Status:
TERMINATED
Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer Survivor
No Evidence of Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 surviv...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on metabolic dysregulation. SECONDARY OBJECTIVES: I. To dete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03284346
Start Date
August 17 2017
End Date
July 15 2019
Last Update
September 29 2025
Active Locations (1)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033