Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer

PRIMARY OBJECTIVES:

I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance
exercise (CARE) intervention on obesity-associated chronic inflammation.

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 breast cancer prognosis and
assess whether reductions in chronic inflammation are associated with breast cancer
prognosis.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients undergo supervised CARE program over 50 minutes comprising of warm up over
5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool
down over 5 minutes 3 days per week for 16 weeks.

GROUP II: Patients undergo supervised traditional aerobic and resistance exercise (TARE)
program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15
minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week
for 16 weeks.

GROUP III: Patients undergo home-based stretching program comprising of one set of 3-4 static
stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive
instructional digital video disc (DVD) and booklet of the flexibility exercises. Patients
also complete a weekly activity log. After completion of the stretching program, patients may
optionally undergo the CARE program as in group I.

After completion of study, patients are followed up at week 34, 8 and 12 months, and then
every year for 8 years.

Inclusion Criteria:

- Postmenopausal (at time of diagnosis; including artificial menopause induced by
previous hysterectomy) women newly diagnosed (stage I-III) breast cancer low grade
disease positive for estrogen and progesterone receptors

- Are centrally obese with the following criteria (determined by study team at
eligibility screening): body mass index (BMI) > 30 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 inches (in)

- Have undergone a lumpectomy or mastectomy

- Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation
therapy within the past 12 months

- Speak English or Spanish

- Is 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, hypertension or
thyroid disease

- 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

- Does not smoke (no smoking during previous 12 months)

- Willing to travel to the exercise facility at University of Southern California (USC)

Exclusion Criteria:

- Patients with metastatic disease

- Is not centrally obese

- Has not completed surgery, chemotherapy, or radiation treatment associated with their
diagnosis

- History of any musculoskeletal, cardiorespiratory or neurological diseases that
preclude the participation in exercise

- Participates in more than 60 minutes of structured exercise/week

- Is planning reconstructive surgery with flap repair during trial and follow-up period

- Currently smokes

- Is unable to travel to the exercise facility at USC