Exercise Program for Early Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combined Exercise Program for Early Breast Cancer Survivors

Conditions
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Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Procedure: management of therapy complications
* Behavioral: exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (Control)<br>Patients refrain from increasing physical activity levels for 16 weeks. | Other: questionnaire administration<br>* Administered within 3 days of baseline testing and at post-trial visit<br>Procedure: quality-of-life assessment<br>* Administered within 3 days of baseline testing and at post-trial visit<br>* Other names: quality of life assessment;Procedure: management of therapy complications<br>* Assessed within 3 days of baseline testing and at post-trial visit<br>* Other names: complications of therapy, management of;|
| Experimental: Arm II (Exercise)<br>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. | Other: questionnaire administration<br>* Administered within 3 days of baseline testing and at post-trial visit<br>Procedure: quality-of-life assessment<br>* Administered within 3 days of baseline testing and at post-trial visit<br>* Other names: quality of life assessment;Procedure: management of therapy complications<br>* Assessed within 3 days of baseline testing and at post-trial visit<br>* Other names: complications of therapy, management of;Behavioral: exercise intervention<br>* 12 week exercise intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Feasibility of a supervised exercise program for cancer survivors |  | At week 16 | 
| Maintain positive benefits of an exercise intervention |  | 12 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivor