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

NCT ID: NCT02328313

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-01-16

Brief Summary

To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.

Detailed Description

LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.

Conditions

Breast Cancer; Aging; Physical Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Cohort

Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.

Group Type: EXPERIMENTAL

Walk with Ease Program

Intervention Type: BEHAVIORAL

The Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal.

Interventions

Walk with Ease Program

The Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 65 or older, 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 neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
• 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 intervention.

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyman Muss, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Amy Garrett

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)

Other Identifiers

14-2074

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC1410

Identifier Type: -

Identifier Source: org_study_id