To determine if exercise will affect the increase in p16 expression that is associated with
both chemotherapy administration and advancing age.
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.
- 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
- Patient-assessed ability to walk and engage in moderate physical activity
- Willing and able to meet all study requirements.
- One or more significant medical conditions that in the physician's judgment preclude
participation in the walking intervention.