Chapel Hill, North Carolina 27599


Purpose:

To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.


Study summary:

LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.


Criteria:

Inclusion Criteria: - Age 65 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 neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org) - 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 intervention.


NCT ID:

NCT02328313


Primary Contact:

Principal Investigator
Hyman Muss, MD
University of North Carolina

Shani M Alston, MPH
Phone: 9198431906
Email: shani_alston@med.unc.edu


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States

Shani M Alston, MPH
Phone: 919-843-1906
Email: shani_alston@med.unc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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