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Combined Exercise Program for Early Breast Cancer Survivors

Description

PRIMARY OBJECTIVES: 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/A

Inclusion 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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