Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging

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) and patient-reported measures of function and quality of life. The
research team has determined that p16 increases dramatically during chemotherapy and that p16
levels among persons of similar age are lower among those who exercise as compared to those
who are sedentary. The research team hypothesizes that engagement in physical activity during
chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To
test this hypothesis, the study proposes to build on a completed trial, LCCC1334, and enroll
100 evaluable patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to
start adjuvant or neoadjuvant chemotherapy in an intervention that entails both aerobic and
resistance exercises.

Results from both LCCC1334 and the proposed study, LCCC1749, will be used to provide evidence
for a future grant application to conduct a randomized controlled trial in a larger study
population to (1) establish the effect of physical activity on p16 levels during chemotherapy
and (2) further evaluate how baseline and post-chemotherapy p16 levels correlate with
measures of treatment-related toxicity and patient-reported outcomes over time. Findings from
this study will also provide preliminary evidence for further investigations of the potential
benefits of exercise during early breast cancer chemotherapy for (1) reducing the incidence
and severity of peripheral neuropathy and (2) managing the interface of fatigue and perceived
cognition deficits.

Inclusion Criteria:

- Study subjects must meet all of the inclusion criteria listed below to participate in
this study:

- 21 to 64 years of age, 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 Criteria:

- 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.