: EQ-5D-5L Vascular Analog Scale (VAS), The EQ-5D-5L also includes a 20 cm vertical, VAS (visual analogue scale) with on a scale of 0-100, with endpoints labeled 100 = ‘the best health you can imagine’ and 0 = ‘the worst health you can imagine’. A single index value is analyzed for the VAS score. An increase from baseline in the EQ-ED-5L VAS is indicative of an improvement., Baseline, W48, W72, Last available assessment|Change From Baseline in the Physical Features of Cushing’s Disease by Photography, Improvement from baseline to Weeks 48, 72 and End of Treatment (Extension period) in each of the following clinical signs of Cushing’s disease by photography: facial rubor, hirsutism, striae, supraclavicular fat pad, dorsal fat pad, proximal muscle wasting (atrophy), central (abdominal) obesity, and ecchymoses (bruises)., Week 48, Week 72, Last available assessment|Change From Baseline in Bone Mineral Density – All Participants, Actual change from baseline to Week 48 and the LOV in bone mineral density as measured by DXA scan at the lumbar spine and total hip. An increase in bone mineral density is indicative of an improvement.., Baseline, Week 48, Last observed value (LOV)|Time-to-escape, Escape was defined as the time (in days) from the first mUFC ≤ ULN to the first mUFC results \> 1.5 x ULN with at least 2 individual UFC results \> 1.5 x ULN the loss happened beyond 12-week dose titration period. Participants randomized to placebo were not included in the analysis., From the first mUFC ≤ ULN to the first mUFC results > 1.5 x ULN with at least 2 individual UFC results > 1.5 x ULN|LCI699 Exposures, To evaluate exposures of LCI699 in patients with Cushing’s disease. Plasma concentrations (predose, 0.75 h, 1.5 h, and 4 h post-dose) of LCI699. These are the maximum number of PAS subjects analyzed for each incident dose., from week 2 to 10 at Predose, 0.75h, 1.5h, and 4h post-dose|Percentage of Participants With Complete Response Rate (CRR), Complete response rate is defined as percentage of enrolled participants with mUFC ≤ ULN., Week 12, Week 24, Week 48, Week 72, last available assessment|Percentage of Participants With Partial Response Rate (PRR), Partial response rate is defined as percentage of enrolled participants with ≥ 50% reduction from baseline in mUFC, but mUFC\>ULN), Week 12, Week 24, Week 48, Week 72, last available assessment|Percentage of Participants With Overall Response Rate (ORR), Overall response rate is defined as percentage of enrolled participants with mUFC ≤ ULN or at least 50% reduction from baseline., Week 12, Week 24, Week 48, Week 72, last available assessment | Novartis Pharmaceuticals | ALL | ADULT, OLDER_ADULT | PHASE3 | 137 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | CLCI699C2301|2013-004766-34 | 2014-10-06 | 2018-02-21 | 2019-12-04 | 2014-07-02 | 2020-06-16 | 2021-01-06 | University of Colorado Hospital SC – LCI699C2301, Aurora, Colorado, 80045, United States|Emory University School of Medicine G2304 – C2301, Atlanta, Georgia, 30322, United States|Northwestern University SC – LCI699C2301, Chicago, Illinois, 60611, United States|The Johns Hopkins University School of Medicine Johns Hopkins University, Baltimore, Maryland, 21205, United States|Massachusetts General Hospital Neuroendocrine Unit, Boston, Massachusetts, 02114, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States|Mount Sinai School of Medicine SC – LCI699C2301, New York, New York, 10029, United States|Columbia University Medical Center New York Presbyterian SC – LCI699C2301, New York, New York, 10032, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Oregon Health and Science University SC LCI699C2301, Portland, Oregon, 97239, United States|University of Pennsylvania Clinical Studies Unit Unniv SC, Philadelphia, Pennsylvania, 19104, United States|Medical College of Wisconsin MCW 2, Milwaukee, Wisconsin, 53226, United States|Novartis Investigative Site, Caba, Buenos Aires, C1180AAX, Argentina|Novartis Investigative Site, Caba, Buenos Aires, C1426AAI, Argentina|Novartis Investigative Site, Wien, 1090, Austria|Novartis Investigative Site, Sofia, 1431, Bulgaria|Novartis Investigative Site, Edmonton, Alberta, T6G 2B7, Canada|Novartis Investigative Site, Halifax, Nova Scotia, B3H 1V7, Canada|Novartis Investigative Site, Montreal, Quebec, H2W 1T8, Canada|Novartis Investigative Site, Sherbrooke, Quebec, J1H 5N4, Canada|Novartis Investigative Site, Beijing, Beijing, 100730, China|Novartis Investigative Site, Chengdu, Sichuan, 610041, China|Novartis Investigative Site, Beijing, 100034, China|Novartis Investigative Site, Cali, Colombia|Novartis Investigative Site, Le Kremlin Bicetre, 94275, France|Novartis Investigative Site, Lille Cedex, 59037, France|Novartis Investigative Site, Marseille, 13385, France|Novartis Investigative Site, Paris, 75014, France|Novartis Investigative Site, Pessac Cedex, 33604, France|Novartis Investigative Site, Erlangen, 91054, Germany|Novartis Investigative Site, Muenchen, 81377, Germany|Novartis Investigative Site, Bangalore, Karnataka, 560054, India|Novartis Investigative Site, Chandigarh, Punjab, 160012, India|Novartis Investigative Site, Vellore, Tamil Nadu, 632004, India|Novartis Investigative Site, New Delhi, 110029, India|Novartis Investigative Site, Ancona, AN, 60126, Italy|Novartis Investigative Site, Genova, GE, 16132, Italy|Novartis Investigative Site, Messina, ME, 98125, Italy|Novartis Investigative Site, Milano, MI, 20122, Italy|Novartis Investigative Site, Padova, PD, 35128, Italy|Novartis Investigative Site, Pisa, PI, 56124, Italy|Novartis Investigative Site, Napoli, 80131, Italy|Novartis Investigative Site, Nagoya, Aichi, 460-0001, Japan|Novartis Investigative Site, Fukuoka city, Fukuoka, 812-8582, Japan|Novartis Investigative Site, Kobe-shi, Hyogo, 650-0017, Japan|Novartis Investigative Site, Nishinomiya, Hyogo, 663 8501, Japan|Novartis Investigative Site, Yokohama, Kanagawa, 245-8575, Japan|Novartis Investigative Site, Bunkyo-ku, Tokyo, 113-8603, Japan|Novartis Investigative Site, Shinjuku-ku, Tokyo, 160-0023, Japan|Novartis Investigative Site, Seoul, 03080, Korea, Republic of|Novartis Investigative Site, Seoul, 03722, Korea, Republic of|Novartis Investigative Site, Seoul, 06351, Korea, Republic of|Novartis Investigative Site, Rotterdam, 3015 GD, Netherlands|Novartis Investigative Site, Moscow, 117036, Russian Federation|Novartis Investigative Site, Sevilla, Andalucia, 41013, Spain|Novartis Investigative Site, Madrid, 28009, Spain|Novartis Investigative Site, Madrid, 28046, Spain|Novartis Investigative Site, Songkla, 90110, Thailand|Novartis Investigative Site, Istanbul, TUR, 34098, Turkey|Novartis Investigative Site, Sheffield, South Yorkshire, S10 2JF, United Kingdom | Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/17/NCT02180217/SAP_002.pdf|Study Protocol, https://cdn.clinicaltrials.gov/large-docs/17/NCT02180217/Prot_003.pdf | |||
| NCT02157974 | Liver and Fat Regulation in Overweight Adolescent Girls | https://clinicaltrials.gov/study/NCT02157974 | APPLE | Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis compared to weight similar women with regular menses. It is unclear if this is related to high testosterone or insulin resistance. The investigators will assess hepatic glucose release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine if alterations in the processes contribute to hepatic steatosis. Participants will be overweight, sedentary girls with or without PCOS. Those with PCOS will either be medication naive, or must be taking metformin or combined oral contraceptives (COCPs) for a period of at least 6 months prior to study procedures. | YES | Hepatic Steatosis|Polycystic Ovarian Syndrome|Obesity | DRUG: Byetta 5Mcg Pen Injection | Hepatic Glucose Release, Hepatic glucose release will be measured by the rate of appearance of a glucose tracer. Glucose rate of appearance reflects the amount of glucose being release by primarily the liver during fasting. A higher glucose rate of appearance is often seen with dysglycemia, Measured up to 4 months from enrollment | Hepatic Phosphate Concentrations, Hepatic phosphate relative concentrations will be measured with 31 phosphorus magnetic resonance spectroscopy. The ratio of the following will be reported over total phosphate concentration: Phosphodiesterase (PDE), phosphomonoester (PME), Adenosine triphosphate (ATP), Inorganic Phosphate (Pi),Nicotinamide adenine dinucleotide phosphate (NADPH), Uridine diphosphate glucose (UDPG), Measured up to 4 months from enrollment|Rates of Lipolysis, Rate of lipolysis will be measured by the rate of appearance of a glycerol tracer. Glycerol rate of appearance reflects the amount of glycerol being released into the blood stream as a results of lipolysis. Higher rates of lipolysis are thought to be associated with insulin resistance., Measured up to 4 months from enrollment|Hepatic Fat Fraction, Amount of fat in the liver measured by MRI and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver., Measured up to 4 months from enrollment|Hepatic de Novo Lipogenesis, Hepatic de novo lipogenesis will be measured by with an acetate tracer by mass spectroscopy. De novo lipogenesis can contribute to non-alcoholic fatty liver disease, so having a lower value is better., Measured up to 4 months from enrollment | Whole Body Insulin Sensitivity, Participants will undergo a 75 gram oral glucose tolerance test, and whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model using SAMM II software. This software uses participant weight, glucose and insulin concentrations at various time points during the oral glucose tolerance test to calculate the participant insulin sensitivity. The higher the Si value means more insulin sensitivity., Measured up to 4 months from enrollment|Sleep Quality, Apnea Hypopnea Index (AHI) will be measured using WatchPAT. In children and adolescents the scale that will be used is AHI\>5 is considered mild sleep apnea. The higher the AHI, indicates more severe sleep apnea. The AHI is the number of times you have apnea or hypopnea during one night, divided by the hours of sleep. Normal sleep: An AHI of fewer than five events, on average, per hour Mild sleep apnea: An AHI of five to 14 events per hour Moderate sleep apnea: An AHI of 15 to 29 events per hour Severe sleep apnea: An AHI of 30 or more events per hour, Measured up to 4 months from enrollment|Sleep Duration, Sleep duration will be assessed using home actigraphy using the Philips Actigraph wrist-worn watch, and collects 7 days of data., Measured up to 4 months from enrollment | University of Colorado, Denver | National Center for Advancing Translational Sciences (NCATS)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | FEMALE | CHILD, ADULT | PHASE2|PHASE3 | 92 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | 14-0542|UL1TR001082|K23DK107871 | 2014-08 | 2022-12 | 2022-12 | 2014-06-06 | 2024-06-04 | 2024-06-04 | University of Colorado Anshutz Medical Campus/Children’s Hospital Colorado, Aurora, Colorado, 80045, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/74/NCT02157974/Prot_SAP_000.pdf |
| NCT02152462 | Exergaming Intervention and Breast Cancer Biomarkers in Black Women | https://clinicaltrials.gov/study/NCT02152462 | POWER | Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to a control group. The investigators will randomize Black sedentary overweight/obese women to Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will come to the Georgetown community-based exercise facility 3 days/wk. The control group will be asked to maintain their current daily activities and not to exercise for the duration of the study. Based on the investigators previous findings that women who engage in 75-150 mins/wk of brisk walking had an 18% decreased risk of breast cancer, the investigators will target this level of activity in the investigators intervention arm. Also, this 150 min/week of physical activity meets the current recommendations of the American College of Sports Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals and is in line with recommendation of the American Cancer Society (ACS) for cancer prevention. | NO | Breast Cancer|Obesity | OTHER: Exergaming | Biomarkers related to obesity and breast cancer risk, Outcomes for plasma leptin, adiponectin, Insulin-like growth factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP3), C-reactive protein (CRP), Interleukin 6 (IL-6), insulin, c-peptide, and Hb-A1c levels at baseline and 24 weeks., 6 months | Cardiovascular fitness (VO2 max), Cardiovascular fitness is measured using metabolic cart at baseline, 12 weeks, and 24 weeks., 6 months|Reported stress levels, Reported stressed levels was assessed using the Perceived Stress Scale (PSS) at baseline, 12 weeks, and 24 weeks., 6 months | Georgetown University | FEMALE | ADULT | PHASE2 | 150 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION | Pro00000116 Georgetown Lombard | 2012-12 | 2014-09 | 2019-12 | 2014-06-02 | 2020-02-10 | Georgetown Lombardi Office of Minority Health & Health Disparities Research, Washington, District of Columbia, 20003, United States | ||||
| NCT02143830 | HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy | https://clinicaltrials.gov/study/NCT02143830 | RAFA | The purpose of this study is to determine whether the use of lower doses of busulfan and the elimination of cyclosporine will further reduce transplant-related side effects for patients with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or matched unrelated donors following a preparative regimen of busulfan, fludarabine, anti-thymocyte globulin and cyclophosphamide. | NO | Fanconi Anemia|Severe Marrow Failure|Myelodysplastic Syndrome (MDS)|Acute Myelogenous Leukemia (AML) | DRUG: Busulfan|DRUG: Cyclophosphamide|DRUG: Fludarabine|DRUG: rabbit ATG|DRUG: G-CSF|BIOLOGICAL: Peripheral blood stem cell | Graft Failure or Rejection, Primary non-engraftment is diagnosed when the patient fails to achieve an ANC \>=500/mm3 at any time in the first 28 days post-transplant. If (1) after achievement of an absolute neutrophil count (ANC) \>=500/mm3, the ANC declines to \<500/mm3 for more than 3 consecutive days in the absence of relapse, or, (2) there is absence of donor cells in the marrow and/or blood as demonstrated by chimerism assay in the absence of relapse, a diagnosis of secondary graft failure is made. The patient is not evaluable for graft failure or rejection if recurrence of host MDS is detected concurrently., 5 years | Post-transplant severe morbidity and mortality, The occurrence of severe post-transplant regimen-related severe morbidity (grade IV toxicity) and/or mortality will be the second endpoint of this study. In the context of the agents or agent-combination used for cytoreduction used, particular attention will be given to toxicity involving (1) the liver, (2) the lungs, (3) the oral mucosa and gastrointestinal tract, and (4) the central nervous system., 2 years post-transplant | Graft Versus Host Disease, Patients will be observed for acute and/or chronic graft versus host disease (GvHD). Standard clinical criteria for the grading of acute and chronic GvHD will be done according to IBMTR guidelines., One year|Leukemic Relapse, For patients with MDS or AML, relapse will be analyzed as to type and genetic origin of the MDS/leukemic cells., 5 years|Secondary malignancies, Patients will be followed for 5 years through annual contact with their treatment center in order to track the risk of developing a secondary malignancy., 5 years | Children’s Hospital Medical Center, Cincinnati | Memorial Sloan Kettering Cancer Center|Fred Hutchinson Cancer Center | ALL | CHILD, ADULT, OLDER_ADULT | PHASE2 | 70 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 2013-7501 | 2014-04 | 2025-07 | 2027-07 | 2014-05-21 | 2024-12-12 | Memorial Sloan Kettering Cancer Center, New York, New York, 10174, United States|Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States | ||
| NCT02135562 | Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors | https://clinicaltrials.gov/study/NCT02135562 | This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual’s body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life. | NO | Endometrial Cancer|Obesity | DIETARY_SUPPLEMENT: Dietary Intervention|OTHER: Informational Material|OTHER: Dietary Education|DIETARY_SUPPLEMENT: Weight Maintenance|OTHER: Average score of Obesity and Weight-Loss Quality of Life Questionnaire | Mean Weight loss assessed with the digital scale, Mean weight loss will be presented as mean total weight loss in kilograms from baseline, Baseline up to 6 months|Mean Weight loss assessed with the digital scale, Mean Weight loss will be presented as mean total weight loss in kilograms from baseline., Baseline up to 12 months | Changes in levels of total cholesterol, Average differences in total cholesterol between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Baseline up to 6 months|Changes in levels of markers of inflammation (C-reactive protein), Average differences in C-reactive protein between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Up to 6 months|Changes in levels of glucose, Differences in glucose levels between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Up to 6 months|Number of drop-out participants, Presented as the difference in the number of participants who completed the study from the number of participants enrolled at baseline. This is reported as one of the markers of feasibility., Up to 6 months|Average percentage of positive urinary ketone tests as a marker of dietary adherence, Assessed using the presence of urinary ketones beginning on day four of the intervention. Adherence rates will be presented as the percentage of positive urinary ketone tests for the duration of the intervention., Up to 6 months|Number of Participant with reported side effects, Adverse events will be recorded by participants on a daily basis. Number of participants with related adverse events will be reported as one of the measures of feasibility, Up to 6 months|Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire, The difference between mean quality of life scores at the two time points will be assessed using a one-sided anova test with statistical significance set at p \< 0.05., Baseline up to 6 months|Changes in levels of markers of inflammation (interleukin 6), Average differences in interleukin 6 between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Up to 6 months|Changes in levels of markers of inflammation (tumor necrosis factor - alpha), Average differences in tumor necrosis factor - alpha between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Up to 6 months|Changes in levels of markers of inflammation (leptin), Average differences of leptin between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Up to 6 months|Changes in levels of LDL-cholesterol, Average differences between time points for LDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Baseline up to 6 months|Changes in levels of HDL-cholesterol, Average differences between time points for HDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Baseline up to 6 months|Changes in levels of triglycerides, Average differences between time points for triglycerides will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05., Baseline up to 6 months | Case Comprehensive Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 11 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | CASE1814|NCI-2014-00832|CASE1814|CASE 1814|P30CA043703 | 2014-08-08 | 2017-04-19 | 2017-04-19 | 2014-05-12 | 2017-09-20 | Cleveland Medical Center, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106-5065, United States|MetroHealth Medical Center, Cleveland, Ohio, 44109, United States | ||||
| NCT02122380 | The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome | https://clinicaltrials.gov/study/NCT02122380 | Adults with abdominal obesity are at high risk for cardiovascular disease and also exhibit diminished growth hormone (GH) secretion; the latter further contributes to the development of visceral adiposity, impaired fibrinolysis and inflammation.Growth hormone releasing hormone (GHRH), the primary stimulus for endogenous GH secretion, is a substrate of dipeptidyl peptidase 4 (DPP4); inhibition of DPP4 with the currently available anti-diabetic therapy, sitagliptin, may therefore increase GH secretion by decreasing the degradation of GHRH. The proposed research will test the hypothesis that chronic sitagliptin therapy will enhance GH secretion and vascular function while improving glucose tolerance in patients with impaired GH secretion who are at risk for the development of diabetes mellitus and cardiovascular disease, specifically obese women with polycystic ovary syndrome. | YES | Polycystic Ovary Syndrome | DRUG: Sitagliptin|DRUG: Placebo | Mean Overnight Growth Hormone Levels, Growth hormone levels were determined every 10 minutes from 8 PM until 8 AM during the inpatient visit on the last day of each treatment. A mean of the GH levels was calculated for each participant, and then the value from each participant was averaged across all participants., At completion of 30 days of placebo treatment and at completion of 30 days of sitagliptin treatment; every 10 minutes from 8 PM until 8 AM. | Early Insulin Secretion During Oral Glucose Tolerance Test, Oral glucose tolerance testing was performed with 75 grams of glucose solution. Baseline venous blood samples of insulin were obtained prior to ingestion of oral glucose solution (time 0). Insulin levels were then obtained through a peripheral IV line every 15 minutes for 270 minutes after glucose solution is swallowed. Early insulin secretion was determined by calculating area under the curve using data (i.e. insulin levels) obtained at baseline (time 0), 15 minutes and 30 minutes., During Outpatient Visit (after 2 weeks of therapy) during placebo and sitagliptin treatment periods. Insulin levels were obtained at time 0, 15 and 30 minutes following 75 gram glucose ingestion.|Area Under the Curve (AUC) for Blood Glucoses During 75 Gram Oral Glucose Tolerance Test, Oral glucose tolerance testing was performed with 75 grams of glucose solution. Baseline blood glucose was obtained prior to ingestion of oral glucose solution (time 0). Blood glucose levels were then obtained through a peripheral IV line every 15 minutes from timepoint 0 until 120 minutes to calculate the area under the curve., During Outpatient Visit (after 2 weeks of therapy) during placebo and sitagliptin treatment periods. Every 15 minutes from time 0 to 120 minutes after oral glucose ingestion.|Visceral Adipose Tissue, During the inpatient visit of each treatment (placebo and sitagliptin), visceral adipose tissue was determined by a certified densitometrist using dual-energy x-ray absorptiometry with enCore software (v. 13.6), At completion of 30 days of placebo treatment and at completion of 30 days of sitagliptin treatment.|Vascular Function (Endothelium-dependent Vasodilation), Endothelium-dependent vasodilation was evaluated by measuring the diameter of the brachial artery under basal (i.e. rest) condition and during reactive hyperemia. The percentage change in diameter (i.e. endothelium-dependent vasodilation) was calculated as percent change=\[(peak diameter-baseline diameter)/baseline diameter\]\*100. Endothelium-dependent vasodilation was determined twice during the study: at completion of 30 days of placebo treatment and at completion of 30 days of sitagliptin treatment., Vascular function was determined by measuring brachial artery diameter at rest and during reactive hyperemia and calculating percent change. This was determined after 30 days of placebo treatment and after 30 days of sitagliptin treatment. | Vanderbilt University | National Heart, Lung, and Blood Institute (NHLBI) | FEMALE | ADULT | PHASE4 | 23 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER | 131969|K23HL119602-01A1 | 2016-02 | 2019-08-01 | 2019-08-01 | 2014-04-24 | 2020-05-08 | 2020-05-08 | Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/80/NCT02122380/Prot_SAP_000.pdf | ||
| NCT02121691 | Faith-Based Initiative to Promote Health in Appalachia | https://clinicaltrials.gov/study/NCT02121691 | The project will target two behavioral causes of obesity: a sedentary lifestyle and an unhealthy diet. The goal is to test a faith-based intervention among men and women who are members of participating Appalachian churches. The primary hypothesis being tested in this project is: The change in body mass index from baseline to one year follow-up in intervention churches will be greater than among comparison churches, such that the differential change will be negative on average. | NO | Cancer|Obesity | BEHAVIORAL: Walk by Faith | Change in body mass index from baseline to one year follow-up, Baseline, month 12 | Mark Dignan, PhD | ALL | ADULT, OLDER_ADULT | NA | 669 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 2012-085|NCI-2013-01400 | 2013-04 | 2013-12 | 2014-04-23 | 2017-06-16 | Markey Cancer Center, Lexington, Kentucky, 40536, United States|Ohio State University, Columbus, Ohio, 43210, United States|Penn State University, University Park, Pennsylvania, 16802, United States|Virginia Tech, Blacksburg, Virginia, 24061, United States|West Virginia University, Morgantown, West Virginia, 26506, United States | |||||||
| NCT02105428 | Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation | https://clinicaltrials.gov/study/NCT02105428 | A goal of this study is to use a novel methodology to determine whether insulin resistance in women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with modifications. This could lead to future research to determine if these modifications interfere with their proper function. Additionally, the investigators will determine how protein quality is affected by exercise training. Aerobic exercise enhances the endogenous oxidant buffering systems which may minimize oxidative damage to proteins. The investigators propose that aerobic exercise minimizes the accrual of modified proteins by increasing the synthesis of new proteins, but also by increasing the degradation and removal of old and damaged proteins. Based on our previous studies the investigators observed that insulin affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only in muscle but also in liver. The investigators therefore propose that aerobic exercise and related increase in insulin sensitivity (and decline in insulin levels) will reduce accumulation of old and modified skeletal muscle and plasma proteins leading to improved function. | NO | Polycystic Ovarian Syndrome (PCOS)|Insulin Resistance|Overweight|Obese | BEHAVIORAL: Aerobic Exercise Training | Change in insulin sensitivity, To determine the effect of 12 weeks of aerobic exercise training or sedentary behavior on insulin sensitivity measured by a 3 hour hyperinsulinemic-euglycemic clamp and response to a mixed-meal., Measured before and after 12 weeks | Protein modifications and accumulation, Alterations in protein modifications and accumulation will be measured by a novel methodology developed within our laboratory. Infusion of stable amino acid isotopes will be used to measure the accumulation of proteins before and after 12 weeks of aerobic exercise training or sedentary behavior. Plasma and muscle will be resolved using a two dimensional gel electrophoresis which will allow the identification of protein modifications and age., Before and after 12 weeks | Mayo Clinic | FEMALE | ADULT | NA | 44 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 09-007006 | 2010-07 | 2015-12 | 2015-12 | 2014-04-07 | 2016-05-17 | Mayo Clinic, Rochester, Minnesota, 55905, United States | |||||
| NCT02103140 | An Exercise RCT Targeting African-American Women With Metabolic Syndrome and High Risk for Breast Cancer | https://clinicaltrials.gov/study/NCT02103140 | Among African-American women, in whom metabolic syndrome (MetS) is very prevalent and breast cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the MetS profile may prove to be a means to reduce breast cancer risk. Specific recommendations for breast cancer prevention are now focused on maintaining a healthy weight via increased physical activity levels, and losing weight if overweight or obese. This pilot project compares two exercise interventions: a supervised facility-based and a home-based exercise intervention to a control group in African-American women with metabolic syndrome who are at high risk for breast cancer. This study is a 6-month three-arm RCT to assess the impact of the exercise interventions on biomarkers related to obesity, insulin-related pathways, inflammation, hormones, and micro-RNAs. The specific aim of the proposed study is to compare the impact of a supervised facility-based and a home-based exercise intervention on obesity, metabolic syndrome and known breast cancer biomarkers in postmenopausal African-American women with metabolic syndrome who are at increased risk of breast cancer. | NO | Metabolic Syndrome|Obesity | BEHAVIORAL: Facility-based Exercise|BEHAVIORAL: Home-based Exercise | Waist circumference, Reduction in waist circumference, 6 months|Body Mass Index, Reduction in body mass index, 6 months|Biomarkers of breast cancer risk – biomarkers of inflammation, Serum IL-6, TNF-alpha, High sensitivity CRP, 6 months|Biomarkers of breast cancer risk – biomarkers of insulin pathway, Fasting glucose, seruminsulin, IGF-1, IGFBP-3, 6 months|Biomarkers of breast cancer risk – adipokines, Serum leptin and adiponectin, 6 months|Metabolic syndrome, Greater improvements in metabolic syndrome and metabolic syndrome components, 6 months | Cardiorespiratory fitness, VO2Max using the Bruce treadmill protocol, 6 months|Body composition, Measured using DEXA scan: fat mass, lean mass, 6 months|Health-related Quality of Life, Measured using the SF-36 questionnaire, 6 months | Georgetown University | FEMALE | ADULT, OLDER_ADULT | NA | 213 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION | 2012-012 Georgetown Lombardi | 2012-01 | 2023-09 | 2025-12 | 2014-04-03 | 2024-02-20 | Georgetown Lombardi Office of Minority Health community site, Washington, District of Columbia, 20003, United States | |||||
| NCT02095184 | GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients | https://clinicaltrials.gov/study/NCT02095184 | More than three quarter of patients with breast cancer are treated by hormone pills called tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production. This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal women. The female hormone estrogen is an important hormone for the growth of breast cancer cells. Anastrozole (Arimidex®) and Letrozole (Femara®) are AIs that are approved by the Food and Drug Administration (FDA). They have been used since 2005 to treat women with early stage breast cancer. When given before surgery (neoadjuvant), both anastrozole and letrozole have been shown to successfully shrink breast cancer tumors in most patients. In over 50% of patients, anastrozole and letrozole when given for about 4 months also helped to improve surgery outcomes. On top of that, whether or not a patient responds to anastrozole and letrozole before surgery can help the doctor decide whether that patient needs additional chemotherapy. One of the things may influence the level of hormone is body weight. It has been previously shown that postmenopausal women with higher body fat have higher level of female hormone as well as an increased risk of breast cancer. This is likely due to an increase in aromatase activity in the fatty tissue. However, at the current time AIs are used at the same doses in all women with breast cancer no matter whether they have different body weight. Currently, we do not know for certain whether the same doses of AIs work as well in patients with higher body fat compared to patients with less body fat. The purpose of this study is to see if women with higher body fat respond differently to AI treatment compared to women with lower body fat. | NO | Breast Cancer | DRUG: Anastrozole|DRUG: Letrozole | Percent change in proliferative index (Ki67) after treatment with the standard dose anastrozole or letrozole in normal, obese, and overweight patients, Core biopsy, 2-4 weeks Post-treatment | To evaluate differences in baseline GP88 level, GP88-6ml Blood Serum Sample, B,0-Prior to starting anastrozole or letrozole|To evaluate differences in baseline GP88 level, GP88-6ml Blood Serum Sample, B,1-On the day of surgery or within 3 days of surgery|To evaluate differences in baseline GP88 level, GP88-6ml Blood Serum Sample, B,2-obtained 2-4 weeks after initiation of AI therapy( for persons rec. extended neoadjuvant tx)|To assess estradiol levels at baseline and after treatment (in primary ER positive breast tumors), 10ml Blood Serum Sample, Baseline|To assess estradiol levels at baseline and after treatment (in primary ER positive breast tumors), 10ml Blood Serum Sample, 2-4 weeks Post treatment|To evaluate the association of AI-induced Ki67 response, (IHC)–Immunohistochemistry, Baseline|To evaluate the association of AI-induced Ki67 response, (IHC)–Immunohistochemistry, 2-4 weeks Post-Treatment|To evaluate differences in Oncotype Dx, Tumor Tissue Assay, Baseline(T0)|To evaluate differences in Oncotype Dx, Tumor Tissue Assay, 2-4 Post-treatment | Metabolomic Profiling, 10ml Blood Serum Sample, B-0|Metabolomic Profiling, 10ml Blood Serum Sample, B-1|Metabolomic Profiling, 10ml Blood Serum Sample, B-2 | University of Maryland, Baltimore | FEMALE | ADULT, OLDER_ADULT | NA | 90 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | HP-00060250 | 2015-05-25 | 2024-07-24 | 2025-03-20 | 2014-03-24 | 2024-08-05 | University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, 21201, United States | ||||
| NCT02094170 | Global Positioning System (GPS) Exposure to Environments & Relations With Biomarkers of Cancer Risk | https://clinicaltrials.gov/study/NCT02094170 | The prevalence of overweight and obesity are increasing worldwide. In the U.S., approximately 85,000 new cancer cases per year are related to obesity. Understanding lifestyle behaviors, their causes, and relations to cancer are critical. Where people spend their time during the day may be related to their risk of getting cancer. This project will assess behaviors in different locations across the day and relate exposure to different environments to biological outcomes. | NO | Physical Activity|Sedentary Lifestyle | Blood Insulin Levels, 14 Days | University of California, San Diego | ALL | ADULT, OLDER_ADULT | 601 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1R01CA179977 | 2014-07 | 2017-09-29 | 2017-09-29 | 2014-03-21 | 2019-06-19 | UC San Diego, La Jolla, California, 92093, United States | ||||||||
| NCT02085408 | Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia | https://clinicaltrials.gov/study/NCT02085408 | This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia. | YES | Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome|Adult Acute Megakaryoblastic Leukemia (M7)|Adult Acute Minimally Differentiated Myeloid Leukemia (M0)|Adult Acute Monoblastic Leukemia (M5a)|Adult Acute Monocytic Leukemia (M5b)|Adult Acute Myeloblastic Leukemia With Maturation (M2)|Adult Acute Myeloblastic Leukemia Without Maturation (M1)|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities|Adult Acute Myeloid Leukemia With Del(5q)|Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)|Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)|Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)|Adult Acute Myelomonocytic Leukemia (M4)|Adult Erythroleukemia (M6a)|Adult Pure Erythroid Leukemia (M6b)|Secondary Acute Myeloid Leukemia|Untreated Adult Acute Myeloid Leukemia | DRUG: Daunorubicin|DRUG: Cytarabine|DRUG: Clofarabine|DRUG: Decitabine|OTHER: Observation|PROCEDURE: Allogeneic hematopoietic stem cell transplantation | Overall Survival, Overall survival is defined as the time from randomization to death or date last known alive., Assessed every 3 months for 4 years and then every 6 months for 1 year | Proportion of Patients With Complete Remission, Patients are required to have all of the following to be considered as having a completion remission (CR). * Peripheral Blood Counts 1. Neutrophil count \> 1.0 x 10\^9 /L 2. Platelet count ≥ 100 x 10\^9 /L 3. Reduced hemoglobin concentration or hematocrit has no bearing on remission status 4. Leukemic blasts must not be present in the peripheral blood * Bone Marrow Aspirate and Biopsy 1. Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines 2. \< 5% blasts by morphologic review 3. Auer rods must not be detectable * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present, Assessed every 3 months for 4 years and then every 6 months for 1 year|Overall Survival by Donor Status, Overall survival is defined as time between achieving leukemia-free state after induction therapy to death from any cause or date last known alive. The association between overall survival and donor status was evaluated regardless of assigned treatment arms. Patients with transplant donor information (either had donor or did not have a donor) reported after achieving CR/Cri/leukemia-free state post induction therapy were included in this analysis., Assessed every 3 months for 4 years and then every 6 months for 1 year|Disease-free Survival for Maintenance, DFS for maintenance comparison is defined as the time from maintenance randomization until relapse or death of any cause. The censored follow-up time for patients without relapse and death information is the date of last contact. Only patients who remained in CR or CRi after completion of consolidation therapy that were randomized to either observation or decitabine in the maintenance Step were included in this analysis., Assessed every 3 months for 4 years and then every 6 months for 1 year | Expression and Methylation Profiling, DNA methylation profiling and gene expression are evaluated using peripheral blood samples collected at baseline of the maintenance treatment (prior to 2nd randomization). These are to be compared between patients with decitabine and patients on observation., Baseline of maintenance treatment|Relapse After Decitabine Maintenance by Epigenetic Signature of Normal Bone Marrow, To examine the epigenetic profiles of remission marrow among patients randomized to observation vs. decitabine to determine whether epigenetic signature of apparently morphologically normal bone marrow is predictive of relapse or response to decitabine maintenance. Relapse following complete remission is defined as: 1. Peripheral Blood Counts * Reappearance of blasts in the blood 2. Bone Marrow Aspirate and Biopsy * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse., Assessed every 3 months for 4 years and then every 6 months for 1 year|Complete Remission Rate by ABC-transporter P-glycoprotein (Pgp), Patients with all the following are considered as having a complete remission. * Peripheral Blood Counts 1. Neutrophil count \> 1.0 x 109 /L 2. Platelet count ≥ 100 x 109 /L 3. Reduced hemoglobin concentration or hematocrit has no bearing on remission status 4. Leukemic blasts must not be present in the peripheral blood * Bone Marrow Aspirate and Biopsy 1. Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines 2. \< 5% blasts by morphologic review 3. Auer rods must not be detectable * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present The proportion of patients with complete remission will be compared between patients who overexpress Pgp and patients who do not overexpress Pgp., Assessed every 3 months for 4 years and then every 6 months for 1 year|To Assess the Intensity of Expression of CXCR4 on Diagnostic Leukemia Cells and to Correlate This Parameter With Other Established Prognostic Factors, Expression of CXCR4 will be assessed in this study by flow cytometric assay. The associations between the expression level and other prognostic factors in patients receiving induction treatment will be evaluated., Baseline|The Association Between Somatic Mutations and Relapse, Relapse following complete remission is defined as: 1. Peripheral Blood Counts * Reappearance of blasts in the blood 2. Bone Marrow Aspirate and Biopsy * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * If there are no circulating blasts and the bone marrow contains 5% to 20% blasts, then a repeat bone marrow performed ≥ 1 week later documenting more than 5% blasts is necessary to meet the criteria for relapse., Assessed every 3 months for 4 years and then every 6 months for 1 year|Overall Survival by Patient Characteristics and Lifestyle, Overall survival is defined as time from randomization to death or date last known alive. The associations between overall survival and smoking status, obesity, regular acetaminophen use, regular aspirin use, benzene exposure, living in a rural/farm environment and some other underlying exposures and lifestyle factors will be evaluated., Assessed every 3 months for 4 years and then every 6 months for 1 year|Copy Number Changes Using Array Comparative Genomic Hybridization (CGH) by Patient Characteristics, Copy number changes will be tested based on array CGH technology. The associations between copy number changes and acute myeloid leukemia patient characteristics will be evaluated., Baseline|Quality of Life (QOL) Assessed by Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu), QOL will be assessed using the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu). This instrument combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL., Assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatment|Change in Health-related QOL Over Time, QOL will be assessed using the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu). This instrument combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. Changes in QOL will be calculated by subtracting baseline QOL score from follow-up QOL score., Assessed at baseline, 14 days after 1st induction treatment, prior to consolidation therapy (day 35-36), prior to maintenance treatment, end of maintenance treatment|Patient Function Assessed by Functional Assessment of Cancer Therapy – General (FACT-G), QOL will be assessed using the Functional Assessment of Cancer Therapy – General (FACT-G). FACT-G includes 4 subscales, physical well-being (score range: 0-28), social/family well-being (score range: 0-28), emotional well-being (score range: 0-24), and functional well-being (score range: 0-28). The total score of FACT-G ranges between 0 and 108. Higher score indicates better QOL., Assessed at baseline|Change in QOL Post Transplant From Baseline, For those patients who go to allo transplant, the FACT-Leu and the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) instruments will be administered at the beginning of the conditioning regimen and 100 days (+14 days) post transplant. FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. FACIT-Fatigue has 13 items and the total score ranges between 0 and 52. Higher score indicates better QOL. Changes in QOL will be calculated by subtracting baseline QOL score from follow-up QOL score., Assessed prior to transplant and 100 days after transplant|Baseline QOL Scores by Treatment Completion Status, The associations between baseline QOL scores and the ability to finish treatment will be evaluated. Baseline QOL will be assessed using the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) and the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue). FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific subscale. The total score of FACT-Leu ranges between 0 and 176. Higher score indicates better QOL. FACIT-Fatigue has 13 items and the total score ranges between 0 and 52. Higher score indicates better QOL., Assessed at baseline | ECOG-ACRIN Cancer Research Group | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | PHASE3 | 727 | NETWORK | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | E2906|NCI-2011-01992|CDR0000659585|E2906|E2906|U10CA021115 | 2011-02-04 | 2021-02-22 | 2022-12-21 | 2014-03-12 | 2023-03-09 | 2024-12-13 | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States|Arizona Cancer Center at University Medical Center North, Tucson, Arizona, 85719, United States|University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States|The Medical Center of Aurora, Aurora, Colorado, 80012, United States|Boulder Community Hospital, Boulder, Colorado, 80301, United States|Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, 80907, United States|Saint Anthony Central Hospital, Denver, Colorado, 80204, United States|Porter Adventist Hospital, Denver, Colorado, 80210, United States|Exempla Saint Joseph Hospital, Denver, Colorado, 80218, United States|Presbyterian – Saint Lukes Medical Center – Health One, Denver, Colorado, 80218, United States|Rose Medical Center, Denver, Colorado, 80220, United States|Colorado Cancer Research Program CCOP, Denver, Colorado, 80224-2522, United States|Swedish Medical Center, Englewood, Colorado, 80110, United States|North Colorado Medical Center, Greeley, Colorado, 80631, United States|Littleton Adventist Hospital, Littleton, Colorado, 80122, United States|Sky Ridge Medical Center, Lone Tree, Colorado, 80124, United States|Longmont United Hospital, Longmont, Colorado, 80501, United States|McKee Medical Center, Loveland, Colorado, 80539, United States|Parker Adventist Hospital, Parker, Colorado, 80138, United States|Saint Mary Corwin Medical Center, Pueblo, Colorado, 81004, United States|North Suburban Medical Center, Thornton, Colorado, 80229, United States|Exempla Lutheran Medical Center, Wheat Ridge, Colorado, 80033, United States|Saint Francis Hospital and Medical Center, Hartford, Connecticut, 06105, United States|The Hospital of Central Connecticut, New Britain, Connecticut, 06050, United States|Beebe Medical Center, Lewes, Delaware, 19958, United States|Christiana Care Health System-Christiana Hospital, Newark, Delaware, 19718, United States|University of Florida, Gainesville, Florida, 32610, United States|Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States|Florida Hospital, Orlando, Florida, 32803, United States|Piedmont Hospital, Atlanta, Georgia, 30309, United States|Atlanta Regional CCOP, Atlanta, Georgia, 30342, United States|Northside Hospital, Atlanta, Georgia, 30342, United States|Saint Joseph’s Hospital of Atlanta, Atlanta, Georgia, 30342, United States|Georgia Regents University, Augusta, Georgia, 30912, United States|Well Star Cobb Hospital, Austell, Georgia, 30106, United States|John B Amos Cancer Center, Columbus, Georgia, 31904, United States|Dekalb Medical Center, Decatur, Georgia, 30033, United States|Piedmont Fayette Hospital, Fayetteville, Georgia, 30214, United States|Gwinnett Medical Center, Lawrenceville, Georgia, 30045, United States|Wellstar Kennestone Hospital, Marietta, Georgia, 30060, United States|Southern Regional Medical Center, Riverdale, Georgia, 30274, United States|Harbin Clinic Medical Oncology and Clinical Research, Rome, Georgia, 30165, United States|Kapiolani Medical Center at Pali Momi, ‘Aiea, Hawaii, 96701, United States|Oncare Hawaii Inc – Kapiolani Medical Center at Pali Momi, ‘Aiea, Hawaii, 96701, United States|Oncare Hawaii Inc-POB II, Honolulu, Hawaii, 96813, United States|Queen’s Medical Center, Honolulu, Hawaii, 96813, United States|Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States|University of Hawaii, Honolulu, Hawaii, 96813, United States|OnCare Hawaii-Liliha, Honolulu, Hawaii, 96817-3169, United States|Kuakini Medical Center, Honolulu, Hawaii, 96817, United States|Oncare Hawaii Inc-Kuakini, Honolulu, Hawaii, 96817, United States|Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States|Castle Medical Center, Kailua, Hawaii, 96734, United States|Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, 96766, United States|Saint Alphonsus Regional Medical Center, Boise, Idaho, 83706, United States|Saint Anthony’s Health, Alton, Illinois, 62002, United States|Illinois CancerCare-Bloomington, Bloomington, Illinois, 61701, United States|Saint Joseph Medical Center, Bloomington, Illinois, 61701, United States|Graham Hospital Association, Canton, Illinois, 61520, United States|Illinois CancerCare-Canton, Canton, Illinois, 61520, United States|Illinois CancerCare-Carthage, Carthage, Illinois, 62321, United States|Memorial Hospital, Carthage, Illinois, 62321, United States|Mount Sinai Hospital Medical Center, Chicago, Illinois, 60608, United States|Hematology and Oncology Associates, Chicago, Illinois, 60611, United States|Northwestern University, Chicago, Illinois, 60611, United States|University of Illinois, Chicago, Illinois, 60612, United States|Decatur Memorial Hospital, Decatur, Illinois, 62526, United States|Eureka Hospital, Eureka, Illinois, 61530, United States|Illinois CancerCare-Eureka, Eureka, Illinois, 61530, United States|Illinois CancerCare Galesburg, Galesburg, Illinois, 61401, United States|Western Illinois Cancer Treatment Center, Galesburg, Illinois, 61401, United States|Illinois CancerCare-Havana, Havana, Illinois, 62644, United States|Mason District Hospital, Havana, Illinois, 62644, United States|Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, 60035, United States|Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, 60521, United States|Presence Saint Mary’s Hospital, Kankakee, Illinois, 60901, United States|Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, 61443, United States|North Shore Hematology Oncology, Libertyville, Illinois, 60048, United States|Illinois CancerCare-Macomb, Macomb, Illinois, 61455, United States|Mcdonough District Hospital, Macomb, Illinois, 61455, United States|Loyola University Medical Center, Maywood, Illinois, 60153, United States|Holy Family Medical Center, Monmouth, Illinois, 61462, United States|Illinois CancerCare-Monmouth, Monmouth, Illinois, 61462, United States|Illinois Cancer Specialists-Niles, Niles, Illinois, 60714, United States|Bromenn Regional Medical Center, Normal, Illinois, 61761, United States|Community Cancer Center Foundation, Normal, Illinois, 61761, United States|Illinois CancerCare-Community Cancer Center, Normal, Illinois, 61761, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350, United States|Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, 61350, United States|Pekin Cancer Treatment Center, Pekin, Illinois, 61554, United States|Illinois CancerCare-Pekin, Pekin, Illinois, 61603, United States|Methodist Medical Center of Illinois, Peoria, Illinois, 61603, United States|Proctor Hospital, Peoria, Illinois, 61614, United States|Illinois CancerCare-Peoria, Peoria, Illinois, 61615, United States|Illinois Oncology Research Association CCOP, Peoria, Illinois, 61615, United States|OSF Saint Francis Medical Center, Peoria, Illinois, 61637, United States|Illinois CancerCare-Peru, Peru, Illinois, 61354, United States|Illinois Valley Hospital, Peru, Illinois, 61354, United States|Illinois CancerCare-Princeton, Princeton, Illinois, 61356, United States|Perry Memorial Hospital, Princeton, Illinois, 61356, United States|Swedish American Hospital, Rockford, Illinois, 61104, United States|Hematology Oncology Associates of Illinois – Skokie, Skokie, Illinois, 60076, United States|Illinois CancerCare-Spring Valley, Spring Valley, Illinois, 61362, United States|Memorial Medical Center, Springfield, Illinois, 62781-0001, United States|Saint Francis Hospital and Health Centers, Beech Grove, Indiana, 46107, United States|Fort Wayne Medical Oncology and Hematology Inc – State Boulevard, Fort Wayne, Indiana, 46845, United States|Franciscan St. Francis Health, Indianapolis, Indiana, 46237, United States|Reid Hospital and Health Care Services, Richmond, Indiana, 47374, United States|McFarland Clinic, Ames, Iowa, 50010, United States|Siouxland Hematology Oncology Associates, Sioux City, Iowa, 51101, United States|Mercy Medical Center-Sioux City, Sioux City, Iowa, 51104, United States|Saint Luke’s Regional Medical Center, Sioux City, Iowa, 51104, United States|University of Kentucky, Lexington, Kentucky, 40536, United States|Norton Health Care Pavilion – Downtown, Louisville, Kentucky, 40202, United States|Ochsner Clinic Foundation-Baton Rouge, Baton Rouge, Louisiana, 70809, United States|Ochsner Baptist Medical Center, New Orleans, Louisiana, 70115, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States|Harold Alfond Center for Cancer Care, Augusta, Maine, 04330, United States|Eastern Maine Medical Center, Bangor, Maine, 04401, United States|Johns Hopkins University, Baltimore, Maryland, 21287-8936, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, 20889-5600, United States|Union Hospital of Cecil County, Elkton, Maryland, 21921, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Caritas Saint Elizabeth’s Medical Center, Brighton, Massachusetts, 02135-2997, United States|Baystate Medical Center, Springfield, Massachusetts, 01199, United States|Saint Joseph Mercy Hospital, Ann Arbor, Michigan, 48106-0995, United States|Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan, 48106, United States|Bronson Battle Creek, Battle Creek, Michigan, 49017, United States|Mecosta County Medical Center, Big Rapids, Michigan, 49307, United States|Oakwood Hospital, Dearborn, Michigan, 48124, United States|Wayne State University, Detroit, Michigan, 48202, United States|Saint John Hospital and Medical Center, Detroit, Michigan, 48236, United States|Hurley Medical Center, Flint, Michigan, 48502, United States|Genesys Hurley Cancer Institute, Flint, Michigan, 48503, United States|Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, 48532, United States|Genesys Regional Medical Center, Grand Blanc, Michigan, 48439, United States|Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, 49503, United States|Saint Mary’s Health Care, Grand Rapids, Michigan, 49503, United States|Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, 49503, United States|Allegiance Health, Jackson, Michigan, 49201, United States|Borgess Medical Center, Kalamazoo, Michigan, 49001, United States|Bronson Methodist Hospital, Kalamazoo, Michigan, 49007, United States|West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States|Sparrow Hospital, Lansing, Michigan, 48912, United States|Saint Mary Mercy Hospital, Livonia, Michigan, 48154, United States|Mercy Health Partners-Mercy Campus, Muskegon, Michigan, 49444, United States|Saint Joseph Mercy Oakland, Pontiac, Michigan, 48341-2985, United States|Saint Joseph Mercy Port Huron, Port Huron, Michigan, 48060, United States|Spectrum Health Reed City Hospital, Reed City, Michigan, 49677, United States|Saint Mary’s of Michigan, Saginaw, Michigan, 48601, United States|Providence Hospital, Southfield, Michigan, 48075, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|Saint John Macomb-Oakland Hospital, Warren, Michigan, 48093, United States|Sanford Clinic North-Bemidgi, Bemidji, Minnesota, 56601, United States|Essentia Health Saint Joseph’s Medical Center, Brainerd, Minnesota, 56401, United States|Essentia Health Duluth Clinic CCOP, Duluth, Minnesota, 55805, United States|Essentia Health Saint Mary’s Medical Center, Duluth, Minnesota, 55805, United States|Miller-Dwan Hospital, Duluth, Minnesota, 55805, United States|Lake Region Healthcare Corporation-Cancer Care, Fergus Falls, Minnesota, 56537, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, 63703, United States|Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, 63109, United States|Saint Louis University Hospital, Saint Louis, Missouri, 63110, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Saint John’s Mercy Medical Center, Saint Louis, Missouri, 63141, United States|Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri, 63141, United States|Montana Cancer Consortium CCOP, Billings, Montana, 59101, United States|Saint Vincent Healthcare, Billings, Montana, 59101, United States|Hematology-Oncology Centers of the Northern Rockies PC, Billings, Montana, 59102, United States|Billings Clinic, Billings, Montana, 59107-7000, United States|Bozeman Deaconess Cancer Center, Bozeman, Montana, 59715, United States|Bozeman Deaconess Hospital, Bozeman, Montana, 59715, United States|Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, 59701, United States|Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, 59405, United States|Great Falls Clinic, Great Falls, Montana, 59405, United States|Northern Montana Hospital, Havre, Montana, 59501, United States|Saint Peter’s Community Hospital, Helena, Montana, 59601, United States|Glacier Oncology PLLC, Kalispell, Montana, 59901, United States|Kalispell Medical Oncology, Kalispell, Montana, 59901, United States|Kalispell Regional Medical Center, Kalispell, Montana, 59901, United States|Montana Cancer Specialists, Missoula, Montana, 59802, United States|Saint Patrick Hospital – Community Hospital, Missoula, Montana, 59802, United States|Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, 89106, United States|Cooper Hospital University Medical Center, Camden, New Jersey, 08103, United States|Winthrop University Hospital, Mineola, New York, 11501, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|University of Rochester, Rochester, New York, 14642, United States|Park Ridge Hospital Breast Health Center, Hendersonville, North Carolina, 28792, United States|Kinston Medical Specialists PA, Kinston, North Carolina, 28501, United States|Roger Maris Cancer Center, Fargo, North Dakota, 58122, United States|Sanford Clinic North-Fargo, Fargo, North Dakota, 58122, United States|Sanford Medical Center-Fargo, Fargo, North Dakota, 58122, United States|Summa Akron City Hospital, Akron, Ohio, 44304, United States|Akron General Medical Center, Akron, Ohio, 44307, United States|Summa Barberton Hospital, Barberton, Ohio, 44203, United States|Aultman Health Foundation, Canton, Ohio, 44710, United States|The Jewish Hospital, Cincinnati, Ohio, 45236, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States|Grandview Hospital, Dayton, Ohio, 45405, United States|Good Samaritan Hospital – Dayton, Dayton, Ohio, 45406, United States|Miami Valley Hospital, Dayton, Ohio, 45409, United States|Samaritan North Health Center, Dayton, Ohio, 45415, United States|Dayton CCOP, Dayton, Ohio, 45420, United States|Blanchard Valley Hospital, Findlay, Ohio, 45840, United States|Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, 45005-1066, United States|Wayne Hospital, Greenville, Ohio, 45331, United States|Kettering Medical Center, Kettering, Ohio, 45429, United States|Saint Rita’s Medical Center, Lima, Ohio, 45801, United States|Upper Valley Medical Center, Troy, Ohio, 45373, United States|Clinton Memorial Hospital, Wilmington, Ohio, 45177, United States|Greene Memorial Hospital, Xenia, Ohio, 45385, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Clackamas Radiation Oncology Center, Clackamas, Oregon, 97015, United States|Providence Milwaukie Hospital, Milwaukie, Oregon, 97222, United States|Providence Newberg Medical Center, Newberg, Oregon, 97132, United States|Providence Willamette Falls Medical Center, Oregon City, Oregon, 97045, United States|Providence Portland Medical Center, Portland, Oregon, 97213, United States|Columbia River Oncology Program, Portland, Oregon, 97225, United States|Providence Saint Vincent Medical Center, Portland, Oregon, 97225, United States|Lehigh Valley Hospital, Allentown, Pennsylvania, 18105, United States|Lehigh Valley Hospital – Muhlenberg, Bethlehem, Pennsylvania, 18017, United States|Geisinger Medical Center, Danville, Pennsylvania, 17822-2001, United States|Geisinger Medical Center-Cancer Center Hazelton, Hazleton, Pennsylvania, 18201, United States|Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States|Lewistown Hospital, Lewistown, Pennsylvania, 17044, United States|Abramson Cancer Center of The University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111-2497, United States|Geisinger Medical Group, State College, Pennsylvania, 16801, United States|Mount Nittany Medical Center, State College, Pennsylvania, 16803, United States|Geisinger Wyoming Valley, Wilkes-Barre, Pennsylvania, 18711, United States|York Hospital, York, Pennsylvania, 17405, United States|AnMed Health Cancer Center, Anderson, South Carolina, 29621, United States|Saint Francis Hospital, Greenville, South Carolina, 29601, United States|Carolina Blood and Cancer Care Associates PA-Lancaster, Lancaster, South Carolina, 29720, United States|Carolina Blood and Cancer Care Associates PA, Rock Hill, South Carolina, 29732, United States|Spartanburg Regional Medical Center, Spartanburg, South Carolina, 29303, United States|Upstate Carolina CCOP, Spartanburg, South Carolina, 29303, United States|Sanford Cancer Center-Oncology Clinic, Sioux Falls, South Dakota, 57104, United States|Medical X-Ray Center, Sioux Falls, South Dakota, 57105, United States|Sanford USD Medical Center – Sioux Falls, Sioux Falls, South Dakota, 57117-5134, United States|Erlanger Medical Center, Chattanooga, Tennessee, 37403, United States|Jackson-Madison County General Hospital, Jackson, Tennessee, 38301, United States|Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232, United States|PeaceHealth Southwest Medical Center, Vancouver, Washington, 98664, United States|Northwest Cancer Specialists, Vancouver, Washington, 98684, United States|West Virginia University Charleston, Charleston, West Virginia, 25304, United States|West Virginia University, Morgantown, West Virginia, 26506, United States|Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, 54301-3526, United States|Saint Vincent Hospital, Green Bay, Wisconsin, 54301, United States|Green Bay Oncology Limited at Saint Mary’s Hospital, Green Bay, Wisconsin, 54303, United States|Saint Mary’s Hospital, Green Bay, Wisconsin, 54303, United States|Gundersen Lutheran, La Crosse, Wisconsin, 54601, United States|University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792, United States|Holy Family Memorial Hospital, Manitowoc, Wisconsin, 54221, United States|Bay Area Medical Center, Marinette, Wisconsin, 54143, United States|Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|D N Greenwald Center, Mukwonago, Wisconsin, 53149, United States|Oconomowoc Memorial Hospital-ProHealth Care Inc, Oconomowoc, Wisconsin, 53066-3896, United States|Saint Nicholas Hospital, Sheboygan, Wisconsin, 53081, United States|Waukesha Memorial Hospital – ProHealth Care, Waukesha, Wisconsin, 53188, United States|Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, 53226, United States|Rocky Mountain Oncology, Casper, Wyoming, 82609, United States|Welch Cancer Center, Sheridan, Wyoming, 82801, United States|Mayo Clinic Methodist Hospital, Nagpur, 440 018, India|Rambam Medical Center, Haifa, 31096, Israel|Shaare Zedek Medical Center, Jerusalem, 91031, Israel | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/08/NCT02085408/Prot_SAP_000.pdf | |
