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

NCT02167932 | Completed DMC

• 1 other identifier: LCCC1334
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Aging

Keywords

Breast Cancer; Walk With Ease; Physical Activity; Walking; Younger Women; Cancer; p16; Aging; Biomarkers; Biomarkers of Aging; Chemotherapy; Chemotherapy Treatment; Adjuvant Chemotherapy; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Compare the change in p16 from baseline to the end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in a previous study

  Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in a previous study (LCCC810) of similar patients who did not participate in a physical activity intervention

  One Year

Secondary Outcomes (5)

• Measure the association of change in physical activity levels with change in with p16 levels from baseline to end of chemo and baseline to 6-months post.

  One year

• Compare changes in p16 between patients who do and do not experience any grade 3/4 toxicities

  One year

• Predict changes in physical function, fatigue, and quality of life over

  One year

• Measure the association of change in physical activity levels with changes in physical function, fatigue, and quality of life measures

  One year

• Measure the association of change in p16 levels with changes in physical function, fatigue, and quality of life measures

  One year

Study Arms (1)

Breast Cancer Patients

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

Behavioral: Walk With Ease

Interventions

Walk With Ease 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.

Also known as: WWE

Breast Cancer Patients

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Breast Cancer Patients age 21-59

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 38153568 DERIVED

Related Links

• UNC Geriatric Oncology Program

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken collect p16 levels, CBC + Differential and senescence markers.

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Neoplasms

Interventions

Walking; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Hyman B Muss, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: March 1, 2014
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

US (1)