Combined Exercise Program for Early Breast Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stage I Breast Cancer
- Sponsor
- University of Southern California
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.
Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c
Time Frame: At week 16
Improvement of physical fitness, cardiorespiratory fitness, and muscle strength
Time Frame: At week 16
Feasibility of a supervised exercise program for cancer survivors
Time Frame: At week 16
Maintain positive benefits of an exercise intervention
Time Frame: 12 weeks post-intervention