| NCT02071251 | A Study to Evaluate a Quality Improvement Intervention to Reduce Wound Separation Rates in Obese Gynecologic Oncology Service Patients Undergoing Abdominal Surgery | https://clinicaltrials.gov/study/NCT02071251 | Approximately 500,000 surgical site infections occur annually in the US. These lead to worse patient quality of life, more outpatient and emergency room visits, readmissions and home services, with an estimated increase in costs of at least $3500 per complication. Surgical site infections are associated with increasing body mass index. There is limited and conflicting data of the utility of multiple surgical interventions to decrease the risk of surgical site complications. The investigators explored the effect of a prospective care pathway for closure of vertical abdominal wounds on patient’s wound complications. | NO | Wound Complications|Wound Infection|Wound Separation | PROCEDURE: Prospective wound complication protocol | Wound complication, The primary outcome for our study was a wound complication within eight weeks of laparotomy. Wound complication was defined as seroma, hematoma, separation, or infection requiring additional medical and/or surgical management within eight weeks of laparotomy., Within 8 weeks of surgery | Wound separation, Wound separation within 8 weeks of surgery, 8 weeks of surgery|Wound infection, Wound infection within 8 weeks of surgery, 8 weeks of surgery | Washington University School of Medicine | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 105 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 201108303 | 2011-12 | 2013-07 | 2013-07 | 2014-02-25 | 2015-08-25 | Washington University School of Medicine and Barnes Jewish Hospital, St Louis, Missouri, 63110, United States | |||||
| NCT02065687 | Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer | https://clinicaltrials.gov/study/NCT02065687 | This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer. | YES | Endometrial Adenocarcinoma|Endometrial Clear Cell Adenocarcinoma|Endometrial Serous Adenocarcinoma|Endometrial Undifferentiated Carcinoma|Recurrent Uterine Corpus Carcinoma|Stage III Uterine Corpus Cancer AJCC v7|Stage IIIA Uterine Corpus Cancer AJCC v7|Stage IIIB Uterine Corpus Cancer AJCC v7|Stage IIIC Uterine Corpus Cancer AJCC v7|Stage IV Uterine Corpus Cancer AJCC v7|Stage IVA Uterine Corpus Cancer AJCC v7|Stage IVB Uterine Corpus Cancer AJCC v7 | DRUG: Carboplatin|OTHER: Laboratory Biomarker Analysis|DRUG: Metformin Hydrochloride|DRUG: Paclitaxel|OTHER: Placebo Administration|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Progression-free Survival (PFS) (Phase II), Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years|Overall Survival (OS) (Phase II and III), The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of death or the date of last contact, assessed up to 5 years | Proportion of Patients Responding to Therapy, The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI., During study treatment, up to 5 years.|Duration of Response by Treatment, Duration of response until disease progression, death, or date last seen among patients who responded., From the date of response to disease progression, death, or date last seen assessed up to 5 years|Overall Survival (OS) (Phase II), The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of death or the date of last contact, assessed up to 5 years.|Progression Free Survival (PFS) (Phase III), Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years|Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4, Toxicities will be assessed by organ or organ system. For each category of toxicity, each patient will be evaluated by the worst grade experienced during the course of therapy. Data will be summarized by frequency and severity according to the regimen administered. The number of patients with a grade three or greater adverse event will be reported (by system organ class)., Up to 5 years|Level of Obesity, Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model., Up to 5 years | Metabolic Factor Levels, Hip-to-waist ratio, diabetes status, hemoglobin A1c, fasting insulin glucose levels, and homeostatic model assessment scores will be assessed for their predictive and prognostic significance. Variables will be analyzed as continuous covariates (or as appropriate with transformations such as the logarithm) with Cox models or logistic regression., Up to 5 years|Incidence of PIK3 Mutations/Amplifications, PIK3CA mutations/amplifications and PIK3R1/PIK3R2 mutations will be examined for prognostic and predictive significance., Up to 5 years|Expression of MATE 2, Expression will be examined by immunohistochemistry with intensity of staining and the percentage of cells staining positive. From these statistics, an H-score will be calculated. Expression will be further dichotomized as high expression and low expression at the median to maximize the power of the study., Up to 5 years|Levels of Key Targets of the Metformin/mTOR Signaling Pathway, Levels before and after treatment will be assessed for their predictive and prognostic significance., Up to 5 years | Gynecologic Oncology Group | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | PHASE2|PHASE3 | 469 | NETWORK | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | GOG-0286B|NCI-2013-02284|s14-01068|GOG-0286B|GOG-0286B|GOG-0286B|U10CA180830|U10CA180868|U10CA027469 | 2014-03-17 | 2019-04-17 | 2023-09-13 | 2014-02-19 | 2021-01-12 | 2021-09-30 | University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, 35233, United States|Tennessee Valley Gynecologic Oncology, Huntsville, Alabama, 35805, United States|Cancer Center at Saint Joseph’s, Phoenix, Arizona, 85004, United States|Saint Joseph’s Hospital and Medical Center, Phoenix, Arizona, 85013, United States|Arizona Oncology Associates-Biltmore Cancer Center, Phoenix, Arizona, 85016, United States|Arizona Oncology Associates-West Orange Grove, Tucson, Arizona, 85704, United States|Arizona Oncology Associates-Wilmot, Tucson, Arizona, 85710, United States|Banner University Medical Center – Tucson, Tucson, Arizona, 85719, United States|University of Arizona Cancer Center-North Campus, Tucson, Arizona, 85719, United States|University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|John Muir Medical Center-Concord Campus, Concord, California, 94520, United States|UC San Diego Moores Cancer Center, La Jolla, California, 92093, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Los Angeles County-USC Medical Center, Los Angeles, California, 90033, United States|USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States|Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040, United States|Kaiser Permanente-Oakland, Oakland, California, 94611, United States|Saint Joseph Hospital – Orange, Orange, California, 92868, United States|UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, 92868, United States|Palo Alto Medical Foundation Health Care, Palo Alto, California, 94301, United States|Stanford Cancer Institute Palo Alto, Palo Alto, California, 94304, United States|Keck Medical Center of USC Pasadena, Pasadena, California, 91105, United States|Kaiser Permanente-Roseville, Roseville, California, 95661, United States|University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States|Kaiser Permanente – Sacramento, Sacramento, California, 95825, United States|Zuckerberg San Francisco General Hospital, San Francisco, California, 94110, United States|California Pacific Medical Center-Pacific Campus, San Francisco, California, 94115, United States|Kaiser Permanente-San Francisco, San Francisco, California, 94115, United States|UCSF Medical Center-Mount Zion, San Francisco, California, 94115, United States|UCSF Medical Center-Mission Bay, San Francisco, California, 94158, United States|Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, 95119, United States|Kaiser Permanente San Leandro, San Leandro, California, 94577, United States|Kaiser Permanente Medical Center – Santa Clara, Santa Clara, California, 95051, United States|Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, 95065, United States|Kaiser Permanente-South San Francisco, South San Francisco, California, 94080, United States|Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, 94086, United States|Olive View-University of California Los Angeles Medical Center, Sylmar, California, 91342, United States|Kaiser Permanente-Vallejo, Vallejo, California, 94589, United States|Kaiser Permanente-Walnut Creek, Walnut Creek, California, 94596, United States|John Muir Medical Center-Walnut Creek, Walnut Creek, California, 94598, United States|University of Colorado Hospital, Aurora, Colorado, 80045, United States|Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, 80907, United States|Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States|Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, 06418, United States|Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, 06824, United States|Smilow Cancer Hospital Care Center – Guiford, Guilford, Connecticut, 06437, United States|Hartford Hospital, Hartford, Connecticut, 06102, United States|Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, 06105, United States|Midstate Medical Center, Meriden, Connecticut, 06451, United States|The Hospital of Central Connecticut, New Britain, Connecticut, 06050, United States|Yale University, New Haven, Connecticut, 06520, United States|Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, 06473, United States|Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, 06477, United States|Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, 06790, United States|Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, 06611, United States|Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, 06708, United States|Christiana Gynecologic Oncology LLC, Newark, Delaware, 19713, United States|Helen F Graham Cancer Center, Newark, Delaware, 19713, United States|Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States|Christiana Care Health System-Christiana Hospital, Newark, Delaware, 19718, United States|Beebe Health Campus, Rehoboth Beach, Delaware, 19971, United States|Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, 19801, United States|University of Florida Health Science Center – Gainesville, Gainesville, Florida, 32610, United States|AdventHealth Orlando, Orlando, Florida, 32803, United States|Women’s Cancer Associates, Saint Petersburg, Florida, 33713, United States|Sarasota Memorial Hospital, Sarasota, Florida, 34239, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Northside Hospital, Atlanta, Georgia, 30342, United States|Augusta University Medical Center, Augusta, Georgia, 30912, United States|Dekalb Medical Center, Decatur, Georgia, 30033, United States|Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, 30501, United States|Lewis Cancer and Research Pavilion at Saint Joseph’s/Candler, Savannah, Georgia, 31405, United States|Pali Momi Medical Center, ‘Aiea, Hawaii, 96701, United States|Queen’s Cancer Center – Pearlridge, ‘Aiea, Hawaii, 96701, United States|The Cancer Center of Hawaii-Pali Momi, ‘Aiea, Hawaii, 96701, United States|Hawaii Cancer Care Inc – Waterfront Plaza, Honolulu, Hawaii, 96813, United States|Queen’s Medical Center, Honolulu, Hawaii, 96813, United States|Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States|University of Hawaii Cancer Center, Honolulu, Hawaii, 96813, United States|Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, 96817, United States|Kuakini Medical Center, Honolulu, Hawaii, 96817, United States|Queen’s Cancer Center – Kuakini, Honolulu, Hawaii, 96817, United States|The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, 96817, United States|Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States|Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, 96766, United States|Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, 83706, United States|Northwest Community Hospital, Arlington Heights, Illinois, 60005, United States|Rush – Copley Medical Center, Aurora, Illinois, 60504, United States|Illinois CancerCare-Bloomington, Bloomington, Illinois, 61704, United States|Illinois CancerCare-Canton, Canton, Illinois, 61520, United States|Illinois CancerCare-Carthage, Carthage, Illinois, 62321, United States|Northwestern University, Chicago, Illinois, 60611, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States|Carle on Vermilion, Danville, Illinois, 61832, United States|Cancer Care Specialists of Illinois – Decatur, Decatur, Illinois, 62526, United States|Decatur Memorial Hospital, Decatur, Illinois, 62526, United States|Carle Physician Group-Effingham, Effingham, Illinois, 62401, United States|Crossroads Cancer Center, Effingham, Illinois, 62401, United States|AMITA Health Alexian Brothers Medical Center, Elk Grove Village, Illinois, 60007, United States|Illinois CancerCare-Eureka, Eureka, Illinois, 61530, United States|NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, 60201, United States|Illinois CancerCare-Galesburg, Galesburg, Illinois, 61401, United States|Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, 60134, United States|NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, 60026, United States|NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, 60035, United States|Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, 60521, United States|Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, 61443, United States|Illinois CancerCare-Macomb, Macomb, Illinois, 61455, United States|Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, 61938, United States|UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, 60451, United States|Cancer Care Center of O’Fallon, O’Fallon, Illinois, 62269, United States|University of Chicago Medicine-Orland Park, Orland Park, Illinois, 60462, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350, United States|Illinois CancerCare-Pekin, Pekin, Illinois, 61554, United States|Illinois CancerCare-Peoria, Peoria, Illinois, 61615, United States|Illinois CancerCare-Peru, Peru, Illinois, 61354, United States|Illinois CancerCare-Princeton, Princeton, Illinois, 61356, United States|North Shore Medical Center, Skokie, Illinois, 60076, United States|Central Illinois Hematology Oncology Center, Springfield, Illinois, 62702, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States|Springfield Clinic, Springfield, Illinois, 62702, United States|Memorial Medical Center, Springfield, Illinois, 62781, United States|Carle Cancer Center, Urbana, Illinois, 61801, United States|The Carle Foundation Hospital, Urbana, Illinois, 61801, United States|Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, 60555, United States|Rush-Copley Healthcare Center, Yorkville, Illinois, 60560, United States|Michiana Hematology Oncology PC-Crown Point, Crown Point, Indiana, 46307, United States|Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, 46514, United States|Elkhart General Hospital, Elkhart, Indiana, 46515, United States|Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States|Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, 46260, United States|IU Health La Porte Hospital, La Porte, Indiana, 46350, United States|Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, 46360, United States|Woodland Cancer Care Center, Michigan City, Indiana, 46360, United States|Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana, 46545, United States|Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, 46545, United States|Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, 46601, United States|Michiana Hematology Oncology PC-Westville, Westville, Indiana, 46391, United States|Mary Greeley Medical Center, Ames, Iowa, 50010, United States|McFarland Clinic PC – Ames, Ames, Iowa, 50010, United States|McFarland Clinic PC-Boone, Boone, Iowa, 50036, United States|Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, 50325, United States|Mercy Cancer Center-West Lakes, Clive, Iowa, 50325, United States|Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, 50314, United States|Mercy Medical Center – Des Moines, Des Moines, Iowa, 50314, United States|McFarland Clinic PC-Trinity Cancer Center, Fort Dodge, Iowa, 50501, United States|University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242, United States|McFarland Clinic PC-Jefferson, Jefferson, Iowa, 50129, United States|McFarland Clinic PC-Marshalltown, Marshalltown, Iowa, 50158, United States|Mercy Medical Center – North Iowa, Mason City, Iowa, 50401, United States|Saint Elizabeth Medical Center South, Edgewood, Kentucky, 41017, United States|Saint Elizabeth Fort Thomas, Fort Thomas, Kentucky, 41075, United States|University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536, United States|Woman’s Hospital, Baton Rouge, Louisiana, 70817, United States|Ochsner Medical Center Jefferson, New Orleans, Louisiana, 70121, United States|Maine Medical Center- Scarborough Campus, Scarborough, Maine, 04074, United States|Greater Baltimore Medical Center, Baltimore, Maryland, 21204, United States|Sinai Hospital of Baltimore, Baltimore, Maryland, 21215, United States|Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, 21287, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, 20889-5600, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Brigham and Women’s Hospital, Boston, Massachusetts, 02115, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Lowell General Hospital, Lowell, Massachusetts, 01854, United States|Baystate Medical Center, Springfield, Massachusetts, 01199, United States|UMass Memorial Medical Center – Memorial Division, Worcester, Massachusetts, 01605, United States|Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, 48106, United States|Saint Joseph Mercy Hospital, Ann Arbor, Michigan, 48106, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States|Bronson Battle Creek, Battle Creek, Michigan, 49017, United States|Beaumont Hospital – Dearborn, Dearborn, Michigan, 48124, United States|Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|Green Bay Oncology – Escanaba, Escanaba, Michigan, 49829, United States|Weisberg Cancer Treatment Center, Farmington Hills, Michigan, 48334, United States|Genesys Hurley Cancer Institute, Flint, Michigan, 48503, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Helen DeVos Children’s Hospital at Spectrum Health, Grand Rapids, Michigan, 49503, United States|Mercy Health Saint Mary’s, Grand Rapids, Michigan, 49503, United States|Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, 49503, United States|Green Bay Oncology – Iron Mountain, Iron Mountain, Michigan, 49801, United States|Allegiance Health, Jackson, Michigan, 49201, United States|West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States|Sparrow Hospital, Lansing, Michigan, 48912, United States|Saint Mary Mercy Hospital, Livonia, Michigan, 48154, United States|Monroe Cancer Center, Monroe, Michigan, 48162, United States|Mercy Health Mercy Campus, Muskegon, Michigan, 49444, United States|Saint Joseph Mercy Oakland, Pontiac, Michigan, 48341, United States|Lake Huron Medical Center, Port Huron, Michigan, 48060, United States|Spectrum Health Reed City Hospital, Reed City, Michigan, 49677, United States|William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, 48073, United States|Ascension Saint Mary’s Hospital, Saginaw, Michigan, 48601, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|William Beaumont Hospital – Troy, Troy, Michigan, 48085, United States|Saint John Macomb-Oakland Hospital, Warren, Michigan, 48093, United States|Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, 56601, United States|Mercy Hospital, Coon Rapids, Minnesota, 55433, United States|Fairview Southdale Hospital, Edina, Minnesota, 55435, United States|Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407, United States|University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, 55455, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States|Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, 55416, United States|Park Nicollet Clinic – Saint Louis Park, Saint Louis Park, Minnesota, 55416, United States|United Hospital, Saint Paul, Minnesota, 55102, United States|Lakeview Hospital, Stillwater, Minnesota, 55082, United States|Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, 55125, United States|Saint Dominic-Jackson Memorial Hospital, Jackson, Mississippi, 39216, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, 63703, United States|Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, 65401, United States|Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, 65401, United States|Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Mercy Hospital Saint Louis, Saint Louis, Missouri, 63141, United States|Cancer Research for the Ozarks NCORP, Springfield, Missouri, 65804, United States|Mercy Hospital Springfield, Springfield, Missouri, 65804, United States|CoxHealth South Hospital, Springfield, Missouri, 65807, United States|Billings Clinic Cancer Center, Billings, Montana, 59101, United States|Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, 59405, United States|Kalispell Regional Medical Center, Kalispell, Montana, 59901, United States|CHI Health Saint Francis, Grand Island, Nebraska, 68803, United States|CHI Health Good Samaritan, Kearney, Nebraska, 68847, United States|Nebraska Methodist Hospital, Omaha, Nebraska, 68114, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Women’s Cancer Center of Nevada, Las Vegas, Nevada, 89169, United States|Center of Hope at Renown Medical Center, Reno, Nevada, 89502, United States|Renown Regional Medical Center, Reno, Nevada, 89502, United States|Wentworth-Douglass Hospital, Dover, New Hampshire, 03820, United States|Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States|Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States|Cooper Hospital University Medical Center, Camden, New Jersey, 08103, United States|Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States|Morristown Medical Center, Morristown, New Jersey, 07960, United States|Virtua Memorial, Mount Holly, New Jersey, 08060, United States|Overlook Hospital, Summit, New Jersey, 07902, United States|MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, 08043, United States|Virtua Voorhees, Voorhees, New Jersey, 08043, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87102, United States|Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, 87106, United States|Women’s Cancer Care Associates LLC, Albany, New York, 12208, United States|Montefiore Medical Center-Einstein Campus, Bronx, New York, 10461, United States|Montefiore Medical Center-Weiler Hospital, Bronx, New York, 10461, United States|Montefiore Medical Center – Moses Campus, Bronx, New York, 10467, United States|State University of New York Downstate Medical Center, Brooklyn, New York, 11203, United States|New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, 11215, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|Memorial Sloan Kettering Commack, Commack, New York, 11725, United States|Glens Falls Hospital, Glens Falls, New York, 12801, United States|Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States|NYU Winthrop Hospital, Mineola, New York, 11501, United States|Mount Sinai Union Square, New York, New York, 10003, United States|Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, 10016, United States|Mount Sinai Hospital, New York, New York, 10029, United States|NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, 10032, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Sleepy Hollow, Sleepy Hollow, New York, 10591, United States|Stony Brook University Medical Center, Stony Brook, New York, 11794, United States|Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States|Westchester Medical Center, Valhalla, New York, 10595, United States|Dickstein Cancer Treatment Center, White Plains, New York, 10601, United States|UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States|Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, 28203, United States|Novant Health Presbyterian Medical Center, Charlotte, North Carolina, 28204, United States|Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, 28328, United States|Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, 28025, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, 27534, United States|Wayne Memorial Hospital, Goldsboro, North Carolina, 27534, United States|AdventHealth Hendersonville, Hendersonville, North Carolina, 28792, United States|Onslow Memorial Hospital, Jacksonville, North Carolina, 28546, United States|Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, 28546, United States|Novant Health Cancer Institute – Kernersville, Kernersville, North Carolina, 27284, United States|Novant Health Cancer Institute – Mount Airy, Mount Airy, North Carolina, 27030, United States|FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States|Duke Raleigh Hospital, Raleigh, North Carolina, 27609, United States|Novant Health Cancer Institute – Statesville, Statesville, North Carolina, 28625, United States|Novant Health Cancer Institute – Thomasville, Thomasville, North Carolina, 27360, United States|Novant Health Cancer Institute – Wilkesboro, Wilkesboro, North Carolina, 28659, United States|New Hanover Regional Medical Center/Zimmer Cancer Center, Wilmington, North Carolina, 28401, United States|Novant Health Oncology Specialists, Winston-Salem, North Carolina, 27103, United States|Winston-Salem Health Care, Winston-Salem, North Carolina, 27103, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States|Sanford Bismarck Medical Center, Bismarck, North Dakota, 58501, United States|Sanford Broadway Medical Center, Fargo, North Dakota, 58122, United States|Sanford Clinic North-Fargo, Fargo, North Dakota, 58122, United States|Sanford Roger Maris Cancer Center, Fargo, North Dakota, 58122, United States|Summa Health System – Akron Campus, Akron, Ohio, 44304, United States|University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, 45219, United States|Good Samaritan Hospital – Cincinnati, Cincinnati, Ohio, 45220, United States|Bethesda North Hospital, Cincinnati, Ohio, 45242, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States|Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, 44111, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States|Riverside Methodist Hospital, Columbus, Ohio, 43214, United States|Columbus NCI Community Oncology Research Program, Columbus, Ohio, 43215, United States|The Mark H Zangmeister Center, Columbus, Ohio, 43219, United States|Grandview Hospital, Dayton, Ohio, 45405, United States|Good Samaritan Hospital – Dayton, Dayton, Ohio, 45406, United States|Miami Valley Hospital, Dayton, Ohio, 45409, United States|Miami Valley Hospital North, Dayton, Ohio, 45415, United States|Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, 44124, United States|UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, 44060, United States|ProMedica Flower Hospital, Sylvania, Ohio, 43560, United States|ProMedica Toledo Hospital/Russell J Ebeid Children’s Hospital, Toledo, Ohio, 43606, United States|Wright-Patterson Medical Center, Wright-Patterson Air Force Base, Ohio, 45433, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, 74146, United States|Jefferson Abington Hospital, Abington, Pennsylvania, 19001, United States|Saint Luke’s University Hospital-Bethlehem Campus, Bethlehem, Pennsylvania, 18015, United States|Geisinger Medical Center, Danville, Pennsylvania, 17822, United States|Adams Cancer Center, Gettysburg, Pennsylvania, 17325, United States|UPMC Cancer Centers – Arnold Palmer Pavilion, Greensburg, Pennsylvania, 15601, United States|Cherry Tree Cancer Center, Hanover, Pennsylvania, 17331, United States|Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, 18201, United States|Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, 17837, United States|Lewistown Hospital, Lewistown, Pennsylvania, 17044, United States|University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, 19104, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States|UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, 15213, United States|University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, 15232, United States|UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, 15237, United States|Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, 17901, United States|UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, 16346, United States|Geisinger Medical Group, State College, Pennsylvania, 16801, United States|UPMC Uniontown Hospital Radiation Oncology, Uniontown, Pennsylvania, 15401, United States|Chester County Hospital, West Chester, Pennsylvania, 19380, United States|Reading Hospital, West Reading, Pennsylvania, 19611, United States|Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, 18711, United States|WellSpan Health-York Hospital, York, Pennsylvania, 17403, United States|Women and Infants Hospital, Providence, Rhode Island, 02905, United States|AnMed Health Cancer Center, Anderson, South Carolina, 29621, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Saint Francis Hospital, Greenville, South Carolina, 29601, United States|Gibbs Cancer Center-Pelham, Greer, South Carolina, 29651, United States|Carolina Blood and Cancer Care Associates PA-Lancaster, Lancaster, South Carolina, 29720, United States|Carolina Blood and Cancer Care Associates PA, Rock Hill, South Carolina, 29732, United States|Spartanburg Medical Center, Spartanburg, South Carolina, 29303, United States|Black Hills Obstetrics and Gynecology, Rapid City, South Dakota, 57701, United States|Rapid City Regional Hospital, Rapid City, South Dakota, 57701, United States|Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, 57104, United States|Avera Cancer Institute, Sioux Falls, South Dakota, 57105, United States|Sanford USD Medical Center – Sioux Falls, Sioux Falls, South Dakota, 57117-5134, United States|Chattanooga’s Program in Women’s Oncology, Chattanooga, Tennessee, 37403, United States|University of Tennessee – Knoxville, Knoxville, Tennessee, 37920, United States|Dell Seton Medical Center at The University of Texas, Austin, Texas, 78701, United States|Texas Oncology-Austin Midtown, Austin, Texas, 78705, United States|Texas Oncology – Central Austin Cancer Center, Austin, Texas, 78731, United States|Texas Oncology – South Austin Cancer Center, Austin, Texas, 78745, United States|Texas Oncology Bedford, Bedford, Texas, 76022, United States|MD Anderson in The Woodlands, Conroe, Texas, 77384, United States|Texas Health Presbyterian Hospital Dallas, Dallas, Texas, 75231, United States|Parkland Memorial Hospital, Dallas, Texas, 75235, United States|Texas Oncology at Baylor Charles A Sammons Cancer Center, Dallas, Texas, 75246, United States|UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, 75390, United States|Texas Oncology – Fort Worth Cancer Center, Fort Worth, Texas, 76104, United States|Lyndon Baines Johnson General Hospital, Houston, Texas, 77026-1967, United States|Houston Methodist Hospital, Houston, Texas, 77030, United States|M D Anderson Cancer Center, Houston, Texas, 77030, United States|Memorial Hermann Texas Medical Center, Houston, Texas, 77030, United States|Methodist Willowbrook Hospital, Houston, Texas, 77070, United States|MD Anderson West Houston, Houston, Texas, 77079, United States|MD Anderson League City, League City, Texas, 77573, United States|Texas Oncology-Longview Cancer Center, Longview, Texas, 75601, United States|MD Anderson in Sugar Land, Sugar Land, Texas, 77478, United States|Houston Methodist Sugar Land Hospital, Sugar Land, Texas, 77479, United States|Texas Oncology Cancer Center Sugar Land, Sugar Land, Texas, 77479, United States|Texas Oncology-The Woodlands, The Woodlands, Texas, 77380, United States|Tyler Cancer Center, Tyler, Texas, 75702, United States|Deke Slayton Cancer Center, Webster, Texas, 77598, United States|American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, 84003, United States|Sandra L Maxwell Cancer Center, Cedar City, Utah, 84720, United States|Logan Regional Hospital, Logan, Utah, 84321, United States|Intermountain Medical Center, Murray, Utah, 84107, United States|McKay-Dee Hospital Center, Ogden, Utah, 84403, United States|Utah Valley Regional Medical Center, Provo, Utah, 84604, United States|Dixie Medical Center Regional Cancer Center, Saint George, Utah, 84770, United States|Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, 84106, United States|Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112, United States|LDS Hospital, Salt Lake City, Utah, 84143, United States|Southwestern Vermont Medical Center, Bennington, Vermont, 05201, United States|Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, 05602, United States|University of Vermont Medical Center, Burlington, Vermont, 05401, United States|University of Vermont and State Agricultural College, Burlington, Vermont, 05405, United States|Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, 05819, United States|University of Virginia Cancer Center, Charlottesville, Virginia, 22908, United States|Inova Schar Cancer Institute, Fairfax, Virginia, 22031, United States|Inova Fairfax Hospital, Falls Church, Virginia, 22042, United States|Henrico Doctor’s Hospital, Richmond, Virginia, 23229, United States|Virginia Gynecologic Oncology, Richmond, Virginia, 23229, United States|Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, 23298, United States|Carilion Clinic Gynecological Oncology, Roanoke, Virginia, 24016, United States|Highline Medical Center-Main Campus, Burien, Washington, 98166, United States|MultiCare Gig Harbor Medical Park, Gig Harbor, Washington, 98335, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States|Seattle Cancer Care Alliance, Seattle, Washington, 98109, United States|University of Washington Medical Center – Northwest, Seattle, Washington, 98133, United States|Women’s Cancer Center of Seattle, Seattle, Washington, 98133, United States|University of Washington Medical Center – Montlake, Seattle, Washington, 98195, United States|MultiCare Tacoma General Hospital, Tacoma, Washington, 98405, United States|Edwards Comprehensive Cancer Center, Huntington, West Virginia, 25701, United States|Monongalia Hospital, Morgantown, West Virginia, 26505, United States|Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, 54729, United States|Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, 54701, United States|Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, 54301-3526, United States|Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, 54301, United States|Green Bay Oncology Limited at Saint Mary’s Hospital, Green Bay, Wisconsin, 54303, United States|Saint Vincent Hospital Cancer Ce | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT02065687/Prot_SAP_000.pdf | |
| NCT02063295 | An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury | https://clinicaltrials.gov/study/NCT02063295 | The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury. | NO | Obesity|Over-weight|Hypothalamic Injury|Craniopharyngioma | DRUG: ZGN-440 sterile diluent|DRUG: ZGN-440 for injectable suspension | Change in body weight from baseline to the end of the randomized dosing period., 4 weeks | Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period, 4 weeks|Change in hs-CRP from baseline to the end of the randomized dosing period., 4 weeks|Change in hunger from baseline to the end of the randomized dosing period., 4 weeks|Change in quality of life from baseline to the end of the randomized dosing period., 4 weeks | Zafgen, Inc. | ALL | ADULT, OLDER_ADULT | PHASE2 | 14 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | ZAF-221 | 2014-04 | 2014-11 | 2014-11 | 2014-02-14 | 2016-07-18 | Children’s Hospitals and Clinics of Minnesota, St. Paul, Minnesota, 55102, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|The Boden Institute, Sydney, New South Wales, 2006, Australia|Austin Health, Metabolic Disorders Centre, Heidelberg Heights, Victoria, 3081, Australia | |||||
| NCT02062255 | Impact of COX2 on Sera Biomarkers From Obese Subjects | https://clinicaltrials.gov/study/NCT02062255 | Obesity promotes worse outcome for post-menopausal breast cancer patients. | NO | Breast Cancer Survivors | DRUG: Aspirin|DIETARY_SUPPLEMENT: Omega 3 FFA | Biomarker levels, Blood levels of Prostaglandin E2, aromatase, pro-inflammatory cytokines, steroids, and lipids will be measured pre and post treatment., 29 days | BMI, Correlation for body mass index impact on response to COX2 inhibition., 29 Days | The University of Texas Health Science Center at San Antonio | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 126 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | CTRC 13-0041|HSC20130426H | 2013-10 | 2016-04 | 2016-04 | 2014-02-13 | 2016-10-26 | Cancer Therapy and Research Center at UTHSCSA, San Antonio, Texas, 78229, United States | |||||
| NCT02037542 | A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer | https://clinicaltrials.gov/study/NCT02037542 | The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study. | NO | Weight | BEHAVIORAL: Diet and exercise | Lifestyle intervention, To examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study., One year | Lipid Profiles, hemoglobin A1C, To assess the impact of such intervention on lipid profiles and hemoglobin A1C. The study group will be compared with a historical control group of patients with early stage breast cancer who are obese or overweight who were not given the intervention and to examine whether an active intervention program will lead into longstanding lifestyle modification in breast cancer patients with a BMI greater or equal to 25., 1 year | Baptist Health South Florida | FEMALE | ADULT, OLDER_ADULT | NA | 100 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | 072013 | 2013-09 | 2016-05 | 2016-05 | 2014-01-16 | 2016-07-21 | South Miami Hospital, Miami, Florida, 33143, United States | |||||
| NCT02028221 | Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk | https://clinicaltrials.gov/study/NCT02028221 | Overweight and obesity are well established risk factors for breast cancer that develop after menopause. The increased postmenopausal breast cancer risk in women who are overweight or obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly used medication in diabetics to stabilize blood sugar. Association studies and laboratory studies have shown its potential to reduce the risk for development of cancer, including breast cancer. Recent pilot clinical studies in breast cancer patients suggest that metformin may only be effective in overweight or obese women with metabolic disturbances. We propose to conduct a clinical study of metformin in overweight or obese premenopausal women with metabolic disturbances. Study participants will be randomly assigned to receive metformin or placebo for 12 months. The study will evaluate whether metformin can result in favorable changes in risk features that have been associated with increased breast cancer risk. The risk features that will be examined in our study include breast density, certain proteins and hormones, products of body metabolism, and body weight and composition. The study should help determine the potential breast cancer preventive activity of metformin in a growing population at risk for multiple diseases. | YES | Breast Cancer Prevention | DRUG: Metformin|DRUG: Placebo | Change in Breast Density at 6 Months, change of dense breast volume at 6 months, baseline, 6 months|Change in Breast Density at 12 Months, Change in dense breast volume at 12 months, Baseline, 12 months | Change From Baseline in Serum Insulin Levels at 6 and 12 Months, baseline, 6 months, 12 months|Change From Baseline in Serum IGF-1 to IGFBP-3 Ratio at 6 and 12 Months, baseline, 6 months, 12 months|Change From Baseline in Serum Testosterone Levels at 6 and 12 Months, baseline, 6 months, 12 months|Change From Baseline in Serum Leptin to Adiponectin Ratio at 6 and 12 Months, baseline, 6 months, 12 months|Change From Baseline in Body Weight at 6 and 12 Months, baseline, 6 months, 12 months|Change From Baseline in Waist Circumference at 6 and 12 Months, baseline, 6 months, 12 months|Change From Baseline in Serum IGF-2 Levels at 6 and 12 Months, baseline, 6 months, 12 months | Change From Baseline in Plasma Metabolomics Profile at 6 and 12 Months, baseline, 6 months, 12 months|Change From Baseline in Metabolomics Profile in Nipple Aspirate Fluid at 6 and 12 Months, baseline, 6 months, 12 months | University of Arizona | National Cancer Institute (NCI) | FEMALE | ADULT | PHASE2 | 151 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION | 1300000596|1R01CA172444-01A1 | 2014-03-07 | 2018-11-30 | 2022-06-14 | 2014-01-07 | 2021-03-12 | 2023-06-27 | University of Arizona, Tucson, Arizona, 85719, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/21/NCT02028221/Prot_SAP_000.pdf | |
| NCT02015078 | Black Family Eating Behaviors Study | https://clinicaltrials.gov/study/NCT02015078 | Despite broad awareness of the role that diet plays in increasing obesity risk, adherence to public health recommendations for maintaining healthy eating is low. Insights gained from weight loss intervention trials find that trial participants report difficulty in restricting calories, dissatisfaction with the pace of weight loss, inability to control eating, low palatability of recommended foods and strong food cravings. Indeed, recent systematic reviews provide empirical support that these subjective experiences that trial participants describe likely represent eating-related traits or phenotypes . While amassing evidence supports individual variation in these eating-related traits, to date there has been no systematic effort to characterize robust eating-related phenotypes. Proposed is a Sub-study initially planned to be piggy-backed on a planned Study being conducted by investigators at the University of North Carolina (UNC– Linnan, Dilworth- Anderson \& Evans). The UNC Parent Study was a feasibility study using community-based participatory research (CBPR) approaches to explore possible intervention strategies aimed to reduce the burden of chronic disease and cancer among African American families. The NHGRI-led eating behavior Sub-study is proposed to be integrated with the UNC Parent Study (hereafter referred to as Phase 1). The additional aims of the Sub-study (hereafter referred to as Phase 2) are to gain understanding of whether we can characterize clusters of eating-related behaviors that may be associated with adherence to weight management and weight outcomes. This current protocol lays out the specific qualitative activities planned for Phase 1 which include conducting structured interviews with Black Family Reunion organizers (N=8) and a sample of reunion participants (N=40). We also describe the larger quantitative survey proposed for Phase 2. Pending the feasibility of the sub-study with the African-American community, we will collect information on eating-related behaviors in a large sample of individuals (N=350). If the initial assessments (Phase1) prove that this is not a viable study to be conducted in that setting, we will consider other population groups and other settings. We are also considering Phase 3 activities if we identify clusters of eating-related phenotypes within individuals. Amended IRB applications will be submitted prior to launching Phase 3. | NO | Cancer|Obesity | Phase 3, To assess whether the occurrence of robust eating- related behavior clusters differ significantly between blood relatives and non-blood relatives (i.e., spouses and unrelated kin)., Completed|Phase 2, To assess whether robust phenotypes of eating-related behaviors (e.g., appetite for palatable foods, disinhibition, pickiness, and new food phobia) can be characterized., Completed|Phase 1, To assess the feasibility of:(a)recruiting African American family reunion-organizers and participants to take part in a health promotion and genetics- related research study. (b)administering survey assessments to assess individual s and kindreds (blood and nonblood relatives ) interest in learning about eating-related (ER) behaviors and weight outcomes., Completed | National Human Genome Research Institute (NHGRI) | Duke University|National Cancer Institute (NCI)|University of North Carolina | ALL | ADULT, OLDER_ADULT | 314 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999914014|14-HG-N014 | 2013-12-14 | 2015-04-15 | 2015-06-22 | 2013-12-19 | 2024-01-16 | University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States | |||||||
| NCT02005510 | Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women | https://clinicaltrials.gov/study/NCT02005510 | The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV) screening kits is effective in increasing uptake of cervical cancer screening and early detection and treatment of cervical neoplasia in underscreened women. | YES | Cervical Cancer | BEHAVIORAL: Mailed in-home high-risk HPV testing kit|OTHER: Usual care | Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse, Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse, Assessed for up to 12 months post-randomization|Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse, Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse, Assessed for up to 18 months post-randomization | Number of Participants That Completed Uptake of Cervical Cancer Screening, Uptake of cervical cancer screening is defined as either: \[1\] receipt of a Pap or co-test; \[2\] self-sample hrHPV-positive (16/18-negative) OR unsatisfactory AND receipt of follow-up diagnostic testing (Pap or co-test or colposcopy); \[3\] self-sample HPV16/18-positive; or \[4\] self-sample hrHPV-negative) Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for cervical cancer screening uptake for the in-home HPV screening arm versus the usual care arm. We will also use log-binomial regression to estimate the effects of EMR-derived patient characteristics (e.g. age, race/ethnicity, geocoded socioeconomic status, geocoded distance form primary care clinic, insurance type, time since last Pap test, tobacco use, obesity, and Charlson comorbidity score) on cervical cancer screening uptake, stratified subdivided by randomization arm., Assessed for up to 6 months post-randomization|Number of Participants With an Abnormal Screening Result, Screening result that warrants repeat testing, surveillance, or immediate colposcopy (per current guidelines) before returning to a routine screening schedule Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for an abnormal screening result for the in-home HPV screening arm versus the usual care arm., Assessed for up to 6 months post-randomization|Experiences and Attitudes Associated With In-home HPV Testing Uptake, Experiences and attitudes will be measured with online surveys. A subset of intervention arm participants who do and do not return the in-home HPV kit will be invited to complete a survey (target n=200). We will examine psychosocial factors (e.g., cervical cancer/HPV knowledge, attitudes toward screening), experiences, and reactions to kits. We will compare responses in women who do versus do not return a mailed HPV kit., Survey invitation mailed 6 months post-randomization|Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results, Intervention arm participants who return in-home HPV kits and test positive for HPV will be invited to complete an in-depth semi-structured interview (target n=50). We will explore patient perspectives following a positive human papillomavirus (HPV) self-sampling result to describe experiences and information needs for this home-based screening modality., Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization | University of Washington | Kaiser Permanente|University of Texas Southwestern Medical Center|National Cancer Institute (NCI)|University of California, Davis | FEMALE | ADULT | NA | 19851 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SCREENING | 44731|R01CA168598 | 2014-02 | 2018-02 | 2018-02 | 2013-12-09 | 2020-09-16 | 2020-09-16 | Kaiser Permanente Washington Health Research Institute, Seattle, Washington, 98101, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/10/NCT02005510/Prot_SAP_000.pdf | ||
| NCT02001051 | Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism | https://clinicaltrials.gov/study/NCT02001051 | Background: – Adrenal tumors are a common kind of tumor. Some of these secrete extra cortisol into the body, which can lead to diabetes, obesity, and other diseases. Some people with extra cortisol will show symptoms like bruising and muscle weakness. Others will show no signs. This is called subclinical hypercortisolism. Some of these adrenal tumors become malignant. Researchers want to know the best way to treat people with subclinical hypercortisolism. They want to know if removing the tumor by surgery reduces the long-term effects of the disease. Objectives: – To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity, osteoporosis, or cholesterol, and cancer detection. Eligibility: – Adults 18 and older with an adrenal tumor and high cortisol levels. Design: * Participants will be screened with medical history, blood tests, and a computed tomography (CT) scan. * Participants will have a baseline visit. They will have blood and urine tests and 7 scans. For most scans, a substance is injected through a tube in the arm. Participants will lie still on a table in a machine that takes images. * Participants will have surgery to remove their tumor. Some will have surgery right away. Some will have surgery 6 months later, after 2 follow-up appointments. * Participants will have 4 follow-up visits in the first year after surgery. They will have 2 visits the second year, then yearly visits for 3 years. At each follow-up visit, they will have scans and blood tests. | YES | Subclinical Hypercortisolism|Cushing Syndrome|Adrenal Neoplasm | PROCEDURE: Adrenalectomy|OTHER: Observation | Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy, Normalization and/or improvement of metabolic complications including hypertension, diabetes, osteoporosis, hypercholesterolemia and/or obesity after adrenalectomy is defined as 35% of patients who improve with surgery versus 5% who do not have surgery., Assessed at 6 months|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0), Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned., Date treatment consent signed to date off study, approximately 39 months and 27 days | Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy, Patients who were tested for and found to have adrenal cancer after adrenalectomy., Assessed at 6 months|Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan, Proportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan., Assessed at 6 months|To Determine the Optimal Diagnostic Test for Subclinical Hypercortisolism, An assessment of whether 1 mg dexamethasone suppression test, basal adrenocorticotropic hormone (ACTH), midnight salivary cortisol, or urinary free cortisol is the optimal test to diagnose patients with subclinical hypercortisolism., Assessed at 6 months|Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy, QOL questionnaires were provided to participants to assess well being pre and post operatively. Participants take a self-administered questionnaire to assess physical and mental health according to Cushing’s Quality of Life Questionnaire. The score has a minimum of 12 and maximum of 60. A higher score indicates an improved quality of life., Assessed at 6 months|Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism, Proportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not., Assessed at 6 months|Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism, A skin biopsy and skin ultrasound were done to measure the dermal layer of skin to look for a decrease in the thickness of skin as compared to normal values reported in the literature as measured in millimeters of thickness. Diagnostic sensitivity and changes in skin thickness were assessed., Assessed at 6 months | National Cancer Institute (NCI) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Clinical Center Office of the Associates Director for Radiologic&Imaging Sciences | ALL | ADULT, OLDER_ADULT | PHASE2 | 4 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 140021|14-C-0021 | 2013-11-27 | 2017-08-22 | 2018-02-26 | 2013-12-04 | 2018-05-08 | 2018-06-14 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | Study Protocol, Statistical Analysis Plan, and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/51/NCT02001051/Prot_SAP_ICF_000.pdf | ||
| NCT01975363 | Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer | https://clinicaltrials.gov/study/NCT01975363 | This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer. | NO | Atypical Ductal Breast Hyperplasia|BRCA1 Gene Mutation|BRCA2 Gene Mutation|Ductal Breast Carcinoma in Situ|Lobular Breast Carcinoma in Situ | DIETARY_SUPPLEMENT: curcumin|OTHER: Biomarker analysis|OTHER: Assessment of Dietary Intake|OTHER: Daily Log | Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer., Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests., Up to 3 months | Evaluate possible correlations between physical factors such as body mass (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue., up to 3 months | Ohio State University Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 29 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | OSU-13034|NCI-2013-01199 | 2013-06 | 2016-09-19 | 2016-09-19 | 2013-11-03 | 2019-08-30 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, 43210, United States | |||||
| NCT01953224 | STEP AND GO: A Study of Technology-based Exercise Promotion | https://clinicaltrials.gov/study/NCT01953224 | The purpose of the study is to test an intervention that uses a mobile game to encourage increased physical activity among adults. | YES | Cardiovascular Disease|Obesity|Cancer|Diabetes | BEHAVIORAL: Game-based intervention|DEVICE: Smartphone | Change in Physical Activity From Baseline to 12 Weeks, Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup., Baseline to 12 weeks | Change in Physical Fitness From Baseline to 12 Weeks, Maximal treadmill test to measure fitness (operationalized as the amount of oxygen used by the body during maximal effort). Baseline values were carried forward for participants lost to followup., Baseline to 12 weeks|Change in Body Fat Percentage From Baseline to 12 Weeks, We will use dual x-ray absorptiometry to measure body fat percentage. Baseline values were carried forward for participants lost to followup., Baseline to 12 weeks|Change in Blood Pressure From Baseline to 12 Weeks, Systolic and diastolic blood pressure will be measured using standard methods. Baseline values were carried forward for participants lost to followup., Baseline to 12 weeks|Change in Weight From Baseline to 12 Weeks, We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup., Baseline to 12 weeks|Change in Motivation From Baseline to 12 Weeks, We will measure intrinsic motivation using the intrinsic regulation subscale from the Behavioral Regulation in Exercise Questionnaire-2. This measure uses a scale from 0 (not true for me) to 4 (very true for me). Positive changes indicate increases in intrinsic motivation over time. Baseline values were carried forward for participants lost to followup., Baseline to 12 weeks | Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks, We will investigate the number of participants who drop out of the intervention group in comparison to the control group and to norms for similar studies, 12 weeks|Acceptability, Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability, 12 weeks|Frequency of App Use Over 12 Weeks, Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app, 12 weeks|Number of Counseling Calls Completed From Baseline to 12 Weeks, Based on counselor logs, we will determine the number of counseling phone calls completed for each participant, 12 weeks|Number of Participants With Adverse Events, We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed., 12 weeks | The University of Texas Medical Branch, Galveston | American Heart Association | ALL | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 13-0285 | 2014-09 | 2016-11 | 2016-11 | 2013-09-30 | 2018-08-01 | 2018-08-01 | The University of Texas Medical Branch, Galveston, Texas, 77555, United States | ||
| NCT01927432 | Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea | https://clinicaltrials.gov/study/NCT01927432 | In women with regular menstrual cycles, antral follicles have been shown to grow in synchronous cohorts, called waves, 2-3 times in a menstrual cycle. It is unknown whether these waves of follicle growth also occur in women with amenorrhea or if there is abnormal/absent follicle growth. Further, oligo- or amenorrhea has been associated with metabolic disturbances, such as over- or under-nutrition, central obesity and insulin resistance. Yet, mechanisms whereby metabolic factors influence folliculogenesis in women are poorly understood. To understand potential mechanisms, the investigators plan to characterize follicle growth dynamics in women with or without regular menstrual cycles and identifying key metabolic differences in these women which may be important in normal follicle development and fertility. | NO | Oligomenorrhea|Amenorrhea|Polycystic Ovary Syndrome (PCOS) | Follicle number, The number of all antral follicles in each ovary will be determined using ultrasonography for each participant. Changes in follicle number over time will be compared between groups., 4-5 weeks|Follicle diameter, The diameter of all follicles \>2mm will be determined using ultrasonography for each participant. Changes in follicle diameter over time will be compared between groups., 4-5 weeks | Ovarian Volume, The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups., 4-5 weeks|Anti-Müllerian hormone, The serum AMH concentration will be determined during study participation and assessed in association with the change in follicle number, diameter and between groups., 4-5 weeks|Serum FSH concentration, The serum FSH concentration will be determined during study participation and assessed in association with the change in follicle number, diameter and between groups., 4-5 weeks|Serum LH concentration, The serum FSH concentration will be determined during study participation and assessed in association with the change in follicle number, diameter and between groups., 4-5 weeks|Serum progesterone concentration, The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups., 4-5 weeks|LH-FSH ratio, The ratio of circulating LH to FSH concentrations will be determined for each participant and compared between groups., 4-5 weeks|Insulin sensitivity, Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups., 1 day|Androgen concentrations, Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared between groups., 1 day|Menstrual Cycle Length, Average menstrual cycle length as determined by self-reported history and the menstrual cycle length during study participation will be determined and compared between groups., 4-5 weeks|Hirsutism, Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared between groups., 1 day|Serum markers of metabolic syndrome, Lipids, glucose and HbA1C concentrations will be determined and compared between groups., 1 day|Blood Pressure, Blood pressure will be determined and compared between groups., 1 day|Body mass index, The ratio of weight to height will be determined and compared between groups., 1 day|Waist-to-hip ratio, The ratio of waist circumference to hip circumference will be determined and compared between groups., 1 day|Body fat distribution, Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups., 1 day|Subcutaneous fat biopsy (optional), Fat cells, representing an important site of reproductive hormone production, will be compared between groups., 1 day | Cornell University | FEMALE | ADULT | 73 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IRB #: 0908000633 | 2011-09 | 2021-09 | 2021-09 | 2013-08-22 | 2024-02-09 | Human Metabolic Research Unit, Cornell University, Ithaca, New York, 14853, United States | |||||||
| NCT01922778 | Screening for Endometrial Abnormalities in Overweight and Obese Women | https://clinicaltrials.gov/study/NCT01922778 | The purpose of this study is to develop an endometrial biopsy screening program for endometrial cancer and its precursor lesions in overweight and obese women. There is a BMI threshold at and above which optimal screening parameters exist for identifying endometrial cancer and its precursor lesions in overweight and/or obese women. Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in overweight and/or obese women offers substantial health benefits. | NO | Endometrial Cancer | PROCEDURE: Endometrial Biopsy | A BMI cut-point will be identified at and above which an endometrial biopsy yields optimal sensitivity, specificity, positive predictive value, and negative predictive value to screen for endometrial cancer and abnormal pathologies, up to 1 year | St. Luke’s-Roosevelt Hospital Center | FEMALE | ADULT, OLDER_ADULT | NA | 303 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 13-0105 | 2013-09 | 2016-03-31 | 2016-03-31 | 2013-08-14 | 2017-07-21 | Mount Sinai Roosevelt, New York, New York, 10019, United States | ||||||
| NCT01911247 | Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer | https://clinicaltrials.gov/study/NCT01911247 | The overall goal of this proposal is to investigate the potential benefit of metformin as a novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect of short-term metformin treatment on the endometrium of obese women with endometrial cancer by comparing each patient’s endometrial biopsy before treatment with metformin to their post-treatment hysterectomy specimen. Participants: Obese women who are to undergo surgical staging for endometrial cancer will also receive short-term treatment (1-4 weeks) with metformin that will continue until the day prior to surgical staging. The effect of metformin on proliferation, apoptosis and downstream signaling pathways will be compared between pre-treatment endometrial biopsies and post-treatment hysterectomy specimens. Tissue microarrays will be constructed and immunohistochemstry performed to evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by metformin, and these findings will be correlated with our in vitro preclinical studies. Fresh tissue will also be obtained, and Western immunoblotting will be used to assess expression of the phosphorylated forms of the downstream targets of metformin. The hypothesis is that treatment with metformin will result in a decrease in proliferative markers and an increase in markers of apoptosis in the endometrial cancer tumors. AMPK phosphorylation and inhibition of critical downstream targets of the mTOR pathway will be seen in the post-treatment hysterectomy specimens. Metabolomic profiling will also be performed of tumors and associated biofluids (i.e. serum and urine) before and after treatment with metformin to identify potential biomarkers of response to this therapy. | NO | Endometrial Cancer | DRUG: Metformin | Change in Ki-67 mean levels between pre-metformin treatment endometrial biopsies and post-metformin treatment hysterectomy specimens, The primary null hypothesis of interest, that there is no difference between the pre- and post-treatment Ki-67 mean levels will be evaluated using a paired t-test (two-sided, α\<0.05 level). Paired t-tests will also be used to compare pre- and post-treatment measures of secondary endpoints. General linear models will be used to explore the relationship between pre-treatment characteristics (e.g., ER, PR, tumor grade) and change in Ki-67, Ki-max and Ki-min., 4 weeks | UNC Lineberger Comprehensive Cancer Center | National Institutes of Health (NIH)|National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 28 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | LCCC1102|1K23CA143154-01A1 | 2011-05 | 2013-02 | 2013-02 | 2013-07-30 | 2013-07-30 | Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States | |||||
| NCT01899001 | Mood and Nutrition Interventions in Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT01899001 | MANI-PCOS | The purpose of this study is to help determine the best treatment plan for women with PCOS who are overweight or obese and experiencing significant symptoms of depression and anxiety. Specifically, the investigators are attempting to see if there is a difference between cognitive behavioral therapy in combination with nutritional counseling in improving mood symptoms, response to stress, and risk factors for heart disease compared to nutrition counseling alone. The investigators hypothesize that combined treatment with Cognitive Behavioral Therapy (CBT) and nutritional counseling will be more beneficial. | NO | Polycystic Ovary Syndrome (PCOS) | BEHAVIORAL: Cognitive Behavioral Therapy|BEHAVIORAL: Nutrition Counseling | Assess change in mood symptoms after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone., Changes in mood symptoms will be assessed using the CES-D, STAI, HRQOL, Baseline, Week 8, Week 16 | Assess change in cardio metabolic risk factors after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone., Changes in cardio metabolic risk factors will be assessed using clinical parameters (blood pressure, waist circumference, BMI) and serum parameters (lipid profile, fasting glucose, insulin, total testosterone, free testosterone, sex hormone binding globulin, Apo A1, Apo B, hsCRP, IL-6), Baseline, Week 8, Week 16|Assess change in perceived stress and stress response after Cognitive Behavioral Therapy (CBT) and nutritional/exercise counseling compared to nutritional/exercise counseling alone., Changes in perceived stress and stress response will be assessed using the PSS and cortisol response to the Trier Social Stress Test (TSST), Baseline, Week 8 | University of Pennsylvania | FEMALE | ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 818103 | 2013-07 | 2016-08 | 2013-07-15 | 2016-11-23 | Penn PCOS Center, Philadelphia, Pennsylvania, 19104, United States | |||||
| NCT01896050 | Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer | https://clinicaltrials.gov/study/NCT01896050 | LOGRIBMET | Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled. | YES | Breast Cancer|Arthralgia|Obesity | DRUG: anastrozole, letrozole, exemestane|DRUG: Tamoxifen | Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy, Change in BMI between baseline and 12 months of endocrine therapy, baseline and 12 months | Effect of Medication on Change in Grip Strength, Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months, baseline and 12 months|Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months, Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment, baseline and 12 months | University of Michigan Rogel Cancer Center | FEMALE | ADULT, OLDER_ADULT | 115 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | UMCC 2009.029 | 2009-09 | 2014-08 | 2014-08 | 2013-07-11 | 2016-05-12 | 2016-06-28 | University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States | ||||
| NCT01886677 | Improving Energy Balance in Men With Prostate Cancer | https://clinicaltrials.gov/study/NCT01886677 | RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression. PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer. | NO | Prostate Cancer | BEHAVIORAL: Immediate diet and exercise intervention|BEHAVIORAL: Delayed diet and exercise intervention | Tumor Proliferation Rate (Ki-67), Changes in tumor proliferation rate (Ki-67) over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms., Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks) | Changes in body weight and composition, energy intake and physical activity, Changes in body composition, energy intake and physical activity over the presurgical study period (minimum of 3.5 weeks, up to 24 weeks) will be explored and compared between the intervention and wait-list control arms., Participants will be followed until their prostatectomy (minimum of 3.5 weeks, up to 24 weeks) | University of Alabama at Birmingham | National Cancer Institute (NCI) | MALE | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | R21CA161263-01A1 | 2012-09 | 2014-12 | 2015-01 | 2013-06-26 | 2017-03-03 | University of Alabama at Birmingham (UAB), Birmingham, Alabama, 35294, United States | ||||
| NCT01877564 | A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women | https://clinicaltrials.gov/study/NCT01877564 | The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients. | YES | Adenocarcinoma of the Endometrium | DRUG: Metformin | IHC-based Tissue Markers of Proliferation, 1 year | University of Arkansas | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 10 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 138647 | 2013-08-29 | 2016-08-10 | 2017-07-10 | 2013-06-13 | 2017-10-25 | 2017-10-25 | University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/64/NCT01877564/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/64/NCT01877564/SAP_001.pdf | ||||
| NCT01871116 | POWER-remote Weight Loss Program in Early Stage Breast Cancer | https://clinicaltrials.gov/study/NCT01871116 | This research is being done to assess the effectiveness of a weight loss program in women with early stage breast cancer whose body mass index (BMI) is in the overweight or obese range (\>25). Weight loss is beneficial in improving cardiovascular risk factors and overall health, but may also decrease the chance of breast cancer coming back. A weight loss counseling program was studied in a general population and was found to be effective to help reduce weight over a 2 year period. The main goal of this study is to determine if women with a recent diagnosis of early breast cancer will also lose weight with this program. To better understand the effect that weight loss has on women with breast cancer, we will compare the patterns in blood and breast tissue samples (tissue biopsies will be optional), and questionnaires evaluating different aspects of one’s well-being, before and after a dietary intervention or no intervention. | NO | Early Stage Breast Cancer | BEHAVIORAL: POWER-remote|BEHAVIORAL: Self-directed | Change in body weight, To compare the proportion of women with early stage breast cancer, who have completed all local therapy and adjuvant chemotherapy, who lose ≥5% of their baseline body weight after 6 and 12 months between a control arm (self-directed weight loss) and an experimental arm (POWER-remote), After 12 months | Change in biomarkers, To evaluate the effects of weight loss and POWER-remote on serum biomarkers (including fasting glucose, fasting lipids, fasting insulin, insulin like growth factor (IGF), high-sensitivity C-reactive protein (hsCRP), interleukin 1 and 6 (IL-1 and IL-6), tumor necrosis factor- alpha (TNF-α), leptin, adiponectin, and estradiol) at baseline and 6 months, After 12 months|Change in PROs (Patient Reported Outcomes), To evaluate the effects of weight loss and POWER-remote on PROs, with a specific interest in comparing the change in Physical Function at 6 months from baseline as a function of weight los, After 12 months | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Breast Cancer Research Foundation | FEMALE | ADULT, OLDER_ADULT | NA | 96 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | J12128|J12128 | 2013-07 | 2016-12 | 2016-12 | 2013-06-06 | 2018-02-05 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21287-0013, United States | ||||
| NCT01870947 | Assisted Exercise in Obese Endometrial Cancer Patients | https://clinicaltrials.gov/study/NCT01870947 | This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain’s responses to different visual images will also be assessed. | NO | Stage I Endometrial Adenocarcinoma|Uterine Cancer|Obesity | BEHAVIORAL: Exercise on stationary recumbent exercise cycle|BEHAVIORAL: Health Education|BEHAVIORAL: Questionnaires|PROCEDURE: Neuroimaging|PROCEDURE: Genetic and Biomarkers | Weight change from pre- to post-intervention, 24 weeks after exercise intervention (EOT) | Change in Body Composition from baseline, Body fat, lean mass and bone mass will be measured with a Lunar iDXA™ (GE Healthcare, Madison, WI. BMI will be computed (weight in kg divided by square of height in meters) and categorized as: \< 18.5 (underweight), 18.5 to 24.9 (normal weight), 25.0 to 29.9 (overweight), at 4 weeks after exercise intervention(EOT)|Change in Motivation to Exercise from baseline, Evaluate motivation to exercise using the Exercise Motivations Inventory (EMI-2) 122 and the Intrinsic Motivational Inventory (IMI) modified for exercise. Past physical activity habits will be assessed with the Godin Leisure-Time Exercise (LSI) questionnaire., 24 weeks after exercise intervention (EOT)|Change in Eating Behavior from baseline, Eating behavior will be assessed using the Three-Factor Eating Questionnaire (TFEQ). The TFEQ includes 51 items and addresses three dimensions of human eating behavior; restraint, disinhibition, and perceived hunger., 24 weeks after exercise intervention (EOT)|Change in Quality of Life (QoL)from baseline, The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item core questionnaire evaluating various domains of QoL including, physical, functional, family-social, and emotional well-being. The FACT-En is a 16-item subscale specific for endometrial cancer (EC) and assesses hormone withdrawal, pelvic symptoms, and possible adjuvant therapy side effects. Short-form Medical Outcomes (SF-36) consists of 36 questions scored on a Likert scale, producing overall physical and mental component summary measures., 24 weeks after exercise intervention (EOT)|Change in Depression from baseline, The Beck Depression Inventory (BDI) is a 21-item, Likert-scaled instrument of depressive symptoms that is well-validated and frequently used in lifestyle research studies. Each item is rated on a 4- point scale ranging from 0 to 3 (higher scores are associated with greater symptoms)., 24 weeks after exercise intervention (EOT)|Exercise Session Adherence, Barriers to adhering to the exercise protocol will be assessed prospectively using an elicitation procedure similar to that suggested in the theory of planned behavior, whereby an open-ended question is asked to solicit the barrier without any preconceived notion of what the barrier might be. Specifically, participants in the exercise groups will be asked to book their weekly supervised exercise sessions with the Exercise Specialist/Physiologist. Participants cancelling an exercise session or requesting to be removed from the study will be asked why they are no longer interested in completed the program., 24 weeks after exercise intervention (EOT) | Case Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 95 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | CASE5811 | 2011-09-07 | 2019-09-04 | 2019-09-04 | 2013-06-06 | 2020-01-27 | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106, United States|The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States | |||||
| NCT01869348 | IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial | https://clinicaltrials.gov/study/NCT01869348 | IMPACT | As individuals age, their physical activity decreases and sedentary time increases. Even small changes in these two behaviors can greatly decrease risks for several major health problems, including cardiovascular disease, diabetes, and many cancers. Studies that use pedometers to encourage walking have successfully increased physical activity, but do not address sedentary behaviors such as television watching. The investigators propose to use a novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and decreased sedentary time. First, the investigators will recruit 10 adults to participate in a brief intervention for six weeks. They will wear the wrist-based activity monitor and use a mini-tablet device to see feedback on their activity and sedentary time. They will also receive brief counseling weekly. The investigators will use this first study to investigate the basic feasibility of the intervention materials. Next, the investigators will recruit 20 adults and randomize them to receive the intervention for 12 weeks or to a waiting list. Here, the investigators will test the intervention with refinements made based on participant responses from the first small study. Our primary outcomes will be measures of feasibility and acceptability across all parts of the study. The investigators hypothesize that the intervention will be feasible and acceptable to the participants. The investigators will also measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings of motivation. | YES | Obesity|Cardiovascular Disease|Cancer|Diabetes|Sarcopenia | BEHAVIORAL: Monitor intervention | Change in Physical Activity From Baseline to 12 Weeks, Minutes of physical activity measured over a seven day period, 12 weeks | Change in Sedentary Behavior From Baseline to 12 Weeks, Minutes of total sedentary time measured over a seven day period, 12 weeks|Change in Autonomous Motivation From Baseline to 12 Weeks, We will measure feelings of autonomous and controlled motivation/regulation for physical activity, 12 weeks|Change in Physical Fitness From Baseline to 12 Weeks, We will use the six minute walk test to measure physical fitness, 12 weeks|Change in Body Composition From Baseline to 12 Weeks, We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass, 12 weeks|Change in Physical Function From Baseline to 12 Weeks, Functional measurements will be made using the Senior Fitness Test, 12 weeks|Change in Weight From Baseline to 12 Weeks, We will measure weight (and height at baseline) using a calibrated scale, 12 weeks | Feasibility, We will use many different measures of feasibility, including adherence to study protocol, attrition, barriers to adherence, exposure/dose of intervention received, and any adverse events that occur, 12 weeks|Acceptability, Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability, 12 weeks | The University of Texas Medical Branch, Galveston | ALL | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | 13-071 | 2014-06 | 2016-04-15 | 2016-04-15 | 2013-06-05 | 2017-10-04 | 2017-10-04 | The University of Texas Medical Branch, Galveston, Texas, 77550, United States | ||
| NCT01859663 | Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT01859663 | The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS. | NO | Polycystic Ovary Syndrome|Dietary Habits|Physical Activity | Differences in diet between women with and without PCOS, A food frequency questionnaire will be administered to assess diet composition for the last three months., 1 week | Differences in exercise between women with and without PCOS, An accelerometer will be administered to assess physical activity for 1 week., 1 week|Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS, A questionnaire will be administered to assess psychosocial factors of women with PCOS., 1-2 weeks|Differences in sleep patterns between women with and without PCOS, A wrist-worn accelerometer will be administered to assess sleep patterns for 6 consecutive nights., 6 consecutive nights|LH-FSH ratio, The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups, 1 day|Hirsutism Score, Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups, 1 day|Androgen concentrations, Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups., 1 day|Menstrual Cycle Length, Average menstrual cycle length as determined by self-reported history will be determined and compared across groups, 1 day|Body Mass Index, The ratio of weight to height will be determined and compared across groups., 1 day|Waist-to-Hip Ratio, The ratio of waist circumference to hip circumference will be determined and compared across groups, 1 day|Ovarian Volume, The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups., 1 day|Insulin Sensitivity, Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups., 1 day|Serum progesterone concentration, The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups., 1 day|Blood pressure, Blood pressure will be determined and compared between groups., 1 day|Serum markers of metabolic syndrome, Lipids, glucose and HbA1C concentrations will be determined and compared between groups., 1 day|Body fat distribution, Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups., 1 day|Subcutaneous fat biopsy (optional), Subcutaneous fat cells, which represent important sites of reproductive hormone synthesis, will be assessed and compared across groups, 1 day | Cornell University | University of Rochester | FEMALE | ADULT | 126 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IRB 1303003665 | 2013-05 | 2022-05 | 2022-05 | 2013-05-22 | 2024-02-09 | Human Metabolic Research Unit, Cornell University, Ithaca, New York, 14853, United States|Strong Fertility Center, Rochester, New York, 14623, United States|CRC at University of Rochester Medical Center, Rochester, New York, 14642, United States | ||||||
| NCT01840618 | Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents | https://clinicaltrials.gov/study/NCT01840618 | Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent girls and women capable of having children. Polycystic ovary syndrome is associated with missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes. Girls with polycystic ovary syndrome may have a breathing problem known as “sleep apnea.” Sleep apnea may cause a person to stop breathing for short periods of time while sleeping. People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The purpose of this study is to understand how insulin function is affected in presence of sleep apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls with PCOS without sleep apnea. Insulin is one of the hormones made in your body to convert food into energy. In people with increase weight body cannot use insulin properly. The investigators also want to see if insulin action is also affected by sleep apnea. | NO | Obstructive Sleep Apnea Syndrome|Polycystic Ovary Syndrome|Sleep Apnea | DEVICE: Nasal Continuous positive airway pressure (CPAP) | The purpose of this study is to understand how insulin function is affected and how endothelial function as a surrogate marker for cardiovascular risk is affected in presence of sleep apnea as compared to girls (13-21 yrs) with PCOS without sleep apnea, Obese adolescents with PCOS will be assessed for presence or absence of Obstructive Sleep Apnea (OSA) at baseline. Obese PCOS with OSA will be compared with obese PCOS with out OSA for difference in Glucose Infusion Rate (GIR) as a measure of insulin resistance and for Reactive Hyperemia Peripheral Arterial Tonometry (RHPAT) score, baseline to two years | We also want to see if there is any change in the levels of adipocytokines (Leptin, adiponectin, C Reactive Protein (CRP), Tumor Necrosis Factor (TNF) alpha, Free fatty acids) because of sleep apnea in obese PCOS adolescents., Obese adolescents with PCOS will be assessed for presence or absence of Obstructive Sleep Apnea (OSA) at baseline. Obese PCOS with OSA will be compared with obese PCOS with out OSA for increase in the levels of leptin, CRP, TNF alpha, free fatty acids and the reduction in the levels of adiponectin compared to Non OSA adolescents with PCOS., baseline to two years | The purpose of this study is to to determine the role that PCOS plays in insulin resistance in non-obese adolescents by comparing insulin resistance in adolescent girls ages 13-21 with lean PCOS to normal weight adolescents ages 18-21 without PCOS., Insulin sensitivity will be compared in adolescents with non-obese PCOS (BMI ≤85%) to non-obese adolescents (BMI ≤85%) without PCOS, baseline to two years | Albert Einstein College of Medicine | FEMALE | CHILD, ADULT | 50 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 11-09-336E | 2012-02 | 2015-06 | 2015-06 | 2013-04-26 | 2019-08-28 | Children’s Hospital at Montefiore, Bronx, New York, 10467, United States | |||||
| NCT01837147 | Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study) | https://clinicaltrials.gov/study/NCT01837147 | Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body’s movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity. | NO | Breast Cancer | BEHAVIORAL: Technology-Based Physical Activity Promotion|BEHAVIORAL: Pedometer Intervention | Change in objectively-measured physical activity, Assessed using ActiGraph., Baseline to 16 weeks | Self-reported physical activity, Assessed using questionnaires., Baseline to 16 weeks|Body weight (kg), Measured in clinic., Baseline to 16 weeks|Uptake of technology-based intervention components, To be assessed via data downloaded from the website used in this study., During 16-week intervention|Quality of life, To be assessed via self-report questionnaire., Baseline to 16 weeks | University of California, San Diego | FEMALE | ADULT, OLDER_ADULT | NA | 51 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 1R03CA168450-01 | 2013-04 | 2014-10 | 2014-10 | 2013-04-23 | 2020-02-07 | Moores UCSD Cancer Center, La Jolla, California, 92093, United States | |||||
| NCT01828554 | Capecitabine Pharmacokinetics(PK)-Actual Versus Ideal Body Weight | https://clinicaltrials.gov/study/NCT01828554 | The purpose of this research study is to find what happens to capecitabine in the body when dosed using actual versus ideal body weight in subjects with advanced tumors and elevated body mass index. | YES | Obesity|Neoplasms | DRUG: Xeloda | Area Under the Curve (AUC) on Cycle 1 Day 1 and Cycle 1 Day 9, AUC will be calculated for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). \[nonlinear mixed effects modeling approach\], Up to 15 days|Cmax During Cycle 1, Cmax will be reported for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). \[nonlinear mixed effects modeling approach\], Up to 15 days | Response Rate, Responses will be determined using RECIST v. 1.1 criteria and summarized in tabular format. The complete and partial response rates will be calculated and reported along with the corresponding 95% confidence intervals., Up to 6 months|Progression Free Survival, Progression-free survival will be analyzed using the Kaplan-Meier method., Up to 6 months | University of Wisconsin, Madison | ALL | ADULT, OLDER_ADULT | NA | 8 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | OS12903|NCI-2013-01267|2013-0280|A534260|SMPH\MEDICINE\HEM-ONC | 2013-06 | 2018-04 | 2018-04 | 2013-04-10 | 2019-08-06 | 2019-11-25 | University of Wisconsin-Carbone Cancer Center, Madison, Wisconsin, 53792, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/54/NCT01828554/Prot_SAP_000.pdf | |||
| NCT01793948 | Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer | https://clinicaltrials.gov/study/NCT01793948 | This randomized clinical trial studies metformin hydrochloride in overweight or obese patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the expression of early tumor makers in breast tissue of patients at increased risk for breast cancer | NO | Breast Cancer|Obesity | DRUG: metformin hydrochloride|OTHER: placebo|OTHER: laboratory biomarker analysis | Changes in the phosphorylation of proteins after metformin exposure, Reverse phase proteomic assays (RPPA) will be performed to measure changes in the phosphorylation of proteins after metformin exposure. Changes in the phosphorylation of proteins after metformin exposure will be calculated and compared using two-sample t-tests. As a supplemental analysis, analysis of covariance (ANCOVA) will be used to model the 12 month levels adjusted for baseline. Assumptions for analysis will be checked and non-parametric methods used if needed; however it is expected that the data will be normally distributed on the log scale., Baseline and 12 months | Changes in ordinal level of breast density, Changes in ordinal level of breast density will be performed using the breast density criteria previously established by Boyd and colleagues (New England Journal of Medicine 2007). Each image will be grouped into one of six categories: 0%, \<10%, 10-25%, 25-50%, 50-75% and \>75%. Changes will be compared between the two groups using Wilcoxon Rank-Sum tests., Baseline and 12 months|Proportion of patients experiencing adverse events assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Will be tabulated by arm and grade., Up to 30 days | Anna Maria Storniolo | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 24 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: PREVENTION | IUCRO-0365|NCI-2013-00422|1301010355 | 2013-04-16 | 2018-01-09 | 2018-01-09 | 2013-02-18 | 2018-03-30 | Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States | ||||
| NCT01793168 | Rare Disease Patient Registry & Natural History Study – Coordination of Rare Diseases at Sanford | https://clinicaltrials.gov/study/NCT01793168 | CoRDS | CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll. | NO | Rare Disorders|Undiagnosed Disorders|Disorders of Unknown Prevalence|Cornelia De Lange Syndrome|Prenatal Benign Hypophosphatasia|Perinatal Lethal Hypophosphatasia|Odontohypophosphatasia|Adult Hypophosphatasia|Childhood-onset Hypophosphatasia|Infantile Hypophosphatasia|Hypophosphatasia|Kabuki Syndrome|Bohring-Opitz Syndrome|Narcolepsy Without Cataplexy|Narcolepsy-cataplexy|Hypersomnolence Disorder|Idiopathic Hypersomnia Without Long Sleep Time|Idiopathic Hypersomnia With Long Sleep Time|Idiopathic Hypersomnia|Kleine-Levin Syndrome|Kawasaki Disease|Leiomyosarcoma|Leiomyosarcoma of the Corpus Uteri|Leiomyosarcoma of the Cervix Uteri|Leiomyosarcoma of Small Intestine|Acquired Myasthenia Gravis|Addison Disease|Hyperacusis (Hyperacousis)|Juvenile Myasthenia Gravis|Transient Neonatal Myasthenia Gravis|Williams Syndrome|Lyme Disease|Myasthenia Gravis|Marinesco Sjogren Syndrome(Marinesco-Sjogren Syndrome)|Isolated Klippel-Feil Syndrome|Frasier Syndrome|Denys-Drash Syndrome|Beckwith-Wiedemann Syndrome|Emanuel Syndrome|Isolated Aniridia|Axenfeld-Rieger Syndrome|Aniridia-intellectual Disability Syndrome|Aniridia – Renal Agenesis – Psychomotor Retardation|Aniridia – Ptosis – Intellectual Disability – Familial Obesity|Aniridia – Cerebellar Ataxia – Intellectual Disability|Aniridia – Absent Patella|Aniridia|Peters Anomaly – Cataract|Peters Anomaly|Potocki-Shaffer Syndrome|Silver-Russell Syndrome Due to Maternal Uniparental Disomy of Chromosome 11|Silver-Russell Syndrome Due to Imprinting Defect of 11p15|Silver-Russell Syndrome Due to 11p15 Microduplication|Syndromic Aniridia|WAGR Syndrome|Wolf-Hirschhorn Syndrome|4p16.3 Microduplication Syndrome|4p Deletion Syndrome, Non-Wolf-Hirschhorn Syndrome|Autosomal Recessive Stickler Syndrome|Stickler Syndrome Type 2|Stickler Syndrome Type 1|Stickler Syndrome|Mucolipidosis Type 4|X-linked Spinocerebellar Ataxia Type 4|X-linked Spinocerebellar Ataxia Type 3|X-linked Intellectual Disability – Ataxia – Apraxia|X-linked Progressive Cerebellar Ataxia|X-linked Non Progressive Cerebellar Ataxia|X-linked Cerebellar Ataxia|Vitamin B12 Deficiency Ataxia|Toxic Exposure Ataxia|Unclassified Autosomal Dominant Spinocerebellar Ataxia|Thyroid Antibody Ataxia|Sporadic Adult-onset Ataxia of Unknown Etiology|Spinocerebellar Ataxia With Oculomotor Anomaly|Spinocerebellar Ataxia With Epilepsy|Spinocerebellar Ataxia With Axonal Neuropathy Type 2|Spinocerebellar Ataxia Type 8|Spinocerebellar Ataxia Type 7|Spinocerebellar Ataxia Type 6|Spinocerebellar Ataxia Type 5|Spinocerebellar Ataxia Type 4|Spinocerebellar Ataxia Type 37|Spinocerebellar Ataxia Type 36|Spinocerebellar Ataxia Type 35|Spinocerebellar Ataxia Type 34|Spinocerebellar Ataxia Type 32|Spinocerebellar Ataxia Type 31|Spinocerebellar Ataxia Type 30|Spinocerebellar Ataxia Type 3|Spinocerebellar Ataxia Type 29|Spinocerebellar Ataxia Type 28|Spinocerebellar Ataxia Type 27|Spinocerebellar Ataxia Type 26|Spinocerebellar Ataxia Type 25|Spinocerebellar Ataxia Type 23|Spinocerebellar Ataxia Type 22|Spinocerebellar Ataxia Type 21|Spinocerebellar Ataxia Type 20|Spinocerebellar Ataxia Type 2|Spinocerebellar Ataxia Type 19/22|Spinocerebellar Ataxia Type 18|Spinocerebellar Ataxia Type 17|Spinocerebellar Ataxia Type 16|Spinocerebellar Ataxia Type 15/16|Spinocerebellar Ataxia Type 14|Spinocerebellar Ataxia Type 13|Spinocerebellar Ataxia Type 12|Spinocerebellar Ataxia Type 11|Spinocerebellar Ataxia Type 10|Spinocerebellar Ataxia Type 1 With Axonal Neuropathy|Spinocerebellar Ataxia Type 1|Spinocerebellar Ataxia – Unknown|Spinocerebellar Ataxia – Dysmorphism|Non Progressive Epilepsy and/or Ataxia With Myoclonus as a Major Feature|Spasticity-ataxia-gait Anomalies Syndrome|Spastic Ataxia With Congenital Miosis|Spastic Ataxia – Corneal Dystrophy|Spastic Ataxia|Rare Hereditary Ataxia|Rare Ataxia|Recessive Mitochondrial Ataxia Syndrome|Progressive Epilepsy and/or Ataxia With Myoclonus as a Major Feature|Posterior Column Ataxia – Retinitis Pigmentosa|Post-Stroke Ataxia|Post-Head Injury Ataxia|Post Vaccination Ataxia|Polyneuropathy – Hearing Loss – Ataxia – Retinitis Pigmentosa – Cataract|Muscular Atrophy – Ataxia – Retinitis Pigmentosa – Diabetes Mellitus|Non-hereditary Degenerative Ataxia|Paroxysmal Dystonic Choreathetosis With Episodic Ataxia and Spasticity|Olivopontocerebellar Atrophy – Deafness|NARP Syndrome|Myoclonus – Cerebellar Ataxia – Deafness|Multiple System Atrophy, Parkinsonian Type|Multiple System Atrophy, Cerebellar Type|Multiple System Atrophy|Maternally-inherited Leigh Syndrome|Machado-Joseph Disease Type 3|Machado-Joseph Disease Type 2|Machado-Joseph Disease Type 1|Leigh Syndrome|Late-onset Ataxia With Dementia|Infection or Post Infection Ataxia|GAD Ataxia|Hereditary Episodic Ataxia|Gliadin/Gluten Ataxia|Friedreich Ataxia|Fragile X-associated Tremor/Ataxia Syndrome|Familial Paroxysmal Ataxia|Exposure to Medications Ataxia|Episodic Ataxia With Slurred Speech|Episodic Ataxia Unknown Type|Episodic Ataxia Type 7|Episodic Ataxia Type 6|Episodic Ataxia Type 5|Episodic Ataxia Type 4|Episodic Ataxia Type 3|Episodic Ataxia Type 1|Epilepsy and/or Ataxia With Myoclonus as Major Feature|Early-onset Spastic Ataxia-neuropathy Syndrome|Early-onset Progressive Neurodegeneration – Blindness – Ataxia – Spasticity|Early-onset Cerebellar Ataxia With Retained Tendon Reflexes|Early-onset Ataxia With Dementia|Childhood-onset Autosomal Recessive Slowly Progressive Spinocerebellar Ataxia|Dilated Cardiomyopathy With Ataxia|Cataract – Ataxia – Deafness|Cerebellar Ataxia, Cayman Type|Cerebellar Ataxia With Peripheral Neuropathy|Cerebellar Ataxia – Hypogonadism|Cerebellar Ataxia – Ectodermal Dysplasia|Cerebellar Ataxia – Areflexia – Pes Cavus – Optic Atrophy – Sensorineural Hearing Loss|Brain Tumor Ataxia|Brachydactyly – Nystagmus – Cerebellar Ataxia|Benign Paroxysmal Tonic Upgaze of Childhood With Ataxia|Autosomal Recessive Syndromic Cerebellar Ataxia|Autosomal Recessive Spastic Ataxia With Leukoencephalopathy|Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay|Autosomal Recessive Spastic Ataxia – Optic Atrophy – Dysarthria|Autosomal Recessive Spastic Ataxia|Autosomal Recessive Metabolic Cerebellar Ataxia|Autosomal Dominant Spinocerebellar Ataxia Due to Repeat Expansions That do Not Encode Polyglutamine|Autosomal Recessive Ataxia, Beauce Type|Autosomal Recessive Ataxia Due to Ubiquinone Deficiency|Autosomal Recessive Ataxia Due to PEX10 Deficiency|Autosomal Recessive Degenerative and Progressive Cerebellar Ataxia|Autosomal Recessive Congenital Cerebellar Ataxia Due to MGLUR1 Deficiency|Autosomal Recessive Congenital Cerebellar Ataxia Due to GRID2 Deficiency|Autosomal Recessive Congenital Cerebellar Ataxia|Autosomal Recessive Cerebellar Ataxia-pyramidal Signs-nystagmus-oculomotor Apraxia Syndrome|Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to WWOX Deficiency|Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to TUD Deficiency|Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to KIAA0226 Deficiency|Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome|Autosomal Recessive Cerebellar Ataxia With Late-onset Spasticity|Autosomal Recessive Cerebellar Ataxia Due to STUB1 Deficiency|Autosomal Recessive Cerebellar Ataxia Due to a DNA Repair Defect|Autosomal Recessive Cerebellar Ataxia – Saccadic Intrusion|Autosomal Recessive Cerebellar Ataxia – Psychomotor Retardation|Autosomal Recessive Cerebellar Ataxia – Blindness – Deafness|Autosomal Recessive Cerebellar Ataxia|Autosomal Dominant Spinocerebellar Ataxia Due to a Polyglutamine Anomaly|Autosomal Dominant Spinocerebellar Ataxia Due to a Point Mutation|Autosomal Dominant Spinocerebellar Ataxia Due to a Channelopathy|Autosomal Dominant Spastic Ataxia Type 1|Autosomal Dominant Spastic Ataxia|Autosomal Dominant Optic Atrophy|Ataxia-telangiectasia Variant|Ataxia-telangiectasia|Autosomal Dominant Cerebellar Ataxia, Deafness and Narcolepsy|Autosomal Dominant Cerebellar Ataxia Type 4|Autosomal Dominant Cerebellar Ataxia Type 3|Autosomal Dominant Cerebellar Ataxia Type 2|Autosomal Dominant Cerebellar Ataxia Type 1|Autosomal Dominant Cerebellar Ataxia|Ataxia-telangiectasia-like Disorder|Ataxia With Vitamin E Deficiency|Ataxia With Dementia|Ataxia – Oculomotor Apraxia Type 1|Ataxia – Other|Ataxia – Genetic Diagnosis – Unknown|Acquired Ataxia|Adult-onset Autosomal Recessive Cerebellar Ataxia|Alcohol Related Ataxia|Multiple Endocrine Neoplasia|Multiple Endocrine Neoplasia Type II|Multiple Endocrine Neoplasia Type 1|Multiple Endocrine Neoplasia Type 2|Multiple Endocrine Neoplasia, Type IV|Multiple Endocrine Neoplasia, Type 3|Multiple Endocrine Neoplasia (MEN) Syndrome|Multiple Endocrine Neoplasia Type 2B|Multiple Endocrine Neoplasia Type 2A|Atypical Hemolytic Uremic Syndrome|Atypical HUS|Wiedemann-Steiner Syndrome|Breast Implant-Associated Anaplastic Large Cell Lymphoma|Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA)|Hemophagocytic Lymphohistiocytosis|Behcet’s Disease|Alagille Syndrome|Inclusion Body Myopathy With Early-onset Paget Disease and Frontotemporal Dementia (IBMPFD)|Lowe Syndrome|Pitt Hopkins Syndrome|1p36 Deletion Syndrome|Jansen Type Metaphyseal Chondrodysplasia|Cockayne Syndrome|Chronic Recurrent Multifocal Osteomyelitis|CRMO|Malan Syndrome|Hereditary Sensory and Autonomic Neuropathy Type Ie|VCP Disease|Hypnic Jerking|Sleep Myoclonus|Mollaret Meningitis|Recurrent Viral Meningitis|CRB1|Leber Congenital Amaurosis|Retinitis Pigmentosa|Rare Retinal Disorder|KCNMA1-Channelopathy|Primary Biliary Cirrhosis|ZMYND11|Transient Global Amnesia|Glycogen Storage Disease|Alstrom Syndrome|White Sutton Syndrome|DNM1|EIEE31|Myhre Syndrome|Recurrent Respiratory Papillomatosis|Laryngeal Papillomatosis|Tracheal Papillomatosis|Refsum Disease|Nicolaides Baraitser Syndrome|Leukodystrophy|Tango2|Cauda Equina Syndrome|Rare Gastrointestinal Disorders|Achalasia-Addisonian Syndrome|Achalasia Cardia|Achalasia Icrocephaly Syndrome|Anal Fistula|Congenital Sucrase-Isomaltase Deficiency|Eosinophilic Gastroenteritis|Idiopathic Gastroparesis|Hirschsprung Disease|Rare Inflammatory Bowel Disease|Intestinal Pseudo-Obstruction|Scleroderma|Short Bowel Syndrome|Sacral Agenesis|Sacral Agenesis Syndrome|Caudal Regression|Scheuermann Disease|SMC1A Truncated Mutations (Causing Loss of Gene Function)|Cystinosis|Juvenile Nephropathic Cystinosis|Nephropathic Cystinosis|Kennedy Disease|Spinal Bulbar Muscular Atrophy|Warburg Micro Syndrome|Mucolipidoses|Mitochondrial Diseases|Mitochondrial Aminoacyl-tRNA Synthetases|Mt-aaRS Disorders|Hypertrophic Olivary Degeneration|Non-Ketotic Hyperglycinemia|Fish Odor Syndrome|Halitosis|Isolated Congenital Asplenia|Lambert Eaton (LEMS)|Biliary Atresia|STAG1 Gene Mutation|Coffin Lowry Syndrome|Borjeson-Forssman-Lehman Syndrome|Blau Syndrome|Arginase 1 Deficiency|HSPB8 Myopathy|Beta-Mannosidosis|TBX4 Syndrome|DHDDS Gene Mutations|MAND-MBD5-Associated Neurodevelopmental Disorder|Constitutional Mismatch Repair Deficiency (CMMRD)|SPATA5 Disorder|SPATA5L1 Related Disorder | To accelerate research into rare disorders by connecting individuals who are interested in research and who have been diagnosed with a rare disorder (or a disorder of unknown prevalence, or who are undiagnosed) with researchers who study rare diseases., 100 years | Sanford Health | National Ataxia Foundation|International WAGR Syndrome Association|4p- Support Group|ML4 Foundation|Cornelia de Lange Syndrome Foundation|Stickler Involved People|Kawasaki Disease Foundation|Klippel-Feil Syndrome Alliance|Klippel-Feil Syndrome Freedom|Hyperacusis Research Limited|Hypersomnia Foundation|Kabuki Syndrome Network|Kleine-Levin Syndrome Foundation|Leiomyosarcoma Direct Research Foundation|Marinesco-Sjogren Syndrome Support Group – NORD|Mucolipidosis Type IV (ML4) Foundation|People with Narcolepsy 4 People with Narcolepsy (PWN4PWN)|Soft Bones Incorporated|American Multiple Endocrine Neoplasia Support|Atypical Hemolytic Uremic Syndrome Foundation|All Things Kabuki|Wiedemann-Steiner Syndrome Foundation|Breast Implant Victim Advocates|PROS Foundation|American Behcet’s Disease Association|Alstrom United Kingdom|Athymia|Curing Retinal Blindness Foundation|HSAN1E Society|1p36 Deletion Support and Awareness|The Alagille Syndrome Alliance|Autoinflammatory Alliance|Beyond Batten Disease Foundation|Bohring-Opitz Syndrome Foundation, INC|Cockayne Syndrome Network (Share and Care)|CRMO Foundation|Cure VCP Disease,INC|FOD Support|Cystinosis Research Foundation|Global DARE Foundation|Hypnic Jerk-Sleep Myoclonus Support Group|Jansen’s Foundation|KCNMA1 Channelopathy International Advocacy Foundation|Kawasaki Disease Foundation Australia|Life with LEMS Foundation|Lowe Syndrome Association|The Malan Syndrome Foundation|Maple Syrup Urine Disease Family Support Group|International Association for Muscle Glycogen Storage Disease (IamGSD)|Myhre Syndrome Foundation|DNM1 Families|Nicolaides Baraitser Syndrome (NCBRS) Worldwide Foundation|The PBCers Organization|Pitt Hopkins Research Foundation|Recurrent Meningitis Association|Recurrent Respiratory Papillomatosis Foundation|Remember the Girls|Smith-Kingsmore Syndrome Foundation|SPG Research Foundation|Team Telomere|Transient Global Amnesia Project|The Charlotte & Gwenyth Gray Foundation|The Cute Syndrome Foundation|The Maddi Foundation|White Sutton Syndrome Foundation|Zmynd11 Gene Disorder|Cauda Equina Foundation, Inc|Tango2 Research Foundation|Noah’s Hope – Hope4Bridget Foundation|Project Sebastian|SMC1A Epilepsy Foundation|International Foundation for Gastrointestinal Disorders|Endosalpingiosis Foundation, Inc|International Sacral Agenesis/Caudal Regression Association (ISACRA)|Scheuermann’s Disease Fund|Batten Disease Support and Research Association|Kennedy’s Disease Association|Cure Mito Foundation|Warburg Micro Research Foundation|Cure Mucolipidosis|Riaan Research Initiative|CureARS A NJ Nonprofit Corporation|CACNA1H Alliance|IMBS Alliance|SHINE-Syndrome Foundaion|Non- Ketotic Hyperglycinemia (NKH) Crusaders|Hypertrophic Olivary Degeneration Association (HODA)|National Organization for Disorders of the Corpus Callosum (NODCC)|Team4Travis|Taylor’s Tale Foundation|Lambert Eaton (LEMS) Family Association|BARE Inc|STAG1 Gene Foundation|Coffin Lowry Syndrome Foundation|BLFS Incorporate|Aniridia North America|Cure Blau Syndrome Foundation|ARG1D Foundation|CURE HSPB8 Myopathy|International Society of Mannosidosis and Related Disorders|TBX4Life|Cure DHDDS|MANDKind Foundation|Krishnan Family Foundation|SPATA Foundation | ALL | CHILD, ADULT, OLDER_ADULT | 20000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 03-10-014|Hypersomnia Foundation|National Ataxia Foundation|4p- Support Group|CdLS Foundation|Hyperacusis Research Limited|Kabuki Syndrome Network|Kawasaki Disease Foundation|Klippel-Feil Syndrome Freedom|Leiomyosarcoma Direct Research|MSS Support Group|ML4 Foundation|Stickler Involved People|IWSA|Soft Bones|PWN4PWN|aHUS|Klippel-Feil Syndrome Alliance|American MEN Support|Kleine-Levin Syndrome|All Things Kabuki|WSS Foundation|BIVA|ABDA|PROS Foundation (HLH)|Alagille Syndrome Association|Cure VCP Disease, Inc.|Lowe Syndrome Association|Pitt Hopkins|Cure Batten Disease|Hypnic Jerk/Sleep Myoclonus|1p36 DSA|Jansen Foundation|Share and Care Network|CRMO|The Malan Syndrome Foundation|HSAN1E Society|Alstrom United Kingdomg|Athymia|CRB1 Foundation|DNM1 Families|Global DARE Foundation|KCIAF|MSUD FSG|IamGSD|Myhre Syndrome Foundation|NCBRS|PBCers Organization|Remember the Girls|RRPF|SKS Foundation|SPG15 Research Foundation|Team Telomere|TGA Project|The Cute Syndrome Foundation|WSS Foundation|Zmynd11 Gene Disorder|SPG11 and SPG15|Endosalpingiosis Foundation|Cauda Equina Foundation|Tango2 Research Foundation|SMC1A Epilepsy|IFFGD|Noah’s Hope – Hope4Bridget|Project Sebastian|ISACRA|Scheuermann’s Disease Fund|BDSRA|Kennedy’s Disease Assocation|Cystinosis Research Foundation|Cure Mito Foundation|Warburg Micro Research|Riaan Research Initiative|Cure Mucolipidosis|CACNA1H Alliance|IMBS Alliance|Non-Ketotic Hyperglycinemia|Corpus Callosum Disorders|SHINE Syndrome Foundation|HODA|Team4Travis|Taylor’s Tale Foundation|Lambert Eaton (LEMS) Family|BARE Inc.|STAG1 Gene Foundation|Coffin Lowry Syndrome|BLFS Incorporate|Aniridia North America|Cure Blau Syndrome Foundation|ARG1D Foundation|CURE HSPB8 Myopathy|ISMRD – Beta Mannosidosis|TBX4Life|Cure DHDDS|MANDKind Foundation|Krishnan Family Foundation|SPATA Foundation | 2010-07 | 2100-12 | 2100-12 | 2013-02-15 | 2024-01-19 | Sanford Health, Sioux Falls, South Dakota, 57104, United States|Online Patient Enrollment System, Sydney, Australia | ||||||
| NCT01784042 | Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue | https://clinicaltrials.gov/study/NCT01784042 | The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk. | NO | Breast Cancer | DRUG: Placebo|DRUG: Lovaza|OTHER: Dietary energy restriction | Ki67 expression, Ki67 expression by hyperplastic breast lesions, about 1 year | Milton S. Hershey Medical Center | FEMALE | ADULT | EARLY_PHASE1 | 0 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | PSHCI 12-075 | 2013-03 | 2017-03 | 2018-03 | 2013-02-05 | 2017-05-09 | Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States | ||||||
| NCT01768533 | Pediatric Behavioral Informatics to Prevent Cancer | https://clinicaltrials.gov/study/NCT01768533 | TIDE | The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration. | NO | Obesity | sugar-sweetened beverages, Behavioral outcome measure of the amount of sugar-sweetened beverages consumed., one time point (baseline only) | BMI, weight status as defined by body mass index (BMI), one time point (baseline only) | Physical activity, amount of time spent in moderate or greater physical activity, one time point (baseline only)|fruit and vegetables, amount of fruit servings and vegetable servings consumed per day., one time point (baseline only)|screen time, amount of time spent watching television or recreational videos or computers, one time point (baseline only) | University of Massachusetts, Boston | ALL | ADULT, OLDER_ADULT | 305 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 5K07CA113643 | 2009-09 | 2011-08 | 2011-08 | 2013-01-15 | 2013-01-15 | UMass Boston, Boston, Massachusetts, 02155, United States | |||||
| NCT01745471 | Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL) | https://clinicaltrials.gov/study/NCT01745471 | EIFFEL | The purpose of this study is to collect data to help understand why some women develop Polycystic Ovary Syndrome (PCOS) associated with decreased lower-body fat. | NO | Polycystic Ovary Syndrome|Metabolic Diseases|Overweight | Difference of angiogenesis capacity in abdominal and gluteal adipose tissue, The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test., Day 7 | Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women, Measurement will be obtained with Fluorescence-activated cell sorting (FACS). Identify different and similar biomarkers in obese and PCOS women, from abdominal and gluteal adipose tissue samples. Total RNA, micro RNA and DNA will be extracted from each type of cells using FACS-cell sorting analysis., Day 7|Difference in oxygen content of abdominal and gluteal adipose tissue, Adipose tissue oxygen content will be measured using the Licox CMP microprocessor., Day 6 | The rates of carbohydrate oxidation, Resting Metabolic Rate (RMR) will measure the resting metabolic rate/respiratory quotient (RMR/RQ) and substrate utilization. Energy expenditure and respiratory quotient standardized for temperature, pressure, and moisture will be calculated at one-minute intervals, over 30 minutes., Day -7|The rates of lipid oxidation, Resting Metabolic Rate (RMR) will measure the resting metabolic rate/respiratory quotient (RMR/RQ) and substrate utilization. Energy expenditure and respiratory quotient standardized for temperature, pressure, and moisture will be calculated at one-minute intervals, over 30 minutes., Day -7 | AdventHealth Translational Research Institute | Sanford-Burnham Medical Research Institute|Pennington Biomedical Research Center|Boston University|Tufts University | FEMALE | ADULT | 36 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | TRIMDFH 348525|348525 | 2012-12-06 | 2015-02-03 | 2024-12 | 2012-12-10 | 2024-08-05 | Translational Research Institute for Metabolism and Diabetes, Orlando, Florida, 32804, United States | ||||
| NCT01733147 | Modulation of Esophageal Inflammation in Barrett’s Esophagus by Omega-3 Fatty Acids | https://clinicaltrials.gov/study/NCT01733147 | This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett’s esophagus. | YES | Barrett’s Esophagus|Obesity | DRUG: Omega-3 polyunsaturated fatty acids|DRUG: Placebo | Change in Serum PGE2 Levels, Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw, Baseline, 6 months|Change in Esophageal Tissue PGE2 Levels, Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection, Baseline, 6 months | Change in Esophageal Macrophage Markers, Percent change from baseline to 6 months in esophageal macrophage markers MCP-1 (Pro-inflammatory, M1 marker), CD 206 (Anti-inflammatory, M2 marker), and IL-10 (Anti-inflammatory, M2 marker) obtained from endoscopic esophageal tissue collection, Baseline, 6 months | Mayo Clinic | ALL | ADULT, OLDER_ADULT | PHASE4 | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 12-005914 | 2012-11 | 2018-09-12 | 2018-09-12 | 2012-11-26 | 2022-01-11 | 2022-01-11 | Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/47/NCT01733147/Prot_SAP_000.pdf | |||
| NCT01728506 | An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT01728506 | iWEB | The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people. This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations. Participants will be recruited from three New England Cancer Centers – the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires. Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line “chats” about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study. | NO | Breast Cancer | BEHAVIORAL: Weight Loss and Exercise | Feasibility, Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study., Change from baseline fesability at 6 months|Change in diet measures, Efficacy will be measured using total calories and fat grams before and after the intervention, Change from baseline diet measures at 6 months|Change in anthropometric measures, Change in Weight, BMI, body fat percentage before and after the intervention, Change from baseline anthropometrics at 6 months|Change in active energy expenditure (ie exercise), exercise will be measured using an accelerometer before and after the intervention, Change from baseline active energy expenditure at 6 months | Change in inflammatory biomarkers, Change in Il-6, hsCRP before and after the intervention, Change from baseline inflammatory biomarkers at 6 months|Change in insulin resistance markers, Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention, Change from baseline insulin resistance markers at 6 months | University of Vermont | Dartmouth-Hitchcock Medical Center|University of Massachusetts, Worcester | FEMALE | ADULT, OLDER_ADULT | NA | 48 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | VCC 1109 | 2012-10 | 2015-07 | 2015-07 | 2012-11-19 | 2015-05-18 | University of Massachusetts, Worcester, Massachusetts, 01655, United States|Dartmouth Hitchcock Medical Center, Hannover, New Hampshire, 03755, United States|Unviersity of Vermont/Fletcher Allen Health Care, Burlington, Vermont, 05405, United States | |||
| NCT01719432 | Effect of Body Mass on Filgrastim Pharmacokinetics | https://clinicaltrials.gov/study/NCT01719432 | Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan. Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study. | NO | Hematological Malignancy|Neutropenia | Systemic clearance of filgrastim in obese and non-obese patients, 24 hours | Alpha and beta half-life of filgrastim in obese and non-obese patients, 24 hours|Maximum concentration (Cmax) of filgrastim in obese and non-obese patients, 24 hours|Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients, 24 hours|Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients, 24 hours | Aaron Cumpston, PharmD, BCOP | ALL | ADULT, OLDER_ADULT | 30 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | WVU 021112 | 2012-12-05 | 2020-12 | 2020-12 | 2012-11-01 | 2020-12-17 | West Virginia University Mary Babb Randolph Cancer Center, Morgantown, West Virginia, 26506, United States | |||||||
| NCT01716429 | Healthy Eating for Reproductive Health: Greenville | https://clinicaltrials.gov/study/NCT01716429 | HER Health | This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means the consumer will be asked to favor foods that don’t cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach the participants are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group. | NO | Polycystic Ovarian Syndrome|Infertility|Obesity|Overweight | BEHAVIORAL: Vegan diet|BEHAVIORAL: Low calorie diet | Changes in body weight, 6 months | Pregnancy rates, 6 months | Menstrual cycle length, 6 months | University of South Carolina | Prisma Health-Upstate | FEMALE | ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | Pro00019109 | 2012-10 | 2013-09 | 2013-09 | 2012-10-29 | 2019-04-18 | Fertility Center of the Carolinas: Greenville Hospital System, Greenville, South Carolina, 29605, United States | ||
| NCT01714180 | Effect of Body Mass on Acyclovir Pharmacokinetics | https://clinicaltrials.gov/study/NCT01714180 | Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking acyclovir to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan. Patients receiving acyclovir as standard of care will be enrolled into this study. They will have blood draws once before they take acyclovir and 10 times after they take the acyclovir (over a total of 12 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 4-5 tablespoons of blood will be drawn for this study. 7 obese patients and 7 matched, non-obese patients will be enrolled into this study. | NO | Hematological Malignancy|Pharmacokinetics of Acyclovir | Systemic clearance of acyclovir in obese and non-obese patients, 12 hours after acyclovir dose | Alpha and beta half-life of acyclovir in obese and non-obese patients, 12 hours after acyclovir dose|Maximum concentration (Cmax) of acyclovir in obese and non-obese patients, 12 hours after acyclovir dose|Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients, 12 hours after acyclovir dose|Volume of distribution (Vd and Vdss) of acyclovir in obese and non-obese patients, 12 hours after acyclovir dose|Time that concentration is above IC50 for varicella and herpes viruses 4,5,6,7 for acyclovir in obese and non-obese patients, 12 hours after acyclovir dose | West Virginia University | ALL | ADULT, OLDER_ADULT | 14 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | WVU 031112|24368 | 2012-10 | 2014-03 | 2015-03 | 2012-10-25 | 2015-06-03 | West Virginia University Hospitals Mary Babb Randolph Cancer Center, Morgantown, West Virginia, 26506, United States | |||||||
| NCT01697566 | An Endometrial Cancer Chemoprevention Study of Metformin | https://clinicaltrials.gov/study/NCT01697566 | The goal of this clinical research study is to learn about the effects of metformin and/or a program called “lifestyle intervention” on the endometrium (inner lining of the uterus) in post-menopausal women who are also obese (both are risk factors for endometrial cancer). Researchers also want to learn how insulin levels will be affected by metformin, diet and/or exercise. Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a condition in which the body makes insulin but does not use it properly. It is often referred to as “pre-diabetes”. Many people with insulin resistance have high levels of both sugar and insulin in their blood at the same time, which have been reported in patients with endometrial cancer. In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. Lifestyle intervention is made up of a series of in-person sessions where you meet with a coach to discuss strategies for losing weight and ways to increase physical activity. It also consists of materials designed to help you lose weight and will offer opportunities for supervised exercise. | NO | Gynecology | DRUG: Metformin|OTHER: Placebo|PROCEDURE: Endometrial Biopsy|BEHAVIORAL: Lifestyle Intervention|BEHAVIORAL: Questionnaires | Effect of Metformin and/or Lifestyle Intervention on Biomarkers., Differences in Ki-67 and other biomarkers analyzed using a 2×2 ANOVA. Other biomarkers examined include a) a panel of genes relevant to estrogen dependent endometrial proliferation, hyperplasia and cancer using Q-PCR, b) biomarkers specific to the effect of metformin treatment (phospho-AMPKa, phospho-ACC, phospho-mTOR and phospho-S6 ribosomal protein and c) potential biomarkers of modulation of insulin sensitivity on the human endometrial proteome using reverse phase protein arrays (RPPA)., 4 months | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | PHASE3 | 100 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 2011-0739|5P50CA098258|NCI-2013-00834 | 2013-05-02 | 2024-05-30 | 2024-05-30 | 2012-10-02 | 2024-07-05 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | |||||
| NCT01647776 | Screening and Risk Factors of Colon Neoplasia | https://clinicaltrials.gov/study/NCT01647776 | The investigators propose a screening population-based study to systematically evaluate the accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy screening. In addition, the investigators propose a genetic epidemiologic study of the relation between colon polyps, an established precursor of colon cancer, and two factors that may influence risk for colon cancer: candidate genes and diet. | NO | Colon Cancer | OTHER: Stool DNA Test|PROCEDURE: biopsies of rectal and colon mucosa|OTHER: Questionnaires | Stool DNA (sDNA) Feasibility and Compliance, For this aim, we will recruit a sub-sample of the study participants to perform the sDNA test for aberrantly methylated markers in addition to their colonoscopy to assess willingness to participate, compliance with test protocol and patient satisfaction to determine potential for a larger study to evaluate the effectiveness of this test for detection of colon adenomas., within 12 weeks prior to the colonoscopy|Efficacy of sDNA testing for the detection of advanced adenomas, For the sDNA test aims, the primary goals are to assess the sensitivity and specificity of sDNA testing for the detection of advanced adenomas, and to compare the performance of the Exact sDNA Panel with that of FIT. The sensitivity and specificity of sDNA and FIT will be estimated based on the concordance and discordance of advanced adenomas detected against that of colonoscopy as the gold standard, prior to the colonoscopy | Concordance/discordance between tissue and stool DNA aberrant methylation markers, Biopsies of rectal and colon mucosa collected at the beginning of the colonoscopy for analysis of 15-PGDH pathway factors \[levels of prostaglandin E2 (PG E2), and mRNA for 15-PGDH, COX-1 and COX-2 expression\] as markers of risk of developing adenoma., Stool sample within 2 weeks of colonoscopy|Persistence of positive sDNA testing after removal of advanced adenomas, For this aim we will follow-up participants who have had positive sDNA tests and at least one advanced adenoma removed during colonoscopy. At 12 months after their initial sDNA test and colonoscopy, we will ask them to repeat the sDNA test in addition to colonoscopy recommended by their physician as standard of care., at 12 months after initial colonoscopy|Assess the frequency of missed or occult colonic and upper gastrointestinal neoplasia in patients with initially normal colonoscopies and persistently positive sDNA testing., For this aim we will follow-up participants who have had positive sDNA tests and negative colonoscopy (i.e., no adenomatous polyps observed at initial colonoscopy). At 12 months after their initial sDNA test and colonoscopy, we will ask them to repeat the sDNA test. If this second sDNA test is also positive, the participant will be offered the opportunity to have both a colonoscopy and an upper GI endoscopy (also called esophagogastroduodenoscopy or EGD), at 12 months after initial colonoscopy|Insulin Resistance Syndrome, Use latent structural equation models to fully incorporate information on the overall relations among insulin resistance syndrome pathway factors and colon polyps, including both direct and indirect effects as well as interactions between these factors., at the time of the colonoscopy|Analyses stratified by ethnicity (Caucasians versus African Americans), and gender., The analysis by ethnicity is of particular interest in sDNA testing as there is evidence that large right-sided adenomas are more prevalent among African Americans, and this ethnic population is less likely to receive screening colonoscopy as compared to Caucasians. Furthermore, the ability of sDNA and FIT for the detection of nonadvanced adenomas will be evaluated. These lesions will be defined as adenomas that are less than 1 cm in diameter and without evidence of high grade dysplasia., at the time of the colonoscopy|Examine the impact of candidate gene variants in the insulin-GH-IGF-IRS axis on colon polyps., Evaluate whether each of the following candidate gene polymorphisms and their haplotypes are linked to colon polyps: 1) Insulin; 2) Growth Hormone; 3) IGF-1; and 4) IRS-1., at the time of the colonoscopy|Evaluate the association of dietary patterns, glycemic index (GI) and glycemic load (GL) with colon polyps., Conceptually, dietary patterns represent a broader picture of human diet, and thus may be more predictive of disease risk than individual foods or nutrients. In addition, there is growing evidence relating GI and/or GL to risks of obesity, type 2 diabetes as well as colon neoplasia. Therefore, we hypothesize that high dietary GL and/or GI, and/or a Western dietary pattern defined by a diverse array of dietary factors are associated with increased risk of colon polyps., at 12 months|Synthesize the information on candidate genes and diet by looking at their joint effects on colon polyps, 1) investigate their potential joint actions \[i.e., gene-diet and gene-gene\]; 2) use a latent structural equation modeling approach to comprehensively evaluate these factors’ potential direct as well as indirect (mediated by insulin resistance syndrome) impact, on colon polyps., at the time of the colonoscopy|To investigate the association of activated (phosphorylated) IRS1, AKT and mTOR with colon adenomas., We will compare the immunohistochemistry of phosphorylated IRS1, AKT and mTOR in colon adenoma tissues with that in colon tissues from healthy control patients. Investigate the effect of obesity on the activation of the IRS1, AKT and mTOR by stratifying our cases and controls into lean and obese individuals. Evaluate the effects of serum levels of insulin, glucose, and insulin resistance index (HOMA-IR) on the activation of the IRS1, AKT and mTOR in colonic tissue., at the time of the colonoscopy | Case Comprehensive Cancer Center | ALL | ADULT, OLDER_ADULT | 3315 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | CASE1207|SPORE 2 | 2012-04-01 | 2015-08-11 | 2016-08-11 | 2012-07-24 | 2021-02-09 | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106, United States | ||||||
