Status:
COMPLETED
Exercise Program for Early Breast Cancer Survivors
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Breast Cancer
Stage II Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 br...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01140282
Start Date
May 21 2012
End Date
October 1 2018
Last Update
June 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089