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

NCT ID: NCT02167932

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-11-30

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer; Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast Cancer Patients

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

Walk With Ease

Intervention Type: BEHAVIORAL

Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.

Interventions

Walk With Ease

Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.

Intervention Type: BEHAVIORAL

Other Intervention Names

WWE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyman B Muss, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

References

Nyrop KA, Page A, Deal AM, Wagoner C, Kelly EA, Kimmick GG, Copeland A, Speca J, Wood WA, Muss HB. Association of self-directed walking with toxicity moderation during chemotherapy for the treatment of early breast cancer. Support Care Cancer. 2023 Dec 28;32(1):68. doi: 10.1007/s00520-023-08275-4.

Reference Type: DERIVED

PMID: 38153568 (View on PubMed)

Related Links

https://unclineberger.org/patientcare/programs/geriatric

UNC Geriatric Oncology Program

Other Identifiers

LCCC1334

Identifier Type: -

Identifier Source: org_study_id