| NCT01630499 | My Lifestyle Intervention of Food and Exercise | https://clinicaltrials.gov/study/NCT01630499 | MyLIFE | Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program. | NO | Breast Cancer | BEHAVIORAL: Tailored Lifestyle Intervention (TLI)|BEHAVIORAL: Commercial Weight Loss Program (CWLP) | Change in body weight from baseline to post-intervention, baseline (month 0), post-intervention (month 3)|Change in body weight from post-intervention to follow-up, post-intervention (month 3), follow-up (month 9) | Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention, baseline (month 0), post-intervention (month 3)|Change in HDL Cholesterol from baseline to post-intervention, baseline (month 0), post-intervention (month 3)|Change in blood glucose control from baseline to post-intervention., HgA1c and fasting glucose to assess blood glucose control, baseline (month 0), post-intervention (month 3)|Change in caloric intake from baseline to post-intervention., National Cancer Institute’s Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake., baseline (month 0), post-intervention (month 3)|Change in body composition from baseline to post-intervention., Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc)., baseline (month 0), post-intervention (month 3)|Change in waist circumference from baseline to post-intervention., Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation., baseline (month 0), post-intervention (month 3)|Change in sagittal abdominal diameter from baseline to post-intervention., Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation., baseline (month 0), post-intervention (month 3)|Change in physical activity from baseline to post-intervention., Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ)., baseline (month 0), post-intervention (month 3)|Change in health-related quality of life from baseline to post-intervention., Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer – Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23)., baseline (month 0), post-intervention (month 3)|Change in self-efficacy from baseline to post-intervention., Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire., baseline (month 0), post-intervention (month 3)|Use of weight management strategies, The frequency of participants’ utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ)., post-intervention (month 3)|Height, Height will be assessed in order to determine BMI., baseline (month 0)|Change in blood pressure from baseline to post-intervention., Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes., post-intervention (month 3), follow-up (month 9)|Change in LDL cholesterol at from baseline to post-intervention., baseline (month 0), post-intervention (month 3)|Change in total cholesterol from baseline to post-intervention., baseline (month 0), post-intervention (month 3)|Change in triglycerides from baseline to post-intervention., baseline (month 0), post-intervention (month 3)|Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up., post-intervention (month 3), follow-up (month 9)|Change in HDL Cholesterol from post-intervention to follow-up., post-intervention (month 3), follow-up (month 9)|Change in blood glucose control from post-intervention to follow-up., post-intervention (month 3), follow-up (month 9)|Change in caloric intake from post-intervention to follow-up., National Cancer Institute’s Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake., post-intervention (month 3), follow-up (month 9)|Change in body composition from post-intervention to follow-up., Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc)., post-intervention (month 3), follow-up (month 9)|Change in waist circumference from post-intervention to follow-up., Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation., post-intervention (month 3), follow-up (month 9)|Change in sagittal abdominal diameter from post-intervention to follow-up., Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation., post-intervention (month 3), follow-up (month 9)|Change in physical activity from post-intervention to follow-up., Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ)., post-intervention (month 3), follow-up (month 9)|Change in health-related quality of life from post-intervention to follow-up., Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer – Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23)., post-intervention (month 3), follow-up (month 9)|Change in self-efficacy from post-intervention to follow-up., Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire., post-intervention (month 3), follow-up (month 9)|Use of weight management strategies at follow-up., The frequency of participants’ utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ)., follow-up (month 9)|Change in blood pressure from post-intervention to follow-up., Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes., post-intervention (month 3), follow-up (month 9)|Change in LDL cholesterol at from post-intervention follow-up, post-intervention (month 3), follow-up (month 9)|Change in total cholesterol from post-intervention to follow-up., post-intervention (month 3), follow-up (month 9)|Change in triglycerides from post-intervention to follow-up., post-intervention (month 3), follow-up (month 9) | University of Florida | FEMALE | ADULT, OLDER_ADULT | NA | 87 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | MyLIFE2012|427-2012 | 2012-10 | 2016-03 | 2016-07 | 2012-06-28 | 2016-09-30 | University of Florida, Gainesville, Florida, 32611, United States|University of North Florida, Jacksonville, Florida, 32224, United States | ||||
| NCT01627067 | Exemestane-RAD001-Metformin | https://clinicaltrials.gov/study/NCT01627067 | The goal of this clinical research study is to learn if exemestane and everolimus combined with metformin can help to control breast cancer in patients who are obese or overweight and post-menopausal with hormone-receptor-positive breast cancer that has spread to other parts of the body. Exemestane is designed to decrease the ability of estrogen to help cancer cells grow. This could cause the cancer cells to die. Metformin is commonly used to control blood sugar levels in patients with diabetes. It is designed to lower insulin levels, which may slow or stop the growth of breast cancer cells. Everolimus is designed to block cells from dividing. This may cause cancer cells to die. Everolimus may also stop the growth of new blood vessels that help tumors grow. | YES | Breast Cancer | DRUG: Everolimus|DRUG: Exemestane|DRUG: Metformin | Progression-Free Survival (PFS), The primary end point of this study was progression-free survival (PFS), defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. Data for PFS were censored at the time of a patient’s removal from study. All other analyses were post-hoc and should be regarded as such., From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 67 months|Compare Progression Free Survival (PFS) Between the Number of Obese and Overweight Participants, The primary end point of this study was progression-free survival (PFS), defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. Data for PFS were censored at the time of a participants removal from study. Compare PFS between overweight patients (n=11; BMI \/=25 kg/m2) on univariable cox regression analysis., From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 67 months | M.D. Anderson Cancer Center | Susan G. Komen Breast Cancer Foundation | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 23 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2011-1239|NCI-2012-01164 | 2012-09 | 2019-02-01 | 2019-02-01 | 2012-06-25 | 2020-06-19 | 2020-06-19 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/67/NCT01627067/Prot_SAP_000.pdf | |||
| NCT01582685 | Exercise in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT01582685 | The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival. | NO | Breast Cancer|Obesity | BEHAVIORAL: Exercise | Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors., Number of participants that enroll in the study and actually complete the study, 12 months | IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:, IFG-1 levels,unbound VEGF levels, Endostatin levels, 12 months|Amount of adipose tissue mass as measured on CT scans in obese breast cancer survivors before and after exercise intervention as a measure of weight loss, Adipose tissue mass volume as measured on CT scan, 12 months | University of Mississippi Medical Center | FEMALE | ADULT, OLDER_ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION | 2011-0121 | 2012-04 | 2014-06 | 2014-06 | 2012-04-23 | 2014-12-02 | University of Mississippi Health Care, Jackson, Mississippi, 39216, United States | |||||
| NCT01559194 | Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk | https://clinicaltrials.gov/study/NCT01559194 | LEAF | The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk. | NO | Breast Cancer|Weight Loss | BEHAVIORAL: Low Fat Diet plus exercise|BEHAVIORAL: Low Carbohydrate diet + Exercise | Number of women who lose weight when following 1 of 2 different calorie-restricted diets, 18 months | Number of women that long-term weight loss impacted biomarkers (including Insulin-like growth factor (IGF)- 1 and IGFBP-3) associated with breast cancer risk, 12 months | Ohio State University Comprehensive Cancer Center | Breast Cancer Research Foundation | FEMALE | ADULT, OLDER_ADULT | PHASE3 | 82 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | LEAF|OSU 0372 | 2005-05 | 2007-12 | 2007-12 | 2012-03-21 | 2014-04-14 | Ohio State University, Columbus, Ohio, 43201, United States | |||
| NCT01542203 | Impact of Body Weight on Pharmacokinetic Analysis of Doxorubicin + Cyclophosphamide in Breast Cancer | https://clinicaltrials.gov/study/NCT01542203 | This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This study is designed to measure drug concentrations in the blood of 18 female breast cancer patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care. Up to a total of 40 adult female participants will be consented for the study at the cancer center. Eighteen of these participants are needed to complete the study. The others will likely be screen failures. The participants will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous catheter will be removed when the participant is discharged from the cancer center on day 1. The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have the final 2 blood draws conducted. The participants must be treated with Doxorubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study. | NO | Breast Cancer | University of Texas Southwestern Medical Center | Texas Tech University Health Sciences Center | FEMALE | ADULT, OLDER_ADULT | 0 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | STU 062011-056 | 2012-06-25 | 2016-09-15 | 2017-06-05 | 2012-03-02 | 2018-06-06 | UTSouthwestern Medical Center, Dallas, Texas, 75390, United States | ||||||||
| NCT01537029 | Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide | https://clinicaltrials.gov/study/NCT01537029 | To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases. | YES | Breast Cancer|Obesity | DRUG: Doxorubicin|DRUG: Cyclophosphamide | Clearance (Cl) for Doxorubicin and Cyclophosphamide, Cyclophosphamide analysis was not possible due to rapid drug degradation, 0-48 hours | Texas Tech University Health Sciences Center | University of Texas | FEMALE | ADULT, OLDER_ADULT | PHASE4 | 15 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER | A11-3691 | 2012-02 | 2016-12 | 2016-12 | 2012-02-22 | 2018-08-22 | 2018-08-22 | University of Texas Southwestern, Dallas, Texas, 75390, United States | ||||
| NCT01515124 | The Women In Steady Exercise Research (WISER) Survivor Trial | https://clinicaltrials.gov/study/NCT01515124 | WISER Survivor | WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality. | NO | Lymphedema | BEHAVIORAL: Exercise Intervention|BEHAVIORAL: Weight Loss Intervention | Percent interlimb difference, change over 12 months., Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome, Baseline and 12 months | Clinical Lymphedema Events, Flare-ups and cellulitic infections (number and type recorded), Data collected over the 12 month follow-up, with events collected as reported|Clinical Evaluation Score for Lymphedema, Standardized clinical evaluation survey completed by certified lymphatic therapists, Baseline and 12 months|Norman Lymphedema Survey, Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey), Baseline and 12 months|Weight loss, body weight loss over 12 months, Baseline and 12 months|Biomarkers: Estradiol, circulating estradiol levels in the blood, baseline and 12 months|Biomarkers: Testosterone, circulating testosterone levels in the blood, baseline and 12 months|Biomarkers – Sex Hormone Binding Globulin, circulating sex hormone binding globulin levels in the blood, baseline and 12 months|Inflammation: Interleukin six, Circulating interleukin six levels in the blood, baseline and 12 months|Inflammation: C reactive protein, Circulating c reactive protein levels in the blood, baseline and 12 months|Adiponectin, circulating Adiponectin levels in the blood, baseline and 12 months|Leptin, circulating leptin levels in the blood, baseline and 12 months|F2-isoprostanes, circulating F2-isoprostane levels in the blood, baseline and 12 months|Insulin, circulating insulin levels in the blood, baseline and 12 months|Glucose, circulating glucose levels in the blood, baseline and 12 months|insulin like growth factor one, circulating levels of insulin like growth factor one in the blood, baseline and 12 months|insulin like growth factor binding protein three, circulating levels of insulin like growth factor binding protein three in the blood, baseline and 12 months|Upper limb lymphedema twenty seven, 27 item survey on lymphedema quality of life, baseline and 12 months|body image and relationship survey, 32 item survey on body image specifically developed for breast cancer survivors, baseline and 12 months | breast cancer recurrence, participants will be followed for breast cancer recurrence, 10 years post trial|mortality, participants will be followed for mortality, 10 years post trial | Milton S. Hershey Medical Center | FEMALE | CHILD, ADULT, OLDER_ADULT | NA | 450 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | U54CA155850 | 2012-01 | 2016-05 | 2016-05 | 2012-01-23 | 2022-10-10 | The Penn TREC Survivorship Center, Hershey, Pennsylvania, 17033, United States | |||
| NCT01512810 | Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer | https://clinicaltrials.gov/study/NCT01512810 | Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient’s cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy. | NO | Endometrial Cancer | PROCEDURE: Lymphadenectomy | Recurrence-free survival, Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)., 24 months | Frederick R. Ueland, M.D. | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 200 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 11-GYN-130 | 2012-01 | 2021-08-26 | 2021-08-26 | 2012-01-19 | 2021-11-24 | University of Kentucky Markey Cancer Center, Lexington, Kentucky, 40536, United States | ||||||
| NCT01509066 | Healthy Eating for Reproductive Health (HERHealth) | https://clinicaltrials.gov/study/NCT01509066 | HERHealth | This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means you will be asked to favor foods that don’t cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach you are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group. | NO | Polycystic Ovarian Syndrome|Infertility|Obesity|Overweight | OTHER: Diet | Body weight changes, body weight will be assessed at 0, 3, and 6 months, 6 months | Pregnancy rates, We will measure any occurrences of pregnancy over the course of the study, 6 months|Menstrual cycle length, We will measure changes in the length of menstrual cycles over the course of the 6 month study, 6 months | University of South Carolina | Academy of Nutrition and Dietetics | FEMALE | ADULT | NA | 18 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | Pro00014149 | 2012-01 | 2013-06 | 2013-06 | 2012-01-12 | 2019-04-18 | University of South Carolina, Columbia, South Carolina, 29208, United States | |||
| NCT01504919 | Reducing Cancer Disparities Among Latinos in Texas | https://clinicaltrials.gov/study/NCT01504919 | The goal of this research study is to learn if a wellness program can help improve diet and physical activity levels and encourage smoking cessation in Latino individuals who are overweight. | NO | Psychosocial Problem | BEHAVIORAL: Health Education|BEHAVIORAL: Questionnaires|BEHAVIORAL: Telephone Counseling Sessions|DRUG: Nicotine Patches | Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction, Generalized linear mixed model regression (GLMM) used in analyzing the effects of motivation and problem solving (MAPS) on the primary outcomes across the 6, 12, and 18-month time points., 6 months | M.D. Anderson Cancer Center | National Institutes of Health (NIH)|National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 301 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 2010-0606|NCI-2012-00029|5U54CA153505 | 2012-01 | 2022-01-18 | 2022-01-18 | 2012-01-06 | 2022-05-31 | William Marsh Rice University, Houston, Texas, 77005, United States|University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | |||||
| NCT01504789 | Part II: Exercise in Hispanic Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT01504789 | The goal of this research study is to test an exercise program that is designed for Hispanic breast cancer survivors. Researchers want to learn the most effective strategies for promoting exercise. | NO | Breast Cancer | BEHAVIORAL: Baseline Fitness Test|BEHAVIORAL: Questionnaires|BEHAVIORAL: Individualized Exercise Program|BEHAVIORAL: Written Materials | Changes in Exercise Behavior and Energy Expenditure, Exercise behavior measured as frequency of exercise as assessed by the IPAQ score. Multiple linear regression used to test for differences in the changes between groups adjusting for relevant covariates, such as baseline activity level (IPAQ score) and BMI. Linear mixed model analysis also performed for weekly change in exercise behavior. The continuous score (MET minutes/week) used as primary physical activity outcome, measured at baseline and follow-up. Compliance measured using exercise logs, which will record resistance exercise and pedometer steps., 6 months | Effects of Behavioral Exercise Intervention on Biological Markers, Blood (about 1½ tablespoons) collected at baseline and 4 months visits following a 12-hour fast. Blood will be processed and stored for later biomarker analysis – body adiposity, sex hormone binding globulin, estradiol, adipokines (adiponectin, leptin, resistin), cytokines (TNF, CRP, IL-6)., 16 weeks | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 53 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | 2011-0201|U54|NCI-2015-01759 | 2012-02-07 | 2026-02-28 | 2026-02-28 | 2012-01-05 | 2024-11-25 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States|University of Puerto Rico, San Juan, 00936, Puerto Rico | ||||
| NCT01498536 | Effect of Diet and Exercise in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT01498536 | F4F tri neg | This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life. | NO | Breast Cancer|Obesity | BEHAVIORAL: aerobic exercise | weight loss, aim for loss of 10% of BMI, 12 weeks|quality of life, Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires, 12 weeks | markers of inflammation, blood draws at beginning and end of study to analyze any effect on inflammation, 12 weeks | West Virginia University | FEMALE | ADULT, OLDER_ADULT | NA | 28 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | H-22426 | 2011-07 | 2013-08 | 2013-08 | 2011-12-23 | 2013-10-30 | West Virginia University, Morgantown, West Virginia, 26506, United States | ||||
| NCT01489319 | Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS) | https://clinicaltrials.gov/study/NCT01489319 | ELI-ROAS | The purpose of this study is to determine the relationship between lipid-induced inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine the effect of salsalate and polygonum cuspidatum extract (PCE) containing resveratrol on lipid-induced inflammation, ovarian androgen secretion, body composition and ovulation in a subset of normal weight women with PCOS. | NO | Polycystic Ovary Syndrome | DRUG: Salsalate|DRUG: Salsalate | White blood cell nuclear factor kappa B (NFkappaB) activation in response to oral lipid ingestion and ovarian androgen secretion in response to human chorionic gonadotropin (HCG) stimulation., This outcome along with insulin sensitivity derived from an oral glucose tolerance test (OGTT) and body composition measured by dual energy absorptiometry (DEXA) will be assessed in all study subjects (PCOS and controls)., 3 years | White blood cell NFkappaB activation following oral lipid ingestion in response to 12 weeks of salsalate or PCE administration., This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity., 3 years|Ovarian androgen secretion following HCG administration in response to 12 weeks of salsalate or PCE administration., This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity., 3 years|Body composition status measured by DEXA in response to 12 weeks of salsalate or PCE administration., This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity., 3 years|Insulin sensitivity derived from an OGTT in response to 12 weeks of salsalate or PCE administration., This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity., 3 years|Ovulation rates documented by serum progesterone in response to 12 weeks of salsalate or PCE administration, This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity., 3 years | Indiana University | FEMALE | ADULT | PHASE1 | 47 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | IU-PCOS-0112 | 2012-02 | 2015-06 | 2015-06 | 2011-12-09 | 2017-02-10 | Indiana University Hospital, Indianapolis, Indiana, 46202, United States | ||||
| NCT01487486 | Proteomics & Glyco-Proteomic Analysis of Follicular Fluid | https://clinicaltrials.gov/study/NCT01487486 | To the best of the investigators knowledge, exhaustive characterization of the low and high abundant proteins and glyco-proteins of the Follicular Fluid (FF) has not yet been achieved. Such an analysis may provide critical molecular data on the role of the FF in oocyte maturation and may identify specific changes in the FF proteome of patients with gynecologic problems, such as Polycystic Ovary Syndrome (PCOS). Specific Aims 1. To perform a comprehensive analysis of normal human FF using sensitive mass spectrometry in combination with conventional approaches for proteomic evaluation and using HPLC and Western blot for glyco-proteomic analysis. 2. Characterize differential proteomic and glyco-proteomic patterns of the FF in normal women compared to lean and obese women with PCOS. 3. To supplement the differential proteomic and glyco-proteomic analysis with steroid hormone analysis in all FF samples. | NO | Polycystic Ovary Syndrome|Normal Volunteers | DRUG: IVF Antagonist Protocol | Proteomic analysis, For proteomic analysis the follicular fluid samples will be either directly analyzed by MS or will be processed to deplete albumin which is likely to be present in very high abundance in the FF., Participants will be followed for one IVF cycle including pregnancy outcomes, on average this will be 6-8 weeks. | Hormone analysis, An aliquot of FF from each patient will be analyzed for the following steroid hormones: progesterone, 17-alpha-hydroxyprogesterone, androstenedione, testosterone, estradiol, and dihydrotestosterone., Participants will be followed for one IVF cycle including pregnancy outcomes, on average this will be 6-8 weeks. | University of Cincinnati | Merck Sharp & Dohme LLC | FEMALE | ADULT, OLDER_ADULT | 30 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Proteomics of FF in PCOS | 2011-12 | 2013-12 | 2014-01 | 2011-12-07 | 2011-12-07 | Center for Reproductive Health, Cincinnati, Ohio, 45219, United States | |||||
| NCT01484873 | Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor | https://clinicaltrials.gov/study/NCT01484873 | The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion. | YES | Obesity|Overweight|Craniopharyngioma | DRUG: Exenatide | Body Weight (kg), Change in body weight from baseline to end of study, baseline, 50 weeks | Resting Energy Expenditure (Kcals Per Day), Change in resting energy expenditure from baseline to 50 weeks, baseline, 50 weeks|Visual Analogue Scales for Post-meal Satiety, Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100)., baseline, 50 weeks|Insulin Secretion (Area Under the Curve), Change in insulin secretion from baseline, baseline, 50 weeks|Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life), Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks, baseline, 50 weeks | Vanderbilt University Medical Center | ALL | ADULT | PHASE2 | 10 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 111185 | 2012-06 | 2015-03 | 2015-03 | 2011-12-02 | 2016-08-11 | 2017-03-03 | Vanderbilt University, Nashville, Tennessee, 37232, United States | ||||
| NCT01482286 | Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS | https://clinicaltrials.gov/study/NCT01482286 | PULSE | Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age and despite decades of research the etiology the disorder is not known. The characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine function and insulin resistance. Obesity is a common correlated phenotype of Polycystic ovary syndrome and weight gain worsens the reproductive and metabolic complications. Currently there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet weight loss by dietary restriction and regular exercise are strongly advocated. Weight loss and increased insulin sensitivity appear to drive improvements in reproductive outcomes in women with Polycystic ovary syndrome; however, the mechanism connecting these changes with the reproductive axis is not fully understood. | YES | Polycystic Ovary Syndrome | DRUG: Metformin|BEHAVIORAL: Dietary Restriction|BEHAVIORAL: Exercise Training | Luteinizing Hormone (LH) Pulse Frequency, Change in Luteinizing Hormone (LH) Pulse Frequency measured over a 12-hour period (7:00 PM – 7:00 AM). The Mean and Standard Deviation (SD) are the number of pulses recorded on the 12-hour period (7:00 PM – 7:00 AM) and presented as the change from baseline to week 24. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention LF pulse frequency., Baseline and Week 24 | Insulin Sensitivity Expressed as Glucose Disposal Rate (GDR), Change in insulin sensitivity measured by the euglycemic hyperinsulinemic clamp. Unit of measure established as glucose disposal rate (GDR) adjusted to account for kilograms of fat-free mass (FFM)+17.7 per minute to reflect the amount of exogenous glucose necessary to fully compensate for hyperinsulinemia and expressed as a function of metabolic body size. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention Insulin Sensitivity expressed as Glucose Disposal Rate., Baseline and Week 24 | Pennington Biomedical Research Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | ADULT | PHASE3 | 32 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | PBRC11016|R00HD060762 | 2012-05 | 2016-04 | 2016-12 | 2011-11-30 | 2022-03-02 | 2022-03-15 | Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States | ||
| NCT01482702 | Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT01482702 | VCC0910 | Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese. The American Cancer Society has called for weight loss treatment to be standard of care for overweight women with breast cancer. During therapy women with breast cancer often gain weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have their cancer come back. The reason why overweight breast cancer survivors are more likely to re-occur has not been well studied, but changes in how insulin works may contribute. Overweight survivors are also at risk for the other chronic diseases associated with obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the internet has been developed at the University of Vermont. This successful intervention has not been tested among breast cancer survivors. Given that women tend to lose muscle mass during cancer therapy the addition of a resistance training component to the weight loss intervention may be important. Therefore the overall goal of this project is to pilot test a proven distantly- delivered behavioral weight loss intervention among overweight breast cancer survivors and to evaluate whether a resistance program results in improvements in lean body mass, while studying how both interventions change insulin sensitivity. Specifically, this project is a randomized, controlled clinical trial designed to test the effectiveness and acceptability of a 6-month behavioral weight loss intervention with and without resistance training. Participants will be randomized to one of two groups: 1) behavioral weight control treatment via the Internet; or 2) behavioral weight control treatment via the Internet plus a resistance training program. Women eligible to participate include overweight breast cancer survivors who are age 50 or older and 6-36 months past receiving chemotherapy. Assessments will be conducted at baseline and six months and will include measures of body weight, muscle mass, adherence to treatment, and insulin sensitivity. | NO | Overweight|Postmenopausal|Breast Cancer | BEHAVIORAL: weight loss intervention|BEHAVIORAL: Weight Loss|BEHAVIORAL: Weight Loss | Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention., Primary outcome measures include weight, fat free mass, fat mass, total and active energy expenditure, calorie intake and oral glucose tolence test, Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.|Determine whether the addition of resistance training to a behavioral weight loss intervention preserves muscle mass and improves weight loss or insulin sensitivity in breast cancer survivors., Outcomes include weight, fat free mass, fat mass, strength (upper extremity and lower extremity) and oral glucose tolerence test, Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011. | Identify differences in weight loss and energy balance between post menopausal breast cancer survivors who received chemotherapy and those who did not receive chemotherapy as part of their oncologic management., Outcomes: weight, fat mass, Fat free mass, total and active energy expenditure, calorie intake, Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.|Determine differences in insulin sensitivity parameters between post menopausal breast cancer survivors who received chemotherapy and those who did not., Oral glusoe tolerence test, Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.|Determine feasibility, acceptability, and safety of weight loss intervention without resistance training for breast cancer survivors., Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey., Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.|Assess changes in health-related quality of life after a weight loss intervention., Outcomes include SF-36 and FACT-fatigue surveys, Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.|Determine feasibility, acceptability, and safety of weight loss intervention with resistance training for breast cancer survivors., Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey., Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011. | University of Vermont | University of Vermont Medical Center | FEMALE | ADULT, OLDER_ADULT | NA | 72 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 10-031 | 2009-10 | 2012-01 | 2012-01 | 2011-11-30 | 2013-01-15 | Vermont Cancer Center, Burlington, Vermont, 05405, United States | |||
| NCT01475565 | Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT01475565 | The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy complications. It is unknown if there are factors that may predict which women are more at risk. The goal of this study is to evaluate the risk factors of gestational diabetes, such as dietary and physical activity factors, race, and how the body handles its own hormones during pregnancy. Our long term goal is to contribute in finding ways to successfully prevent gestational diabetes. | NO | Polycystic Ovary Syndrome|Insulin Resistance|Insulin Sensitivity|Obesity|Pregnancy | Change from Gestation Week 12-14 in Estrogen Metabolites at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Insulin Sensitivity at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34 | Change from Gestation Week 12-14 in Fasting Insulin at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Fasting Glucose at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Areas-under-the-response-curve of Insulin at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Areas-under-the-response-curve of Glucose at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation 12-14 in Matsuda Insulin Sensitivity Index at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Insulin Secretory Response at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Macronutrients at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Urinary Estrogen Metabolites at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Body Weight at Gestation Week 32-34, Gestation weeks 12-14, 24-26, and 32-34|Change from Gestation Week 12-14 in Physical Activity at Gestation Week 32-34, Gestational week 12-14, 24-26, 32-34 | Virginia Commonwealth University | National Institute on Minority Health and Health Disparities (NIMHD) | FEMALE | ADULT | 2 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | HM13733 | 2013-05 | 2014-08 | 2014-08 | 2011-11-21 | 2015-12-14 | Virginia Commonwealth University Medical Center, Richmond, Virginia, 23298-5051, United States | ||||||
| NCT01472445 | Vitamin D and Breast Cancer: Does Weight Make a Difference? | https://clinicaltrials.gov/study/NCT01472445 | This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight. | YES | Breast Cancer | DRUG: Vitamin D | Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene, To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non-obese subjects diagnosed with breast cancer. IGFBP-3 is an endocrine factors. Insulin-like growth factor-binding protein 3 (IGFBP-3) gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and \> 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect., up to 6 weeks | Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene, p21 \[aka p21Cip1; p21Waf1, cyclin-dependent kinase inhibitor 1 (CDKI1) or cyclin-dependent kinase (CDK)-interacting protein 1 (CDKIP1)\] gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and \> 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect., up to 6 weeks|Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene, Matrix metalloproteinase-11 (MMP-11), aka Stromelysin-3 (SL-3), gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and \> 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect., up to 6 weeks | Expression Level of MKI67 Gene, Ki 67 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and \> 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect., up to 6 weeks|Expression Level of ESR1 Gene, ESR1 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and \> 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect., up to 6 weeks|Leptin to Adiponectin Ratio (Leptin:Adiponectin) in Blood, Levels in blood of leptin \& adiponectin were assessed at baseline \& after treatment in participants with body mass index ≤25 and \>25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day and 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin and adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on both leptin and adiponectin collectively, with a value \<1.00 meaning that the effect on leptin levels was reduced relative to the effect on adiponectin levels, and a value \>1.00 that the effect on leptin levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 means no measure change)., up to 6 weeks|HOMA-IR to Adiponectin Ratio (HOMA-IR:Adiponectin) in Blood, The Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR) was used to assess fasting insulin \& glucose levels. HOMA-IR \& adiponectin were assessed at baseline \& after treatment in participants with body mass index ≤25 and \>25. By protocol design, the outcome is for non-obese vs obese participants stratified between 400 \& 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin \& adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome expresses the treatment effect on HOMA-IR \& adiponectin collectively, with \<1.00 meaning effect on HOMA-IR levels is reduced relative to the effect on adiponectin levels, \& \>1.00 meaning the effect is increased relative, with a greater difference meaning greater effect (1.00 represents no measure change)., up to 6 weeks|cRP (C-reactive Protein) to Adiponectin Ratio (cRP:Adiponectin) in Blood, Levels in blood of cRP (C-reactive protein) \& adiponectin were assessed at baseline \& after treatment in participants with body mass index (BMI) ≤25 and \>25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day \& 10,000 IU/day. For all serum protein levels, the outcome is the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin \& adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on cRP and adiponectin collectively, with a value \< 1.00 meaning effect on cRP levels was reduced relative to the effect on adiponectin levels, and a value \> 1.00 meaning effect on cRP levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 represents no measure change)., up to 6 weeks|Pharmacokinetics of Vitamin D Metabolite Calcitriol, Blood levels (pharmacokinetics) of Vitamin D were evaluated as the blood levels of Vitamin D metabolite calcitriol (also known as 1,25-dihydroxycholecalciferol or 1,25(OH)2D) in participants receiving 400 IU/day Vitamin D. The outcome is reported as the mean calcitriol level pre-treatment and post-treatment, with standard deviation., up to 6 weeks | Melinda Telli | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 41 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE | IRB-21034|SU-09262011-8486|BRSADJ0024 | 2011-11 | 2014-10 | 2015-10 | 2011-11-16 | 2019-04-19 | 2019-04-19 | Stanford University Cancer Institute, Stanford, California, 94305, United States | |||
| NCT01464398 | Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS) | https://clinicaltrials.gov/study/NCT01464398 | The purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities. | NO | Polycystic Ovary Syndrome|Overweight|Obesity|Stress, Physiological|Stress, Psychological | BEHAVIORAL: Stress reduction|BEHAVIORAL: Stress reduction with Health education | Change from Baseline in Toronto Mindfulness Scale at 8 weeks, baseline and 8 weeks | Change from Baseline in Toronto Mindfulness Scale at 16 weeks, baseline and 16 weeks|Change from Baseline in Hemoglobin A1c at 8 weeks, baseline and 8 weeks|Change from Baseline in Hemoglobin A1c at 16 weeks, baseline and 16 weeks|Change from Baseline in Mean Arterial Pressure at 8 weeks, baseline and 8 weeks|Change from Baseline in Mean Arterial Pressure at 16 weeks, baseline and 16 weeks|Change from Baseline in SF-36 at 8 weeks, baseline and 8 weeks|Change from Baseline in SF-36 at 16 weeks, baseline and 16 weeks|Change from Baseline in Brief Symptom Inventory-18 at 8 weeks, baseline and 8 weeks|Change from Baseline in Brief Symptom Inventory-18 at 16 weeks, baseline and 16 weeks | Milton S. Hershey Medical Center | National Center for Complementary and Integrative Health (NCCIH)|Thomas Jefferson University | FEMALE | ADULT, OLDER_ADULT | NA | 86 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 34145EP|K23AT006340 | 2011-11 | 2014-06 | 2014-06 | 2011-11-03 | 2015-05-14 | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States | ||||
| NCT01459237 | Effects of Hormone Stimulation on Brain Scans for Cushing s Disease | https://clinicaltrials.gov/study/NCT01459237 | Background: * Cushing s disease can be caused by a tumor of the pituitary gland, a small gland about the size of a pea located at the base of the brain. These tumors produce high levels of hormones, which cause obesity, diabetes, and growth problems. The cure for this type of Cushing s disease is to have surgery that removes the tumor but leaves the pituitary gland alone. Currently, magnetic resonance imaging scans are the best way to find these tumors. However, many of these tumors do not show up on the scan. * Positron emission tomography (PET) scans use radioactive chemicals to light up parts of the body that are more active, such as tumors. Researchers want to try to make the small Cushing s disease tumors more active to help them show up on the scans. A special hormone will be given before the scan to make the tumors more active. Objectives: – To test the use of hormone stimulation to improve brain scans for Cushing s disease tumors. Eligibility: – Individuals at least 8 years of age who will be having surgery to remove Cushing s disease tumors. Design: * Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. * They will have three brain scans before surgery. The first scan is a magnetic resonance imaging scan to show a full picture of the brain. The second and third scans are PET scans. * The first PET scan will be given without the special hormone. The second PET scan will be done more than 24 hours but less than 14 days after the first PET scan. The second PET scan will be given with the special hormone. * Participants will have tumor removal surgery through another study protocol. | NO | Pituitary Neoplasm | DRUG: Acthrel | To determine effect of CRH stimulation on 18F-FDG uptake in high-resolution PET-imaging of ACTH-adenomas in CD., Ongoing | To determine if CRH stimulation (compared to without CRH stimulation) enhances the detection of ACTH-adenomas as demonstrated on 18F-FDG high-resolution PET-imaging in CD., Ongoing|To assess the accuracy and sensitivity of 18F-FDG high-resolution PET-imaging detection of ACTH-adenomas in CD compared to MR-imaging., Ongoing | National Institute of Neurological Disorders and Stroke (NINDS) | ALL | CHILD, ADULT, OLDER_ADULT | EARLY_PHASE1 | 30 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC | 120007|12-N-0007 | 2011-10-11 | 2018-01-30 | 2018-06-12 | 2011-10-25 | 2018-06-14 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | |||||
| NCT01457976 | A Survey on Attitudes on Financial Incentives | https://clinicaltrials.gov/study/NCT01457976 | The study concerns a survey of attitudes of the public on issues around personal responsibility for health and the use of financial incentives to promote health in the U.S. and Germany. All data are gathered anonymously through online platforms. Two separate professional panel providers are used for access to members of the public. All participants are people who have voluntarily joined a survey panel in the past through an informed consent process and currently serve as panel members. | NO | Obesity|Colon Cancer | Survey respondents are presented with scenarios that seek to elicit views and attitudes on the concepts of personal responsibility, and the acceptability of financial incentives. The analysis will present these views and attitudes in aggregate form., Attitudes are measured using 5 point Likert scales, indicating the extent of agreement or disagreement with particular scenarios or questions. Other forms of multiple choice options are also used, in which respondents express their preferences by selecting one option over others. At the end of the surveys, an open text box is provided for general comments., 2 weeks | University of Pennsylvania | ALL | ADULT, OLDER_ADULT | 0 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 814399 | 2011-09 | 2011-10 | 2011-10 | 2011-10-24 | 2016-08-18 | Online survey, Philadelphia, Pennsylvania, United States | ||||||||
| NCT01443156 | The Effects of Work Schedule and Sleep Patterns on Caregivers’ Health | https://clinicaltrials.gov/study/NCT01443156 | BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and can lead to many harmful health outcomes such as a higher risk of obesity, heart disease, and diabetes. Sleep deficiency can also harm cognitive performance, which refers to one’s awareness and thinking ability. Sleep deficiency and sleep-related health issues are of high interest among those who have irregular and/or extended work schedules, because such schedules can interfere with normal biological rhythms of sleepiness and wakefulness. PURPOSE. This study will examine the health and cognitive effects of work schedule and sleep patterns in caregivers (such as nurses, laboratory technicians, and non-clinical hospital staff). The investigators hypothesize that the nontraditional, irregular, and extended work hours common in these professions will have adverse health and cognitive effects. The purposes of this protocol are to: * Enroll caregivers into a one year cohort study on the relationships among work schedule, sleep, diet, chronic disease, and cognitive performance. (A cohort study follows a group of participants over time to see how different behaviors or risk factors affect health.) * Collect data from caregivers on work schedule, sleep, diet, chronic disease, and cognitive performance. * Give personalized information and feedback to caregivers about these health factors. * Educate caregivers about healthy diet and exercise choices. * Collect saliva from caregivers for future research on the role of genes in health. (Specimen collection for genetic testing will be offered as a separate option for study participants.) RECRUITMENT. This study will use the Let’s Get Healthy! health research and education program (OHSU IRB #3694) as a platform for recruitment and data collection. Caregivers will be invited to participate in a Let’s Get Healthy! event and will be given information prior to the event about the cohort study. At the Let’s Get Healthy! event, caregivers will first consent to the anonymous research study (OHSU IRB #3694), in which demographic and health screening data are linked to a random number. Caregivers will then have the option to consent to a cohort study, in which data are no longer anonymous but instead linked to participants’ names and contact information. PROCEDURES. This cohort study piggybacks on procedures already approved for the Let’s Get Healthy! program (OHSU IRB #3694). Let’s Get Healthy! is a study in which participants provide anonymous data at health fairs through any or all of the following manners: short computer surveys on cancer awareness, risk factors, and family history (with immediate feedback given on cancer risk and prevention); short computer surveys on diet and sleep patterns (with immediate printed feedback given); health screening measurements (blood pressure, height, weight, waist circumference, body mass index, body fat percentage); a finger stick to assess sugar and fat levels in blood; and a mouthwash swish to provide a saliva specimen. However, this cohort study (OHSU IRB #7542) will make the following changes and additions: * Personal health data, instead of being anonymous, will be linked to participants’ names and contact information (for follow-up data collection). * Let’s Get Healthy! events will include cognitive performance tests, a preventative-care survey, and a work schedule survey. * Participants will provide data not only at an initial Let’s Get Healthy! event, but also at a follow-up event and during the time period between events. Between events, participants will do the surveys on work schedule, diet, and sleep, and they will complete cognitive performance tests. * There will be a separate consent process for participants to provide a fully identifiable saliva specimen. DATA ANALYSIS. Participants’ health data will be fully identifiable at the time of data collection but will be coded and stored in a physically separate location from the identifiable information. The link between identifiable information and coded health information will be stored on a password protected computer, and all identifiable information will be deleted upon completion of data analyses. Data will be analyzed to explore relationships among work schedule, sleep, diet, body composition, metabolic health, chronic disease, and cognitive performance in caregivers. Genetic relationships with these factors will be analyzed in those who provided a saliva specimen during entry visit data collection. | NO | Obesity|Diabetes|Cancer|Metabolic Syndrome|Sleep Deprivation | Cognitive performance, Brief computerized tasks of attention, vigilance, and memory., Up to one year|Body Composition, Height, weight, waist circumference, body fat percentage, body mass index, Up to one year|Diet, Brief computerized survey on fruit, vegetable, and fat intake., Up to one year|Work Schedule, Survey on the quantity and distribution of work hours., Up to one year | Blood Pressure, Up to one year|Blood cholesterol, glucose, triglycerides, Fingerstick test, Up to one year|Breast, skin, and lung cancer prevention behaviors and knowledge, Brief computerized questionnaires., Up to one year|Preventive care habits, Brief survey on basic health behaviors and use of preventive care resources., Up to one year | Oregon Health and Science University | ALL | ADULT, OLDER_ADULT | 211 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | OHSU eIRB7542 | 2012-01 | 2013-02 | 2014-01 | 2011-09-29 | 2023-11-02 | St. Charles Medical Center, Bend, Oregon, 97701, United States | |||||||
| NCT01441323 | Strength Training and Nutrition Development for African American Youth | https://clinicaltrials.gov/study/NCT01441323 | STAND | The investigators are conducting an intervention study to examine the effects of a 16-week exercise and diet interventions on prevention of disease, specifically type 2 diabetes and heart disease, in African American youth. Sixty overweight African American boys and girls will be recruited and placed in one of the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake), or 3) Combination of Strength Training (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary Education (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake). The investigators will assess which intervention group has the most effects on health parameters such as weight, body composition, and insulin related measures. | NO | Obesity|Type 2 Diabetes|Cardiovascular Risk|Cancer | BEHAVIORAL: Nutrition|BEHAVIORAL: Strength Training & Nutrition | insulin sensitivity, post interventive (week 16) | adiposity, post intervention (week 16) | University of Southern California | National Cancer Institute (NCI) | ALL | CHILD, ADULT | NA | 62 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION | 195-1642394A1|1U54CA116848 | 2007-06 | 2008-11 | 2008-12 | 2011-09-27 | 2017-03-31 | Veronica Atkins Lifestyle Intervention Laboratory, Los Angeles, California, 90033, United States | |||
| NCT01441011 | Rural Women Connecting for Better Health | https://clinicaltrials.gov/study/NCT01441011 | Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity. | NO | Breast Cancer|Obesity | BEHAVIORAL: Group phone counseling|BEHAVIORAL: Newsletter | Weight loss maintenance, Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors., 6 – 18 months | Quality of life, Compare the effects of treatment conditions on aspects of quality of life important for breast cancer survivorship, including general physical, social, and emotional well-being, fatigue, arthralgia, lymphedema symptoms, menopausal symptoms, and depressive symptoms., Baseline and 6, 12, 18, and 24 months|Breast cancer risk biomarkers, Examine the association of weight change with changes in selected breast cancer risk biomarkers, including bioavailable estradiol, testosterone, and fasting insulin. Examine whether modulation of biomarkers is sustained during weight loss maintenance., Baseline and 6 and 18 months|Cost effectiveness, Compare the incremental cost-effectiveness of weight loss maintenance (kg below baseline) between group and control conditions. Costs include fixed and variable provider costs (facility, time, phone charges, supplies) and fixed and variable participant costs (time, out-of-pocket expenses)., 18 months | University of Kansas Medical Center | National Cancer Institute (NCI) | FEMALE | CHILD, ADULT, OLDER_ADULT | NA | 210 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 12633|1R01CA155014-01A1 | 2011-08 | 2015-04 | 2015-10 | 2011-09-27 | 2016-11-23 | University of Kansas Medical Center, Kansas City, Kansas, 66160, United States | ||||
| NCT01431326 | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care | https://clinicaltrials.gov/study/NCT01431326 | PTN_POPS | Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese). | NO | Adenovirus|Anesthesia|Anxiety|Anxiolysis|Autism|Autistic Disorder|Bacterial Meningitis|Bacterial Septicemia|Benzodiazepine|Bipolar Disorder|Bone and Joint Infections|Central Nervous System Infections|Convulsions|Cytomegalovirus Retinitis|Early-onset Schizophrenia Spectrum Disorders|Epilepsy|General Anesthesia|Gynecologic Infections|Herpes Simplex Virus|Infantile Hemangioma|Infection|Inflammation|Inflammatory Conditions|Intra-abdominal Infections|Lower Respiratory Tract Infections|Migraines|Pain|Pneumonia|Schizophrenia|Sedation|Seizures|Skeletal Muscle Spasms|Skin and Skin-structure Infections|Treatment-resistant Schizophrenia|Urinary Tract Infections|Withdrawal|Sepsis|Gram-negative Infection|Bradycardia|Cardiac Arrest|Cardiac Arrhythmia|Staphylococcal Infections|Nosocomial Pneumonia|Neuromuscular Blockade|Methicillin Resistant Staphylococcus Aureus|Endocarditis|Neutropenia|Headache|Fibrinolytic Bleeding|Pulmonary Arterial Hypertension|CMV Retinitis|Hypertension|Chronic Kidney Diseases|Hyperaldosteronism|Hypokalemia|Heart Failure|Hemophilia|Heavy Menstrual Bleeding|Insomnia | DRUG: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: | Composite of pharmacokinetic outcomes for understudied drugs in children, As appropriate for each study drug, the following additional PK parameters will be estimated: * maximum concentration (Cmax) * time to achieve maximum concentration (Tmax) * absorption rate constant (ka) * elimination rate constant (kel) * half-life (t1/2) * area under the curve (AUC) Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples., Data will be collected throughout the hospital or outpatient stay up to 90 days | Composite pharmacodynamic outcomes of understudied drugs in children, When applicable, Monte Carlo simulations will be performed to evaluate therapeutic target attainment rates (pharmacodynamics) in the population of interest. The final PK model and parameters estimated in the population PK analysis will be used to perform these simulations., Data will be collected throughout the hospital or outpatient stay up to 90 days|Biomarkers associated with understudied drugs in children, The dosing, sampling, and demographic information recorded on the electronic data collection forms will be merged with the bioanalytical information to create a biomarker dataset for each study drug. Biomarkers will be identified using metabolomics/proteomics and pharmacogenomics methodologies. Samples for biomarker analysis will be stored for future use in a PTN designated biorepository. Associations between biomarkers and drug exposure will be explored by visual inspection (i.e. scatter plots) and statistical comparisons as needed., Data will be collected throughout the hospital or outpatient stay up to 90 days | Daniel Benjamin | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|The Emmes Company, LLC | ALL | CHILD, ADULT | 3520 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Pro00029638|IND 113645|IND 114369|IND 114531|IND 118358|HHSN20100006|HHSN27500020|HHSN27500027|HHSN27500043|HHSN27500049 | 2011-11 | 2019-11 | 2019-11 | 2011-09-09 | 2023-09-06 | Alaska Native Medical Center, Anchorage, Alaska, 99508, United States|Arkansas Children’s Hospital, Little Rock, Arkansas, 72202, United States|University of California at San Diego Medical Center, La Jolla, California, 92093, United States|Axis Clinical Trials, Los Angeles, California, 90036, United States|University of California, Los Angeles Medical Center, Los Angeles, California, 90095, United States|The Children’s Hospital Colorado, Aurora, Colorado, 80045, United States|Yale New Haven Children’s Hospital, New Haven, Connecticut, 06504, United States|Alfred I. DuPont Hospital for Children, Wilmington, Delaware, 19803, United States|Children’s National Medical Center, Washington, District of Columbia, 20010, United States|University of Florida Jacksonville Shands Medical Center, Jacksonville, Florida, 32209, United States|Kapiolani Womens and Childrens Medical Center, Honolulu, Hawaii, 96826, United States|Lurie Children’s Hospital of Chicago, Chicago, Illinois, 60614, United States|Riley Hospital for Children at Indiana University, Indianapolis, Indiana, 46202, United States|University of Kansas Medical Center, Fairway, Kansas, 66205, United States|Children’s Mercy Hospital and Clinics, Kansas City, Kansas, 66160, United States|Wesley Medical Center, Wichita, Kansas, 67214, United States|Norton Children’s Hospital, Louisville, Kentucky, 40202, United States|Tulane University Health Science Center, New Orleans, Louisiana, 70112, United States|Ochsner Baptist Clinical Trials Unit, New Orleans, Louisiana, 70115-6969, United States|University of Maryland, Baltimore, Maryland, 21201, United States|Children’s Hospital of Michigan, Detroit, Michigan, 48201, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Children’s Mercy Hospitals and Clinics, Kansas City, Missouri, 64108, United States|University of Montana, Missoula, Montana, 59804, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States|University of New Mexico, Health Sciences Center, Albuquerque, New Mexico, 87131, United States|UNC Hospital Neonatal-Perinatal Medicine, Chapel Hill, North Carolina, 27599, United States|Duke University Medical Center (PICU / NICU), Durham, North Carolina, 27710, United States|Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States|Rainbow Babies and Children’s Hospital, Cleveland, Ohio, 44106, United States|Akron Children’s Hospital, Cleveland, Ohio, 44313, United States|Board of Regents of the University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States|Oregon Health and Science University, Portland, Oregon, 97201-2701, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|University of South Carolina, Columbia, South Carolina, 29203, United States|University of Utah Hospitals and Clinics, Salt Lake City, Utah, 84108, United States|University of Vermont Medical Center, Burlington, Vermont, 05405, United States|University of Virginia Children’s Hospital, Charlottesville, Virginia, 22908-0386, United States|Seattle Children’s Hospital, Seattle, Washington, 98105, United States|West Virginia University Hospital, Morgantown, West Virginia, 26506, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Manitoba Institute of Child Health, Winnipeg, Manitoba, R3E 3P4, Canada|Children’s Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Hospital Sainte-Justine, Montreal, Quebec, T3T 1C5, Canada|Assaf Harofeh Medical Center, Zerifin, Tel Aviv, 70300, Israel|Schneider Children’s Medical Center of Israel, Petah Tikva, 49202, Israel|KK Women’s and Children’s Hospital Pte Ltd, Singapore, 229899, Singapore|Southampton General Hospital, Southampton, Hampshire, SO16 6YD, United Kingdom|Alder Hey Children’s Hospital, Liverpool, Merseyside, L12 2AP, United Kingdom | ||||
