View Clinical Trial (Medical Research Study)
Combined Exercise Program for Early Breast Cancer Survivors
| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90089 |
| 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 |
| Purpose: |
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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.
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| Study Summary: |
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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 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.
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| 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
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| NCT ID: |
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NCT01140282 |
| Primary Contact: |
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Principal Investigator
Christina Dieli-Conwright, Ph.D.
USC/Norris Comprehensive Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Los Angeles, California 90089
United States
Christina Dieli-Conwright, PhD
Phone: 323-442-2905
Email: cdieli@usc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
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