Exercise Program for Early Breast Cancer Survivors
- Conditions
- Stage IIIA Breast CancerStage I Breast CancerStage IIIC Breast CancerStage II Breast CancerStage IIIB Breast Cancer
- Interventions
- Other: questionnaire administrationProcedure: quality-of-life assessmentProcedure: management of therapy complicationsBehavioral: exercise intervention
- Registration Number
- NCT01140282
- Lead Sponsor
- University of Southern California
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 106
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (Control) questionnaire administration Patients refrain from increasing physical activity levels for 16 weeks. Arm I (Control) management of therapy complications Patients refrain from increasing physical activity levels for 16 weeks. Arm II (Exercise) exercise intervention 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. Arm I (Control) quality-of-life assessment Patients refrain from increasing physical activity levels for 16 weeks. Arm II (Exercise) questionnaire administration 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. Arm II (Exercise) management of therapy complications 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. Arm II (Exercise) quality-of-life assessment 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.
- Primary Outcome Measures
Name Time Method Feasibility of a supervised exercise program for cancer survivors At week 16 Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c At week 16 Improvement of physical fitness, cardiorespiratory fitness, and muscle strength At week 16 Maintain positive benefits of an exercise intervention 12 weeks post-intervention
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States