| NCT01422746 | Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess | https://clinicaltrials.gov/study/NCT01422746 | This study will test whether metformin administration can ameliorate androgen (male hormone) overproduction in overweight pubertal girls with androgen excess. The investigators hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration will improve androgen levels after adrenal stimulation testing with adrenocorticotropic hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG). | NO | Obesity|Hyperandrogenemia|Polycystic Ovary Syndrome | DRUG: Metformin | Changes in free testosterone or 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after metformin administration for 12 weeks, 12 weeks after metformin administration | Changes in adrenal and ovarian steroid precursors after ACTH and rhCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of metformin administration, 12 weeks after metformin administration | University of Virginia | FEMALE | CHILD, ADULT | EARLY_PHASE1 | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 19302|CBS006 | 2017-03-20 | 2024-12 | 2024-12 | 2011-08-24 | 2023-10-27 | University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, 22908, United States | |||||
| NCT01422733 | Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction | https://clinicaltrials.gov/study/NCT01422733 | This study will test whether longer-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight early pubertal girls with androgen excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin hormone (ACTH) production by 12 weeks of evening oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. Specifically, this intervention will improve androgen levels after adrenal stimulation testing with ACTH or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG). | NO | Hyperandrogenemia|Obesity|Polycystic Ovary Syndrome | DRUG: Hydrocortisone|DRUG: dexamethasone|DRUG: Cosyntropin|DRUG: rhCG | Changes in free testosterone or 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after hydrocortisone administration for 12 weeks, 12 weeks after hydrocortisone administration | Changes in adrenal and ovarian steroid precursors after ACTH and rhCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of hydrocortisone administration, 12 weeks after hydrocortisone administration|Morning cortisol, 72 hours following discontinuation of hydrocortisone | University of Virginia | FEMALE | CHILD | EARLY_PHASE1 | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | CBS004|CBS004 | 2018-06-01 | 2018-07-17 | 2018-07-17 | 2011-08-24 | 2018-07-19 | University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, 22908, United States | |||||
| NCT01422759 | Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess | https://clinicaltrials.gov/study/NCT01422759 | Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal glands of girls with obesity and androgen excess | NO | Obesity|Hyperandrogenemia|Polycystic Ovary Syndrome | DRUG: Spironolactone | Changes in free testosterone and 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after spironolactone administration for 12 weeks, 12 weeks after spironolactone treatment | Changes in adrenal and ovarian steroid precursors after ACTH and rhCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of spironolactone administration, 12 weeks after spironolactone administration | University of Virginia | FEMALE | CHILD, ADULT | NA | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 19258|CBS005 | 2016-12-09 | 2024-12 | 2024-12 | 2011-08-24 | 2023-10-27 | University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, 22908, United States | |||||
| NCT01422707 | Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess | https://clinicaltrials.gov/study/NCT01422707 | Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries | NO | Hyperandrogenemia|Obesity|Polycystic Ovary Syndrome | DRUG: Hydrocortisone | Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks, 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration | Changes in adrenal steroid precursors after ACTH, baseline, and after 4 weeks of hydrocortisone administration, 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration | University of Virginia | FEMALE | CHILD, ADULT | EARLY_PHASE1 | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | CBS003|CBS003 | 2018-01-19 | 2018-07-17 | 2018-07-17 | 2011-08-24 | 2018-07-19 | University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, 22908, United States | |||||
| NCT01421758 | Testing the Efficacy of an Online Social Network Intervention to Increase Social Support for Physical Activity | https://clinicaltrials.gov/study/NCT01421758 | INSHAPE | This study was designed to determine whether participation in an online social network intervention increases perceived social support for physical activity versus a minimal education control group by conducting a randomized controlled trial with 140 female undergraduate students. The investigators hypothesize that participants in the physical activity centered online social network intervention group will have greater increases in perceived social support for physical activity compared to minimal web based physical activity education controls. | NO | Cardiovascular Disease|Cancer|Obesity | BEHAVIORAL: online social network enrollment plus education and self monitoring|BEHAVIORAL: Web education control | Mean perceived social support for physical activity scores on the Peer/Friend Support for Healthy Eating and Physical Activity Scale., The primary outcome measure is the mean score of a 19 item, 7 point scale that measures the frequency of social support interactions over the previous 6 weeks., 10 weeks | Physical activity in kilocalories on the Paffenbarger Physical Activity Questionnaire/College Alumnus Questionnaire, 12 weeks | University of North Carolina, Chapel Hill | FEMALE | CHILD, ADULT | NA | 134 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 10-1122 | 2010-12 | 2011-04 | 2011-05 | 2011-08-23 | 2016-04-19 | University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States | ||||
| NCT01422096 | Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess | https://clinicaltrials.gov/study/NCT01422096 | This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG). | NO | Hyperandrogenemia|Obesity|Polycystic Ovary Syndrome | DRUG: Leuprolide | 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration, 4 weeks after leuprolide | Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration, 4 weeks after leuprolide | University of Virginia | FEMALE | CHILD, ADULT | EARLY_PHASE1 | 0 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | CBS007|CBS007 | 2018-06-01 | 2018-07-17 | 2018-07-17 | 2011-08-23 | 2018-07-19 | University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, 22908, United States | |||||
| NCT01421810 | Ovarian Contribution to Androgen Production in Adolescent Girls | https://clinicaltrials.gov/study/NCT01421810 | CBS001 | Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens. | NO | Polycystic Ovary Syndrome|Obesity|Hyperandrogenism | DRUG: Dexamethasone|DRUG: rhCG | Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin (rhCG) administration in normal weight and overweight girls across puberty, 24 hours after administration of rhCG administration | University of Virginia | University of California, San Diego | FEMALE | CHILD, ADULT | NA | 80 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 15298 | 2011-03-10 | 2025-12 | 2025-12 | 2011-08-23 | 2023-10-27 | University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, 22908, United States | ||||
| NCT01421797 | Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation | https://clinicaltrials.gov/study/NCT01421797 | Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight. | NO | Hyperandrogenemia|Polycystic Ovary Syndrome|Obesity | DRUG: Dexamethasone|DRUG: Cortrosyn | Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls., A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls., Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning). | Overnight changes in male and female hormones in response to ACTH suppression, Secondary endpoints will include overnight changes in testosterone, estradiol, cortisol, dehydroepiandrosterone (DHEA), and luteinizing hormone (LH) pulse patterns in response to adrenocorticotropic hormone (ACTH) suppression. These secondary endpoints will be evaluated in a similar manner to the primary endpoint., 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning)|Response to ACTH stimulation in normal weight and overweight girls, Examine the differences in hormone responses to ACTH in normal weight and overweight girls., 14 hours (1900 – 0800 hrs) | University of Virginia | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|University of California, San Diego | FEMALE | CHILD, ADULT | NA | 84 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 12702|JCM022|U54HD028934-18|12702 | 2006-10-10 | 2024-08-27 | 2024-12 | 2011-08-23 | 2023-10-27 | University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, 22902, United States | ||||
| NCT01365975 | Follow-up Study of Late Effects of Periconceptional Folic Acid in Mothers and Offspring in the Community Intervention Program Population: The Chinese Children and Families Study | https://clinicaltrials.gov/study/NCT01365975 | Periconceptional folic acid supplements of 400 (Micro) daily prevent neural tube defects (NTD) in offspring. Some data suggest that periconceptional folic acid supplements, folate levels during pregnancy, and/or certain variants in the gene that encodes methylenetetrahydrofolate reductase (MTHFR), a key enzyme that catalyzes synthesis of 5-methyltetrahydrofolate \[the primary methyl donor in most metabolic pathways involving methylation including DNA methylation\] from 5,10 methylenetetrahydrofolate may be associated with reduced risks of certain adverse events during the prenatal period, birth weight and certain serious diseases in offspring, while other studies have raised concerns about increased risks of specific serious disorders. Only one study has examined late health effects in mothers that might be associated with use of periconceptional folic acid supplements. We propose to study potential health benefits and adverse effects of periconceptional folic acid supplements in a 15-year follow-up of offspring and mothers. In the offspring, we will evaluate whether periconceptional folic acid supplements reduced risk of external congenital birth defects and childhood acute lymphoblastic leukemia, and whether risks are reduced or increased for other pediatric disorders linked with periconceptional folic acid supplements including asthma, pervasive developmental disorders and autism, diabetes, obesity and blood pressure. In the mothers, we will assess cardiovascular diseases and associated risk factors, breast and colorectal cancers and precursor conditions, and other cancers. We will also conduct exploratory assessment of other serious diseases in mothers. To increase the limited data on the morbidity and survival of children born with a major birth defect, particularly in low- or middle-income countries, we plan to assess morbidity and mortality outcomes in children identified with neural tube defects as part of our follow-up. The women and children who participated in the joint China-U.S. Community Intervention Program (CIP) trial (N=243,779 women treated or not treated with folic acid in the periconceptional period and their offspring) represent unique cohorts whose periconceptional exposure to folic acid is well documented. We propose to follow a sample of 22,000 CIP mothers and their offspring (currently 14 to 17 years of age), to ascertain vital status, medical history, and lifestyle habits. The study will clarify whether there are differences with respect to growth, physical development during the puberty period, selected serious morbidity and mortality in offspring and risks of serious health outcomes and mortality in mothers associated with periconceptional folic acid supplements. Data from this study will inform us about cohort participation rate, cost, and effective approaches for future follow-up of the full cohort. The current protocol focuses on a pilot study (Pilot Study # 1) in which we will carry out two specific aims in 500 families. We will test and evaluate the most effective approaches to trace the mothers who enrolled in the CIP in 1993-1995 in CIP counties, fathers, and children. If the child is not living with the biological mother, we will trace the caretaker or next of kin with whom the child is living. We will also conduct in-person interviews, obtain anthropometric and blood pressure measurements and determine cohort participation rate in a sample of 500 CIP families from two of the 21 CIP project counties to obtain health information, medical history, and vital status. We will attempt to enroll in the pilot study 500 mothers/caretakers and 500 offspring, and 500 fathers (Total N=1500). Excluded from the Pilot Study #1 at this time are the families in which the mother or the child is deceased. We will seek permission from the IRB to enroll these families at a later date. | NO | Pediatric Leukemia|Other Pediatric Cancers | Evaluation of long term health effects, observational study inquiring about various measures of health including cancer, hypertension, and diabetes., 1994-2012 | National Cancer Institute (NCI) | ALL | CHILD, ADULT | 1382 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999911165|11-C-N165 | 2011-06-01 | 2012-12-31 | 2020-03-02 | 2011-06-03 | 2020-03-03 | National Cancer Institute (NCI), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | ||||||||
| NCT01360996 | Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism | https://clinicaltrials.gov/study/NCT01360996 | BEYAZ-PCOS | The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Although OCs are the most common and one of the oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of PCOS women with different body mass index (BMI) are limited. This study is being done to compare the hormone and metabolic changes after treatment with low-dose oral birth control regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with different body weights. | YES | Polycystic Ovary Syndrome | DRUG: 3 mg DRSP/20 μg EE | Biochemical Assessment of Hyperandrogenism, The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units. FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100, 24 weeks | Cardiometabolic Measures, Values represent blood pressure at 24 weeks., 24 weeks|Post Therapy BMI., Post-treatment body mass index at 24 weeks, 24 weeks|Biochemical Indicator of B-vitamin Status, Post-treatment in folate concentrations after 24 weeks of treatment, 24 weeks|Menstrual Cycle Regularity, Post treatment menstrual frequency over 24 weeks normalized to number of menses per year .., 24 weeks|Adrenal Androgen DHEAS, Post-treatment levels of adrenal androgen DHEAS, 24 weeks|Oral Disposition Index, Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism, 24 weeks | Woman’s | Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma | FEMALE | CHILD, ADULT | PHASE4 | 64 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | RP 11-003 | 2011-08 | 2015-02 | 2015-02 | 2011-05-26 | 2017-03-31 | 2017-03-31 | Woman’s Hospital, Baton Rouge, Louisiana, 70815, United States | ||
| NCT01317940 | Nutrition and Body Composition in Acute Lymphoblastic Leukemia | https://clinicaltrials.gov/study/NCT01317940 | Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue. In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements – Vitamin D insufficiency, obesity, and ALL – and their impact on bone density. | YES | Precursor Cell Lymphoblastic Leukemia-Lymphoma|Vitamin D Deficiency | DIETARY_SUPPLEMENT: Vitamin D and Calcium Citrate | Change in Serum Vitamin D Level (Group A), Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification), +6 months | Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A), Bone mineral density (vBMD) at end of study period (Group A: end of Delayed Intensification), +6 months|Change in Vitamin D Level (Group B), Change in serum vitamin D level was assessed in survivors at baseline and after 6 months of supplementation, +6 months|Bone Mineral Density by QCT in Survivors at Study End (Group B), Bone mineral density (vBMD) at end of study period (Group B: after 6 months), +6 months|Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings, Insufficiency defined as 25(OH)D \< 30 ng/ml, 1 timepoint | Children’s Hospital Los Angeles | The Leukemia and Lymphoma Society | ALL | CHILD, ADULT | PHASE2 | 76 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | CCI-10-00273|LLS 6249-11 | 2011-03 | 2014-12 | 2016-01 | 2011-03-18 | 2020-07-08 | 2020-07-08 | Children’s Hospital Los Angeles, Los Angeles, California, 90027, United States | |||
| NCT01315483 | Diet Composition, Weight Control, and Breast Carcinogenesis | https://clinicaltrials.gov/study/NCT01315483 | CHOICE | In the United States, overweight (BMI \> 25 but \< 30 Kg/m2) and obesity (BMI \> 30Kg/m2) are increasing at epidemic rates. A significant association exists between being overweight or obese and breast cancer recurrence and survival. However, evidence continues to accumulate indicating that achieving or maintaining a healthy weight for height (Body Mass Index, BMI, 18.5-25Kg/m2) is associated with a reduced risk for breast cancer and with a decrease in breast cancer associated mortality. Despite this, there is a lack of randomized controlled trials exploring this association and how the process of fat loss or being successful in actually reaching a healthy weight for height differentially affects biomarkers for cancer recurrence. Many dietary approaches for weight loss are currently available to the public, and each purports to offer advantages. However, there is little scientific evidence to indicate how these dietary approaches, some of which vary markedly in the foods that they limit or exclude, affect biomarkers for breast cancer risk. In particular, it is not know whether the critical factor in relation to weight and breast cancer is simply weight loss (negative energy balance), irrespective of the manner in which it is achieved, or if certain dietary approaches affect breast cancer risk biomarkers more favorably than others. Published data from our laboratory suggest that dietary pattern does matter, and therefore the goal of this study is to investigate the effects of two popular weight loss dietary approaches that differ in the extent to which they limit carbohydrate or fat consumption (with effects on dietary glycemic load) compared to a usual care group on prognostic markers for cancer recurrence in postmenopausal breast cancer survivors. The investigators hypothesize that in addition to the anticipated effects of fat loss on circulating levels of bioavailable sex steroid hormones, that the effects of excess fat on breast cancer prognosis can be attributed to three interrelated metabolic processes that affect cancer progression: altered glucose metabolism, chronic inflammation and excessive cellular oxidation. | NO | Breast Cancer | OTHER: Weight Loss Dietary Pattern | Inflammation Markers, C-reactive protein, IL-6, TNF-alpha, Baseline and montlhly for 6 months | Body Fat Percentage (%), % Body fat, % lean muscle mass, Resting Metabolic Rate (RMR) using the BODPOD (Volumetric weighing; Life Measurement, Inc.) and Tanita Bioelectrical Impedence (BI), Baseline and monthly for 6 months|Waist Hip Ratio, Calculated by measuring and dividing waist and hip circumferences, Baseline and monthly for 6 months|Weight, Using 1) BODPOD (Life Measurement, Inc.) and 2) Tanita Bioelectrical Impedence Scale, Baseline and monthly for 6 months|Bioavailable sex steroid hormones, estradiol, estrone, sex hormone binding globulin (SHBG), Baseline and monthly for 6 months|Glucose metabolism, glucose, insulin, IGF-1, IGFBP-3, glycated proteins (HbA1c), Baseline and monthly for 6 months|Cellular oxidation, 8-hydroxy-2-deoxyguanosine, DNA damage sensitivity and repair and 8-isoprostane-F-2-alpha, Baseline and monthly for 6 months | Colorado State University | FEMALE | ADULT, OLDER_ADULT | NA | 259 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | CA125243 | 2008-09 | 2012-01 | 2012-06 | 2011-03-15 | 2013-02-15 | Rocky Mountain Cancer Center, Denver, Colorado, 80220, United States | ||||
| NCT01313455 | Adrenal Hyperplasia Among Young People With PCOS | https://clinicaltrials.gov/study/NCT01313455 | Background: – Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the secretion of certain hormones, which can lead to reproductive and other issues in women. Frequent complications of PCOS include irregular menstruation, development of ovarian cysts, and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in the production of certain hormones and the regulation of steroid levels in the blood, and may be affected in women with PCOS. Researchers are interested in studying possible connections between the adrenal glands and PCOS in young women who have been diagnosed with PCOS and healthy volunteers with normal menstrual function. Objectives: – To investigate possible connections between adrenal gland steroid hormone secretion and polycystic ovarian syndrome. Eligibility: * Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are healthy volunteers with normal menstrual function. * Participants must be willing to discontinue the use of oral contraceptives or any other medications that alter steroid hormone production for at least 1 month before the start of the study. Design: * Participants will be screened with a physical examination, medical history, and blood and urine tests. All participants will also have a pelvic (ovarian) ultrasound. * All participants will be admitted to the hospital for a 1-week testing period, which will involve the following tests: * Regular blood draws for two 2-hour periods (late evening and early morning) to measure hormone levels * Fasting blood draws with a dose of corticotropin to test the body’s adrenal function * Hormone level measurement following regular doses of dexamethasone (a drug that controls the function of the adrenal gland) * Daily urine collection for 6 days. * Other studies, such as imaging studies of the adrenal glands, may be conducted as required by the study researchers. | NO | Adrenal Hyperplasia|Polycystic Ovarian Syndrome|Oligomenorrhea|Obesity|Hyperandrogenism | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | CHILD, ADULT | 96 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 110119|11-CH-0119 | 2011-03-10 | 2017-10-24 | 2011-03-11 | 2019-05-31 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | ||||||||||
| NCT01312467 | Trial of Metformin for Colorectal Cancer Risk Reduction for History of Colorectal Adenomas and Elevated BMI | https://clinicaltrials.gov/study/NCT01312467 | The purpose of this study is to find out whether METFORMIN decreases protein markers in colorectal tissue. This is a phase IIA study of the pharmacodynamics, safety and tolerability of Metformin in decreasing colorectal mucosa in patients with a history of colorectal adenomas in the past 3 years and a BMI \>= 30, with decimals rounded to the nearest whole integer. Metformin as a potential chemopreventive agent for inhibition of the relevant molecular pathways involved in human colorectal carcinogenesis. | YES | Adenomatous Polyp|Colorectal Cancer|Obesity | DRUG: metformin hydrochloride | Change in Activated S6serine235 (i.e., the Ratio of pS6serine235/S6serine235), Tissue S6Ser235 immunostaining was analyzed by the study pathologist using Histo Score (HScore) analysis at baseline and post- metformin (Week 12). The Hscore is determined by estimation of the percentage of cells positively stained with mild, moderate, or strong staining intensity. The final score is determined by weighted estimate, as follows: Hscore = (# cell stained with High intensity/total # cells)x3 + (# cells stained with median intensity/total # cells)x2 + (# cells stained with low intensity/total # cells)x1. Mean and standard deviation of the change in the histo score (H score) of pS6serine235 from baseline were calcuated., From baseline to 12 weeks | Effects of Metformin Hydrochloride on Colorectal Mucosa Proliferation (Ki-67, Phosphorylated IGF-1 Receptor, Phosphorylated Insulin Receptor, Phosphorylated AKT, Phosphorylated mTOR, and Phosphorylated AMP Kinase), Data not collected., Up to 16 weeks|Effects of Metformin Hydrochloride on Serum (Fasting and 2 Hour Postprandial Insulin and Glucose, Fasting IGF-1, IGFBP-1, IGFBP-3, Leptin, Adiponectin and Metformin Levels), Data not collected., Up to 16 weeks|Safety and Tolerability of Metformin Hydrochloride Treatment, All participants will be evaluable for toxicity from the time of their first dose of metformin. Since toxicities in this study are measured as categorical data, primary analysis shall be by tests of binomial proportions (e.g., Mantel-Haenszel chi-squared statistic). This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting., Up to 16 weeks | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | PHASE2 | 45 | NIH | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | NCI-2011-01744|NCI-2011-01744|UCI 10-31|2010-7705|UCI09-13-01|P30CA062203|N01CN35160 | 2011-03 | 2014-03 | 2014-12 | 2011-03-10 | 2015-06-25 | 2019-03-05 | Veterans Administration Long Beach Medical Center, Long Beach, California, 90822, United States|University of California Medical Center At Irvine-Orange Campus, Orange, California, 92868, United States|Kaiser Permanente – Sacramento, Sacramento, California, 95825, United States|Jewish General Hospital, Montreal, Quebec, H3T 1E2, Canada | ||||
| NCT01302379 | Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT01302379 | This objective of this randomized controlled trial is to conduct a 2×2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months. | YES | Breast Neoplasms | DRUG: Metformin|DRUG: Placebo|BEHAVIORAL: Lifestyle intervention|BEHAVIORAL: Standard printed dietary guidelines | Insulin, Insulin measured as percent change from baseline, change from baseline to 6 months|Glucose, Glucose measured as percent change from baseline, change from baseline to 6 months|C-reactive Protein, C-reactive protein measured as percent change from baseline, change from baseline to 6 months|Bioavailable Testosterone, Bioavailable testosterone measured as percent change from baseline, change from baseline to 6 months|Serum Hormone Binding Globulin, Serum hormone binding globulin measured as percent change from baseline, change from baseline to 6 months | University of California, San Diego | FEMALE | CHILD, ADULT, OLDER_ADULT | NA | 333 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | U54 CA155435-01 Project 3 | 2011-08 | 2015-12 | 2016-12 | 2011-02-24 | 2020-06-05 | 2020-06-05 | Moores UCSD Cancer Center, La Jolla, California, 92093, United States | |||||
| NCT01294657 | Obesity: Cancer Risk Among African Americans | https://clinicaltrials.gov/study/NCT01294657 | The goal of this research study is to learn if a motivation and problem solving (MAPS) program can help improve diet and levels of physical activity in African Americans who are overweight. | NO | Cancer|Obesity | BEHAVIORAL: Health Education|BEHAVIORAL: MAPS | Efficacy of a Motivation and Problem Solving (MAPS) Approach to Promoting and Facilitating Positive Health Behavior Change Among African Americans, Effects of MAPS on each of modifiable risk factors, assessed at 6 and 12-month follow-up visits using, using Questionnaire Design System (QDS), a computer-administered self-interview format., 6 months | M.D. Anderson Cancer Center | ALL | ADULT, OLDER_ADULT | 300 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2010-0161 | 2011-01 | 2020-01 | 2021-01 | 2011-02-11 | 2019-05-10 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | |||||||
| NCT01286155 | Epidemiology of Barrett’s Esophagus: A Population Based Study | https://clinicaltrials.gov/study/NCT01286155 | To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett’s esophagus (BE) in the community. To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient | NO | Barrett’s Esophagus|Gastroesophageal Reflux Disease (GERD)|Olmsted County Resident | The primary outcome from the survey will be the proportion of patients willing to undergo an esophageal capsule study compared to those willing to undergo an endoscopic procedure (Esophagogastroduodenoscopy or transnasal endoscopy), 18 months | Study established (age, gender, ethnicity, reflux) and potential risk factors (sleep apnea, visceral adiposity, Helicobacter pylori infection, Metabolic Syndrome)to develop a clinical risk factor model for diagnosis of Barrett’s esophagus(BE)., Metabolic Syndrome (ATP III criteria, JAMA 2001; 285: 2486-97.) defined as a combination of clinical disorders that includes the presence of three or more of the following indicators: 1. abdominal obesity (waist circumference \> 102 cm in men, \> 88 cm in women); 2. high triglyceride level (≥ 150 mg/dL); 3. low level of high density lipoprotein (\< 40 mg/dL in men; \< 50 mg/dL in women); 4. high blood pressure (≥ 130/85 mmHg); 5. high fasting plasma glucose (≥ 110 mg/dL)., 18 months | Mayo Clinic | American College of Gastroenterology | ALL | ADULT, OLDER_ADULT | 534 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 09-002718 | 2010-01 | 2011-06 | 2011-06 | 2011-01-31 | 2013-05-06 | Mayo Clinic, Rochester, Minnesota, 55905, United States | ||||||
| NCT01262664 | A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity | https://clinicaltrials.gov/study/NCT01262664 | The goal of this clinical research study is to find the highest tolerable dose of PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there are no standard therapy options. The safety of this drug will also be studied. | NO | Prostate Cancer | DRUG: Prohibitin-TP01 | Acceptable Dose of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity, Dose is acceptable if is not unlikely that a dose has at least a 50% response rate, and that it is not unlikely that the dose has at most a 30% toxicity rate., 58 days|Biologic Activity of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity, Biologic Activity (BA) defined as loss of 10% of baseline body weight (or equivalently, a 10% reduction in BMI) as measured at the end of the 28 day dosing period., 28 days | M.D. Anderson Cancer Center | MALE | ADULT, OLDER_ADULT | PHASE1 | 4 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2010-0369|NCI-2011-00300 | 2012-05-24 | 2019-01-02 | 2019-01-02 | 2010-12-17 | 2019-01-04 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | ||||||
| NCT01253720 | PACE CALL: Weight Loss Study for Childhood Leukemia Survivors | https://clinicaltrials.gov/study/NCT01253720 | UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesized that those study participants randomized to the intervention will demonstrate greater reduction in BMI-z score as compared to the control group. | NO | Acute Lymphoblastic Leukemia|Cancer|Obesity | BEHAVIORAL: PACE CALL/Fit4Life | BMI, To determine the impact of a weight loss intervention on BMI compared to a control group, Baseline, 4 months | Weight Loss Behaviors, To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity., Baseline, 4 months|Metabolic Blood Measures, To determine the impact of a weight loss intervention vs. control on fasting serum insulin, fasting blood glucose, and blood lipid levels., Baseline, 4 months|Psychosocial Mediators of Weight Loss Behaviors, To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes, Baseline, 4 months|Quality of Life, To determine the impace of a weight loss intervention vs. control on quality of life and depression., Baseline, 4 months | Huang, Jeannie, M.D. | University of California, San Diego | ALL | CHILD, ADULT | NA | 38 | INDIV | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 070731 | 2008-06 | 2013-06 | 2013-06 | 2010-12-03 | 2016-01-26 | UC San Diego, La Jolla, California, 92093, United States | ||||
| NCT01240213 | Vitamin D, Diet and Activity Study | https://clinicaltrials.gov/study/NCT01240213 | ViDA | Experimental and human data suggests that vitamin D could protect against breast cancer. Overweight/obese individuals are at increased risk of low vitamin D levels. Vitamin D may reduce production of fat tissue, thereby reducing weight gain, which would result in lower levels of adipose-derived hormones and other breast cancer risk factors.The purpose of this study is to test the effect of vitamin D supplementation on the response to a weight loss (diet + exercise) intervention and select breast cancer risk factors in overweight and obese postmenopausal women with low blood vitamin D levels. | NO | Breast Cancer|Obesity|Hypovitaminosis D | DIETARY_SUPPLEMENT: Vitamin D|DIETARY_SUPPLEMENT: Placebo | Compare the effects of a 1-year one year Vitamin D supplementation vs placebo, on weight loss in postmenopausal women following a weight loss diet and exercise program., One Year | Determine the effects of 12-months vitamin D vs. placebo on blood biomarkers (insulin,glucose,CRP) associated with increased breast cancer risk., One Year|Test 12-months vitamin D effects on muscle strength as measured by 1RM leg press and bench press in women undergoing weight loss., One Year|Test the effect of 12-month vitamin D supplementation on effects on quality of life (QOL) in women undergoing weight loss., One Year|Effect of Vitamin D supplementation on breast epithelial cell cytomorphology, In a 50% subset of women, test the effect of 12-month vitamin D supplementation vs. placebo on breast epithelial cell cytomorphology (quantified by the Masood cytology index) obtained through random periareolar fine needle aspiration (RPFNA)., One Year|Effect of Vitamin D on epithelial cell gene expression, In a 50% subset of women, test the effect of 12-month vitamin D supplementation vs. placebo on breast epithelial cell gene expression as measured by qRT-PCR. The breast epithelial cells are collected by RPFNA, One year | Fred Hutchinson Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 218 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: | SAC110024|IR 7297 | 2010-10 | 2012-08 | 2012-09 | 2010-11-15 | 2013-08-07 | Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States | ||||
| NCT01195337 | Social Contextual Influences on Physical Activity | https://clinicaltrials.gov/study/NCT01195337 | The goal of this study is to learn why some black and Latino men and women choose not to exercise very often. Researchers also want to learn more about any social and environmental factors that may affect the way an exercise program is followed. | NO | Cancer|Prevention Harmful Effects | BEHAVIORAL: PA Prescription Plan|DEVICE: Pedometer|BEHAVIORAL: Newsletters | Participant Physical Activity Outcome, Physical Activity (PA) outcome measured at four time points post baseline (weeks 8, 26, 39, and 52), 1 year | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | ALL | ADULT | 336 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2008-0763 | 2010-08-16 | 2020-08-31 | 2020-08-31 | 2010-09-06 | 2020-01-13 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | ||||||
| NCT01166672 | BCRL Prevention Pilot | https://clinicaltrials.gov/study/NCT01166672 | The purpose of this study is to establish feasiblity of recruiting obese breast cancer survivors at the end of treatment, getting those survivors to lose weight and attend follow-up visits for 6 months. | NO | Obesity|Breast Cancer | Follow-up Appts., The primary outcome will be the precent of participants who complete 6 month follow-up appointments., 6 months | Response Rates, Secondary outcomes will include response rates (% approached who enroll, consent, and attend intervention sessions), weight loss at 6 months, and arm volumes and lymphedema survey responses at 6 months., 6 months | Abramson Cancer Center at Penn Medicine | FEMALE | ADULT, OLDER_ADULT | 20 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | UPCC 15110 | 2010-07 | 2012-10 | 2012-10 | 2010-07-21 | 2012-10-12 | Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States | |||||||
| NCT01157130 | Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory | https://clinicaltrials.gov/study/NCT01157130 | The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity. | NO | Early Stage Breast Cancer (Stage 0-III) | OTHER: Exercise Regimen | Changes in CRP, The primary endpoint for this study change in C-reactive protein. | Change in laboratory values, Compare changes in: * Glucose * Insulin * Estradiol * Testosterone|Change in body composition, Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups.|Quality of Life, Quality of Life will be measured and compared between the groups|Overall Survival, Comparing overall survival and progression free survival between groups. | Nevada Cancer Institute | Vons | FEMALE | ADULT, OLDER_ADULT | NA | 100 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | NVCI 10-09 | 2010-07 | 2010-07-05 | 2011-07-20 | Nevada Cancer Institute, Las Vegas, Nevada, 89135, United States | ||||||
| NCT01150539 | Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT01150539 | POLY | The effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with Polycystic ovary syndrome (PCOS). | NO | Polycystic Ovary Syndrome|Obesity | OTHER: 16-week exercise training program|OTHER: Control Group without PCOS | Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp, 16-weeks of aerobic exercise training on: peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp) and catecholamines (microdialysis) during a euglycemic-hyperinsulinemic clamp., Baseline and 16-weeks | Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging), 16-weeks of aerobic exercise training on total and free testosterone concentraions and frequency of menstruation, Body lipolysis, and visceral fat., Baseline and 16-weeks | Pennington Biomedical Research Center | FEMALE | ADULT | NA | 8 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | PBRC 26038 | 2007-01 | 2007-05 | 2007-06 | 2010-06-25 | 2021-08-25 | Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States | ||||
| NCT01127867 | A Pilot Study of Docosahexaenoic Acid (DHA) in Obese Menopausal Women | https://clinicaltrials.gov/study/NCT01127867 | This study aims to determine if a supplement of an omega-3-fatty acid (docosahexaenoic – DHA) lowers inflammation in human fat tissue thereby lowering estrogen production and the potential risk for breast cancer. The investigators also aim to study how this occurs to discover the basis for other potential treatments to lower estrogen production in fat tissue and decrease the risk of breast cancer. | NO | Breast Cancer|Obesity | DIETARY_SUPPLEMENT: dietary intervention | Reduced subcutaneous fat (obese), Reduced subcutaneous fat inflammation changes between pre and post treatment for 5 pilot subject as seen by histologic quantification of monocyte aggregations (crowns), CD68 and CD163 stained macrophages in fat biopsies., 6 weeks|Reduced subcutaneous fat (morbidly obese), Reduced subcutaneous fat between pre and post treatment for an additional 12 morbidly obese subjects as seen by histologic quantification of monocyte aggregations (crowns), CD68 and CD163 stained macrophages in fat biopsies., 6 weeks | multiplex bead assay/immunoassay, Lowered aromatase expression in fat biopsies accompanied by decreases in the synthetic enzyme COX1-MPGES-1 and/or increase in the catabolic enzyme 15-PGDH and associated changes in BRAC-1 and SIRT-1 expression by immunohistochemical evaluation of CD68, CD168 and CD3 stained monocytes and through examination of the mRNA of imune inflammatory markers in fat biopsies. Alteration in serum estradiol and testosterone levels and/or changes in circulating cytokines/chemokines measured by multiplex bead assay and immunoassay., 6 weeks | Rockefeller University | FEMALE | ADULT, OLDER_ADULT | NA | 17 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | PHO-0702 | 2010-05 | 2013-04 | 2013-04 | 2010-05-21 | 2017-03-13 | The Rockefeller University, New York, New York, 10065, United States | |||||
| NCT01112839 | Reducing Breast Cancer Recurrence With Weight Loss | https://clinicaltrials.gov/study/NCT01112839 | ENERGY | The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups. | NO | Breast Cancer|Overweight|Obesity | BEHAVIORAL: Less Intensive|BEHAVIORAL: Intensive Group | Weight loss, 2 years | Improvement in quality of life, 2 years|Improvement in fatigue, 2 years | University of California, San Diego | Washington University School of Medicine|University of Colorado, Denver|University of Alabama at Birmingham | FEMALE | ADULT, OLDER_ADULT | NA | 692 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | CA148791-01 | 2010-05 | 2015-02 | 2015-02 | 2010-04-28 | 2015-06-18 | University of Alabama at Birmingham, Birmingham, Alabama, 35294-3360, United States|Moores UCSD Cancer Center, La Jolla, California, 92093, United States|University of Colorado Denver, Aurora, Colorado, 80045, United States|Washington University in St. Louis:, St. Louis, Missouri, 63110, United States | |||
| NCT01107327 | Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) in Cancer Associated Venothromboembolism | https://clinicaltrials.gov/study/NCT01107327 | Venothromboembolic disease (VTE), which includes deep venous thrombosis (DVT) and pulmonary embolism (PE), is a severe health problem, effecting 1.5/1000 per year in the general population. In patients over 60 years of age, the incidence is 1/100 per year. Of the two million Americans per year who will develop VTE, one third will develop pulmonary embolism (PE). VTE is usually diagnosed by Doppler ultrasound or contrast venography when present in the extremities, VQ scan or pulmonary angiography when PE is present. However, there are many instances when the diagnosis of VTE by conventional modalities is limited. These include obesity, recent trauma or surgery, the presence of a mass, the presence of clot around central lines, and clot occurring in the abdomen and pelvis. Furthermore, the differentiation between new and old clot has evaded all diagnostic imaging modalities, and no existing modality allows for an accurate delineation of all sites of thrombus within the body. New approaches to the diagnostic imaging of VTE in complicated cases are needed. The first hypothesis of this project is that FDG PET/CT can be used to accurately diagnose the presence and extent of acute VTE, and that it will distinguish new clot from old. Approximately 20-25% of all new cases of venous thromboembolism occur in known cancer patients. The risk of VTE is 4-6 fold greater in patients with cancer as those without (8-12% vs. 2%, respectively, lifetime risk). In many cases, the development of VTE occurs as the first clinical sign of the cancer, even before it is diagnosed. Among patients presenting with acute VTE have no obvious cause (defined as “idiopathic” or “unprovoked”, as opposed to “secondary” VTE), the literature reports that up to 20% (range of reported incidence 7-20%) may ultimately prove to have cancer, depending on the series and whether the thrombosis is unifocal or multifocal. Despite the substantial prevalence of occult cancer in patients presenting with idiopathic VTE, there are no current recommendations that these patients be screened for the presence of cancer. The second hypothesis of the project is that FDG PET/CT can accurately be used to screen for the presence of cancer in patients with unprovoked (idiopathic) acute VTE. Objectives: There are two specific objectives to test the hypotheses associated with this project: 1. To establish the sensitivity of FDG PET/CT in the diagnosis of acute VTE. 2. To perform a pilot project to aid in the design of a larger trial to define the incidence of occult cancer in patients rigorously selected for idiopathic (unprovoked) VTE, and to investigate the value of FDG PET in the early detection of occult cancer in this population. | NO | Venothromboembolism | PROCEDURE: FDG-PET/CT | Accuracy of FDG PET/CT scanning to diagnose presence, extent, and acuity of Ventothromboembolism diagnosis., We believe that FDG PET/CT can be used to accurately diagnose the presence, extent, and acuity of VTE. We intend to establish the value of FDG PET, instead, as an alternative modality for the diagnosis of VTE. Clinical situations where this might prove useful include: 1) the presence of old clot, when the distinction between new and old may be important; 2) evaluation of abdominal, pelvic and thoracic thrombus, where Doppler is difficult-to-impossible because of patient obesity; 3) Complicated anatomy due to the presence of tumor or post-therapeutic changes., April 2012 | University of Utah | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | 26 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | HCI18327|R01CA121003-01 | 2006-08 | 2012-01 | 2012-01 | 2010-04-20 | 2014-10-31 | University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States | ||||||
| NCT01096901 | Choose to Lose for Women-Weight Loss to Reduce Breast Cancer Risk Factors | https://clinicaltrials.gov/study/NCT01096901 | CTL | This study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention. | NO | Obesity|Overweight | BEHAVIORAL: Behavioral Weight loss | Weight loss for one group, One group in this randomized study will be focused on weight loss during a 3 month period. The goal is to acheive a 6% weight loss during this time. Specific blood draws will be conducted pre and post weight loss to measure any hormonal changes due to this weight loss., 3 months | Increased physical activity, The secondary objective in this study is to increase participant activity level to help reduce the risks of certain cancers. As well as increase the overall health of these participants., 3 months | California Polytechnic State University-San Luis Obispo | FEMALE | ADULT | EARLY_PHASE1 | 19 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | CP-CTL|CP-EFI | 2010-11 | 2011-06 | 2011-06 | 2010-03-31 | 2015-10-28 | California Polytechnic State University, San Luis Obispo, California, 93407, United States | ||||
| NCT01079845 | A Cooking and Eating Study | https://clinicaltrials.gov/study/NCT01079845 | ACES | Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body fat amplifies the severity of the syndrome. Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents and young adults with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms. Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet – designed to lower blood levels of glucose and insulin – will be more beneficial than a low-fat diet in obese adolescents and young adults with PCOS. Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Participants in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting. The primary outcome will be bioavailable testosterone (form of testosterone that causes symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high androgen levels (total testosterone, free testosterone, sex hormone binding globulin, dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair, acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive protein levels and blood pressure), body fat percentage and distribution (measured using state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual cyclicity, and health-related quality of life (evaluated by questionnaire). | NO | Polycystic Ovary Syndrome | BEHAVIORAL: Nutrition Education, Dietary Counseling, and Cooking | Bioavailable Testosterone, Baseline, 6 months | Other Biochemical and Clinical Signs of Hyperandrogenism, total and free testosterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), hirsutism, acne, Baseline, 6 months|Insulin Sensitivity and Beta-cell Function, frequently-sampled oral glucose tolerance test, HbA1c, Baseline, 6 months|Risk for Cardiovascular Disease, serum levels of HDL cholesterol, LDL cholesterol, triglycerides, and C-reactive protein; blood pressure, Baseline, 6 months|Body Weight and Composition, body fat percentage and distribution assessed by dual-energy x-ray absorptiometry (DXA), waist circumference, Baseline, 6 months|Cyclicity of Menstrual Periods, Monthly|Quality of Life, Questionnaire, Baseline, 6 months | Boston Children’s Hospital | Thrasher Research Fund | FEMALE | CHILD, ADULT | NA | 19 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 10-02-0069 | 2010-07 | 2013-11 | 2013-11 | 2010-03-03 | 2015-02-05 | Children’s Hospital Boston, Boston, Massachusetts, 02115, United States | |||
| NCT01047735 | The TRIABETES – ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes | https://clinicaltrials.gov/study/NCT01047735 | TRIABETES | This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity. | NO | Type 2 Diabetes Mellitus|Obesity | PROCEDURE: Roux-en-Y Gastric Bypass Surgery|PROCEDURE: Laparoscopic Adjustable Gastric Banding|BEHAVIORAL: Lifestyle Weight Loss Intervention | Feasibility of performing a randomized trial comparing two major types of bariatric surgery versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients with T2DM., 6 months, 1 year | Preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity., 6 months, 1 year | University of Pittsburgh | National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ALL | ADULT | NA | 69 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | STUDY20060163|RC1DK086037|R01DK095128-01 | 2009-09-01 | 2025-07-01 | 2025-07-01 | 2010-01-13 | 2024-08-16 | William F Gourash, Pittsburgh, Pennsylvania, 15213, United States | |||
| NCT01047761 | Exercise for Stable Myasthenia Gravis | https://clinicaltrials.gov/study/NCT01047761 | Generalized fatigue in myasthenia gravis results in physical deconditioning that reduces fitness and increases risk of obesity, hypertension, elevated cholesterol and type 2 diabetes. This study will examine how active and fit are 30 individuals with chronic, generalized myasthenic subjects. This study will also determine whether a 3 month home exercise program with aerobic, resistive, and pulmonary training can improve physical activity, strength, fitness, lung function and reduce cardiovascular disease risk. | NO | Myasthenia Gravis | OTHER: Exercise | Cardiovascular Fitness, Economy of Gait, Physiologic Reserve, Baseline and 3 months | Ambulatory function (6 minute walk, 5 day step activity and accelerometer data), Baseline and 3 month|Muscle strength by dynamometer, Baseline and 3 month|Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale, Baseline and 3 months|Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index, Baseline and 3 months|Body Composition by DEXA and CT of mid-thigh and hip, Baseline and 3 months|Quantitative MG Scale, Baseline and 3 months|Pulmonary function tests – FVC and maximal inspiratory and expiratory pressure, Baseline and 3 months | Baltimore VA Medical Center | University of Maryland | ALL | ADULT, OLDER_ADULT | PHASE1 | 30 | FED | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | Myasthenia and Exercise | 2010-01 | 2020-12 | 2020-12 | 2010-01-13 | 2016-11-01 | University of Maryland and Baltimore VA Medical Center, Baltimore, Maryland, 21201, United States | ||||
| NCT01028989 | A Reduced Carbohydrate Diet Intervention for Polycystic Ovary Syndrome (PCOS) | https://clinicaltrials.gov/study/NCT01028989 | Polycystic ovary syndrome (PCOS) affects 5-10% of women of reproductive age, and is associated with infertility, risk for obesity and type 2 diabetes, and impaired quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. Manipulation of dietary carbohydrate quantity and quality (glycemic load; GL) may lower insulin and improve both reproductive and metabolic outcomes. The purpose of this study is to determine if a lower GL diet intervention is more effective than a standard (STD) diet in improving reproductive and metabolic outcomes of women with PCOS in the absence of weight loss. | NO | Polycystic Ovary Syndrome | DIETARY_SUPPLEMENT: Reduced Glycemic Load Diet|DIETARY_SUPPLEMENT: Standard Diet | Improving reproductive and metabolic outcomes of women with PCOS, 8 weeks | The lower Glycemic Load diet will increase perceived fullness and decrease hunger, effects mediated via gut hormones., 8 weeks | University of Alabama at Birmingham | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | ADULT | NA | 23 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE | F090407003|1R01HD054960-01A2 | 2009-12 | 2011-08 | 2011-08 | 2009-12-09 | 2013-03-15 | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States | ||||
| NCT01004094 | Squire’s Quest! II: Implementation Intentions and Children’s Fruit, Juice, and Vegetable (FJV) Consumption | https://clinicaltrials.gov/study/NCT01004094 | SQ!II | The primary purpose of this research is to test the effects of goal setting on fruit and vegetable goal attainment and consumption in a 10 episode video game. Factors associated with maintenance of behavior change will also be examined. Secondary purposes are to explore the impact of the intervention on psychosocial factors and the home environment. 400 parent-child pairs will be recruited for this research (800 participants total). Children will play the video game and participate in data collection activities. Parents will receive newsletters, have access to a healthy foods web site, and participate in data collection activities. A small subset will be randomly selected to participate in interviews about the intervention and its effect on the home food environment. | NO | Obesity|Cancer | BEHAVIORAL: simple goal setting|BEHAVIORAL: goal setting plus action intentions|BEHAVIORAL: goal setting plus coping intentions|BEHAVIORAL: goal setting plus action intentions plus coping intentions | Fruit and vegetable consumption, baseline, immediate post, 3 months later | Goal attainment, during intervention | Baylor College of Medicine | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|United States Department of Agriculture (USDA) | ALL | CHILD | PHASE2 | 800 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | Thompson_Squires_Quest_II|5R01HD050595 | 2009-10 | 2011-03 | 2011-03 | 2009-10-29 | 2016-01-20 | Baylor College of Medicine, Houston, Texas, 77030, United States | |||
| NCT00988845 | Indole-3-Carbinol Effects on Estrogen Metabolism | https://clinicaltrials.gov/study/NCT00988845 | This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index. | NO | Obesity | DIETARY_SUPPLEMENT: Indole-3-carbinol | Change in urinary 2/16-hydroxyestrone ratio, 8 weeks | University of Wisconsin, Madison | FEMALE | ADULT | PHASE2 | 38 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | H-2009-0093|CC09709|A532800|SMPH\OBSTET & GYNECOL\OB-GYN | 2009-09 | 2010-07 | 2014-01 | 2009-10-02 | 2019-12-13 | University of Wisconsin, Madison, Wisconsin, 53792, United States | ||||||
| NCT00933309 | The Impact of Obesity and Obesity Treatments on Breast Cancer | https://clinicaltrials.gov/study/NCT00933309 | The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body. | NO | Breast Cancer | DRUG: Exemestane|DRUG: Avandamet | Dose-limiting toxicity (DLT), Day 1 of each cycle | M.D. Anderson Cancer Center | Susan G. Komen Breast Cancer Foundation | FEMALE | ADULT, OLDER_ADULT | PHASE1 | 25 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2008-0284 | 2009-07 | 2012-08 | 2012-08 | 2009-07-07 | 2016-02-19 | UT MD Anderson Cancer Center, Houston, Texas, 77030, United States | |||||
| NCT00928759 | Etiological Factors of Obesity-Associated Hyperandrogenemia in Peripubertal Girls | https://clinicaltrials.gov/study/NCT00928759 | CRM002 | The purpose of this study is to learn if obese pre- and early pubertal girls with hyperandrogenemia (HA) are more insulin resistant (i.e., have lower insulin-stimulated glucose disposal) compared to obese peripubertal girls without HA; and that overnight mean luteinizing hormone (LH) concentration is also an independent predictor of free testosterone concentrations, especially in mid- to late pubertal girls. | NO | Obesity|Hyperandrogenemia|Polycystic Ovary Syndrome | Morning free testosterone, 0700 to 0900 hours|Insulin-stimulated glucose disposal, 0900 to 1100 hours | Estimated 24-hour mean insulin concentration, 24 hours|Luteinizing hormone pulse frequency, 1800 to 0900 hours|Mean luteinizing hormone concentration, 1800 to 0900 hours | University of Virginia | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | CHILD | 40 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 13552|P50HD028934 | 2008-03 | 2023-05 | 2023-08 | 2009-06-26 | 2022-05-18 | University of Virginia, Charlottesville, Virginia, 22908, United States | |||||
| NCT00920738 | Metabolic Syndrome in Childhood Cancer Survivors | https://clinicaltrials.gov/study/NCT00920738 | RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease. PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers. | NO | Brain and Central Nervous System Tumors|Leukemia|Lymphoma|Metabolic Syndrome|Sarcoma | OTHER: metabolic assessment|OTHER: questionnaire administration | Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls, Day 1 and Day 2|Insulin resistance (IR) in CCS vs controls, Day 1 and Day 2|Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS, Day 1 and Day 2|Dietary and a physical activity assessments of CCS vs controls, Day 1 and Day 2 | Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS, Day 1 and Day 2 | University of Minnesota | ALL | CHILD, ADULT | 512 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2003NT064|0411M65666 | 2005-04 | 2010-07 | 2011-06 | 2009-06-15 | 2014-08-22 | University of Minnesota Children’s Hospital – Fairview, Minneapolis, Minnesota, 55455, United States | ||||||
| NCT00920842 | Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant | https://clinicaltrials.gov/study/NCT00920842 | RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors. PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant. | NO | Cardiovascular Complications|Leukemia|Long-term Effects Secondary to Cancer Therapy in Children|Metabolic Syndrome | Comparison of the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) with age- and gender-matched controls, ≥2 years post-HSCT|Comparison of insulin resistance in patients with age- and gender-matched controls, ≥2 years post-HSCT|Correlation between insulin sensitivity and risk factors associated with metabolic syndrome, ≥2 years post-HSCT|Influence of time since transplant on insulin resistance, ≥2 years post-HSCT|Peak growth hormone secretion in patients with insulin resistance and in those without, ≥2 years post-HSCT|Growth hormone deficiency in patients with metabolic syndrome and in those without, ≥2 years post-HSCT|Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity, ≥2 years post-HSCT|Correlation of adiponectin with insulin resistance and central obesity, ≥2 years post-HSCT|Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease, ≥2 years post-HSCT|Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without, ≥2 years post-HSCT | Fred Hutchinson Cancer Center | National Cancer Institute (NCI) | ALL | CHILD, ADULT | 244 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IR 7141|P30CA077598|UMN-2003NT063|CDR0000642276|IR-6980|FHCRC-2357.00 | 2005-04 | 2011-07 | 2012-11 | 2009-06-15 | 2012-12-03 | Clinical Research Center – Seattle Children’s Hospital, Seattle, Washington, 98105, United States | |||||||
| NCT00907153 | Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS) | https://clinicaltrials.gov/study/NCT00907153 | The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS. | YES | Polycystic Ovary Syndrome | DIETARY_SUPPLEMENT: Vitamin D|DRUG: Placebo | Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI), Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/\[log(I(0)) + log(G(0))\])., Baseline and 12 weeks | Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP), High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation., Baseline and 12 weeks|Change From Baseline in Mean Systolic Blood Pressure, Blood pressure was measured in the right arm in the sitting position after a 15-minute rest., Baseline and 12 weeks|Change From Baseline in Mean Diastolic Blood Pressure, Blood pressure was measured in the right arm in the sitting position after a 15-minute rest., Baseline and 12 weeks|Change From Baseline in Mean Fasting Glucose, Glucose was assessed after 12 hours of fasting., Baseline and 12 weeks|Change From Baseline in Mean Fasting Insulin, Insulin was assessed after 12 hours of fasting., Baseline and 12 weeks|Change From Baseline in Mean 2-hour Glucose, Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120)., Baseline and 12 weeks|Change From Baseline in Mean 2-hour Insulin, Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120)., Baseline and 12 weeks|Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120), Participants underwent a 75-g oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 120 minutes and used to calculate the insulin sensitivity index (ISI0,120). The ISI 0,120 = the glucose uptake rate divided by the mean plasma glucose divided by the log(mean serum insulin)., Baseline and 12 weeks|Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a validated measure of insulin resistance based on fasting insulin and glucose. HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5., Baseline and 12 weeks|Change From Baseline in Mean Total Cholesterol, Lipid profile was assessed after 12 hours of fasting., Baseline and 12 weeks|Change From Baseline in Mean HDL Cholesterol, Lipid profile was assessed after 12 hours of fasting., Baseline and 12 weeks|Change From Baseline in Mean LDL Cholesterol, Lipid profile was assessed after 12 hours of fasting., Baseline and 12 weeks|Change From Baseline in Mean Triglycerides, Lipid profile was assessed after 12 hours of fasting., Baseline and 12 weeks|Change From Baseline in Mean Total Testosterone, Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS., Baseline and 12 weeks|Change From Baseline in Mean Free Testosterone, Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS., Baseline and 12 weeks | Change From Baseline in Mean 25-hydroxyvitamin D, Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay., Baseline and 12 weeks|Change From Baseline in Mean Vitamin D Binding Protein, Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes., Baseline and 12 weeks|Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH), Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance., Baseline and 12 weeks | Milton S. Hershey Medical Center | FEMALE | ADULT | PHASE1|PHASE2 | 36 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 29714 | 2009-05 | 2014-02 | 2014-09 | 2009-05-22 | 2017-12-19 | 2017-12-19 | Penn State College of Medicine, Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, 17033, United States | |||
