Combined Exercise Program for Early Breast Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: questionnaire administration (Other)
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.
Intervention: quality-of-life assessment (Procedure)
Arm I (Control)
Patients refrain from increasing physical activity levels for 16 weeks.
Intervention: questionnaire administration (Other)
Arm I (Control)
Patients refrain from increasing physical activity levels for 16 weeks.
Intervention: quality-of-life assessment (Procedure)
Arm I (Control)
Patients refrain from increasing physical activity levels for 16 weeks.
Intervention: management of therapy complications (Procedure)
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.
Intervention: management of therapy complications (Procedure)
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.
Intervention: exercise intervention (Behavioral)
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
Secondary Outcomes
No secondary outcomes reported