Obesity Clinical Trial
Official title:
Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
Verified date | May 2020 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | July 15, 2019 |
Est. primary completion date | July 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - BREAST CANCER COHORT: - Women newly diagnosed (stage I-III) breast cancer - Are overweight or obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 25 kg/m^2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians? clearance to assess full eligibility) or body fat > 30% (estimated by bioelectrical impedance), and waist circumference > 35 in - Have undergone a lumpectomy or mastectomy - Have completed cancer-related treatment within the past 3 years - Speak English or Spanish - Are in breast cancer remission with no detectable disease present - Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity) - Free from history of chronic disease including uncontrolled diabetes (fasting blood glucose > 125 mg/dL), hypertension (blood pressure > 130/90 mmHg) or thyroid disease (< 0.4 or > 4.0 mIU/L); this will be determined by review of medical records and/or physician clearance - Have not experienced a weight reduction >= 10% within past 6 months - Currently participate in less than 60 minutes of structured exercise/week - No planned reconstructive surgery with flap repair during trial and follow-up period - May use adjuvant endocrine therapy if use will be continued for duration of study intervention - Do not smoke (no smoking during previous 12 months) - Willing to travel to the exercise facility at University of Southern California (USC) - PROSTATE CANCER COHORT: - Men > 18 diagnosed with prostate cancer for which antiandrogen therapy (ADT) (castration therapy) is being prescribed for at least 16 weeks; castration may be achieved surgically or using gonadotrophin releasing hormone (LHRH) agonists (i.e. leuprolide, goserelin, etc.) or LHRH antagonists (i.e. degarelix) - Additional ADT agents may be concurrently administered (abiraterone, bicalutamide, enzalutamide, etc.) - Men must be obese (BMI > 25) and sedentary (< 60 minutes of structured exercise per week) Exclusion Criteria: - Patients with metastatic disease (BREAST ONLY) - Have not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis; a washout period of a minimum of 6 weeks is required from the last anti-cancer treatment received except hormonal therapy - Patients with a history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise must be evaluated by their physician to assess if they are suitable to proceed on study - Are planning reconstructive surgery with flap repair during trial and follow-up period - Are unable to travel to the exercise facility at USC |
Country | Name | City | State |
---|---|---|---|
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Change in metabolic syndrome (Triglycerides) | The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34. | Baseline up to week 34 |
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