| NCT00904033 | Calcitriol, Physical Activity, and Bone Health in Cancer Survivors | https://clinicaltrials.gov/study/NCT00904033 | Both the calcitriol and exercise interventions are aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients and survivors. The combination of calcitriol and exercise, which function through different but similar mechanisms, could produce interactive effects in reducing fracture risk among breast cancer survivors. Hypothesis: A combination of calcitriol along with a structured home-based walking and progressive resistance exercise program will be efficacious in preventing bone resorption and in increasing bone formation among survivors of invasive breast cancer. | YES | Breast Neoplasms|Bone and Bones | DRUG: Calcitriol|BEHAVIORAL: Exercise|DIETARY_SUPPLEMENT: Multivitamin | Bone Resorption (Exercise), Bone Resorption using Serum NTx (Exercise comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE)., Week 12|Bone Resorption (Calcitriol), Bone Resorption using Serum NTx (Calcitriol comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE)., Week 12|Bone Formation (Exercise), Bone Formation using Serum BSAP (Exercise comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies., Week 12|Bone Formation (Calcitriol), Bone Formation using Serum BSAP (Calcitriol comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies., Week 12 | Handgrip (kg) Strength – (Exercise), Handgrip (kg) Strength (Exercise comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 –\> 20.3-34.1kg; AGE 40-44 –\> 18.9-32.7kg; AGE 45-49 –\> 18.6-32.4kg; AGE 50-54 –\> 18.1-31.9kg; AGE 55-59 –\> 17.7-31.5kg; AGE 60-64 –\> 17.2-31.0kg; AGE 65-69 –\> 15.4-27.2kg; AGE 70-99 –\> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength., Week 12|Handgrip (kg) Strength – (Calcitriol), Handgrip (kg) Strength – (Calcitriol comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 –\> 20.3-34.1kg; AGE 40-44 –\> 18.9-32.7kg; AGE 45-49 –\> 18.6-32.4kg; AGE 50-54 –\> 18.1-31.9kg; AGE 55-59 –\> 17.7-31.5kg; AGE 60-64 –\> 17.2-31.0kg; AGE 65-69 –\> 15.4-27.2kg; AGE 70-99 –\> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength., Week 12|Body Mass Index (Exercise), Body Mass Index (BMI) – (Exercise Comparison) Measure Description: Body Mass Index (BMI) is a person’s weight in kilograms divided by the square of height in meters. Values below 18.5 represent “Underweight”, 18.5 to 24.9 represent “Normal or Healthy Weight”, 25.0 to 29.9 represent “Overweight” and 30.0 and above represent “Obese”., Week 12|Body Mass Index (Calcitriol), Body Mass Index(BMI) – (Calcitriol comparison) Measure Description: Body Mass Index (BMI) is a person’s weight in kilograms divided by the square of height in meters. Values below 18.5 represent “Underweight”, 18.5 to 24.9 represent “Normal or Healthy Weight”, 25.0 to 29.9 represent “Overweight” and 30.0 and above represent “Obese”., Week 12 | University of Rochester | FEMALE | ADULT, OLDER_ADULT | PHASE2 | 41 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION | RSRB00025478 | 2008-12-01 | 2018-01-01 | 2018-01-01 | 2009-05-19 | 2019-04-23 | 2019-04-23 | University of Rochester Medical Center, Rochester, New York, 14642, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT00904033/Prot_SAP_000.pdf | |||
| NCT00900445 | Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia | https://clinicaltrials.gov/study/NCT00900445 | This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment | NO | Acute Lymphoblastic Leukemia|Untreated Childhood Acute Lymphoblastic Leukemia | DRUG: Daunorubicin Hydrochloride|OTHER: Pharmacological Study|DRUG: Prednisolone|DRUG: Prednisone|DRUG: Vincristine Sulfate | Pharmacokinetic parameters of prednisone/prednisolone, Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method., Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours|Pharmacokinetic parameters of daunorubicin hydrochloride, Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method., Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours|Pharmacokinetic parameters of vincristine sulfate, Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method., Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours | RER and SER status, To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed., Up to 1.5 years | Children’s Oncology Group | National Cancer Institute (NCI) | ALL | CHILD, ADULT | 0 | NETWORK | OBSERVATIONAL | Observational Model: |Time Perspective: p | ACCL0631|NCI-2011-02151|CDR0000588173|ACCL0631|COG-ACCL0631|ACCL0631|U10CA095861 | 2008-03-24 | 2009-08-17 | 2009-05-12 | 2018-08-07 | Childrens Oncology Group, Philadelphia, Pennsylvania, 19104, United States | ||||||
| NCT00872677 | Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT00872677 | RATIONALE: A culturally sensitive weight loss program for obese African American breast cancer survivors may be more effective than a standard weight loss program in helping women lose weight. PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to see how well it works in African American women who are breast cancer survivors. | NO | Breast Cancer|Obesity|Weight Changes | BEHAVIORAL: Diet|OTHER: Spiritual counseling | Weight change, 18 months | Barbara Ann Karmanos Cancer Institute | National Center for Complementary and Integrative Health (NCCIH)|National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | 31 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | CDR0000612147|013003B3E | 2004-05 | 2006-10 | 2008-11 | 2009-03-31 | 2013-04-29 | Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201, United States | ||||||
| NCT00868140 | Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS) | https://clinicaltrials.gov/study/NCT00868140 | PCOS | Our hypothesis is that hyperinsulinemia increases the renal clearance of D-chiro-inositol (DCI) in women with polycystic ovary syndrome (PCOS) and that this leads to a reduction in circulating insulin-stimulated D-chiro-inositol-containing inositol phosphoglycan (DCI-IPG) release. To assess the effects of a chronic reduction in circulating insulin on DCI metabolism, we propose to reduce circulating insulin in obese women with PCOS by improving insulin sensitivity with the drug pioglitazone. Pioglitazone is a thiazolidinedione that improves peripheral insulin sensitivity, presumably by activation of the peroxisome proliferator-activated receptor gamma (PPARγ) receptor. Administration of pioglitazone to women with PCOS has been shown to improve insulin sensitivity, reduce insulin secretion, and decrease both fasting and post-prandial serum insulin concentrations. | YES | Polycystic Ovary Syndrome | DRUG: pioglitazone|DRUG: Placebo | AUC DCI-IPG (%/Min), Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement., Baseline|AUC DCI-IPG (%/Min), Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement., 6 months|Fasting Serum Insulin, Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo, baseline|Fasting Serum Insulin (uIU/ml), Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo, 6 months | Matsuda Index, Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI\* FPG) \* (xGPC\* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance., Baseline|Matsuda Index, Whole body insulin sensitivity as determined by the Matsuda Index, 6 months | Virginia Commonwealth University | FEMALE | ADULT | NA | 51 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH | VCUIRB4480|GCRC0824 | 2009-02 | 2011-06 | 2011-08 | 2009-03-24 | 2016-06-10 | 2016-06-10 | Virginia Commonwealth University General Clinical Research Center, Richmond, Virginia, 23298, United States|Hospital de Clinical Caracas, Caracas, 1071, Venezuela | |||
| NCT00859989 | A Weight-Loss Program in Helping Obese Black Women Lose Weight | https://clinicaltrials.gov/study/NCT00859989 | RATIONALE: A diet and physical activity program followed by a weight-loss maintenance program may help obese black women lose weight. It is not yet known whether a weight-loss program is more effective than a general health education program in helping obese black women lose weight. Weight loss may reduce a person’s risk of developing cancer. PURPOSE: This randomized phase III trial is studying a weight-loss program to see how well it works in helping obese black women lose weight. | NO | Breast Cancer|Obesity|Weight Changes | BEHAVIORAL: behavioral dietary intervention|BEHAVIORAL: exercise intervention|BEHAVIORAL: telephone-based intervention|OTHER: counseling intervention|OTHER: educational intervention|OTHER: immunoenzyme technique|OTHER: laboratory biomarker analysis|OTHER: questionnaire administration|OTHER: study of socioeconomic and demographic variables|PROCEDURE: evaluation of cancer risk factors|PROCEDURE: support group therapy | Body mass index as assessed at baseline, 24 weeks, and 18 months|Changes in glucose, insulin, and IGF levels as assessed at baseline, 24 weeks, and 18 months | Changes in diet and physical activity as assessed by Block 98 FFQ and Stanford 7-Day Physical Activity Recall questionnaires at baseline, 24 weeks, and 18 months|Changes in knowledge, attitudes, self-efficacy, and social support related to diet, physical activity, and weight loss as assessed by Nutrition Attitudes Scale, Self-Efficacy for Eating and Exercise Behaviors, and Social Support for Eating and Exerci … | University of Illinois at Chicago | National Cancer Institute (NCI) | FEMALE | ADULT | PHASE3 | 200 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: |Masking: |Primary Purpose: | CDR0000635687|UIC-2004-0748 | 2004-07 | 2009-04 | 2009-03-11 | 2013-12-18 | University of Illinois Cancer Center, Chicago, Illinois, 60612-7243, United States | |||||
| NCT00807768 | Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer | https://clinicaltrials.gov/study/NCT00807768 | This randomized phase III trial studies pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether pelvic radiation therapy alone is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer. | YES | Endometrial Clear Cell Adenocarcinoma|Endometrial Serous Adenocarcinoma|Fatigue|Neurotoxicity Syndrome|Obesity|Stage I Uterine Corpus Cancer AJCC v7|Stage II Uterine Corpus Cancer AJCC v7 | RADIATION: 3-Dimensional Conformal Radiation Therapy|DRUG: Carboplatin|RADIATION: Intensity-Modulated Radiation Therapy|RADIATION: Internal Radiation Therapy|OTHER: Laboratory Biomarker Analysis|DRUG: Paclitaxel|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Number of Participants With Recurrence or Death Events at Primary Analysis, Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact, Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years | Number of Participants With Death Events, The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study., Overall survival is measured from study enrollment for up to 10 years.|Number of Participants With Sites of Recurrence, Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event., Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years|Patient Reported Fatigue, Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue., Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment|Patient-reported Neurotoxicity, Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less neurotoxicity., Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.|Patient-reported Quality of Life, Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The FACT-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL, Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment | Gene Expression Based Risk Score, Baseline | Gynecologic Oncology Group | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | PHASE3 | 601 | NETWORK | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | GOG-0249|NCI-2009-00610|CDR0000629591|GOG-0249|GOG-0249|U10CA180868|U10CA027469 | 2009-03-23 | 2014-12-29 | 2008-12-12 | 2018-04-27 | 2019-03-20 | University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, 35233, United States|University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, 36688, United States|Providence Alaska Medical Center, Anchorage, Alaska, 99508, United States|Saint Joseph’s Hospital and Medical Center, Phoenix, Arizona, 85013, United States|Arizona Oncology Associates-West Orange Grove, Tucson, Arizona, 85704, United States|University of Arizona Cancer Center-North Campus, Tucson, Arizona, 85719, United States|Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, 95603, United States|Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, 91505, United States|Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, 95682, United States|Mercy San Juan Medical Center, Carmichael, California, 95608, United States|John Muir Medical Center-Concord Campus, Concord, California, 94520, United States|UC San Diego Moores Cancer Center, La Jolla, California, 92093, United States|Long Beach Memorial Medical Center-Todd Cancer Institute, Long Beach, California, 90806, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States|Memorial Medical Center, Modesto, California, 95355, United States|Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040, United States|Kaiser Permanente Oakland-Broadway, Oakland, California, 94611, United States|Kaiser Permanente-Oakland, Oakland, California, 94611, United States|Saint Joseph Hospital – Orange, Orange, California, 92868, United States|UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, 92868, United States|Stanford Cancer Institute Palo Alto, Palo Alto, California, 94304, United States|Kaiser Permanente-Redwood City, Redwood City, California, 94063, United States|Kaiser Permanente-Richmond, Richmond, California, 94801, United States|Rohnert Park Cancer Center, Rohnert Park, California, 94928, United States|Kaiser Permanente-Roseville, Roseville, California, 95661, United States|Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, 95661, United States|Sutter Roseville Medical Center, Roseville, California, 95661, United States|Sutter Medical Center Sacramento, Sacramento, California, 95816, United States|University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States|Mercy General Hospital Radiation Oncology Center, Sacramento, California, 95819, United States|Kaiser Permanente-South Sacramento, Sacramento, California, 95823, United States|Kaiser Permanente – Sacramento, Sacramento, California, 95825, United States|University of California San Diego, San Diego, California, 92103, United States|Kaiser Permanente-San Francisco, San Francisco, California, 94115, United States|UCSF Medical Center-Mount Zion, San Francisco, California, 94115, United States|Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, 95119, United States|Kaiser Permanente San Leandro, San Leandro, California, 94577, United States|Kaiser Permanente-San Rafael, San Rafael, California, 94903, United States|Kaiser Permanente Medical Center – Santa Clara, Santa Clara, California, 95051, United States|Kaiser Permanente-Santa Rosa, Santa Rosa, California, 95403, United States|Kaiser Permanente-South San Francisco, South San Francisco, California, 94080, United States|Kaiser Permanente-Stockton, Stockton, California, 95210, United States|Olive View-University of California Los Angeles Medical Center, Sylmar, California, 91342, United States|Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, 95687, United States|Kaiser Permanente-Vallejo, Vallejo, California, 94589, United States|Kaiser Permanente-Walnut Creek, Walnut Creek, California, 94596, United States|John Muir Medical Center-Walnut Creek, Walnut Creek, California, 94598, United States|Colorado Gynecologic Oncology Group, Aurora, Colorado, 80010, United States|Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, 80012, United States|The Medical Center of Aurora, Aurora, Colorado, 80012, United States|University of Colorado Hospital, Aurora, Colorado, 80045, United States|Boulder Community Hospital, Boulder, Colorado, 80301, United States|Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, 80907, United States|Porter Adventist Hospital, Denver, Colorado, 80210, United States|Presbyterian – Saint Lukes Medical Center – Health One, Denver, Colorado, 80218, United States|SCL Health Saint Joseph Hospital, Denver, Colorado, 80218, United States|Rose Medical Center, Denver, Colorado, 80220, United States|Colorado Cancer Research Program NCORP, Denver, Colorado, 80222, United States|Swedish Medical Center, Englewood, Colorado, 80113, United States|Saint Mary’s Hospital and Regional Medical Center, Grand Junction, Colorado, 81501, United States|North Colorado Medical Center, Greeley, Colorado, 80631, United States|Saint Anthony Hospital, Lakewood, Colorado, 80228, United States|Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, 80120, United States|Littleton Adventist Hospital, Littleton, Colorado, 80122, United States|Sky Ridge Medical Center, Lone Tree, Colorado, 80124, United States|Longmont United Hospital, Longmont, Colorado, 80501, United States|McKee Medical Center, Loveland, Colorado, 80539, United States|Parker Adventist Hospital, Parker, Colorado, 80138, United States|Saint Mary Corwin Medical Center, Pueblo, Colorado, 81004, United States|North Suburban Medical Center, Thornton, Colorado, 80229, United States|SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, 80033, United States|Saint Vincent’s Medical Center, Bridgeport, Connecticut, 06606, United States|Danbury Hospital, Danbury, Connecticut, 06810, United States|University of Connecticut, Farmington, Connecticut, 06030, United States|Hartford Hospital, Hartford, Connecticut, 06102, United States|The Hospital of Central Connecticut, New Britain, Connecticut, 06050, United States|Yale University, New Haven, Connecticut, 06520, United States|Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, 06360, United States|William Backus Hospital, Norwich, Connecticut, 06360, United States|Beebe Medical Center, Lewes, Delaware, 19958, United States|Christiana Care Health System-Christiana Hospital, Newark, Delaware, 19718, United States|MedStar Washington Hospital Center, Washington, District of Columbia, 20010, United States|Sibley Memorial Hospital, Washington, District of Columbia, 20016, United States|Morton Plant Hospital, Clearwater, Florida, 33756, United States|Holy Cross Hospital, Fort Lauderdale, Florida, 33308, United States|Florida Gynecologic Oncology, Fort Myers, Florida, 33905, United States|Southeast Gynecologic Oncology Associates, Jacksonville, Florida, 32204, United States|University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, 33136, United States|Florida Hospital Orlando, Orlando, Florida, 32803, United States|Florida Institute of Research Medicine and Surgery-Cancer Center, Orlando, Florida, 32806, United States|UF Cancer Center at Orlando Health, Orlando, Florida, 32806, United States|Women’s Cancer Associates, Saint Petersburg, Florida, 33701, United States|Grady Health System, Atlanta, Georgia, 30303, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Northside Hospital, Atlanta, Georgia, 30342, United States|Augusta University Medical Center, Augusta, Georgia, 30912, United States|John B Amos Cancer Center, Columbus, Georgia, 31904, United States|Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, 30501, United States|Central Georgia Gynecologic Oncology, Macon, Georgia, 31201, United States|Memorial Health University Medical Center, Savannah, Georgia, 31404, United States|Pali Momi Medical Center, ‘Aiea, Hawaii, 96701, United States|The Cancer Center of Hawaii-Pali Momi, ‘Aiea, Hawaii, 96701, United States|Hawaii Cancer Care Inc-POB II, Honolulu, Hawaii, 96813, United States|Queen’s Medical Center, Honolulu, Hawaii, 96813, United States|Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States|University of Hawaii Cancer Center, Honolulu, Hawaii, 96813, United States|Hawaii Oncology Inc-Kuakini, Honolulu, Hawaii, 96817, United States|The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, 96817, United States|Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States|Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, 96766, United States|Maui Memorial Medical Center, Wailuku, Hawaii, 96793, United States|Saint Luke’s Mountain States Tumor Institute, Boise, Idaho, 83712, United States|Saint Luke’s Mountain States Tumor Institute – Fruitland, Fruitland, Idaho, 83619, United States|Saint Luke’s Mountain States Tumor Institute – Meridian, Meridian, Idaho, 83642, United States|Saint Luke’s Mountain States Tumor Institute – Nampa, Nampa, Idaho, 83686, United States|Saint Luke’s Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, 83301, United States|Saint Anthony’s Health, Alton, Illinois, 62002, United States|Saint Joseph Medical Center, Bloomington, Illinois, 61701, United States|Northwestern University, Chicago, Illinois, 60611, United States|John H Stroger Jr Hospital of Cook County, Chicago, Illinois, 60612, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|University of Illinois, Chicago, Illinois, 60612, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States|Heartland Cancer Research NCORP, Decatur, Illinois, 62526, United States|NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, 60201, United States|Western Illinois Cancer Treatment Center, Galesburg, Illinois, 61401, United States|Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, 60521, United States|Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, 60521, United States|Loyola University Medical Center, Maywood, Illinois, 60153, United States|Good Samaritan Regional Health Center, Mount Vernon, Illinois, 62864, United States|Bromenn Regional Medical Center, Normal, Illinois, 61761, United States|Community Cancer Center Foundation, Normal, Illinois, 61761, United States|Advocate Christ Medical Center, Oak Lawn, Illinois, 60453-2699, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350, United States|Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, 61350, United States|Advocate Lutheran General Hospital, Park Ridge, Illinois, 60068, United States|Illinois CancerCare-Peoria, Peoria, Illinois, 61615, United States|OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, 61615, United States|OSF Saint Francis Medical Center, Peoria, Illinois, 61637, United States|Valley Radiation Oncology, Peru, Illinois, 61354, United States|Swedish American Hospital, Rockford, Illinois, 61104, United States|Memorial Medical Center, Springfield, Illinois, 62781, United States|Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, 60555, United States|Northwestern Medicine Central DuPage Hospital, Winfield, Illinois, 60190, United States|Franciscan Saint Francis Health-Beech Grove, Beech Grove, Indiana, 46107, United States|Franciscan Saint Margaret Health-Dyer Campus, Dyer, Indiana, 46311, United States|Elkhart Clinic, Elkhart, Indiana, 46514-2098, United States|Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, 46514, United States|Elkhart General Hospital, Elkhart, Indiana, 46515, United States|Radiation Oncology Associates PC, Fort Wayne, Indiana, 46804, United States|Parkview Hospital Randallia, Fort Wayne, Indiana, 46805, United States|Franciscan Saint Margaret Health-Hammond Campus, Hammond, Indiana, 46320, United States|Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States|IU Health Central Indiana Cancer Centers-East, Indianapolis, Indiana, 46219, United States|Franciscan Health Indianapolis, Indianapolis, Indiana, 46237, United States|Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, 46260, United States|Community Howard Regional Health, Kokomo, Indiana, 46904, United States|IU Health La Porte Hospital, La Porte, Indiana, 46350, United States|Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana, 46545, United States|Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, 46545, United States|The Community Hospital, Munster, Indiana, 46321, United States|Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, 46563, United States|Reid Health, Richmond, Indiana, 47374, United States|Memorial Hospital of South Bend, South Bend, Indiana, 46601, United States|Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, 46601, United States|South Bend Clinic, South Bend, Indiana, 46617, United States|Northern Indiana Cancer Research Consortium, South Bend, Indiana, 46628, United States|Michiana Hematology Oncology PC-Westville, Westville, Indiana, 46391, United States|McFarland Clinic PC – Ames, Ames, Iowa, 50010, United States|Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, 50325, United States|Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States|Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, 50309, United States|Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, 50309, United States|Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, 50314, United States|Mercy Medical Center – Des Moines, Des Moines, Iowa, 50314, United States|Iowa Lutheran Hospital, Des Moines, Iowa, 50316, United States|University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242, United States|Mercy Medical Center – North Iowa, Mason City, Iowa, 50401, United States|Hospital District Sixth of Harper County, Anthony, Kansas, 67003, United States|Cancer Center of Kansas – Chanute, Chanute, Kansas, 66720, United States|Cancer Center of Kansas – Dodge City, Dodge City, Kansas, 67801, United States|Cancer Center of Kansas – El Dorado, El Dorado, Kansas, 67042, United States|Cancer Center of Kansas – Fort Scott, Fort Scott, Kansas, 66701, United States|Cancer Center of Kansas-Independence, Independence, Kansas, 67301, United States|University of Kansas Cancer Center, Kansas City, Kansas, 66160, United States|Cancer Center of Kansas-Kingman, Kingman, Kansas, 67068, United States|Lawrence Memorial Hospital, Lawrence, Kansas, 66044, United States|Southwest Medical Center, Liberal, Kansas, 67901, United States|Cancer Center of Kansas-Liberal, Liberal, Kansas, 67905, United States|Cancer Center of Kansas – Newton, Newton, Kansas, 67114, United States|Menorah Medical Center, Overland Park, Kansas, 66209, United States|Saint Luke’s South Hospital, Overland Park, Kansas, 66213, United States|Cancer Center of Kansas – Parsons, Parsons, Kansas, 67357, United States|Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, 66208, United States|Cancer Center of Kansas – Pratt, Pratt, Kansas, 67124, United States|Cancer Center of Kansas – Salina, Salina, Kansas, 67401, United States|Cancer Center of Kansas – Wellington, Wellington, Kansas, 67152, United States|Associates In Womens Health, Wichita, Kansas, 67208, United States|Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, 67208, United States|Cancer Center of Kansas – Wichita, Wichita, Kansas, 67214, United States|Via Christi Regional Medical Center, Wichita, Kansas, 67214, United States|Wesley Medical Center, Wichita, Kansas, 67214, United States|Wichita NCI Community Oncology Research Program, Wichita, Kansas, 67214, United States|Cancer Center of Kansas – Winfield, Winfield, Kansas, 67156, United States|Saint Elizabeth Medical Center South, Edgewood, Kentucky, 41017, United States|Baptist Health Lexington, Lexington, Kentucky, 40503, United States|University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536, United States|The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, 40202, United States|Pikeville Medical Center, Pikeville, Kentucky, 41501, United States|Woman’s Hospital, Baton Rouge, Louisiana, 70817, United States|Louisiana State University Health Science Center, New Orleans, Louisiana, 70112, United States|University Medical Center New Orleans, New Orleans, Louisiana, 70112, United States|Ochsner Medical Center Jefferson, New Orleans, Louisiana, 70121, United States|Louisiana State University Health Sciences Center Shreveport, Shreveport, Louisiana, 71103, United States|Maine Medical Center-Bramhall Campus, Portland, Maine, 04102, United States|University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, 21201, United States|Greater Baltimore Medical Center, Baltimore, Maryland, 21204, United States|Sinai Hospital of Baltimore, Baltimore, Maryland, 21215, United States|Saint Agnes Hospital, Baltimore, Maryland, 21229, United States|MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, 21237, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, 20889-5600, United States|Union Hospital of Cecil County, Elkton, Maryland, 21921, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Lahey Hospital and Medical Center, Burlington, Massachusetts, 01805, United States|University of Massachusetts Memorial Health Care, Worcester, Massachusetts, 01605, United States|University of Massachusetts Medical School, Worcester, Massachusetts, 01655, United States|Bronson Battle Creek, Battle Creek, Michigan, 49017, United States|Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, 49307, United States|Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, 49503, United States|Mercy Health Saint Mary’s, Grand Rapids, Michigan, 49503, United States|Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, 49503, United States|Bronson Methodist Hospital, Kalamazoo, Michigan, 49007, United States|West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States|Borgess Medical Center, Kalamazoo, Michigan, 49048, United States|Mercy Health Mercy Campus, Muskegon, Michigan, 49444, United States|Lakeland Hospital Niles, Niles, Michigan, 49120, United States|Spectrum Health Reed City Hospital, Reed City, Michigan, 49677, United States|William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, 48073, United States|Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, 49085, United States|Marie Yeager Cancer Center, Saint Joseph, Michigan, 49085, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, 56601, United States|Fairview Ridges Hospital, Burnsville, Minnesota, 55337, United States|Mercy Hospital, Coon Rapids, Minnesota, 55433, United States|Fairview-Southdale Hospital, Edina, Minnesota, 55435, United States|Unity Hospital, Fridley, Minnesota, 55432, United States|Hutchinson Area Health Care, Hutchinson, Minnesota, 55350, United States|Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, 55109, United States|Saint John’s Hospital – Healtheast, Maplewood, Minnesota, 55109, United States|Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407, United States|Hennepin County Medical Center, Minneapolis, Minnesota, 55415, United States|University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, 55455, United States|New Ulm Medical Center, New Ulm, Minnesota, 56073, United States|North Memorial Medical Health Center, Robbinsdale, Minnesota, 55422, United States|Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, 55416, United States|Park Nicollet Clinic – Saint Louis Park, Saint Louis Park, Minnesota, 55416, United States|Park Nicollet Frauenshuh Cancer Center, Saint Louis Park, Minnesota, 55426, United States|Regions Hospital, Saint Paul, Minnesota, 55101, United States|United Hospital, Saint Paul, Minnesota, 55102, United States|Saint Francis Regional Medical Center, Shakopee, Minnesota, 55379, United States|Lakeview Hospital, Stillwater, Minnesota, 55082, United States|Ridgeview Medical Center, Waconia, Minnesota, 55387, United States|Rice Memorial Hospital, Willmar, Minnesota, 56201, United States|Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, 55125, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Singing River Hospital, Pascagoula, Mississippi, 39581, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, 63703, United States|University of Missouri – Ellis Fischel, Columbia, Missouri, 65212, United States|Truman Medical Center, Kansas City, Missouri, 64108, United States|Saint Luke’s Hospital of Kansas City, Kansas City, Missouri, 64111, United States|Saint Joseph Health Center, Kansas City, Missouri, 64114, United States|North Kansas City Hospital, Kansas City, Missouri, 64116, United States|Heartland Hematology and Oncology Associates Incorporated, Kansas City, Missouri, 64118, United States|Research Medical Center, Kansas City, Missouri, 64132, United States|The University of Kansas Cancer Center-North, Kansas City, Missouri, 64154, United States|Saint Luke’s East – Lee’s Summit, Lee’s Summit, Missouri, 64086, United States|Liberty Radiation Oncology Center, Liberty, Missouri, 64068, United States|Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, 65401, United States|Heartland Regional Medical Center, Saint Joseph, Missouri, 64507, United States|Saint Joseph Oncology Inc, Saint Joseph, Missouri, 64507, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Mercy Hospital Saint Louis, Saint Louis, Missouri, 63141, United States|Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri, 63141, United States|Cancer Research for the Ozarks NCORP, Springfield, Missouri, 65804, United States|Mercy Hospital Springfield, Springfield, Missouri, 65804, United States|CoxHealth South Hospital, Springfield, Missouri, 65807, United States|Billings Clinic Cancer Center, Billings, Montana, 59101, United States|Northern Rockies Radiation Oncology Center, Billings, Montana, 59101, United States|Montana Cancer Consortium NCORP, Billings, Montana, 59102, United States|Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, 59405, United States|Berdeaux, Donald MD (UIA Investigator), Great Falls, Montana, 59405, United States|Great Falls Clinic, Great Falls, Montana, 59405, United States|Nebraska Methodist Hospital, Omaha, Nebraska, 68114, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, 89106, United States|Women’s Cancer Center of Nevada, Las Vegas, Nevada, 89169, United States|Center of Hope at Renown Medical Center, Reno, Nevada, 89502, United States|Renown Regional Medical Center, Reno, Nevada, 89502, United States|Elliot Hospital, Manchester, New Hampshire, 03103, United States|Cooper Hospital University Medical Center, Camden, New Jersey, 08103, United States|Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Saint Barnabas Medical Center, Livingston, New Jersey, 07039, United States|Monmouth Medical Center, Long Branch, New Jersey, 07740, United States|Morristown Medical Center, Morristown, New Jersey, 07960, United States|Virtua Memorial, Mount Holly, New Jersey, 08060, United States|Jersey Shore Medical Center, Neptune, New Jersey, 07753, United States|Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, 08903, United States|Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, 08903, United States|Rutgers New Jersey Medical School, Newark, New Jersey, 07101, United States|Saint Luke’s Hospital-Warren Campus, Phillipsburg, New Jersey, 08865, United States|Valley Hospital, Ridgewood, New Jersey, 07450, United States|Overlook Hospital, Summit, New Jersey, 07902, United States|Community Medical Center, Toms River, New Jersey, 08755, United States|Inspira Medical Center Vineland, Vineland, New Jersey, 08360, United States|Virtua Voorhees, Voorhees, New Jersey, 08043, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87102, United States|Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, 87106, United States|Memorial Medical Center – Las Cruces, Las Cruces, New Mexico, 88011, United States|Women’s Cancer Care Associates LLC, Albany, New York, 12208, United States|Island Gynecologic Oncology, Brightwaters, New York, 11718, United States|State University of New York Downstate Medical Center, Brooklyn, New York, 11203, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|Sands Cancer Center, Canandaigua, New York, 14424, United States|New York Hospital Medical Center of Queens, Fresh Meadows, New York, 11365, United States|Northwell Health NCORP, Lake Success, New York, 11042, United States|Northwell Health/Center for Advanced Medicine, Lake Success, New York, 11042, United States|North Shore University Hospital, Manhasset, New York, 11030, United States|Orange Regional Medical Center, Middletown, New York, 10940, United States|NYU Winthrop Hospital, Mineola, New York, 11501, United States|Long Island Jewish Medical Center, New Hyde Park, New York, 11040, United States|Mount Sinai Union Square, New York, New York, 10003, United States|Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, 10016, United States|Mount Sinai West, New York, New York, 10019, United States|Mount Sinai Hospital, New York, New York, 10029, United States|NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, 10032, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Highland Hospital, Rochester, New York, 14620, United States|University Radiation Oncology, Rochester, New York, 14626, United States|University of Rochester, Rochester, New York, 14642, United States|Stony Brook University Medical Center, Stony Brook, New York, 11794, United States|State University of New York Upstate Medical University, Syracuse, New York, 13210, United States|Randolph Hospital, Asheboro, North Carolina, 27203, United States|Hope Women’s Cancer Centers-Asheville, Asheville, North Carolina, 28816, United States|UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States|Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, 28203, United States|Novant Health Presbyterian Medical Center, Charlotte, North Carolina, 28204, United States|Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, 28025, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Cone Health Cancer Center, Greensboro, North Carolina, 27403, United States|Duke Women’s Cancer Care Raleigh, Raleigh, North Carolina, 27607, United States|Duke Raleigh Hospital, Raleigh, North Carolina, 27609, United States|Annie Penn Memorial Hospital, Reidsville, North Carolina, 27320, United States|Rutherford Hospital, Rutherfordton, North Carolina, 28139, United States|New Hanover Regional Medical Center/Zimmer Cancer Center, Wilmington, North Carolina, 28401, United States|Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, 27104, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States|Roger Maris Cancer Center, Fargo, North Dakota, 58122, United States|Sanford Broadway Medical Center, Fargo, North Dakota, 58122, United States|Sanford Clinic North-Fargo, Fargo, North Dakota, 58122, United States|Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, 44304, United States|Cleveland Clinic Akron General, Akron, Ohio, 44307, United States|Summa Barberton Hospital, Barberton, Ohio, 44203, United States|Aultman Health Foundation, Canton, Ohio, 44710, United States|Adena Regional Medical Center, Chillicothe, Ohio, 45601, United States|University of Cincinnati/Barrett Cancer Center, Cincinnati, Ohio, 45219, United States|Good Samaritan Hospital – Cincinnati, Cincinnati, Ohio, 45220, United States|Bethesda North Hospital, Cincinnati, Ohio, 45242, United States|Oncology Hematology Care Inc-Blue Ash, Cincinnati, Ohio, 45242, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States|Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, 44111, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States|Riverside Methodist Hospital, Columbus, Ohio, 43214, United States|Columbus NCI Community Oncology Research Program, Columbus, Ohio, 43215, United States|Grant Medical Center, Columbus, Ohio, 43215, United States|The Mark H Zangmeister Center, Columbus, Ohio, 43219, United States|Mount Carmel Health Center West, Columbus, Ohio, 43222, United States|Doctors Hospital, Columbus, Ohio, 43228, United States|Good Samaritan Hospital – Dayton, Dayton, Ohio, 45406, United States|Miami Valley Hospital, Dayton, Ohio, 45409, United States|Miami Valley Hospital North, Dayton, Ohio, 45415, United States|Grady Memorial Hospital, Delaware, Ohio, 43015, United States|Blanchard Valley Hospital, Findlay, Ohio, 45840, United States|Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, 45005-1066, United States|Kettering Medical Center, Kettering, Ohio, 45429, United States|Marietta Memorial Hospital, Marietta, Ohio, 45750, United States|Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, 44124, United States|UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, 44060, United States|Licking Memorial Hospital, Newark, Ohio, 43055, United States|Southern Ohio Medical Center, Portsmouth, Ohio, 45662, United States|UH Seidman Cancer Center at Salem Regional Medical Center, Salem, Ohio, 44460, United States|Springfield Regional Medical Center, Springfield, Ohio, 45505, United States|Upper Valley Medical Center, Troy, Ohio, 45373, United States|Saint Ann’s Hospital, Westerville, Ohio, 43081, United States|Cancer Treatment Center, Wooster, Ohio, 44691, United States|Wright-Patterson Medical Center, Wright-Patterson Air Force Base, Ohio, 45433-5529, United States|Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, 43701, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, 74146, United States|Willamette Valley Cancer Center, Eugene, Oregon, 97401, United States|Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, 97210, United States|Compass Oncology Rose Quarter, Portland, Oregon, 97227, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|Salem Hospital, Salem, Oregon, 97301, United States|Abington Memorial Hospital, Abington, Pennsylvania, 19001, United States|Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, 18103, United States|Saint Luke’s University Hospital-Bethlehem Campus, Bethlehem, Pennsylvania, 18015, United States|Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, 19010, United States|Geisinger Medical Center, Danville, Pennsylvania, 17822, United States|Adams Cancer Center, Gettysburg, Pennsylvania, 17325, United States|Cherry Tree Cancer Center, Hanover, Pennsylvania, 17331, United States|Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, 18201, United States|Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States|Lancaster General Hospital, Lancaster, Pennsylvania, 17604, United States|Paoli Memorial Hospital, Paoli, Pennsylvania, 19301, United States|University of | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/68/NCT00807768/Prot_000.pdf | ||
| NCT00805207 | Sex Steroids, Sleep, and Metabolic Dysfunction in Women | https://clinicaltrials.gov/study/NCT00805207 | SCOR | Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease. Obesity is a major risk factor for two conditions that appear to be increasing in prevalence in women: the polycystic ovary syndrome (PCOS) and sleep disordered breathing. PCOS affects 5-8% of women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea (OSA) is the most common cause for sleep disordered breathing and particularly prevalent in obese women with PCOS (\~50%). Both PCOS and OSA augment the increase in plasma triglyceride (TG) concentration associated with obesity, and the effects of PCOS and OSA on plasma TG concentration appear to be additive. The mechanisms responsible for the adverse effects on plasma TG metabolism are not known. The primary goal of this project, therefore, is to determine the mechanisms responsible for the increase in plasma TG concentration in obese women with PCOS and OSA. It is our general hypothesis that alterations in the hormonal milieu that are characteristic of these two conditions are, at least in part, responsible for the increase in plasma TG concentration in obese women with the conditions. Furthermore, we hypothesize that the hormonal aberrations characteristic of the two conditions are particularly harmful to obese, compared with lean, women. The effects of PCOS on skeletal muscle protein metabolism are also not known. However, sex hormones are thought to be important regulators of muscle protein turnover suggesting that muscle protein metabolism is likely to be affected by PCOS. We will examine this by determining the effect of individual sex hormones on muscle protein metabolism and hypothesize that testosterone administration will stimulate muscle protein metabolism while estrogen and progesterone administration will inhibit muscle protein metabolism. | YES | Polycystic Ovary Syndrome (PCOS)|Obstructive Sleep Apnea|Obesity | DRUG: Progesterone|DRUG: testosterone|DRUG: glucocorticoid|DEVICE: continuous positive airway pressure|DRUG: Estrogen|OTHER: Control | Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate, VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration., Before and at the end of interventions | Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration, VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO)., Before and at the end of the interventions|VLDL-TG Plasma Clearance Rate (Means), VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration., Before and at the end of the interventions|VLDL-TG Plasma Clearance Rate (Medians), VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration., Before and at the end of the interventions|Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis, The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of \[5,5,5-2H3\]leucine into muscle proteins. \[5,5,5-2H3\]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model. The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour., Before and at the end of the intervention | Washington University School of Medicine | ALL | ADULT, OLDER_ADULT | NA | 61 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER | 07-0692|NIH P50 HD057796 | 2007-09 | 2013-03 | 2013-03 | 2008-12-09 | 2018-08-01 | 2018-08-01 | Washington University School of Medicine, Saint Louis, Missouri, 63110, United States | |||
| NCT00782366 | Predictive Genetic Risk Assessment Trial | https://clinicaltrials.gov/study/NCT00782366 | PGT | This proof-of-principle clinical trial at Mayo Clinic studies how patients and their physicians understand and utilize predictive genetic risk assessment. A critical goal of this clinical trial is to understand how individual patients and their doctors perceive and respond to genetic risk information that is largely uncertain. | NO | Colon Cancer|Lung Cancer|Atrial Fibrillation|Diabetes Type 2|Obesity|Breast Cancer|Graves Disease|Osteoarthritis|Celiac Disease|Myocardial Infarction|Prostate Cancer | GENETIC: SNP analysis | Assess accessibility and feasibility, including positive and negative aspects of integrating predictive genomics at the clinic focusing on patients’ and physicians’ attitudes, March 2008-March 2009 | Assess effects of predictive genomics on self-reported health behavior and on physician-patient interaction, March 2008-March 2009 | Mayo Clinic | ALL | ADULT, OLDER_ADULT | 26 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 07-007414 | 2008-03 | 2010-01 | 2010-01 | 2008-10-31 | 2011-04-27 | Mayo Clinic, Rochester, Minnesota, 55905, United States | |||||
| NCT00774371 | Weight Reduction Intervention for Breast Cancer Survivors | https://clinicaltrials.gov/study/NCT00774371 | SHAPE | Overweight or obesity is an established negative prognostic factor in both premenopausal and postmenopausal breast cancer. Several mechanisms have been proposed to explain the adverse effect of excess body fat on prognosis following the diagnosis of breast cancer, including increased circulating sex hormones, insulin, leptin, and various growth factors. Results from previous studies suggest that specific strategies can facilitate weight reduction and maintenance of weight loss in this target population. This randomized clinical trial will recruit 253 overweight or obese women who have been previously treated for early stage breast cancer and will test whether a multifaceted approach to promoting healthy weight management can achieve the goal of weight loss and maintenance. Additionally, this study tests whether weight loss is associated with changes in biological and psychosocial factors, including eating attitudes and behaviors and health-related quality of life. The intervention incorporates cognitive-behavioral therapy, increased physical activity, diet modification to facilitate a modest reduction in energy intake, and strategies to improve body image and self-acceptance. This approach and intervention have been pilot-tested with breast cancer survivors in a developmental project, which resulted in the intervention group losing significantly more weight than the wait-list control group. Study Aims include: testing whether an intervention that emphasizes increased physical activity and individualized diet modification to promote an energy imbalance is associated with a greater degree of weight loss and maintenance of that loss over an 18-month time period; describing the effect of the intervention on hormones and growth factors; describing the relationships between body weight and weight reduction and measures of selected psychosocial factors. Measurements of hormonal and psychosocial factors in this study will provide insight into the responsiveness of these factors to weight loss in overweight or obese breast cancer survivors, which will provide an indication of the degree of clinical benefit that is achieved with the intervention efforts. Results from this study may enable the development of broader efforts transferable to clinical practice and public health, and thus, may ultimately have a substantial effect on the risk for recurrence and long-term survival of the estimated 1.98 million breast cancer survivors in the U.S. today. | NO | Breast Cancer | BEHAVIORAL: Cognitive behavioral therapy CBT) for weight loss | Weight loss, 2 years | Increase in physical activity levels, 2 years | University of California, San Diego | American Cancer Society, Inc.|San Diego State University | FEMALE | ADULT, OLDER_ADULT | NA | 253 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | RSGPB-04-258-01-CPPB|UCSD ID# 2004-2839 | 2005-01 | 2009-02 | 2009-12 | 2008-10-17 | 2023-11-30 | Moores UCSD Cancer Center, La Jolla, California, 92093, United States | |||
| NCT00766311 | Aerobic and Strengthening Exercise for Acute Leukemia | https://clinicaltrials.gov/study/NCT00766311 | XRCISL | Survivors of childhood leukemia have muscle weakness and impaired mobility (physical performance), a higher than expected frequency of obesity, and early mortality from cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may complicate physical performance and establish a pattern of sedentary behavior that may lead to a lifetime of inactivity. There is limited evidence that children being treated for leukemia benefit from home exercise programs during the maintenance phase of therapy, particularly in terms of muscle strength and range of motion. However, there are no established guidelines regarding the prescription of exercise for children diagnosed with leukemia. We propose to test the feasibility of an exercise intervention among children being treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate in the exercise intervention will demonstrate improvements in gross motor function, strength, flexibility, and cardio respiratory fitness, and that they will have more favorable body composition when compared to the children who are assigned to the usual activity group. | NO | Acute Lymphoblastic Leukemia | OTHER: Gross Motor Function|OTHER: Knee extension strength|OTHER: Hand grip strength|OTHER: Flexibility|OTHER: Ankle range of motion|OTHER: Aerobic capacity|OTHER: Body composition and vital signs | To determine the feasibility of an aerobic and strengthening exercise intervention trial among children during maintenance therapy for childhood ALL by evaluating participant accrual, participant compliance and burden to institutional staff., 1 year | St. Jude Children’s Research Hospital | ALL | CHILD | NA | 20 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | XRCISL | 2008-01 | 2011-12 | 2011-12 | 2008-10-03 | 2012-01-09 | Oregon Health and Science University, Portland, Oregon, 97239, United States|Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|St. Jude Children’s Research Hospital, Memphis, Tennessee, 38105, United States|Vanderbilt Ingram Cancer Center, Nashville, Tennessee, 37215, United States | |||||
| NCT00758108 | Characterization of WAGR Syndrome and Other Chromosome 11 Gene Deletions | https://clinicaltrials.gov/study/NCT00758108 | This study will explore conditions caused by the absence of certain genes on chromosome 11. These conditions include WAGR syndrome, which is characterized by a kidney tumor called Wilm s tumor, aniridia (absence of the iris of the eye), genital and urinary abnormalities, mental retardation, and possibly other symptoms. This study will examine how the genes on chromosome 11 affect people and whether the absence of specific genes is associated with specific symptoms. Healthy normal volunteers, people with isolated aniridia, and people with WAGR or another chromosome 11 gene deletion may be eligible for this study. Participants must be at least 6 years old. Parents of patients may also participate for genetic studies. Participants undergo some or all of the following procedures, depending on whether they are a child, adult, healthy volunteer or parent of a patient: * Medical history and physical examination, eye examination, blood, urine and saliva tests, electrocardiogram (EKG) and electroencephalogram (EEG) * X-rays, scans and other tests to measure body composition (fat, muscle and bone development and thickness) and MRI to examine the eyes and the brain and to measure abdominal fat * Ultrasound studies of the kidneys, ovaries and uterus (in females) and testes (in males) * Meal tests, food diaries and food preference tests * Questionnaires about eating and sleep habits, personality and character traits and responses to pain and injury * Neuropsychological tests * Tests of resting metabolic rate, energy expenditure and glucose (sugar) tolerance * Hot and cold sensitivity tests, vibration sensitivity test, cold tolerance test and smell identification test * Eye and hearing tests * Nerve conduction studies and study of sensory information conduction from peripheral nerves to the spinal cord and brain * Computer photography * Evaluation by sub-specialists (e.g., endocrinologist, ophthalmologist, physiatrist, neurologist or others) as indicated by the patient s medical history and test results | NO | WAGR Syndrome|Wilm’s Tumor|Aniridia|Urogenital Abnormalities|Mental Retardation | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ALL | CHILD, ADULT, OLDER_ADULT | 197 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 080213|08-CH-0213 | 2008-09-11 | 2015-04-29 | 2008-09-23 | 2019-12-12 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | ||||||||||
| NCT00757185 | Compromised Microcirculation in Women With Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT00757185 | The scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with PCOS. | NO | Polycystic Ovary Syndrome | DRUG: ganirelix acetate|DRUG: methyl testosterone | Skin blood flow and cutaneous vascular conductance, 6 non consecutive days | Yale University | National Heart, Lung, and Blood Institute (NHLBI) | FEMALE | ADULT | EARLY_PHASE1 | 28 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | 0801003437|R21HL093450 | 2008-02 | 2012-04 | 2012-12 | 2008-09-23 | 2016-07-04 | John B. Pierce Laboratory, New Haven, Connecticut, 06520, United States | |||||
| NCT00732173 | Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer | https://clinicaltrials.gov/study/NCT00732173 | RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer. PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to see how well it works compared with standard care in patients in remission from stage I or stage II endometrial cancer. | NO | Endometrial Cancer | BEHAVIORAL: behavioral dietary intervention|BEHAVIORAL: exercise intervention|OTHER: counseling intervention|OTHER: educational intervention|OTHER: survey administration | Weight change, Analysis will be carried out by fitting a mixed model. Weight change will be expressed in terms of absolute and relative weight change. In addition, percent weight change will be calculated. To test the null hypotheses that the groups do not differ in terms of change in weight at 6 or 12 months, parameter estimates from the model will be used to construct subsequent t-test that the difference in means at 3, 6, or 12 months is zero., at baseline and 3, 6, and 12 months. | Quantitative and qualitative nutrient intake, 24 hour dietary recalls will be conducted using the United States Department of Agriculture (USDA) 5 Step Multiple Pass Method. Information about dietary supplement use will also be obtained. Food intake will be entered into Nutritionist Pro. Fruit/vegetable intake will be assessed using the National Cancer Institute (NCI) All-Day Fruit and Vegetable Screener, which has 10 questions which assess intake of fruits and vegetables during the previous month. A mixed modeling approach will be used., at baseline and 3, 6, and 12 months.|Minutes spent in moderate and vigorous physical activity, Assessed with the validated Godin Leisure-Time Exercise questionnaire, a four-item query of usual leisure-time exercise habits. Average frequency of milk, moderate, and strenuous exercise during a typical week are assessed. Duration in minutes of activity along with specific questions regarding walking are included. Complete 7-day pedometer step test at baseline and at 6 and 12 months. A mixed modeling approach will be used., at baseline and 3, 6, and 12 months.|Body composition, using dual energy x-ray absorptiometry/densitometry (DEXA) methodology, Measured in a random subsample. Lean body mass, body fat composition, and bone mineral density will be measured. Body composition will be analyzed to determine changes along with weight to help track effectiveness of the intervention., at baseline and 3, 6, and 12 months.|Biomarkers for metabolic syndrome and nutrition, Serum biomarkers analyzed for changes along with weight to help track effectiveness of the intervention. Risk factors of metabolic syndrome: low density lipoprotein (LDL), high density lipoprotein (HDL), serum triglycerides, and fasting glucose. Plasma carotenoids (alpha-carotene, beta-carotene, lutein, zeaxanthin) and lycopene concentrations for changes in fruit and vegetable intake. Sub-Study, serum for appetite-related hormones and inflammatory cytokines: leptin, insulin, adiponectin, resistin, IGF-1, IGFBP-1, IGFBP-3, IL-6, TNF-α, MCP-1, glucagon, GLP-1 active, and thyroid hormones., at baseline and 3, 6, and 12 months.|Self-efficacy, Self-Efficacy Questionnaire: Physical Activities, an 8 item measure of respondents’ perception of the degree to which they feel able to make changes in their physical activity level. Weight Efficacy Life-Style (WEL) questionnaire, 20 questions in 5 situational factors, where subjects rate their ability to successfully resist the desire to eat using a 10-point scale. Methodology of Baron and Kenny used to test for mediating effect of self-efficacy. Multiple regression analyses used to provide statistical tests of the possible mediating role of self-efficacy., at baseline and 3, 6, and 12 months.|Depression, Assessed using the Beck Depression Inventory (BDI), a 21-item, Likert-scaled instrument of depressive symptoms. Methodology of Baron and Kenny used to test for mediating effect of depression. Multiple regression analyses used to provide statistical tests of the possible mediating role of depression., at baseline and 3, 6, and 12 months.|Quality of life, Using Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating various domains of QOL including physical, functional, family-social, and emotional well-being with questions answered on a 5-point Likert scale and items summated to give scores for each domain; a 13-item fatigue subscale; and the FACT-Endometrial (En), a 16-item subscale specific for EC. Also using Short-Form (SF)-36, with 36 questions scored on a Likert scale, producing overall physical and mental component summary measures. Baseline scores entered in the regression models., at baseline and 3, 6, and 12 months. | Case Comprehensive Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 74 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: | CASE8808|P30CA043703|CASE8808|CASE-8808-CC516 | 2008-07 | 2010-03 | 2011-03 | 2008-08-11 | 2013-02-08 | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106-5065, United States | ||||
