Stage IIIA Breast Cancer Clinical Trial
Official title:
Combined Exercise Program for Early Breast Cancer Survivors
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.
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.
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