The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer

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.

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.