Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors (NCT03284346) | Clinical Trial Compass
TerminatedNot Applicable
Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors
Stopped: PI left
United States23 participantsStarted 2017-08-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 smokin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in insulin resistance
Timeframe: Baseline up to week 34
2
Change in metabolic syndrome (Blood Pressure)
Timeframe: Baseline up to week 34
3
Change in metabolic syndrome (Waist Circumference)
Timeframe: Baseline up to week 34
4
Change in metabolic syndrome (Fasting Plasma Levels of Glucose)
Timeframe: Baseline up to week 34
5
Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)