| NCT00729560 | Effects of Flutamide on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT00729560 | PCOS | Polycystic Ovary Syndrome (PCOS) is the major cause of infertility in the United States. Many women with PCOS demonstrate insulin resistance and a compensatory hyperinsulinemia.This is due to both an intrinsic form of insulin resistance unique to PCOS and, in many cases, acquired insulin resistance due to obesity. The importance of this observation lies in the fact that hyperinsulinemia appears to play an important pathogenetic role in the hyperandrogenism and anovulation of both obese and lean women with PCOS. | YES | Polycystic Ovary Syndrome | DRUG: Flutamide|DRUG: Placebo | DCI-IPG Measurements in Blood and Urine, zero participants analyzed, no assays performed, 2 years | Virginia Commonwealth University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | ADULT | NA | 8 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH | 04487VCUIRB|GCRC0826 | 2008-07 | 2012-02 | 2012-02 | 2008-08-07 | 2014-09-08 | 2014-09-08 | Virginia Commonwealth University General Clinical Research Center, Richmond, Virginia, 23298, United States | |||
| NCT00719303 | Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | https://clinicaltrials.gov/study/NCT00719303 | This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer. | NO | Fallopian Tube Clear Cell Adenocarcinoma|Fallopian Tube Endometrioid Adenocarcinoma|Fallopian Tube Mucinous Adenocarcinoma|Fallopian Tube Serous Adenocarcinoma|Fallopian Tube Transitional Cell Carcinoma|Malignant Ovarian Brenner Tumor|Ovarian Clear Cell Adenocarcinoma|Ovarian Endometrioid Adenocarcinoma|Ovarian Mucinous Adenocarcinoma|Ovarian Seromucinous Carcinoma|Ovarian Serous Adenocarcinoma|Ovarian Transitional Cell Carcinoma|Primary Peritoneal Serous Adenocarcinoma|Stage IIA Fallopian Tube Cancer AJCC v6 and v7|Stage IIA Ovarian Cancer AJCC V6 and v7|Stage IIB Fallopian Tube Cancer AJCC v6 and v7|Stage IIB Ovarian Cancer AJCC v6 and v7|Stage IIC Fallopian Tube Cancer AJCC v6 and v7|Stage IIC Ovarian Cancer AJCC v6 and v7|Stage IIIA Fallopian Tube Cancer AJCC v7|Stage IIIA Ovarian Cancer AJCC v6 and v7|Stage IIIA Primary Peritoneal Cancer AJCC v7|Stage IIIB Fallopian Tube Cancer AJCC v7|Stage IIIB Ovarian Cancer AJCC v6 and v7|Stage IIIB Primary Peritoneal Cancer AJCC v7|Stage IIIC Fallopian Tube Cancer AJCC v7|Stage IIIC Ovarian Cancer AJCC v6 and v7|Stage IIIC Primary Peritoneal Cancer AJCC v7|Stage IV Fallopian Tube Cancer AJCC v6 and v7|Stage IV Ovarian Cancer AJCC v6 and v7|Stage IV Primary Peritoneal Cancer AJCC v7|Undifferentiated Fallopian Tube Carcinoma|Undifferentiated Ovarian Carcinoma | BEHAVIORAL: Behavioral Dietary Intervention|BEHAVIORAL: Compliance Monitoring|OTHER: Counseling|OTHER: Educational Intervention|BEHAVIORAL: Exercise Intervention|OTHER: Laboratory Biomarker Analysis|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Progression-free survival, Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no)., From entry onto the protocol to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 9 years | Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS, Linear mixed effects models for repeated measures will be fitted to general health subscale score, physical functioning subscale score of RAND-36, and to GSRS-IBS overall score respectively., Baseline to up to 24 months|Change in self-reported quality of life measured using RAND-36, Linear mixed effects models for repeated measures will be fitted to general health subscale score, physical functioning subscale score of RAND-36, and to GSRS-IBS overall score respectively., Baseline to up to 24 months | Change in sleep quality measured using Pittsburgh Sleep Quality Index, Baseline to 24 months|Change in telomere length, Baseline to 24 months|Changes in visceral adiposity using CT scan, Changes in visceral adiposity will be associated with changes in biomarkers of metabolic deregulation and inflammation in a random subsample. The association between (continuous) change in visceral adipose and progression free survival will be quantified using Cox proportional hazards regression., Baseline to up to 14 months|Mental health measured using RAND-36 and GSRS-IBS, Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted., Up to 24 months|Pain measured using RAND-36 and GSRS-IBS, Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted., Up to 24 months|Role limitations due to physical health and emotional problems measured using RAND-36 and GSRS-IBS, Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted., Up to 24 months|Social functioning measured using RAND-36 and GSRS-IBS, Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted., Up to 24 months|Total carotenoid level, Will be used to estimate compliance to the dietary portion of the healthy lifestyle intervention., Up to 24 months|Treatment compliance, Up to 9 years|Vitality measured using RAND-36 and GSRS-IBS, Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted., Up to 24 months | Gynecologic Oncology Group | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | PHASE3 | 1070 | NETWORK | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | GOG-0225|NCI-2009-00595|CDR0000594600|GOG-0225|GOG-0225|GOG-0225|U10CA101165|U10CA180830|UG1CA189867 | 2012-06-18 | 2020-12-31 | 2008-07-21 | 2018-02-19 | University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, 35233, United States|Tennessee Valley Gynecologic Oncology, Huntsville, Alabama, 35805, United States|Anchorage Associates in Radiation Medicine, Anchorage, Alaska, 98508, United States|Alaska Breast Care and Surgery LLC, Anchorage, Alaska, 99508, United States|Alaska Oncology and Hematology LLC, Anchorage, Alaska, 99508, United States|Alaska Women’s Cancer Care, Anchorage, Alaska, 99508, United States|Anchorage Oncology Centre, Anchorage, Alaska, 99508, United States|Katmai Oncology Group, Anchorage, Alaska, 99508, United States|Providence Alaska Medical Center, Anchorage, Alaska, 99508, United States|Fairbanks Memorial Hospital, Fairbanks, Alaska, 99701, United States|University of Arizona Cancer Center at Saint Joseph’s, Phoenix, Arizona, 85004, United States|Gynecologic Oncology Group of Arizona, Phoenix, Arizona, 85012, United States|Saint Joseph’s Hospital and Medical Center, Phoenix, Arizona, 85013, United States|University of Arizona Cancer Center-North Campus, Tucson, Arizona, 85719, United States|The University of Arizona Medical Center-University Campus, Tucson, Arizona, 85724, United States|CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, 71913, United States|University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|Sutter Auburn Faith Hospital, Auburn, California, 95602, United States|Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, 95603, United States|Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, 94704, United States|Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, 91505, United States|Mills-Peninsula Medical Center, Burlingame, California, 94010, United States|Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, 95682, United States|Eden Hospital Medical Center, Castro Valley, California, 94546, United States|John Muir Medical Center-Concord Campus, Concord, California, 94520, United States|Sutter Davis Hospital, Davis, California, 95616, United States|City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States|Palo Alto Medical Foundation-Fremont, Fremont, California, 94538, United States|Kaiser Permanente-Irvine, Irvine, California, 92618, United States|UC San Diego Moores Cancer Center, La Jolla, California, 92093, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Los Angeles County-USC Medical Center, Los Angeles, California, 90033, United States|USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States|Memorial Medical Center, Modesto, California, 95355, United States|Palo Alto Medical Foundation-Camino Division, Mountain View, California, 94040, United States|Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040, United States|Saint Joseph Hospital – Orange, Orange, California, 92868, United States|Palo Alto Medical Foundation Health Care, Palo Alto, California, 94301, United States|Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, 95661, United States|Sutter Roseville Medical Center, Roseville, California, 95661, United States|Sutter Medical Center Sacramento, Sacramento, California, 95816, United States|University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States|University of California San Diego, San Diego, California, 92103, United States|California Pacific Medical Center-Pacific Campus, San Francisco, California, 94115, United States|Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, 95065, United States|Sutter Pacific Medical Foundation, Santa Rosa, California, 95403, United States|Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, 94086, United States|Olive View-University of California Los Angeles Medical Center, Sylmar, California, 91342, United States|Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, 95687, United States|Sutter Solano Medical Center/Cancer Center, Vallejo, California, 94589, United States|John Muir Medical Center-Walnut Creek, Walnut Creek, California, 94598, United States|Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, 80012, United States|The Medical Center of Aurora, Aurora, Colorado, 80012, United States|University of Colorado Hospital, Aurora, Colorado, 80045, United States|Boulder Community Hospital, Boulder, Colorado, 80301, United States|Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, 80304, United States|Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, 80907, United States|Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, 80907, United States|Porter Adventist Hospital, Denver, Colorado, 80210, United States|Colorado Blood Cancer Institute, Denver, Colorado, 80218, United States|Presbyterian – Saint Lukes Medical Center – Health One, Denver, Colorado, 80218, United States|Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, 80218, United States|SCL Health Saint Joseph Hospital, Denver, Colorado, 80218, United States|Rocky Mountain Cancer Centers-Rose, Denver, Colorado, 80220, United States|Rose Medical Center, Denver, Colorado, 80220, United States|Colorado Cancer Research Program NCORP, Denver, Colorado, 80222, United States|Mercy Medical Center, Durango, Colorado, 81301, United States|Southwest Oncology PC, Durango, Colorado, 81301, United States|Comprehensive Cancer Care and Research Institute of Colorado LLC, Englewood, Colorado, 80113, United States|Swedish Medical Center, Englewood, Colorado, 80113, United States|Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States|Mountain Blue Cancer Care Center, Golden, Colorado, 80401, United States|North Colorado Medical Center, Greeley, Colorado, 80631, United States|Rocky Mountain Cancer Centers-Greenwood Village, Greenwood Village, Colorado, 80111, United States|Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, 80228, United States|Saint Anthony Hospital, Lakewood, Colorado, 80228, United States|Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, 80120, United States|Littleton Adventist Hospital, Littleton, Colorado, 80122, United States|Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, 80124, United States|Sky Ridge Medical Center, Lone Tree, Colorado, 80124, United States|Longmont United Hospital, Longmont, Colorado, 80501, United States|Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, 80501, United States|McKee Medical Center, Loveland, Colorado, 80539, United States|Parker Adventist Hospital, Parker, Colorado, 80138, United States|Rocky Mountain Cancer Centers-Parker, Parker, Colorado, 80138, United States|Saint Mary Corwin Medical Center, Pueblo, Colorado, 81004, United States|Rocky Mountain Cancer Centers – Pueblo, Pueblo, Colorado, 81008, United States|Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, 80260, United States|SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, 80033, United States|Saint Vincent’s Medical Center, Bridgeport, Connecticut, 06606, United States|Danbury Hospital, Danbury, Connecticut, 06810, United States|University of Connecticut, Farmington, Connecticut, 06030, United States|Hartford Hospital, Hartford, Connecticut, 06102, United States|Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, 06105, United States|Middlesex Hospital, Middletown, Connecticut, 06457, United States|The Hospital of Central Connecticut, New Britain, Connecticut, 06050, United States|Yale University, New Haven, Connecticut, 06520, United States|Beebe Medical Center, Lewes, Delaware, 19958, United States|Christiana Gynecologic Oncology LLC, Newark, Delaware, 19713, United States|Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, 19713, United States|Helen F Graham Cancer Center, Newark, Delaware, 19713, United States|Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States|Regional Hematology and Oncology PA, Newark, Delaware, 19713, United States|Christiana Care Health System-Christiana Hospital, Newark, Delaware, 19718, United States|Beebe Health Campus, Rehoboth Beach, Delaware, 19971, United States|Nanticoke Memorial Hospital, Seaford, Delaware, 19973, United States|Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, 19801, United States|Florida Hospital Orlando, Orlando, Florida, 32803, United States|UF Cancer Center at Orlando Health, Orlando, Florida, 32806, United States|Sarasota Memorial Hospital, Sarasota, Florida, 34239, United States|Piedmont Hospital, Atlanta, Georgia, 30309, United States|Northside Hospital, Atlanta, Georgia, 30342, United States|Augusta University Medical Center, Augusta, Georgia, 30912, United States|John B Amos Cancer Center, Columbus, Georgia, 31904, United States|Northside Hospital-Forsyth, Cumming, Georgia, 30041, United States|Dekalb Medical Center, Decatur, Georgia, 30033, United States|Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, 30501, United States|Central Georgia Gynecologic Oncology, Macon, Georgia, 31201, United States|Memorial University Medical Center, Savannah, Georgia, 31404, United States|Lewis Cancer and Research Pavilion at Saint Joseph’s/Candler, Savannah, Georgia, 31405, United States|Hawaii Cancer Care Inc-POB II, Honolulu, Hawaii, 96813, United States|Queen’s Medical Center, Honolulu, Hawaii, 96813, United States|University of Hawaii Cancer Center, Honolulu, Hawaii, 96813, United States|Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States|Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, 83706, United States|Saint Luke’s Mountain States Tumor Institute, Boise, Idaho, 83712, United States|Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, 83605, United States|Kootenai Medical Center, Coeur d’Alene, Idaho, 83814, United States|Walter Knox Memorial Hospital, Emmett, Idaho, 83617, United States|Saint Luke’s Mountain States Tumor Institute – Fruitland, Fruitland, Idaho, 83619, United States|Idaho Urologic Institute-Meridian, Meridian, Idaho, 83642, United States|Saint Luke’s Mountain States Tumor Institute – Meridian, Meridian, Idaho, 83642, United States|Saint Alphonsus Medical Center-Nampa, Nampa, Idaho, 83686, United States|Saint Luke’s Mountain States Tumor Institute – Nampa, Nampa, Idaho, 83686, United States|Kootenai Cancer Center, Post Falls, Idaho, 83854, United States|Kootenai Cancer Clinic, Sandpoint, Idaho, 83864, United States|Saint Luke’s Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, 83301, United States|Rush – Copley Medical Center, Aurora, Illinois, 60504, United States|Saint Joseph Medical Center, Bloomington, Illinois, 61701, United States|Illinois CancerCare-Bloomington, Bloomington, Illinois, 61704, United States|Illinois CancerCare-Canton, Canton, Illinois, 61520, United States|Memorial Hospital of Carbondale, Carbondale, Illinois, 62902, United States|Illinois CancerCare-Carthage, Carthage, Illinois, 62321, United States|Centralia Oncology Clinic, Centralia, Illinois, 62801, United States|Northwestern University, Chicago, Illinois, 60611, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States|Carle on Vermilion, Danville, Illinois, 61832, United States|Cancer Care Specialists of Central Illinois, Decatur, Illinois, 62526, United States|Decatur Memorial Hospital, Decatur, Illinois, 62526, United States|Carle Physician Group-Effingham, Effingham, Illinois, 62401, United States|Crossroads Cancer Center, Effingham, Illinois, 62401, United States|Illinois CancerCare-Eureka, Eureka, Illinois, 61530, United States|Illinois CancerCare-Galesburg, Galesburg, Illinois, 61401, United States|Western Illinois Cancer Treatment Center, Galesburg, Illinois, 61401, United States|Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, 60134, United States|Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, 60521, United States|Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, 61443, United States|Illinois CancerCare-Macomb, Macomb, Illinois, 61455, United States|Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, 61938, United States|Good Samaritan Regional Health Center, Mount Vernon, Illinois, 62864, United States|UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, 60451, United States|Advocate Christ Medical Center, Oak Lawn, Illinois, 60453-2699, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350, United States|Radiation Oncology of Northern Illinois, Ottawa, Illinois, 61350, United States|Illinois CancerCare-Pekin, Pekin, Illinois, 61554, United States|OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, 61554, United States|Methodist Medical Center of Illinois, Peoria, Illinois, 61603, United States|Illinois CancerCare-Peoria, Peoria, Illinois, 61615, United States|OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, 61615, United States|OSF Saint Francis Medical Center, Peoria, Illinois, 61637, United States|Illinois CancerCare-Peru, Peru, Illinois, 61354, United States|Valley Radiation Oncology, Peru, Illinois, 61354, United States|Illinois CancerCare-Princeton, Princeton, Illinois, 61356, United States|Central Illinois Hematology Oncology Center, Springfield, Illinois, 62702, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States|Springfield Clinic, Springfield, Illinois, 62702, United States|Memorial Medical Center, Springfield, Illinois, 62781, United States|Cancer Care Specialists of Illinois-Swansea, Swansea, Illinois, 62226, United States|Carle Cancer Center, Urbana, Illinois, 61801, United States|The Carle Foundation Hospital, Urbana, Illinois, 61801, United States|Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, 60555, United States|Rush-Copley Healthcare Center, Yorkville, Illinois, 60560, United States|Michiana Hematology Oncology PC-Crown Point, Crown Point, Indiana, 46307, United States|Elkhart Clinic, Elkhart, Indiana, 46514-2098, United States|Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, 46514, United States|Elkhart General Hospital, Elkhart, Indiana, 46515, United States|Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States|Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, 46260, United States|Community Howard Regional Health, Kokomo, Indiana, 46904, United States|IU Health La Porte Hospital, La Porte, Indiana, 46350, United States|Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana, 46545, United States|Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, 46545, United States|Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, 46563, United States|Memorial Hospital of South Bend, South Bend, Indiana, 46601, United States|Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, 46601, United States|South Bend Clinic, South Bend, Indiana, 46617, United States|Northern Indiana Cancer Research Consortium, South Bend, Indiana, 46628, United States|Michiana Hematology Oncology PC-Westville, Westville, Indiana, 46391, United States|Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, 50325, United States|Mercy Cancer Center-West Lakes, Clive, Iowa, 50325, United States|Alegent Health Mercy Hospital, Council Bluffs, Iowa, 51503, United States|Greater Regional Medical Center, Creston, Iowa, 50801, United States|Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, 50314, United States|Mercy Medical Center – Des Moines, Des Moines, Iowa, 50314, United States|Mercy Medical Center-West Lakes, West Des Moines, Iowa, 50266, United States|Cancer Center of Kansas – Chanute, Chanute, Kansas, 66720, United States|Cancer Center of Kansas – Dodge City, Dodge City, Kansas, 67801, United States|Cancer Center of Kansas – El Dorado, El Dorado, Kansas, 67042, United States|Cancer Center of Kansas – Fort Scott, Fort Scott, Kansas, 66701, United States|Cancer Center of Kansas-Independence, Independence, Kansas, 67301, United States|Providence Medical Center, Kansas City, Kansas, 66112, United States|University of Kansas Cancer Center, Kansas City, Kansas, 66160, United States|Cancer Center of Kansas-Kingman, Kingman, Kansas, 67068, United States|Lawrence Memorial Hospital, Lawrence, Kansas, 66044, United States|Kansas Institute of Medicine Cancer and Blood Center, Lenexa, Kansas, 66219, United States|Minimally Invasive Surgery Hospital, Lenexa, Kansas, 66219, United States|Cancer Center of Kansas-Liberal, Liberal, Kansas, 67905, United States|Cancer Center of Kansas-Manhattan, Manhattan, Kansas, 66502, United States|Cancer Center of Kansas – McPherson, McPherson, Kansas, 67460, United States|Cancer Center of Kansas – Newton, Newton, Kansas, 67114, United States|Menorah Medical Center, Overland Park, Kansas, 66209, United States|Saint Luke’s South Hospital, Overland Park, Kansas, 66213, United States|Cancer Center of Kansas – Parsons, Parsons, Kansas, 67357, United States|Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, 66208, United States|Cancer Center of Kansas – Pratt, Pratt, Kansas, 67124, United States|Cancer Center of Kansas – Salina, Salina, Kansas, 67401, United States|Cancer Center of Kansas – Wellington, Wellington, Kansas, 67152, United States|Associates In Womens Health, Wichita, Kansas, 67208, United States|Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, 67208, United States|Cancer Center of Kansas – Wichita, Wichita, Kansas, 67214, United States|Via Christi Regional Medical Center, Wichita, Kansas, 67214, United States|Wichita NCI Community Oncology Research Program, Wichita, Kansas, 67214, United States|Cancer Center of Kansas – Winfield, Winfield, Kansas, 67156, United States|Flaget Memorial Hospital, Bardstown, Kentucky, 40004, United States|Commonwealth Cancer Center-Corbin, Corbin, Kentucky, 40701, United States|Saint Elizabeth Medical Center South, Edgewood, Kentucky, 41017, United States|Saint Joseph Radiation Oncology Resource Center, Lexington, Kentucky, 40504, United States|Saint Joseph Hospital East, Lexington, Kentucky, 40509, United States|University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536, United States|Saint Joseph London, London, Kentucky, 40741, United States|Jewish Hospital, Louisville, Kentucky, 40202, United States|Norton Hospital Pavilion and Medical Campus, Louisville, Kentucky, 40202, United States|Norton Suburban Hospital and Medical Campus, Louisville, Kentucky, 40207, United States|Saints Mary and Elizabeth Hospital, Louisville, Kentucky, 40215, United States|Jewish Hospital Medical Center Northeast, Louisville, Kentucky, 40245, United States|Jewish Hospital Medical Center South, Shepherdsville, Kentucky, 40165, United States|Hematology/Oncology Clinic LLP, Baton Rouge, Louisiana, 70809, United States|Woman’s Hospital, Baton Rouge, Louisiana, 70817, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, 70112, United States|Maine Medical Center-Bramhall Campus, Portland, Maine, 04102, United States|Maine Medical Center- Scarborough Campus, Scarborough, Maine, 04074, United States|Greater Baltimore Medical Center, Baltimore, Maryland, 21204, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, 20889-5600, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Lahey Hospital and Medical Center, Burlington, Massachusetts, 01805, United States|University of Massachusetts Memorial Health Care, Worcester, Massachusetts, 01605, United States|Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, 48106, United States|Saint Joseph Mercy Hospital, Ann Arbor, Michigan, 48106, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States|Bronson Battle Creek, Battle Creek, Michigan, 49017, United States|Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, 49307, United States|IHA Hematology Oncology Consultants-Brighton, Brighton, Michigan, 48114, United States|Saint Joseph Mercy Brighton, Brighton, Michigan, 48114, United States|IHA Hematology Oncology Consultants-Canton, Canton, Michigan, 48188, United States|Saint Joseph Mercy Canton, Canton, Michigan, 48188, United States|Caro Cancer Center, Caro, Michigan, 48723, United States|IHA Hematology Oncology Consultants-Chelsea, Chelsea, Michigan, 48118, United States|Saint Joseph Mercy Chelsea, Chelsea, Michigan, 48118, United States|Hematology Oncology Consultants-Clarkston, Clarkston, Michigan, 48346, United States|Newland Medical Associates-Clarkston, Clarkston, Michigan, 48346, United States|Beaumont Hospital-Dearborn, Dearborn, Michigan, 48124, United States|Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|Saint John Hospital and Medical Center, Detroit, Michigan, 48236, United States|Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, 48054, United States|Weisberg Cancer Treatment Center, Farmington Hills, Michigan, 48334, United States|Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, 48503, United States|Genesee Hematology Oncology PC, Flint, Michigan, 48503, United States|Genesys Hurley Cancer Institute, Flint, Michigan, 48503, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, 49503, United States|Mercy Health Saint Mary’s, Grand Rapids, Michigan, 49503, United States|Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, 49503, United States|Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, 48236, United States|Lymphoma Clinic of Michigan, Grosse Pointe Woods, Michigan, 48236, United States|Michigan Breast Specialists-Grosse Pointe Woods, Grosse Pointe Woods, Michigan, 48236, United States|Allegiance Health, Jackson, Michigan, 49201, United States|Borgess Medical Center, Kalamazoo, Michigan, 49001, United States|Bronson Methodist Hospital, Kalamazoo, Michigan, 49007, United States|West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States|Sparrow Hospital, Lansing, Michigan, 48912, United States|Hope Cancer Clinic, Livonia, Michigan, 48154, United States|Saint Mary Mercy Hospital, Livonia, Michigan, 48154, United States|Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, 48044, United States|Michigan Breast Specialists-Macomb Township, Macomb, Michigan, 48044, United States|Saint Mary’s Oncology/Hematology Associates of Marlette, Marlette, Michigan, 48453, United States|Mercy Health Mercy Campus, Muskegon, Michigan, 49444, United States|Lakeland Community Hospital, Niles, Michigan, 49120, United States|21st Century Oncology-Pontiac, Pontiac, Michigan, 48341, United States|Hope Cancer Center, Pontiac, Michigan, 48341, United States|Newland Medical Associates-Pontiac, Pontiac, Michigan, 48341, United States|Saint Joseph Mercy Oakland, Pontiac, Michigan, 48341, United States|Lake Huron Medical Center, Port Huron, Michigan, 48060, United States|Spectrum Health Reed City Hospital, Reed City, Michigan, 49677, United States|Great Lakes Cancer Management Specialists-Rochester Hills, Rochester Hills, Michigan, 48309, United States|William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, 48073, United States|Saint Mary’s of Michigan, Saginaw, Michigan, 48601, United States|Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, 48604, United States|Lakeland Hospital, Saint Joseph, Michigan, 49085, United States|Marie Yeager Cancer Center, Saint Joseph, Michigan, 49085, United States|Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, 48312, United States|Saint Joseph Health System-Tawas City, Tawas City, Michigan, 48764, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|William Beaumont Hospital – Troy, Troy, Michigan, 48098, United States|Advanced Breast Care Center PLLC, Warren, Michigan, 48088, United States|Bhadresh Nayak MD PC-Warren, Warren, Michigan, 48093, United States|Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, 48093, United States|Macomb Hematology Oncology PC, Warren, Michigan, 48093, United States|Michigan Breast Specialists-Warren, Warren, Michigan, 48093, United States|Saint John Macomb-Oakland Hospital, Warren, Michigan, 48093, United States|Saint Mary’s Oncology/Hematology Associates of West Branch, West Branch, Michigan, 48661, United States|Metro Health Hospital, Wyoming, Michigan, 49519, United States|Huron Gastroenterology PC, Ypsilanti, Michigan, 48106, United States|IHA Hematology Oncology Consultants-Ann Arbor, Ypsilanti, Michigan, 48197, United States|Sanford Clinic North-Bemidgi, Bemidji, Minnesota, 56601, United States|Fairview Ridges Hospital, Burnsville, Minnesota, 55337, United States|Mercy Hospital, Coon Rapids, Minnesota, 55433, United States|Fairview-Southdale Hospital, Edina, Minnesota, 55435, United States|Unity Hospital, Fridley, Minnesota, 55432, United States|Hutchinson Area Health Care, Hutchinson, Minnesota, 55350, United States|Fairview Maple Grove Medical Center, Maple Grove, Minnesota, 55369, United States|Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, 55109, United States|Saint John’s Hospital – Healtheast, Maplewood, Minnesota, 55109, United States|Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407, United States|Hennepin County Medical Center, Minneapolis, Minnesota, 55415, United States|Health Partners Inc, Minneapolis, Minnesota, 55454, United States|New Ulm Medical Center, New Ulm, Minnesota, 56073, United States|North Memorial Medical Health Center, Robbinsdale, Minnesota, 55422, United States|Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, 55416, United States|Park Nicollet Clinic – Saint Louis Park, Saint Louis Park, Minnesota, 55416, United States|Park Nicollet Frauenshuh Cancer Center, Saint Louis Park, Minnesota, 55426, United States|Regions Hospital, Saint Paul, Minnesota, 55101, United States|United Hospital, Saint Paul, Minnesota, 55102, United States|Saint Francis Regional Medical Center, Shakopee, Minnesota, 55379, United States|Lakeview Hospital, Stillwater, Minnesota, 55082, United States|Ridgeview Medical Center, Waconia, Minnesota, 55387, United States|Rice Memorial Hospital, Willmar, Minnesota, 56201, United States|Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, 55125, United States|Fairview Lakes Medical Center, Wyoming, Minnesota, 55092, United States|Saint Dominic-Jackson Memorial Hospital, Jackson, Mississippi, 39216, United States|Central Care Cancer Center-Carrie J Babb Cancer Center, Bolivar, Missouri, 65613, United States|Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, 63628, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, 63703, United States|Southeast Cancer Center, Cape Girardeau, Missouri, 63703, United States|Centerpoint Medical Center LLC, Independence, Missouri, 64057, United States|Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City, Missouri, 65109, United States|Saint Luke’s Hospital of Kansas City, Kansas City, Missouri, 64111, United States|Heartland Hematology and Oncology Associates Incorporated, Kansas City, Missouri, 64118, United States|Research Medical Center, Kansas City, Missouri, 64132, United States|Saint Luke’s East – Lee’s Summit, Lee’s Summit, Missouri, 64086, United States|Liberty Radiation Oncology Center, Liberty, Missouri, 64068, United States|Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, 65401, United States|Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, 65401, United States|Heartland Regional Medical Center, Saint Joseph, Missouri, 64507, United States|Saint Joseph Oncology Inc, Saint Joseph, Missouri, 64507, United States|Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Missouri Baptist Medical Center, Saint Louis, Missouri, 63131, United States|Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, 63670, United States|Cancer Research for the Ozarks NCORP, Springfield, Missouri, 65804, United States|Mercy Hospital Springfield, Springfield, Missouri, 65804, United States|CoxHealth South Hospital, Springfield, Missouri, 65807, United States|Missouri Baptist Sullivan Hospital, Sullivan, Missouri, 63080, United States|Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, 63127, United States|Community Hospital of Anaconda, Anaconda, Montana, 59711, United States|Billings Clinic Cancer Center, Billings, Montana, 59101, United States|Saint Vincent Healthcare, Billings, Montana, 59101, United States|Montana Cancer Consortium NCORP, Billings, Montana, 59102, United States|Bozeman Deaconess Hospital, Bozeman, Montana, 59715, United States|Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, 59701, United States|Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, 59405, United States|Great Falls Clinic, Great Falls, Montana, 59405, United States|Saint Peter’s Community Hospital, Helena, Montana, 59601, United States|Kalispell Regional Medical Center, Kalispell, Montana, 59901, United States|Saint Patrick Hospital – Community Hospital, Missoula, Montana, 59802, United States|Community Medical Hospital, Missoula, Montana, 59804, United States|CHI Health Saint Francis, Grand Island, Nebraska, 68803, United States|Heartland Hematology and Oncology, Kearney, Nebraska, 68845, United States|CHI Health Good Samaritan, Kearney, Nebraska, 68847, United States|Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, 68510, United States|Nebraska Methodist Hospital, Omaha, Nebraska, 68114, United States|Alegent Health Immanuel Medical Center, Omaha, Nebraska, 68122, United States|Hematology and Oncology Consultants PC, Omaha, Nebraska, 68122, United States|Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, 68124, United States|Alegent Health Lakeside Hospital, Omaha, Nebraska, 68130, United States|Creighton University Medical Center, Omaha, Nebraska, 68131, United States|Midlands Community Hospital, Papillion, Nebraska, 68046, United States|Women’s Cancer Center of Nevada, Las Vegas, Nevada, 89169, United States|Center of Hope at Renown Medical Center, Reno, Nevada, 89502, United States|Renown Regional Medical Center, Reno, Nevada, 89502, United States|Wentworth-Douglass Hospital, Dover, New Hampshire, 03820, United States|Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States|Norris Cotton Cancer Center-Manchester, Manchester, New Hampshire, 03102, United States|Norris Cotton Cancer Center-Nashua, Nashua, New Hampshire, 03063, United States|Ocean Medical Center, Brick, New Jersey, 08724, United States|Cooper Hospital University Medical Center, Camden, New Jersey, 08103, United States|Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Morristown Medical Center, Morristown, New Jersey, 07960, United States|Virtua Memorial, Mount Holly, New Jersey, 08060, United States|Jersey Shore Medical Center, Neptune, New Jersey, 07753, United States|Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, 08903, United States|Riverview Medical Center/Booker Cancer Center, Red Bank, New Jersey, 07701, United States|Overlook Hospital, Summit, New Jersey, 07902, United States|MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, 08043, United States|Virtua Voorhees, Voorhees, New Jersey, 08043, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87102, United States|Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, 87106, United States|Women’s Cancer Care Associates LLC, Albany, New York, 12208, United States|Montefiore Medical Center-Einstein Campus, Bronx, New York, 10461, United States|M | ||||
| NCT00714948 | Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma | https://clinicaltrials.gov/study/NCT00714948 | Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body. Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug combination used to treat locally advanced and metastatic urothelial cancer. However, these drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer. New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor’s source of oxygen and nutrients and prevent the tumor from growing. Sorafenib is an example of a drug that works in this way. In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the progression of their disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your cancer. | YES | Bladder Cancer|URINARY BLADDER | DRUG: gemcitabine and cisplatin plus sorafenib | To Determine the Progression Free Survival Rate at One Year Untreated Patients With Advanced/Metastatic Urothelial Carcinoma Treated With the Combination of Sorafenib, Gemcitabine, and Cisplatin., conclusion of the study | Memorial Sloan Kettering Cancer Center | Bayer | ALL | ADULT, OLDER_ADULT | PHASE2 | 2 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 07-168 | 2008-07 | 2011-11 | 2011-11 | 2008-07-14 | 2015-11-16 | 2015-11-16 | Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States | ||||
| NCT00704912 | Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women | https://clinicaltrials.gov/study/NCT00704912 | OWL-PCOS | The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss. | YES | Polycystic Ovary Syndrome | DRUG: Orlistat/Meal Replacement/Lifestyle Modification|DRUG: Loestrin 1/20|DRUG: Combination of treatments | Live Birth Rate, Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months. | Ovulation Rate, Up to 4 months|Change in Weight, Change from baseline to end of the 4-month intervention., Baseline, 4 months|Prevalence of Metabolic Syndrome, Baseline, 4 months | Milton S. Hershey Medical Center | University of Pennsylvania | FEMALE | ADULT | PHASE2 | 217 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 27184 | 2008-09 | 2014-03 | 2014-03 | 2008-06-25 | 2015-12-17 | 2016-11-06 | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States|University of Pennsylvania, Department of Obstetrics and Gynecology, Philadelphia, Pennsylvania, 19104, United States | ||
| NCT00697580 | Strength and Nutrition Outcomes for Latino Adolescents | https://clinicaltrials.gov/study/NCT00697580 | SANO LA | We are conducting an intervention study to examine the effects of a 16-week exercise and diet interventions on prevention of disease, specifically type 2 diabetes and heart disease, in Latino youth. Eighty overweight Latino boys and girls will be recruited and placed in one of the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake), 3) Combination of Strength Training (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary Education (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake) or 4) Combination of Circuit Training (twice/week for 60 min, aerobic + strength training exercises) + Dietary Education (same as above). We will assess which intervention group has the most effects on health parameters such as weight, body composition, and insulin related measures. | NO | Obesity|Type 2 Diabetes|Cardiovascular Risk|Cancer | BEHAVIORAL: Nutrition|BEHAVIORAL: Strength Training & Nutrition|BEHAVIORAL: Circuit Training & Nutrition | insulin sensitivity, post intervention (week 16) | adiposity, post-intervention (week 16) | University of Southern California | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ALL | CHILD, ADULT | NA | 104 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION | 5R01HD033064|5R01HD033064 | 2005-05 | 2007-06 | 2007-07 | 2008-06-16 | 2017-03-31 | Veronica Atkins Lifestyle Intervention Laboratory, Los Angeles, California, 90033-9073, United States | |||
| NCT00683774 | Insulin and Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT00683774 | Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI. | YES | PCOS | DRUG: diazoxide | Renal Clearance of D-chiroinositol (DCI) at 12 Days, Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay, 12 days|Level of Circulating D-chiro Inositol (DCI), Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide, 12 days | Virginia Commonwealth University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | ADULT | NA | 21 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | VCU IRB 4479|2R01HD035629-09A2 | 2005-11 | 2008-12 | 2008-12 | 2008-05-23 | 2014-08-21 | 2017-06-14 | General Clinical Research Center, Richmond, Virginia, 23298, United States | ||||
| NCT00653484 | Energy Balance Interventions for Colorectal Cancer Prevention | https://clinicaltrials.gov/study/NCT00653484 | RATIONALE: Calories and physical exercise may affect the risk of developing cancer. It is not yet known whether a low-calorie diet and/or physical activity program is effective in preventing cancer in participants at increased risk of developing colorectal cancer. PURPOSE: This randomized clinical trial is studying diet and physical activity in healthy overweight, obese, or inactive participants at risk of developing colorectal cancer. | NO | Colorectal Cancer|Obesity | BEHAVIORAL: Physical Activity|BEHAVIORAL: Energy Restriction|BEHAVIORAL: Physical Activity and Energy Restriction | Physical activity-energy expenditure, June 2010 | Physical activity-energy expenditure, June 2010|Dietary-energy intake (kcal/d) and quality, June 2010|Body weight and composition, June 2010 | Vanderbilt University | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | CDR0000592809|VU-VICC-GI-0810|VU-VICC-061020 | 2008-03 | 2009-05 | 2013-06 | 2008-04-07 | 2013-12-17 | Vanderbilt-Ingram Cancer Center – Cool Springs, Nashville, Tennessee, 37064, United States|Vanderbilt-Ingram Cancer Center at Franklin, Nashville, Tennessee, 37064, United States|Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232-6838, United States | ||||
| NCT00640224 | Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study | https://clinicaltrials.gov/study/NCT00640224 | The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS). | YES | Polycystic Ovary Syndrome | DRUG: rosiglitazone|DRUG: drospirenone/ethinyl estradiol | Peripheral Insulin Sensitivity at Baseline and 6 Months., Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp., Baseline and 6 months|Hepatic Insulin Sensitivity at Baseline and 6 Months., Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp., Baseline and 6 months|Glucose Tolerance Status at Baseline and 6 Months., Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria., Baseline and 6 months | Total Fat Mass at Baseline and 6 Months, DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass., Baseline and 6 months|Total Testosterone at Baseline and 6 Months, Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy., Baseline and 6 months|Percent Body Fat at Baseline and 6 Months, DXA scans were done to measure the percentage of body fat., Baseline and 6 months|Free Testosterone at Baseline and 6 Months, Free testosterone was measured by equilibrium dialysis., Baseline and 6 months|SHBG at Baseline and 6 Months, SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay., Baseline and 6 months|DHEAS at Baseline and 6 Months, DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis., Baseline and 6 months|Delta Androstenedione at Baseline and 6 Months, Delta Androstenedione was measured by HPLC-tandem mass spectroscopy., Baseline and 6 months|Delta DHEA at Baseline and 6 Months, Delta DHEA was measured by HPLC-tandem mass spectroscopy., Baseline and 6 months|Delta 17-OHProg at Baseline and 6 Months, Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy., Baseline and 6 months|Delta 17-OHPreg at Baseline and 6 Months, Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy., Baseline and 6 months|Cholesterol at Baseline and 6 Months, Cholesterol was measured using the standards of the Centers for Disease Control and Prevention., Baseline and 6 months|HDL at Baseline and 6 Months, HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention., Baseline and 6 months|LDL at Baseline and 6 Months, LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention., Baseline and 6 months|Triglycerides at Baseline and 6 Months, Triglycerides were measured using the standards of the Centers for Disease Control and Prevention., Baseline and 6 months|Non-HDL Cholesterol at Baseline and 6 Months, Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention., Baseline and 6 months|Adiponectin at Baseline and 6 Months, Adiponectin was measured by radioimmunoassay., Baseline and 6 months|Leptin at Baseline and 6 Months, Leptin was measured by radioimmunoassay., Baseline and 6 months|Hs-CRP at Baseline and 6 Months, hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry., Baseline and 6 months|Morning Blood Pressure at Baseline and 6 Months, Morning blood pressure was measured with an automated sphygmomanometer., Baseline and 6 months|Night Blood Pressure at Baseline and 6 Months, Night blood pressure was measured with an automated sphygmomanometer., Baseline and 6 months | Silva Arslanian | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | CHILD, ADULT | PHASE4 | 65 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | 0503013|2K24HD001357 | 2005-03 | 2015-07 | 2015-07 | 2008-03-21 | 2017-11-17 | 2017-11-17 | Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States | |||
| NCT00624416 | Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas | https://clinicaltrials.gov/study/NCT00624416 | The purpose of this study is to test whether injected medications will increase the amount of fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which are benign fatty tumors. | YES | Lipoma | DRUG: Prednisolone synthetic cortisone and Isoproterenol together | The Average Percent Volume Reduction in the Lipoma., Baseline and 4 weeks | The Number of Lipoma Increased in Volume., After four weeks of treatment up to one year.|The Number of Subjects Elected to Have the Lipoma Removed., After four weeks up to one year. | Pennington Biomedical Research Center | Lipothera | ALL | ADULT | PHASE1|PHASE2 | 10 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | PBRC 27015 | 2007-10 | 2009-03 | 2009-03 | 2008-02-27 | 2012-06-22 | 2015-12-21 | Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States | |||
| NCT00622661 | Carbohydrates and Related Biomarkers | https://clinicaltrials.gov/study/NCT00622661 | CARB | This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. | NO | Healthy|Overweight | OTHER: Low Glycemic Load Diet|OTHER: High Glycemic Load Diet | The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk., two 4-week feeding periods (56 days total) | Questionnaires will generate data on how these diets may influence mood or depression, sleep habits, and measures of appetite and satiety., two 4-week feeding periods (56 days) | Fred Hutchinson Cancer Center | National Cancer Institute (NCI) | ALL | ADULT | NA | 89 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | PHS 2059.00|NIH/NCI U54 CA 116847|IR 6105 | 2006-06 | 2009-07 | 2010-07 | 2008-02-25 | 2012-01-05 | Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States | |||
| NCT00598455 | Tuberous Sclerosis Complex Natural History Study: Renal Manifestations | https://clinicaltrials.gov/study/NCT00598455 | Eighty percent of patients with tuberous sclerosis complex (TSC) have renal angiomyolipomata. These lesions grow and can lead to significant morbidity by hemorrhage or renal failure. Understanding the natural history of these lesions and understanding which lesions may be more prone to grow quickly or develop aneurysms that predispose to hemorrhage will greatly assist clinical care of patients with TSC. The objective is to test the hypothesis that serial MR and CT imaging will allow objective, reproducible quantification of angiomyolipoma growth by volumetric analysis, and analysis of lesions characteristics will identify angiomyolipomata with rapid growth potential that would require intervention. The specific aim of this proposal is to collect clinically obtained serial abdominal imaging from the Tuberous Sclerosis Natural History Consortium Centers and analyze the volume and adiposity of the individual angiomyolipomata. The growth rate is hypothesized to have an inverse relationship to adiposity. Yearly renal MR or CT imaging will be performed of patients with TSC. The images will be coded at the site of acquisition, and transferred via VPN to a secure server at Cincinnati Children’s Hospital Medical Center. Using innovative imaging processing software (Cincinnati Children’s Hospital Image Processing Software (CCHIPS), the image data will be segmented to reveal various tissue components based on signal intensities. Different signal intensities can differentiate normal renal parenchyma, and renal angiomyolipomata. Using the imaging data and the novel software, the volume of an individual angiomyolipoma, as well as the adiposity will be determined. Imaging at enrollment (year 1) will serve as baseline. At years two and three, the lesions will undergo repeat analysis. Angiomyolipoma growth rates and adiposity over three years will be analyzed to test the hypothesis above. | NO | Tuberous Sclerosis Complex | Children’s Hospital Medical Center, Cincinnati | Loma Linda University|Massachusetts General Hospital|Boston Children’s Hospital|University of Alabama at Birmingham|University of Pennsylvania|Connecticut Children’s Medical Center|The University of Texas Health Science Center, Houston | ALL | CHILD, ADULT, OLDER_ADULT | 450 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | TS0500008|W81XWH-06-1-0538 | 2008-02 | 2013-09 | 2013-09 | 2008-01-22 | 2017-05-04 | Cincinnati Children’s, Cincinnati, Ohio, 45229, United States | ||||||||
| NCT00586404 | The Study of Barrett’s Esophagus: What Are the Factors of Progression | https://clinicaltrials.gov/study/NCT00586404 | BEST | This trial is a multi-center clinical and endoscopic outcomes project involving a single large database of patients with Barrett’s Esophagus (BE). The initial goal of this project is to define the incidence and prevalence of cancer and high-grade dysplasia (HGD) in patients with BE. Thus, our hypothesis is that systematic collection of data on the natural history of BE and risk factors for progression of BE will provide useful information to develop a decision model for risk stratification and risk reduction strategies in BE. | NO | Barrett’s Esophagus|Esophageal Neoplasms | To determine the prevalence and incidence of low grade dysplasia, high grade dysplasia and adenocarcinoma in a large cohort of patients with Barrett’s esophagus, up to 10 years | To determine the magnitude of the contribution of selected factors (e.g. age, gender, ethnicity, obesity, tobacco use, alcohol use, ASA/NSAID/PPI use, duration of GERD symptoms, length of BE, HH) to the risk of HGD and CA, up to 10 years | Midwest Biomedical Research Foundation | TAP Pharmaceutical Products Inc.|Kansas City Veteran Affairs Medical Center | ALL | ADULT, OLDER_ADULT | 1250 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PS0048 | 2007-11 | 2017-05 | 2017-05 | 2008-01-04 | 2017-05-30 | Southern Arizona VA Medical Center, Tucson, Arizona, 85723, United States|Bethesda Naval Medical Center, Bethesda, Maryland, 20889, United States|Department of Veterans Affairs Medical Center, Kansas City, Missouri, 64128, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States | |||||
| NCT00566813 | Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression | https://clinicaltrials.gov/study/NCT00566813 | The primary purpose of this study is to demonstrate the safety of allogeneic islet transplantation in type 1 diabetic patients performed at the University of Illinois at Chicago (UIC). The purpose is to reproduce the Edmonton protocol to demonstrate that pancreatic islets isolated at UIC are safe and of sufficient quality to provide reproducible graft function. | YES | Diabetes Mellitus, Type 1 | DRUG: Islet Cell Transplant|DRUG: Islet Cell Transplant plus | Number of Participants With Adverse Events Including Laboratory Abnormalities at the End of Study Participation, * Frequency of adverse events including laboratory abnormalities * HbA1C (less than 6.1% is considered normal) * Glucose control and absence of hypoglycemic coma/unawareness, as evidenced by no further requirement for third-party assistance or hospital attendance resulting from a severe hypoglycemic episode * Renal function, measured both by serum creatinine and calculated GFR using the Cockroft \& Gault * Lipid profiles for cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL) * PRA * Doppler ultrasound to exclude or document portal vein thrombosis * Immunosuppressive drug trough levels * Renal clearance (GFR) * Liver function tests * Diagnosis of opportunistic infections, e.g., CMV, 15 months after the last transplant|Number of Participants With Insulin Independence at End of Study Participation, Primary efficacy outcome: independence from insulin injections with adequate control of blood glucose in subjects with Type 1 diabetes. Transplant is considered a success when 2 weeks after their last transplant, subjects are not using insulin, and fasting glucose levels do not exceed 7.8 mmol/L (140 mg/dL) more than 3 times/week, and two-hour post-prandial glucose values do not exceed 10 mmol/L (180 mg/dL) more than 4 times/week. During the 15 months after last transplant, a subject will be considered a success if an illness or other event (e.g., high tacrolimus level) causes need for insulin not exceeding 14 days providing evidence of graft rejection is not apparent. The proportion of subjects who are insulin independent and meet criteria for glucose control will be determined at 2 weeks and 1, 3, 6, 12, and 15 months following their final islet transplant., End of 15 Month Study Participation/Follow-up|Number of Participants With HbA1c Less Than or Equal to 6.5 & Free of Severe Hypoglycemic Events, HbA1c less than or equal to 6.5 at end of 15 month study participation, and lack of or free from severe hypoglycemic events, defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person and which was associated with either a blood glucose level \< 50 mg/dl (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration., At end of 15 month study participation | University of Illinois at Chicago | ALL | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 10 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | IND11807-2004-0532 | 2004-11 | 2010-07-05 | 2020-07-15 | 2007-12-04 | 2018-11-19 | 2021-04-06 | University of Illinois at Chicago, Chicago, Illinois, 60612, United States | |||||
| NCT00562341 | Effect of Lap-Band Induced Weight Loss on Serum PSA Levels | https://clinicaltrials.gov/study/NCT00562341 | The proposed prospective study aims to determine whether interpretation of PSA levels in morbidly obese men require correction due to the obesity itself. If PSA levels are found to rise after weight loss, interpretation of PSA levels in morbidly obese men may be improved by upward correction of the PSA level. A ‘correction factor’ may be proposed for the interpretation of PSA levels in obese men, toward the clinical decision regarding indication for prostate biopsy. | NO | Obesity|Prostate Cancer | OTHER: Bariatric Surgery | Prostate-Specific Antigen (PSA) value, The PSA serum test measures the level of PSA in a man’s blood. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood., 18 months | Effect of Lapband-induced weight loss on quality of life, Measured using the Expanded Prostate Cancer Index Composite (EPIC). The EPIC for Clinical Practice (EPIC-CP) is a one-page, 16-item questionnaire to measure urinary incontinence, urinary irritation, bowel, sexual, and hormonal HRQOL domains, 18 months|Effect of Lapband-induced weight loss on sexual function, Measured using EPIC and Sexual Health Inventory for Men (SHIM), 18 months|Effect of Lapband-induced weight loss on prostate size and associated urinary symptoms, Measured using EPIC and the International Prostate Symptom Score (IPSS), 18 months|Receiver Operating Curve (ROC) analysis to evaluate PSA cancer detection performance, ROC analysis – prostate cancer vs. no prostate cancer (1-specificity vs. sensitivity for all cutoff values in the range of all PSA levels observed), 18 months | Maimonides Medical Center | MALE | ADULT | 0 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 07/09/VA18 | 2007-11 | 2009-12-31 | 2009-12-31 | 2007-11-22 | 2018-08-23 | Maimonides Medical Center, Brooklyn, New York, 11219, United States | ||||||
| NCT00535990 | Minimally Invasive Surgery (MIS) Database for the Purpose of Research | https://clinicaltrials.gov/study/NCT00535990 | The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to find out more about patient’s undergoing minimally invasive surgery (laparoscopic , open and robot assisted) procedures at UCSD. The hope is that collection of this information will give physicians a better knowledge and understanding of the benefits of minimally invasive surgery and possibly assist physicians to better manage future patients. | YES | Morbid Obesity|Hernia|Colorectal Cancer|Laparoscopy | Post Operative Outcomes, Post-operative outcomes including: 30 day morbidity 30 day mortality 30 day readmission Surgical site infection Surgical site occurrences Surgical Reintervention Specific Surgical outcomes (staple line leak, etc), 1 year | University of California, San Diego | ALL | ADULT, OLDER_ADULT | 250 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 070449|Internally funded | 2007-09 | 2009-11 | 2009-11 | 2007-09-27 | 2021-12-06 | 2021-12-06 | University of California, San Diego, San Diego, California, 92103, United States | |||||||
| NCT00518635 | Low Dose Growth Hormone in Obese PCOS Women | https://clinicaltrials.gov/study/NCT00518635 | Study hypothesis: Growth hormone (GH), through its generation of free ‘bioavailable’ insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of women with polycystic ovary syndrome. Study aims: To determine the mechanism of how low dose GH treatment affects the body’s sensitivity to insulin actions and whether this low GH dose can affect the body’s handling of steroid hormone levels (cortisol clearance) and testosterone (male hormones) in obese women with polycystic ovary syndrome. Study design: Obese women with polycystic ovary syndrome, but not recently been on GH treatment, and presently attending Outpatients Clinic will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participating in the study. If suitable, an equal number of women will be randomized to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study. | NO | Polycystic Ovary Syndrome | DRUG: Nutropin | Changes in insulin sensitivity, and adipocyte IGF-I and insulin receptor signaling., 24 months | Changes in body composition, cortisol production rates, and muscle and liver intramyocellular content., 24 months | Oregon Health and Science University | FEMALE | ADULT | NA | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | IRB3711 | 2010-10 | 2011-10 | 2011-10 | 2007-08-21 | 2013-02-20 | Oregon Health and Science University, Portland, Oregon, 97239, United States | |||||
| NCT00510315 | Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant | https://clinicaltrials.gov/study/NCT00510315 | The purpose of this study is to better understand why some women who survived cancer or a related illness later develop diabetes, problems with their cholesterol, or other problems that may lead to heart disease. Because these problems may be related to treatment with total body irradiation and a stem cell transplant, the investigators will compare the rates of obesity, cholesterol problems, and diabetes between women who were treated with total body irradiation and a stem cell transplant and women who were not. The amount and location of fat stores in the abdomen is more important than overall weight or total body fat in the development of diabetes and cholesterol problems. In general, fat can be stored in several areas in the abdomen: around the organs (visceral fat), under the skin (subcutaneous fat), and in the liver (liver fat). People with higher amounts of fat around the organs (visceral fat), even those with a normal weight, are more likely to become diabetic or have high cholesterol. The amount of fat in each of these areas can be measured with an abdominal magnetic resonance imaging (MRI). In this study, the investigators will use blood tests, height, weight, waist circumference, blood pressure measurements, and an abdominal MRI to evaluate for several risk factors of heart disease, including cholesterol problems, diabetes and pre-diabetes, elevated blood pressure, and increased abdominal fat. | NO | Leukemia|Hodgkin’s Lymphoma|Non-Hodgkin’s Lymphoma|Myelodysplastic Syndrome | OTHER: Questionnaires, Laboratory tests, Abdominal MRI | Explore whether visceral adipose tissue is significantly higher in women who were treated with total body irradiation (TBI) plus stem cell transplant in comparison with women who were not, within 12 months | Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups, within 12 months|Determine the correlation between the amount of visceral adipose tissue and fasting levels of triglycerides, LDL, HDL, insulin, glucose, and HOMA-IR in both groups., within 12 months|To begin to characterize the psychosocial risk factors of the TBI plus stem cell transplant group, in relation to the comparison group, in order to inform a future targeted intervention to reduce risk., within 12 months | Memorial Sloan Kettering Cancer Center | Queen’s University, Kingston, Ontario|Weill Medical College of Cornell University | FEMALE | ADULT | 11 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 07-092 | 2007-07 | 2016-01 | 2016-01 | 2007-08-02 | 2020-12-07 | Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States | |||||
