Clinical trial NCT03284346: Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors
Official title: Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 determine the effects of a 4-month CARE intervention on sarcopenic obesity.

TERTIARY OBJECTIVES:

I. To determine the effects of a 4-month CARE intervention on skeletal muscle strength, physical fitness, and quality of life (QOL).

II. To determine the effects of a 4-month CARE intervention on vascular function.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm I: 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.

Arm II: 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.

After completion of study, patients undergoing CARE are followed up for 4 months.

Eligibility criteria: 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

Primary outcomes:
measure: Change in insulin resistance
timeFrame: Baseline up to week 34
measure: Change in metabolic syndrome (Blood Pressure)
timeFrame: Baseline up to week 34
measure: Change in metabolic syndrome (Waist Circumference)
timeFrame: Baseline up to week 34
measure: Change in metabolic syndrome (Fasting Plasma Levels of Glucose)
timeFrame: Baseline up to week 34
measure: Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)
timeFrame: Baseline up to week 34
measure: Change in metabolic syndrome (Triglycerides)
timeFrame: Baseline up to week 34
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Christina Dieli-Conwright, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: