Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT02235051
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2014-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: