Combined Exercise Program for Early Breast Cancer Survivors
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c
At week 16
No
Christina Dieli-Conwright, Ph.D.
Principal Investigator
USC/Norris Comprehensive Cancer Center
United States: Institutional Review Board
1B-12-1
NCT01140282
May 2012
May 2017
Name | Location |
---|---|
USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |