Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Conditions
Keywords
cancer survivor
Brief 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.
Interventions
OTHERquestionnaire administration
Administered within 3 days of baseline testing and at post-trial visit
PROCEDUREquality-of-life assessment
Administered within 3 days of baseline testing and at post-trial visit
PROCEDUREmanagement of therapy complications
Assessed within 3 days of baseline testing and at post-trial visit
BEHAVIORALexercise intervention
12 week exercise intervention
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed