Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors

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.

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