Stage IIIA Breast Cancer Clinical Trial
Official title:
Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese.
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.
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