NCT01140282

Exercise Program for Early Breast Cancer Survivors

Combined Exercise Program for Early Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration	Administered within 3 days of baseline testing and at post-trial visit
PROCEDURE	quality-of-life assessment	Administered within 3 days of baseline testing and at post-trial visit
PROCEDURE	management of therapy complications	Assessed within 3 days of baseline testing and at post-trial visit
BEHAVIORAL	exercise intervention	12 week exercise intervention

Timeline

• Start date: 2012-05-21
• Primary completion: 2017-09-28
• Completion: 2018-10-01
• First posted: 2010-06-09
• Last updated: 2019-06-18

Locations

1 site across 1 country: United States