| NCT00509626 | Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy | https://clinicaltrials.gov/study/NCT00509626 | RATIONALE: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer. PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy. | NO | Breast Cancer|Depression|Fatigue|Psychosocial Effects of Cancer and Its Treatment|Weight Changes | BEHAVIORAL: exercise intervention|OTHER: questionnaire administration|PROCEDURE: CAM exercise therapy|PROCEDURE: management of therapy complications|PROCEDURE: psychosocial assessment and care|PROCEDURE: quality-of-life assessment | Accrual (phase I)|Retention (phase I)|Weight change after 6 months (phase II) | Adiposity as measured by waist circumference at 3 and 6 months|Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales|Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale | Fox Chase Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | PHASE1|PHASE2 | 380 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: |Masking: |Primary Purpose: SUPPORTIVE_CARE | CDR0000555830|P30CA006927|FCCC-FCRB-05-009 | 2007-06 | 2008-07 | 2007-07-31 | 2010-02-12 | Fox Chase Cancer Center – Philadelphia, Philadelphia, Pennsylvania, 19111-2497, United States | |||||
| NCT00504218 | Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors and Hematopoietic Stem Cell Transplant Recipients | https://clinicaltrials.gov/study/NCT00504218 | This study will determine the prevalence of endocrine-related side effects in children who have been treated for cancer and establish a database and registry organized according to cancer diagnosis, treatments and endocrine side effects. In children, the endocrine system, which includes glands and hormones that help to control metabolism, growth, development and reproduction, is particularly vulnerable to long-term side effects associated with cancer and its treatments. The study will also serve to help train medical fellows, residents and students in identifying and managing endocrine abnormalities in children who have been diagnosed with and treated for cancer. Children between 2 and 24 years of age who have been treated for a childhood cancer and have been disease-free for at least 1 year may be eligible for this study. All participants undergo the following procedures: * Review of cancer treatment record * Review of medical and family history * Blood draw for DNA studies * Physical examination and body measurements (height, weight, waist, body proportions) * Completion of child health questionnaires * Individualized screening and counseling program * Review of the following endocrine systems: growth, pituitary and hypothalamic function, thyroid function, ovary and testicular function, bone health, risk of obesity and diabetes The following additional studies may be done, as clinically indicated: * Magnetic resonance imaging (MRI) of the brain * Thyroid, testicular or ovarian ultrasound * DEXA scan to measure bone density * Wrist x-ray to measure bone age * Blood tests * Urine pregnancy test for girls who are old enough to have menstrual periods * Stimulation testing (tests that involve giving medicine by mouth or in the vein and then measuring blood levels of substances afterwards, such as oral glucose tolerance test, arginine-clonidine growth hormone stimulation test, ACTH stimulation test, and gonadotropin-releasing hormone stimulation test) Children with endocrine abnormalities are offered standard treatments. | NO | Hypopituitarism|Hypogonadism|Thyroid Dysfunction|Bone Diseases, Metabolic | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ALL | CHILD, ADULT | 62 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 070192|07-CH-0192 | 2007-07-17 | 2018-06-12 | 2007-07-19 | 2018-12-03 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | ||||||||||
| NCT00500591 | Prevalence of Endometrial Abnormalities In Obese Women | https://clinicaltrials.gov/study/NCT00500591 | It is known that women who are obese are at higher risk of endometrial cancer (cancer of the lining of the uterus or womb). The goal of this clinical research study is to find out how common abnormalities of the endometrium are in women who are considered obese and to find out if those same abnormalities are less common in women who are considered to be thin. Researchers would like to learn if obese patients have symptoms (like irregular menstrual cycles) that may mean there could be an abnormality present. Researchers would also like to know if obese women have access to regular female exams and whether they routinely go to their primary care doctors. | NO | Obesity | BEHAVIORAL: Questionnaire | Prevalence of Endometrial Abnormalities in Obese and Lean Women, 6 Years | M.D. Anderson Cancer Center | FEMALE | ADULT | 200 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2004-0018 | 2004-06 | 2021-06 | 2021-06 | 2007-07-12 | 2021-02-25 | University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States | |||||||
| NCT00475982 | Effect of Weight Loss on Prostate Cancer Pathology | https://clinicaltrials.gov/study/NCT00475982 | The purpose of this study is to determine if weight loss prior to radical prostatectomy effects chemical substances in the blood stream and prostate tissue that may affect prostate cancer development and progression. | YES | Obesity|Prostate Cancer | BEHAVIORAL: Weight Loss|OTHER: No Weight Loss Group | Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention, The primary objective is to compare the mean apoptotic index in the radical prostatectomy malignant epithelium between the Weight Loss Group and the Control Group-No Weight Loss. The apoptotic index will be measured in the malignant epithelium with the highest Gleason grade. TUNEL staining was used to identify these apoptotic cells and measure the apoptotic index, which is the percent of cells stained from the sample., 8 weeks | Proliferative Index in Prostate Cancer Epithelium Specimen, The proliferative index in prostate cancer epithelium obtained from the radical prostatectomy specimen. This index was procured by staining the Ki67 protein to measure cell proliferation. (Note: Ki67 is a common indicator of cell proliferation.), 8 weeks|Change in Serum IGF-related Analytes: IGF-1, This outcome is the measure of the hormone insulin-like growth factor 1 at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this hormone., baseline and post-intervention|Change in Serum IGF-related Analytes: IGFBP-1, This outcome is the measure of the protein, insulin-like growth factor binding protein 1, at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this protein., baseline and post-intervention|Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells, The BRDU assay measures proliferation of cultured cells such as LNCaP. We expose the cells to the patient blood and see if it inhibits prostate cancer cell growth ex vivo. We use optical density (a measure of the amount of light able to pass through the specimen) to indicate the concentration of cell proliferation., baseline and post-intervention|Change in Body Weight, This change in body weight is observed by DEXA, a scanner that measures total body composition., baseline and post-intervention|Change in Percent Body Fat, This change in percent body fat is observed by DEXA, a scanner that measures total body composition., baseline and post-intervention | VA Office of Research and Development | MALE | CHILD, ADULT, OLDER_ADULT | NA | 44 | FED | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC | CLIN-012-06F | 2009-01 | 2016-03 | 2016-03 | 2007-05-21 | 2019-01-31 | 2019-01-31 | VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, 90073, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/82/NCT00475982/Prot_SAP_000.pdf|Informed Consent Form: VA GLA ICF, https://cdn.clinicaltrials.gov/large-docs/82/NCT00475982/ICF_001.pdf|Informed Consent Form: UCLA ICF, https://cdn.clinicaltrials.gov/large-docs/82/NCT00475982/ICF_002.pdf | |||
| NCT00476203 | Yoga Study in Breast Cancer Patients | https://clinicaltrials.gov/study/NCT00476203 | Yoga | This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors. | NO | Breast Cancer | BEHAVIORAL: Yoga|OTHER: Delayed yoga classes | quality of life, fatigue, and body weight, baseline, 6 months, 12 months | waist and hip circumference, baseline, 6 months, 12 months | Fred Hutchinson Cancer Center | National Institutes of Health (NIH) | FEMALE | ADULT, OLDER_ADULT | NA | 63 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | PHS – 6434|U54CA116847-01 | 2007-05 | 2010-05 | 2011-05 | 2007-05-21 | 2012-11-28 | Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States | |||
| NCT00470119 | Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women | https://clinicaltrials.gov/study/NCT00470119 | RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman’s risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman’s risk of developing breast cancer. PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women. | NO | Breast Cancer|Obesity|Weight Changes | BEHAVIORAL: behavioral dietary intervention|BEHAVIORAL: Exercise intervention | Serum estrone concentrations as measured by radioimmunoassay, At baseline and 12 months timepoint | Serum estradiol and free estradiol concentration as measured by radioimmunoassay, At baseline and 12 months timepoint|Testosterone and free testosterone as measured radioimmunoassay, At baseline and 12 months timepoint|Serum concentrations of Sex hormone binding globulin measured using immunoassays, At baseline and 12 months timepoint|Mammographic density measurements (i.e., percentage density and dense area of breast tissue), At baseline and 12 months timepoint|Change in weight and body mass index (Anthropometrics), At baseline and 12 months timepoint|Total and percentage body fat and body fat distribution (i.e., waist and hip circumferences) as measured by dual x-ray absorptiometry, At baseline and 12 months timepoint|Quality of life (assessed via questionnaires), At baseline and 12 months timepoint|Change in daily caloric intake as measured by Food Frequency Questionnaire, At baseline and 12 months timepoint|Leukocyte and Neutrophil Counts, Baseline and 12 month timepoints|Serum concentrations of Insulin as measured radioimmunoassay, Baseline and 12 months|Serum concentrations of Glucose as measured radioimmunoassay, Baseline and 12 month timepoints|Serum concentrations of Insulin-like growth factor-1, Baseline and 12 month timepoints|Serum concentrations of Insulin-like growth-factor binding protein-3, Baseline and 12-month timepoints|Serum Vitamin D concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum ghrelin concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum C-reactive Protein (CRP) concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum concentrations of Serum Amyloid A (SAA) as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum interleukin-6 (IL-6) concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum adiponectin concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum leptin concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum androtenedione concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints|Serum c-peptide concentrations as measured by radioimmunoassay, Baseline and 12 month timepoints | Fred Hutchinson Cancer Center | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | 439 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION | PHS 1960.00|U54CA116847|P50CA083636|P30CA015704|FHCRC-PHS-1960.00|FHCRC-1960|CDR0000544634 | 2004-12 | 2009-12 | 2010-02 | 2007-05-07 | 2012-09-10 | Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024, United States | ||||
| NCT00444288 | PCOS Twin Study – Environmental Factors in the Development of Polycystic Ovary Syndrome, Phase 2 | https://clinicaltrials.gov/study/NCT00444288 | Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of all women, many of whom do not know they have the syndrome. Women with PCOS produce abnormally high levels of male hormones (hyperandrogenism); this counteracts their ovaries’ ability to make enough of the female hormones estrogen and progesterone needed for normal menstruation. PCOS is the number one cause of hormonally related infertility and also increases women’s risks for diabetes, high blood pressure, hypercholesteremia, cardiovascular disease and certain cancers. It is currently unclear to what extent PCOS and PCOS-associated traits (hyperandrogenisms, hyperinsulinemia, insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the results of environmental factors or genetic predisposition. Therefore, the NIEHS Program in Clinical Research is conducting a multi-phase twin study to measure the extent of PCOS heritability and to identify environmental and genetic factors involved in the development of PCOS. The proposal described here is for Phase 2 of this study. The goals of Phase 2 are to: 1) establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ and DZ twins; and 2) establish a cohort of intact MZ and DZ female twin pairs as a resource for future studies. In Phase 1, about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry (MATR) based on self report of a history of irregular periods and/or cystic ovaries in the MATR General Health Screening Questionnaire. Those twins were surveyed by phone for other traits associated with PCOS. In Phase 2, the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening. This includes providing a blood sample for measuring bioavailable testosterone (BaT) levels. Women with elevated BaT levels are likely to have PCOS. The women with elevated levels will then be asked to undergo a medical evaluation for PCOS confirmation. This includes a physical exam, medical history, ultrasound, 2-hour glucose tolerance and other biochemical blood tests, and a Ferriman-Gallwey evaluation for abnormal hirsutism (another characteristic of PCOS). The women will also be tested for pregnancy and zygosity. Their female co-twins will be invited to undergo… | NO | Polycystic Ovary Syndrome | National Institute of Environmental Health Sciences (NIEHS) | FEMALE | ADULT, OLDER_ADULT | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999907112|07-E-N112 | 2007-02-27 | 2010-03-01 | 2007-03-07 | 2017-07-02 | Duke University Medical Center, Durham, North Carolina, 27710, United States | |||||||||||
| NCT00436865 | Insulin and the Polycystic Ovary Syndrome–Weight Reduction Study | https://clinicaltrials.gov/study/NCT00436865 | The polycystic ovary syndrome is the leading cause of female infertility in the United States. The disorder affects approximately 6-10% of women of reproductive age. It is widely accepted that “insulin resistance” may be responsible for the infertility of this syndrome. Women are insulin resistant when their bodies do not respond to insulin’s action to handle sugar as they normally should. Because of this insulin resistance, women with the polycystic ovary syndrome are also at high risk for developing type 2 diabetes. We have previously shown that D-chiro-inositol (DCI), a substance naturally found in our body that helps insulin’s action, is lacking in women with the polycystic ovary syndrome. Not having enough DCI may lead to insulin resistance. The purpose of this study is to determine if weight loss helps to replenish the body with DCI and help to promote insulin’s action. | NO | Polycystic Ovary Syndrome|Obesity | BEHAVIORAL: Weight loss | Insulin sensitivity (Change from baseline to 8 weeks), Baseline to 8 weeks|Changes of Serum D-Chiro-Inositol (DCI) concentrations (Change from baseline to 8 weeks), Baseline to 8 weeks|Changes of DCI renal clearance (Change from baseline to 8 weeks), Baseline to 8 weeks|Changes of AUC insulin during OGTT (Change from baseline to 8 weeks), Baseline to 8 weeks|AUC of bioactive DCI-IPG during OGTT (Change from baseline to 8 weeks), Baseline to 8 weeks|Ratio of AUC DCI-IPG to AUC insulin during OGTT (Change from baseline to 8 weeks), Baseline to 8 weeks | Weight loss (Change from baseline to 8 weeks), Baseline to 8 weeks|Serum Myo-Inositol (Myo) concentrations (Change from baseline to 8 weeks), Baseline to 8 weeks|MYO bioactivity (Change from baseline to 8 weeks), Baseline to 8 weeks|Serum inflammatory and cardiovascular markers (Change from baseline to 8 weeks), Baseline to 8 weeks | Virginia Commonwealth University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | ADULT | NA | 79 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | HM10313|K23HD049454-01A2 | 2007-02 | 2017-12 | 2017-12 | 2007-02-19 | 2018-03-30 | Virginia Commonwealth University General Clinical Research Center, Richmond, Virginia, 23298, United States | ||||
| NCT00393172 | Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)] | https://clinicaltrials.gov/study/NCT00393172 | WISER | RATIONALE: Exercising regularly may lower the risk of breast cancer. PURPOSE: This randomized clinical trial is studying how well exercise prevents breast cancer in healthy young women. | NO | Breast Cancer|Obesity | BEHAVIORAL: exercise | Changes in urine levels of F2-isoprostanes, Before and after study | Changes in levels of IGF-axis proteins, Before and after study|Changes in insulin and glucose, Before and after study|Changes in estrogen metabolites, Before and after study|Changes in body composition, Before and after study | University of Minnesota | National Cancer Institute (NCI) | FEMALE | ADULT | PHASE2|PHASE3 | 400 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | FWA00000312-5|U54CA116849|UMN-0505M69867 | 2006-05 | 2009-09 | 2010-03 | 2006-10-26 | 2019-11-01 | University of Minnesota – St. Paul Campus, Saint Paul, Minnesota, 55108, United States | |||
| NCT00379353 | The Effects of Thalidomide on Symptom Clusters | https://clinicaltrials.gov/study/NCT00379353 | The goal of this clinical research study is to learn if thalidomide can improve symptoms such as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with advanced cancer. | YES | Advanced Cancers | DRUG: Thalidomide|DRUG: Placebo | Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS), ESAS assessment of appetite (symptom) where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. Evaluated at baseline \[± 3 days\], 2 weeks\[± 3 days\] and 4 weeks \[± 3 days\], Baseline to Day 29 | Functional Assessment of Anorexia/Cachexia Therapy (FAACT), 12-item symptom-specific subscale of the FACT-G designed to measure participants’ additional concerns about their anorexia/cachexia during the previous 7 days. Participant rates concerns from 0 to 4 (0= not at all, 4= very much), combined are the 12 items subscales for a total of 0 to 48 where the higher number would represent greater concern., Baseline to Day 29|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), The FACIT-F consists of 27 general quality of life questions divided into 4 domains (physical, social, emotional and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4 (0= not at all, 4= very much) where the 13-item fatigue subscore totals are combined for a total of 0 to 52, with the higher number representing greater fatigue., Baseline to Day 29|Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety), The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The higher the score The higher the score, the more likely the patient is showing signs of anxiety and as a result may benefit from a counseling/supportive session., Baseline to Day 29|Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression), The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The higher the score, the more likely the patient is showing signs of depression and as a result may benefit from a counseling/supportive session., Baseline to Day 29|Pittsburgh Sleep Quality Index (PSQI), PSQI measures the quality and patterns of sleep. It differentiates poor from good sleep by measuring subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A participant indicates how frequently each item was experienced on a scale from 0 to 3. The 7 component scores are then summed to obtain a global sleep score that can range from 0 to 21. A score of \>/= 5 indicates poor sleepers., Baseline to Day 29|Change in Body Composition as Measured by Body Mass Index (BMI), BMI, commonly used to measure overweight and obesity, is a measure of body fat based on a person’s weight and height., Baseline to Day 29|Change in Serum Cytokines and Receptors, Cytokines Levels of IL-1β and its receptor IL RA, IL-6 its receptor IL-6R, and TNF-α and its receptors (i.e. tumor necrosis factor receptor (TNFR)) of TNFR1, TNFR2, IL-10, IL-8(serum) measured at baseline, Days 15 and 29. Multiplex bead Immunoassay used to measure serum/plasma levels of IL-1, IL-6, TNF-α, IL-10, IL-8 and their receptors where assay sensitivity for the cytokines was 3-6 pg/mL. Serum IL-10, IL-1β, IL-1RA, IL-6R, sTNF-RI, sTNF-R2 were also analyzed using an enzyme-linked immunosorbent assay device. Lowering cytokine levels can decrease fatigue, increase appetite and decrease anxiety and depression., Baseline to Day 15 | M.D. Anderson Cancer Center | Celgene Corporation | ALL | ADULT, OLDER_ADULT | PHASE2 | 32 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | 2005-0980 | 2006-09 | 2013-01 | 2013-01 | 2006-09-21 | 2013-01-01 | 2013-02-04 | UT MD Anderson Cancer Center, Houston, Texas, 77030, United States | |||
| NCT00364949 | Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands | https://clinicaltrials.gov/study/NCT00364949 | Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in premenopausal women, affecting 7-10% of this population. This syndrome is characterized by elevated levels of testosterone and chronic anovulation, and frequently of obesity. This study is designed to test the hypothesis that there is in utero testosterone excess, altered insulin secretion, and/or intrauterine growth retardation in the female offspring of women with PCOS. The allele 8 can be used to identify the reproductive and metabolic abnormalities associated with PCOS. This study will determine whether allele 8 positive \[A8(+)\] female offspring have more profound changes in these parameters compared to A8(-) female offspring. Androgen and insulin levels in amniotic fluid from pregnant women with PCOS will be compared to levels in pregnant control women. Androgen and insulin levels in cord blood will also be measured. Further, gestational age and anthropomorphic measurements in offspring of women with PCOS will be assessed and compared to that in offspring of matched control women. We will test the hypothesis that androgens are elevated in infancy in the female offspring of women with PCOS. We will assess sex steroids, insulin, and c-peptide levels in infants of PCOS women and compare them to the levels in infants of control women up to 1 year of age during the minipuberty of infancy. We will determine whether any of these parameters differ in A8(+) compared to A8(-) PCOS offspring. | YES | Polycystic Ovary Syndrome | Estradiol Level in Female Offspring, The blood that were analyzed were taken from cord blood and not from the offspring., One time sampling from the cord blood|Androstenedione Level in Female Offspring, cord blood|Testosterone Level in Female Offspring, cord blood|17-hydroxyprogesterone Level in Female Offspring, cord blood|Dihydrotestosterone Level in Female Offspring, cord blood|Dehydroepiandrosterone Level in Female Offspring, cord blood|Infant Birth Weight (Male and Female), birth | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | FEMALE | CHILD, ADULT, OLDER_ADULT | 70 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | P50HD044405 | 2003-01 | 2012-07 | 2012-07 | 2006-08-16 | 2010-08-18 | 2013-04-10 | Northwestern University School of Medicine, Chicago, Illinois, 60611, United States | |||||||
| NCT00344851 | Exenatide and Metformin Therapy in Overweight Women With PCOS | https://clinicaltrials.gov/study/NCT00344851 | Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS. | NO | Polycystic Ovary Syndrome | DRUG: metformin, exenatide or combined (metformin & exenatide ) | – Menstrual Cyclicity ( # menses/ 24 weeks), every 4 weeks | BMI, WHR, FAI (T/SHBG), DHEAS, lipids,abdominal girth,, BMI,WHR,abdominal girth at start,12 weeks and 24 weeks, FAI, DHEAS, lipids at start and at 24 weeks|insulin resistance-(HOMA and composite insulin sensitivity index [ SIOGTT),, at start and at 24 weeks|and pancreatic ß-cell function (corrected insulin response [CIRgp] and, at start and at 24 weeks|insulinogenic index [IGI] )., at start and at 24 weeks | Metabolic Center of Louisiana Research Foundation | Amylin Pharmaceuticals, LLC. | FEMALE | ADULT | PHASE2 | 60 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | RP06-010 | 2006-06 | 2007-06 | 2006-06-27 | 2007-07-11 | Facility: Metabolic Center of Louisiana Research Foundation, Baton Rouge, Louisiana, 70808, United States | |||||
| NCT00343434 | Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight | https://clinicaltrials.gov/study/NCT00343434 | RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose weight and improve their quality of life. PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in helping women with stage I, stage II, or stage III breast cancer in complete remission lose weight. | NO | Breast Cancer|Obesity | BEHAVIORAL: behavioral dietary intervention|BEHAVIORAL: exercise intervention|DIETARY_SUPPLEMENT: soy isoflavones|DIETARY_SUPPLEMENT: soy protein isolate|OTHER: counseling intervention|OTHER: educational intervention|PROCEDURE: psychosocial assessment and care|PROCEDURE: quality-of-life assessment | Wake Forest University Health Sciences | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | NA | 25 | OTHER | INTERVENTIONAL | Allocation: |Intervention Model: |Masking: |Primary Purpose: SUPPORTIVE_CARE | CCCWFU-98904|CDR0000481274 | 2005-01 | 2007-07 | 2006-06-23 | 2017-01-19 | Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, 27157-1096, United States | |||||||
| NCT00341731 | Environmental Factors in the Development of Polycystic Ovary Syndrome | https://clinicaltrials.gov/study/NCT00341731 | Polycystic Ovary Syndrome (PCOS) is manifested as a heterogeneous mixture of clinical and bichemical characteristics that complicate study of its etiology. It is currently unclear to what extent PCOS-associated traits (hyperandrogenism, hyperinsulinemia, insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the result of environmental factors or genetic predisposition. We propose to conduct a twin study to investigate the possibility that environmental factors are important in the development of the PCOS phenotype. Twin studies are considered to be the gold standard for determining the extent of heritability of a trait. The proposal described here is only for Step 1 of a larger, multi-step study. The major goal of step 1 is to identify a large cohort of twin pairs, in which at least one member of each pair is likely to have PCOS. Participants for this study will come from the Mid-Atlantic Twin Registry (MATR). Many (3283) potential participants have already been identified based on their answers to a preliminary MATR screening questionnaire. Out of the approximately 7145 twin women of reproductive age who completed these MATR screening questionnaires, 1803 women reported irregular periods, 954 reported ovarian cysts, and 526 reported both irregular periods and ovarian cysts. Many of the women in this last group are likely to have PCOS. They represent 7.4% of the total sample, matching current estimates of PCOS prevalence (4-7%) in reproductive age women. We will also add new twin pairs who meet the criteria (irregular periods and evidence of PCOS or cystic ovaries) as they are recruited into the MATR and take the preliminary surveys. According to MATR statistics, about 33% of twin pairs are monozygotic (MZ, identical). Therefore, approximately 174 of the 526 women likely to have PCOS are members of a MZ pair. Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular periods and/or ovarian cysts. The survey will be conducted by the MATR. The instrument to be used contains a series of simple and direct questions and will take about 10 minutes to complete. The questions were designed to identify PCOS and their content deals with the frequency of menstrual periods (six or fewer per year being a major diagnostic criterion), a previous diagnosis of PCOS, obesity, excess facial hair and other evidence of hyperandrogenism. The women will also be asked if t… | NO | Polycystic Ovary Syndrome | National Institute of Environmental Health Sciences (NIEHS) | FEMALE | ADULT, OLDER_ADULT | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999901047|01-E-N047 | 2000-12 | 2006-06-21 | 2009-12-01 | NIEHS, Research Triangle Park, Research Triangle Park, North Carolina, 27709, United States|Virginia Commonwealth University, Richmond, Virginia, 23284, United States | ||||||||||||
| NCT00339469 | Effect of High-Legume Diet on Colorectal Cancer Risk | https://clinicaltrials.gov/study/NCT00339469 | This study, sponsored by the National Cancer Institute and Penn State University, will examine how a diet high in legumes (dried beans) influences risk factors for colon cancer and polyps. Many scientists believe that colon and rectal cancers develop from polyps (tumors of the lining of the large bowel). This study will test whether a high-legume diet can reduce levels of certain factors (blood insulin, blood glucose, and markers of inflammation such as C-reactive protein) that at elevated levels are known to increase the risk of colorectal polyps and colon cancer. Healthy men between 35 and 75 years of age may be eligible for this study, conducted at Penn State University in University Park, Pennsylvania. Candidates are screened with blood tests and measurements of height, weight, and blood pressure. All candidates must have had a colonoscopy within 2 years of entering the study. They may or may not have had adenomas and may or may not be insulin-resistant. Candidates must not have cancer, heart disease, kidney disease, diabetes, or other serious medical condition, and they must have no history of colorectal cancer, polyp removal, bowel surgery, polyposis syndrome, or inflammatory bowel disease. Participants undergo the following tests and procedures: * Caloric requirement testing: The subject’s resting metabolic rate is measured while fasting and in the early morning at rest to determine daily calorie requirement before beginning the study diet. A special clear plastic hood is placed over the subject’s head while his breathing is measured. He can communicate with the technician at all times during the 30-minute test. * Study diet: Subjects follow two required 4-week diets with a 3-week break in between, followed by an optional third 4-week diet. Subjects eat a healthy American diet for both of the required 4-week diet periods; about 1-1/2 cups of cooked legumes, such as pinto, baked, and navy beans are added to one of the two required diets. For the third (optional) diet period, subjects are given the same 1-1/2 cups of legumes, but are allowed to lose weight. Participants are given packages with all of the food they are to consume during the three diet periods. They may add up to five caffeine-containing beverages per day and up to two alcoholic drinks per week. They must eat all of the food they are given and only the food they are given. Subjects are expected to maintain a constant body weight during the two 4-week required diets, and their caloric intake may be increased or decreased as needed to maintain their screening weight. * Weight measurements: Subjects are weighed regularly at the clinic. * Blood samples: Subjects have blood samples drawn at the mid-point of each of the two required 4-week diets and at the beginning and end of each of the three 4-week diets. * Urine and stool samples: Urine and stool samples are collected at the beginning and end of the two required 4-week diets. | NO | Inflammation|Prevention and Control|Colonic Neoplasms|Diet|Insulin | DIETARY_SUPPLEMENT: LIFE | Biomarkers of insulin resistance and inflammation, At 6 weeks (end of study period) | Weight loss, At 3 weeks | National Cancer Institute (NCI) | MALE | ADULT, OLDER_ADULT | EARLY_PHASE1 | 65 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION | 999905215|05-C-N215 | 2005-08-03 | 2008-05-19 | 2018-02-13 | 2006-06-21 | 2019-12-16 | Pennsylvania State University, University Park, Pennsylvania, 16802, United States | |||||
| NCT00342771 | An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males | https://clinicaltrials.gov/study/NCT00342771 | This study will examine the association of genetic variants and gene expression patterns with the risk of prostate cancer. There will be (It will include?) genotype analysis of blood DNA from 600 patients with the disease and from 600 healthy people, and there will be a gene expression analysis of prostate tumors. Prostate cancer is a leading cause of death among men in Western countries. It is estimated that 220,000 or more new cases of the disease will occur in the United States during 2004. The disease incidence is rising. About 25% to 30% of the cancers become aggressive. The nonhereditary disease rarely occurs in men who are younger than age 40. There are large differences in incidence by geography and race. The highest rates are seen among African-American men in the United States. Also, although Caucasians have a lower rate of disease incidence and mortality in the United States, the rates among them are high compared with rates in some European countries. The reasons for such differences are not well understood, but both environmental and genetic risk factors are thought to be involved. Patients ages 40 to 80 years who have had prostate cancer confirmed within the past 6 months, who reside in Baltimore City or adjacent metropolitan counties, and who were born in the United States may be eligible for this study. They will be recruited in collaboration with the Departments of Pathology and Urology at the University of Maryland and the Baltimore Veterans Affairs Medical Center. Those men serving as controls in this study will be identified through the Department of Motor Vehicles database and will be matched by age and race with the patients who have cancer. The study will include 600 participants with prostate cancer and 600 participants in the control group. Trained interviewers will administer two questionnaires. The primary questionnaire will be used to assess information such as medical and cancer history, tobacco use, current medications, occupational history, family medical history, and socioeconomic status. A supplemental questionnaire will pertain to patients’ exposure to risk factors for prostate cancer. It will assess the human body, diet, medical history, family medical history, and sexual history. The section on sexual history will be self-administered. Patients will undergo collection of blood and urine for various tests. For cancer patients with prostate surgery, there will also be a collection of tissue, to be performed at the time that the prostate gland is scheduled for surgical removal. The pattern of gene expression will be analyzed in low- and high-stage tumors. There will be no direct benefit from participating in the study, but participants will receive an incentive of up to $75 to participate in the study. No form of treatment is involved in this study. However, it is hoped that the study findings will improve researchers’ understanding of prostate cancer biology with respect to the causes of the health variances between African-Americans and Caucasians. … | NO | Prostate Cancer | Identification of risk factors, association of tobacco use, obesity, inflammation and anti- inflammatory drugs, sexual activity and sexually transmitted diseases, and ancestral markers with prostate cancer and lethal disease, After completion of recruitment|Identification of disease biomarkers, association of blood and/or urine-based metabolites, and blood-based immune- inflammation markers with either ancestry, lifestyle factors, prostate cancer, and lethal disease., Ongoing | National Cancer Institute (NCI) | MALE | ADULT, OLDER_ADULT | 2033 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 999905021|05-C-N021 | 2004-11-08 | 2020-08-06 | 2020-08-06 | 2006-06-21 | 2020-08-14 | University of Maryland Medical Center, Baltimore, Maryland, 21201-1595, United States|VA Hospital, Baltimore, Baltimore, Maryland, United States | ||||||||
| NCT00283816 | Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy | https://clinicaltrials.gov/study/NCT00283816 | Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight. | YES | Polycystic Ovary Syndrome | DRUG: Metformin|DRUG: Oral Contraceptive Pill|BEHAVIORAL: Lifestyle Management Program|BEHAVIORAL: Quality of Life Questionnaire|PROCEDURE: Oral Glucose Tolerance Test|PROCEDURE: Blood work|PROCEDURE: Abdominal Ultra Sound|PROCEDURE: Dual-energy x-ray absorptiometry (DEXA scan)|DRUG: placebo | Reduction in Abdominal Fat as Measured by Waist Circumference., Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention, baseline and 24 weeks | Change in Weight Post Minus Pre Intervention., Body mass index change in adolescents enrolled in lifestyle intervention program, baseline and 24 weeks|Total Testosterone Change, Change in total testosterone post minus pre intervention, baseline and 24 weeks|Change in Sex Hormone Binding Globulin (SHBG), SHBG concentration post minus pre-intervention, baseline and 24 weeks | University of Rochester | FEMALE | CHILD, ADULT | PHASE3 | 36 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | RSRB-00012501|GCRC#1083 | 2006-01 | 2008-01 | 2008-01 | 2006-01-30 | 2011-07-13 | 2015-05-15 | University of Rochester Medical Center, Rochester, New York, 14642, United States | ||||
| NCT00262938 | Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission | https://clinicaltrials.gov/study/NCT00262938 | RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably. PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission. | NO | Endometrial Cancer|Weight Changes | BEHAVIORAL: behavioral dietary intervention|OTHER: counseling intervention|OTHER: educational intervention|OTHER: preventative dietary intervention|PROCEDURE: quality-of-life assessment | Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months, baseline, 3, 6, and 12 months|Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months, baseline, 3, 6, and 12 months|Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36), baseline, 3, 6, and 12 months|Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months, baseline, 3, 6, and 12 months | Case Comprehensive Cancer Center | FEMALE | ADULT, OLDER_ADULT | NA | 47 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | CASE5804 | 2005-02 | 2006-01 | 2011-08 | 2005-12-07 | 2020-07-24 | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106-5047, United States | ||||||
| NCT00203996 | Polycystic Ovary Syndrome (PCOS) and Sleep Apnea | https://clinicaltrials.gov/study/NCT00203996 | Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject populations. Women with PCOS are more insulin resistant than weight-matched control women and have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes, as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has not been evaluated. The overall objective of the proposed study is to analyze the direction of causality between sleep disturbances and markers of the metabolic syndrome in PCOS. | YES | Polycystic Ovary Syndrome|Obstructive Sleep Apnea | DEVICE: continuous positive airway pressure (CPAP)|DRUG: depot leuprolide plus estrogen/progestin replacement|DRUG: pioglitazone|PROCEDURE: REM frag|PROCEDURE: SWS supp | Aim 1: Apnea-Hypopnea Index (AHI) [Baseline], Apnea-hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep., baseline|Aim 1: Apnea-hypopnea Index (AHI) [After Treatment], Apnea-hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep., 8 weeks|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline], Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal., baseline (0 weeks)|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP], Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal., 8 weeks|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline], Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion., baseline (0 weeks)|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP], Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion., 8 weeks|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline], Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal., Baseline|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression], Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal., 3 nights | Aim 1: Blood Pressure [Baseline], Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle., baseline (0 weeks)|Aim 1: Blood Pressure [After Treatment], Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle., 8 weeks|Aim 1: Visceral Adiposity [Baseline], Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body’s internal organs., up to half of an hour|Aim 1: Visceral Adiposity [After Treatment], Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body’s internal organs., up to half of an hour|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline], This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually., 10 minutes, over a period of 24 hours|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment], This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually., 10 minutes, over a period of 24 hours|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline], This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually., 15 minutes over a period of 24 hours|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment], This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually., 15 minutes over a period of 24 hours | University of Chicago | National Institutes of Health (NIH)|National Heart, Lung, and Blood Institute (NHLBI) | ALL | ADULT | PHASE4 | 37 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT | 12861B|R01HL075079 | 2003-09 | 2008-06 | 2008-06 | 2005-09-20 | 2013-07-16 | 2023-03-21 | University of Chicago, Chicago, Illinois, 60637, United States | |||
| NCT00161226 | A Randomized, Controlled, Comparative Study of a Levonorgestrel Intrauterine System for the Prevention of Endometrial Cancer in Patients Aged 40-50 With BMI Greater Than 35 | https://clinicaltrials.gov/study/NCT00161226 | Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At this time there are no medications to prevent endometrial cancer. Women who are heavy are at increased risk of this cancer. Progestins have been used to treat endometrial hyperplasia and cancer in women who wanted to retain their fertility or who were not surgical candidates. Oral progestins are associated with side effects such as weight gain, mood changes, headaches, and acne. A device called Mirena has a type of progesterone in it. Because it is placed directly in the uterus it can give a powerful amount of progestin with less side effects. In this project, we will enroll 44 women who are aged 40-50 and who have a body mass index (BMI) greater than 40. (BMI is a measure of obesity. Normal is less than 25.) They will be randomized to either observation or treatment. The women in the treatment group will have a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year. All of the women will have endometrial biopsies and blood work at the beginning and end of the study. All of the women will have an ultrasound at the beginning of the study. The information will then be used to assess whether or not the LNG-IUS will be an effective prevention agent. The women will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or cancer. A special lab study called microarray will be used to see what genes are turned on or off in the uterine lining. | NO | Endometrial Cancer | DEVICE: Levonorgestrel intrauterine system | University of Medicine and Dentistry of New Jersey | FEMALE | ADULT | 44 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 4800|CINJ#100401 | 2004-02 | 2006-06 | 2006-06 | 2005-09-12 | 2009-12-11 | Cancer Institute of New Jersey, New Brunswick, New Jersey, 08901, United States | ||||||||
| NCT00131950 | Effect of Lifestyle Factors and Hormone Function on Breast Density in Healthy Hispanic Women Who Are Undergoing Mammography for Breast Cancer Screening | https://clinicaltrials.gov/study/NCT00131950 | RATIONALE: Lifestyle factors, such as physical activity, diet, and obesity, and hormone function may affect breast density. Screening tests, such as mammography, may help doctors find tumor cells early and plan better treatment for breast cancer. PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function on breast density in healthy Hispanic women who are undergoing mammography for breast cancer screening. | NO | Breast Cancer | OTHER: physiologic testing|OTHER: study of socioeconomic and demographic variables|PROCEDURE: breast imaging study|PROCEDURE: study of high risk factors | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | NA | NIH | INTERVENTIONAL | Allocation: |Intervention Model: |Masking: |Primary Purpose: SCREENING | NU-0212-005|CDR0000437805 | 2003-08 | 2005-11 | 2005-08-19 | 2013-07-10 | Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States | |||||||||
| NCT00124956 | Doxorubicin Pharmacokinetic (PK) Study | https://clinicaltrials.gov/study/NCT00124956 | This protocol is designed to obtain detailed information on the impact of body composition on the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21 years of age or younger. There is no efficacy component. Approximately 9 children will be enrolled at Children’s Hospital Boston. The information gained from this study could be very important in developing dosing strategies for doxorubicin in the obese patient population. | NO | Cancer | DRUG: Doxorubicin | To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children | To explore the relationship between PK parameters and the patients’ characteristics (age, gender, and ethnicity) and to correlate between PK parameters and DXA data (fat mass, lean tissue mass, and bone mineral content) | Boston Children’s Hospital | Glaser Pediatric Research Network|Elizabeth Glaser Pediatric AIDS Foundation | ALL | CHILD, ADULT | PHASE1|PHASE2 | 0 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 03-04-050 | 2003-06 | 2005-07-29 | 2017-09-11 | Children’s Hospital, Boston, Boston, Massachusetts, 02115, United States | ||||||
| NCT00120029 | Peer Counseling for Weight Loss | https://clinicaltrials.gov/study/NCT00120029 | The efficacy of peer counseling for weight loss maintenance is being tested in obese and overweight African American breast cancer survivors. | NO | Breast Cancer | BEHAVIORAL: weight loss counseling | weight loss | markers of oxidative stress in blood and breast fluid|markers of cardiovascular health in blood|body fat|fitness | Wayne State University | Barbara Ann Karmanos Cancer Institute|University of Michigan | FEMALE | ADULT, OLDER_ADULT | NA | 100 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | 057103MP4F|1P50ES012395 | 2004-01 | 2008-06 | 2005-07-14 | 2008-09-05 | Wayne State University, Detroit, Michigan, 48201, United States | |||||
| NCT00038727 | Diabetes Prevention Program Outcomes Study | https://clinicaltrials.gov/study/NCT00038727 | DPPOS | The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import. | YES | Diabetes Mellitus|Cancer|CVD | BEHAVIORAL: DPPOS Group Lifestyle|DRUG: Metformin|BEHAVIORAL: DPPOS Boost Lifestyle|BEHAVIORAL: Intensive Lifestyle Group Session | Development of Diabetes., Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level \>= 126 mg/dL \[7.0 mmol/L\] or 2-hour plasma glucose \>= 200 mg/dL \[11.1 mmol/L\], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test)., Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).|Prevalence of Aggregate Microvascular Complication, Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (\<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (\> 30mg/gm, confirmed)., Outcomes were assessed from 2012-2013 (approximately 2 years).|Total Cancer Except Non-melanoma Skin Cancer, All primary incident cancers except non-melanoma skin cancer, Outcomes were assessed from 1996-2020 (approximately 24 years).|Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD), Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment., Outcomes were assessed from 1996-2025 (approximately 29 years). | Subclinical Atherosclerosis, Measured using coronary artery calcification (CAC)., Outcomes were assessed from 2012-2013 (approximately 2 years).|Cognitive Function, Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test )., Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.|Short Physical Performance Battery, Physical function is measured using the short physical performance battery (SPPB), which is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands., Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.|Frailty, Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss., Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.|Mortality, All cause-mortality through clinic reports and National Death Index search, Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|National Institute on Aging (NIA)|National Institute on Minority Health and Health Disparities (NIMHD)|National Heart, Lung, and Blood Institute (NHLBI)|National Cancer Institute (NCI)|National Eye Institute (NEI)|National Center for Research Resources (NCRR)|Office of Research on Women’s Health (ORWH)|Centers for Disease Control and Prevention|American Diabetes Association|Indian Health Service|General Clinical Research Program|US Department of Veterans Affairs | ALL | ADULT, OLDER_ADULT | PHASE3 | 2779 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | DPPOS|U01DK048489 | 2002-09 | 2024-10 | 2025-01 | 2002-06-05 | 2017-10-24 | 2021-12-28 | George Washington University, Rockville, Maryland, 20852, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/27/NCT00038727/Prot_SAP_002.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/27/NCT00038727/ICF_003.pdf | |
| NCT00032344 | Long-term Follow-up Study Designed to Evaluate the Relative Risk of Two Colonoscopy Schedules for Patients With Small Polyps | https://clinicaltrials.gov/study/NCT00032344 | Colorectal cancer is a leading cause of cancer death in the United States. Mortality remains high because most colorectal cancers are detected after there has been regional or distant spread, precluding curative surgical resection. With this in mind, screening strategies have been recommended for asymptomatic individuals which hope to reduce mortality from colon cancer by detecting and removing premalignant adenomatous polyps or early malignant lesions. Screening of asymptomatic individuals over age 50 with sigmoidoscopy and fecal occult blood tests has been advocated by the American Cancer Society. However, current screening will identify only 50% of patients who have adenomatous polyps. More sensitive tests for polyp detection, like colonoscopy, are costly, require extensive resources and are unlikely to be used for screening large populations. Ideal screening would identify patients with the highest risk of cancer and target more sensitive screening tests at this population. The identification of low cost, easily collectible risk factors which can be used to target patients for the more sensitive screening tests is the primary purpose of this study. Since a major segment of the veteran population is over the age of 50, there will be a substantial impact in reduction of both mortality and morbidity due to colon cancer and attendant cost savings to the VA for treatment if such risk factors can be identified. Phase I is a cross-sectional study designed to identify risk factors for large (\>1 cm) adenomatous polyps. Approximately 3200 asymptomatic subjects (age 50-75) have completed risk factor assessment, medical and dietary histories, and have undergone complete colonoscopy examination. This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group. Data at colonoscopy will characterize the prevalence, size and distribution of adenomatous polyps. This will permit an assessment of sensitivity of sigmoidoscopy in this population. In addition, tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity. The primary focus of Phase I is a risk factor analysis. A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps. A cohort consisting of a subgroup of polyp patients (large and small) and matched polyp-free controls will be tracked longitudinally to determine polyp occurrence/recurrence rates. Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopies. Phase III is an extension in follow-up of an additional five years, a total of ten years in all, to include all study patients. The primary focus will be on documenting long-term mortality and medical outcomes as well as occurrence/reoccurrence of neoplasia with special emphasis on ten-year cancer rates. | NO | Colorectal Cancer | PROCEDURE: Colonoscopy | Phase I: Risk factors include: family history; dietary; fat, fiber, calcium; alcohol history; tobacco use; physical activity; obesity; NSAID use; and, biomarkers: BRDU, PCNA, Cross-sectional | Phase II: Colonoscopy outcomes to determine recurrence rates and compare surveillance strategies, 5 years|Phase III: Medical outcomes including mortality. Colonoscopy outcomes in subgroup of polyp free patient at baseline to determine long term risk., 10 years | US Department of Veterans Affairs | ALL | ADULT, OLDER_ADULT | PHASE3 | 3200 | FED | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 380 | 1993-10 | 2007-02 | 2007-02 | 2002-03-19 | 2018-08-31 | Carl T. Hayden VA Medical Center, Phoenix, Arizona, 85012, United States|Southern Arizona VA Health Care System, Tucson, Tucson, Arizona, 85723, United States|VA Medical Center, Long Beach, Long Beach, California, 90822, United States|VA Palo Alto Health Care System, Palo Alto, California, 94304-1290, United States|VA Medical Center, San Francisco, San Francisco, California, 94121, United States|VA Eastern Colorado Health Care System, Denver, Denver, Colorado, 80220, United States|Edward Hines, Jr. VA Hospital, Hines, Illinois, 60141-5000, United States|VA Medical Center, Minneapolis, Minneapolis, Minnesota, 55417, United States|VA Medical Center, Kansas City MO, Kansas City, Missouri, 64128, United States|VA Medical Center, Durham, Durham, North Carolina, 27705, United States|VA Medical Center, Portland, Portland, Oregon, 97239-2964, United States|VA North Texas Health Care System, Dallas, Dallas, Texas, 75216, United States|VA Medical & Regional Office Center, White River, White River Junction, Vermont, 05009-0001, United States | |||||
| NCT00032201 | Cell Lines From High-Risk Breast Tissue | https://clinicaltrials.gov/study/NCT00032201 | Background: * Many risk factors for breast cancer have been identified, including family history, endocrine background, changes in breast tissue, cancer in one breast, radiation exposure, obesity and others. There is a spectrum of tissue changes seen in cancerous and pre-cancerous breast tissue. * A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen. Cell lines developed from high-risk breast tissue allow researchers to perform metabolic and molecular studies of breast cells over time. Objective: To establish a repository (facility in which tissue samples can be preserved and stored for many years) of cell lines from high-risk breast tissue to allow researchers to learn more about changes in breast cells that may cause them to develop into breast cancer. Eligibility: Women between 20 and 80 years of age who: * Have an increased risk of breast cancer because they are members of a high-risk breast or ovarian cancer family. * Have had breast cancer in one or both breasts. * Have had radiation for lymphoma before the age of 30. * Have a mutation in a breast cancer susceptibility gene, but whose family history is not known. * Are not at increased risk of breast cancer. Design: * A small piece of breast tissue will be obtained from about 10 women without an identified risk of breast cancer and up to 100 women at high risk of developing breast cancer. * Cell lines will be developed from each high-risk category. * The cell lines and tissues will be used to establish a repository of high-risk breast cell lines and breast tissues that can be used to study how the cells develop into breast cancer. | NO | Healthy | National Cancer Institute (NCI) | FEMALE | ADULT, OLDER_ADULT | 43 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 020144|02-C-0144 | 2002-03-06 | 2014-12-03 | 2002-03-11 | 2019-12-17 | Walter Reed Army Medical Center, Washington, District of Columbia, 20301, United States|National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | ||||||||||
| NCT00006515 | Late Effects of Treatment for Sarcomas in Children | https://clinicaltrials.gov/study/NCT00006515 | This study will examine late effects of treatment for sarcoma (bone and soft tissue cancers) in children. Survival of patients with these diseases has improved over the years, but long-term adverse effects of treatment have also been noted. Patients previously treated for sarcoma in the NCI’s Pediatric Oncology Branch who are in their first remission from sarcoma after completion of therapy and who have had no further cancer treatment (chemotherapy, radiation therapy, cancer related surgery or immunotherapy) for at least 24 months may be eligible for this 3- to 4-day study. It will review the incidence and extent of the following late effects of therapy. * Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to the heart muscle. Patients will undergo magnetic resonance imaging (MRI) of the heart to look for changes and compare the findings with information obtained by standard echocardiogram (ultrasound test of the heart) and by MUGA (nuclear medicine scan of the heart). * Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone production, leading to infertility, early menopause or brittle bones. Low sex hormone levels may also increase the risk for heart attack, obesity or fracture. Patients will have blood tests to measure hormone levels as well as mineral levels, lipid levels and blood cell counts. They will also have a DEXA scan to measure bone mineral density and a CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen. Males will be offered a semen analysis as part of the fertility evaluation. * Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can lead to problems with personal relationships, jobs, insurance, education, health care, and personal and professional goal setting. Some patients may become depressed or develop a psychiatric illness. Patients will fill out a questionnaire about their treatment, recovery, and aspects of their current life and will meet with a psychologist and psychiatrist. * Changes in bodily function and capabilities-Patients who undergo surgery and radiation to treat sarcoma treatment may experience muscle, bone and joint changes. Patients will be interviewed about their performance of daily activities, physical limitations, and changes in skill levels. They will do a series of exercises and will have measurements of strength, mobility and physical skills, focusing on the parts of the body that were affected by the sarcoma and subsequent local therapy. * Exposure to viruses-A number of patients received blood transfusions as part of their cancer treatment. Some transfusions were given before HIV screening became available. Patients will be tested for this virus as well as the hepatitis virus and HTLV-1 (human T-cell leukemia virus-1), for which there are also small transfusion-associated risks. * Kidney function-The chemotherapy drug ifosfamide may affect kidney function. Patients will provide a urine specimen for kidney function tests. * Immune function-Chemotherapy affects the function of infection-fighting immune cells called T-lymphocytes. A blood sample will be drawn for studies of the time involved in recovering full immune function. | NO | Sarcoma | National Cancer Institute (NCI) | ALL | CHILD, ADULT, OLDER_ADULT | 39 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 010037|01-C-0037 | 2000-11-16 | 2011-11-18 | 2000-11-22 | 2017-07-02 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States | ||||||||||
| NCT00005664 | Evaluation of Patients With Endocrine-Related Conditions | https://clinicaltrials.gov/study/NCT00005664 | This study will evaluate patients with a variety of endocrine disorders in order to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) to train physicians in endocrinology. Patients of all ages with endocrine-related conditions may be eligible for evaluation under this protocol. Those enrolled may be required to provide blood, saliva, urine or stool samples, and to undergo ultrasound examination of the thyroid gland, ovaries or testes, adrenal glands or other parts of the body. Laboratory or X-ray studies may be done for diagnostic or treatment purposes. In some cases, patients will receive medical or surgical treatment for their disorder. Patients and family members of patients with a hereditary disorder may be asked to provide a blood sample for genetic analysis. | NO | Adrenal Insufficiency|Pituitary Neoplasm|Obesity | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ALL | ADULT, OLDER_ADULT | 1588 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 000127|00-CH-0127 | 2000-05-22 | 2019-12-05 | 2000-05-18 | 2019-12-16 | National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States |