Clinical trial · Interventional
Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors
Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
NCT03284346CI-TRIAL-00095892terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left
Summary
Brief summary (as posted)
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.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| No Evidence of Disease | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Sedentary Lifestyle | — | UNRESOLVED | — |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer | Malignant Breast Neoplasm |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Polar heart rate monitor | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (CARE)
- description
- Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during the CARE sessions.
- interventionNames
- Behavioral: Exercise Intervention
- Other: Laboratory Biomarker Analysis
- Other: Polar heart rate monitor
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard stretching)
- description
- Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16 weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.
- interventionNames
- Behavioral: Exercise Intervention
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.