Combined Exercise Program for Early Breast Cancer Survivors
Description
Detailed Description
I. To determine whether a 16-week exercise intervention will improve components of
metastasis (MetS) in breast cancer survivors soon after completion of cancer-related
treatments by measuring changes in body composition, waist circumference, blood pressure,
and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c
(HbA1c).
II. To determine whether a 16-week exercise intervention will improve physical fitness in
breast cancer survivors soon after completion of cancer-related treatments by measuring
cardiorespiratory fitness and muscle strength.
III. To assesses the feasibility of a supervised exercise intervention in early breast
cancer survivors.
IV. To determine whether a 16-week exercise intervention will result in a reduction in
adipose tissue inflammation in obese breast cancer survivors soon after completion of
cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.
V. To determine whether breast cancer survivors can maintain positive benefits of an
exercise intervention following a 12-week follow-up period by measuring changes in body
composition, waist circumference, blood pressure, and serum levels of insulin, glucose,
lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.
OUTLINE:
Patients are randomized to 1 of 2 arms.
Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.
Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes
thrice weekly and are encouraged to participate in a home-based exercise session over 30-45
minutes once weekly for 16 weeks.
Phase
N/AInclusion and Exclusion Criteria
- Newly diagnosed (I-III) with a first primary invasive breast cancer
- Have undergone a lumpectomy or mastectomy
- Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program (if randomized to that arm) within 12 weeks of therapy completion
- Body mass index (BMI) > 25 kg/m^2 or body fat > 30% (determined by Dr. Dieli-Conwright at baseline visit)
- Currently participate in less than 60 minutes of physical activity per week May use adjuvant endocrine therapy if use will be continued for duration of study period
- Nonsmokers (i.e., not smoking during previous 12 months)
- Willing to travel to the exercise facility and USC
- Able to provide physician clearance to participate in exercise program
- Women of all racial and ethnic backgrounds will be included in the study enrollment process
- History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
- Weight reduction >= 10% within past 6 months
- Diagnosed with human epidermal growth factor receptor 2 (HER2)-positive tumor (exclusion due to patient use of Herceptin medication for 1 year following chemotherapy)
- Metastatic disease
- Planned reconstructive surgery with flap repair during trial and follow-up period
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
Sites
-
California
- USC Norris Comprehensive Cancer Center, Los Angeles, California, 90089
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