Status:
COMPLETED
Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-99 years
Phase:
NA
Brief Summary
Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. Participants: 200 patients age 21 or older w...
Detailed Description
The overall focus of this study remains the investigation of associations between p16 and assessments (independent and patient-reported) of chemotherapy-related toxicity (adverse events and symptoms) ...
Eligibility Criteria
Inclusion
- Study subjects must meet all of the inclusion criteria listed below to participate in this study:
- 21 years of age or older, female
- Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
- Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
- English speaking
- IRB approved, signed written informed consent
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Willing and able to meet all study requirements.
Exclusion
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria are:
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
- Unable to walk or engage in moderate-intensity physical activity.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03761706
Start Date
February 28 2018
End Date
February 1 2025
Last Update
April 1 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599