Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Impact of Physical Activity on Aging Biomarker p65 and Body Composition in Older Patients with Stage I-III Breast Cancer Undergoing Chemotherapy

Protocol: OSU-15087

Full Title

Impact of Physical Activity on Biomarker of Aging and Body Composition among Breast Cancer Survivors Age 65 and Older

Purpose

This clinical trial studies the impact of physical activity on a genetic marker of aging in cells called p16 and the body composition of older patients with stage I-III breast cancer undergoing chemotherapy. The genetic biomarker p16 is a molecule in the cells that is a sign of aging in the body and increases as the body ages. It has also been shown to increase when patients undergo chemotherapy. A walking exercise program may help prevent the levels of p16 from rising and increase lean body mass in patients with breast cancer receiving chemotherapy.

Study Objective

PRIMARY OBJECTIVES:

I. Compare the change in p16 (cyclin-dependent kinase inhibitor 2A) from baseline to end of chemotherapy for participants in Lineberger Comprehensive Cancer Center (LCCC)1410 (who are engaged in a physical activity intervention) to the participants in the concurrent control group (who are not engaged in the physical activity intervention).

SECONDARY OBJECTIVES:

I. Compare changes in geriatric assessment measures from baseline to end of chemotherapy for participants in LCCC1410 (who are engaged in a physical activity intervention) to the participants in the concurrent control group (who are not engaged in the physical activity intervention).

II. Compare changes in inflammation and coagulation (interleukin [IL]-6, D-Dimer and C-reactive protein [CRP]) from baseline to end of chemotherapy for participants in LCCC1410 (who are engaged in a physical activity intervention) to the participants in the concurrent control group (who are not engaged in the physical activity intervention).

III. Evaluate changes in body composition (DEXA) and physical performance (SPPB) between baseline and end of chemotherapy, and between baseline and 6 months post-chemotherapy. (Only LCCC1410 study population)

IV. Evaluate changes in engagement in physical activity, quality of life (FACT-B), fatigue (FACIT-F), self-efficacy for fatigue self-management (PSEFSM), and outcome expectations from exercise (OEE) between baseline and end of chemotherapy, and between baseline and 6 months post-chemotherapy. (Only LCCC1410 study population)

V. Evaluate changes in renal, hepatic and hematologic function between baseline and end of chemotherapy, and between baseline and 6 months post-chemotherapy. (Only LCCC1410 study population)

VI. Report recruitment, retention, safety and satisfaction with the intervention at end-of-chemotherapy and 6 months post-chemotherapy. (Only LCCC1410 study population)

TERTIARY OBJECTIVES:

I. Explore the association of changes in p16 levels with changes in measures of body composition, chemotherapy toxicity, physical activity, physical function, fatigue and quality of life from baseline to end-of-chemotherapy and baseline to 6 months post-chemotherapy.

II. Explore the association of changes in physical activity levels with changes in measures of body composition, chemotherapy toxicity, physical function and quality of life -- between baseline and end of chemotherapy, and between baseline and 6 months post-chemotherapy.

III. Explore the association of data from continuous accelerometer (FitBit) with self-reported measures of physical activity, chemotherapy toxicity, physical functioning, and quality of life at end of chemotherapy.

IV. Explore the association of changes in OEE and PSEFSM scores and self-reported measures of physical activity between baseline and end of chemotherapy, and between baseline and 6 months post-chemotherapy.

OUTLINE:

Patients receive the Arthritis Foundation's Walk with Ease (WWE) workbook that includes chapters on identifying and overcoming barriers to walking, developing a walking plan, and resources for staying motivated. Patients are encouraged to engage in at least 150 minutes of walking per week during chemotherapy, and to sustain this activity level through 6 months after completion of chemotherapy. Patients also maintain a printed daily exercise log and wear a FitBit accelerometer during chemotherapy. Patients compete questionnaires and assessments at baseline (prior to first chemotherapy session), end-of-chemotherapy (within 3 weeks of last chemotherapy session), and 6 months post-end of chemotherapy.

Are you eligible?

Inclusion Criteria:

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 National Comprehensive Cancer Network (NCCN) guidelines

English speaking

Institutional Review Board (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

Breast Cancer