Breast Cancer Clinical Trial
The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer
Summary
This study will look at whether or not participating in a physical activity intervention during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a large increase after chemotherapy.
Full Description
Our research team has determined that p16INK4a - a biomarker of aging -- increases dramatically during chemotherapy and that p16 levels among patients of similar age are lower among those who exercise. We hypothesize that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, we propose to enroll 48 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in a physical activity intervention program. Our primary objective is to compare the change in p16 from baseline to end of chemotherapy for participants in this study (who are engaged in a physical activity intervention) to the mean change in p16 seen in a previous study of similar patients who did not participate in a physical activity intervention. As secondary objectives, we propose to evaluate (1) changes in treatment-related toxicity, physical function, fatigue, and quality of life between baseline, end of chemotherapy and 6 months post-chemotherapy, (2) the association of changes in p16 levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life, and (3) the association of changes in physical activity levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life.
Eligibility Criteria
Inclusion Criteria:
21 to 59 years of age, female (A similar trial LCCC 1226 explores physical activity in women 60 years and older and is now in progress.
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 Criteria:
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.
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There is 1 Location for this study
Chapel Hill North Carolina, 27599, United States
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