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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Aging; Breast Cancer

Treatments: Behavioral: Walk With Ease

Study type: Observational

Funder types: Other

Identifiers

NCT02167932

LCCC1334

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: Female

Ages: 21 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

127 participants in 1 patient group

Breast Cancer Patients

Description:

Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment.

Treatment:

Behavioral: Walk With Ease