Trials / Completed
CompletedNCT02235051
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- Female
- Age
- 56 Years
- Healthy volunteers
- Not accepted
Summary
This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.
Detailed description
PRIMARY OBJECTIVES: I. To test the hypothesis that regular exercise increases DNA repair capacity. II. To test the hypothesis that regular exercise reduces inflammatory response. III. To test the hypothesis that regular exercise modulates telomerase activity. SECONDARY OBJECTIVES: I. To assess adherence to the study protocol. II. To examine differences in body composition before and after the exercise intervention. III. To examine differences in fitness before and after the exercise intervention. IV. To test the hypothesis that regular exercise increases quality of life in breast cancer survivors. V. To examine the safety of the exercise intervention. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at a Curves facility will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine. ARM II: Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.
Conditions
- Cancer Survivor
- Estrogen Receptor-positive Breast Cancer
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Stage IIA Breast Cancer
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
- Postmenopausal
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | exercise intervention | Undergo Curves exercise program |
| OTHER | laboratory biomarker analysis | Correlative studies |
| OTHER | questionnaire administration | Ancillary studies |
| OTHER | quality-of-life assessment | Ancillary studies |
Timeline
- Start date
- 2014-09-07
- Primary completion
- 2016-12-19
- Completion
- 2022-06-03
- First posted
- 2014-09-09
- Last updated
- 2023-03-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02235051. Inclusion in this directory is not an endorsement.