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

Not Applicable

Completed

• Conditions: Breast Cancer; Aging; Physical Activity
• Interventions: Behavioral: Walk with Ease Program

• Registration Number: NCT02328313
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Primary Completion: 2019-01-16
• Study Completion: 2019-01-16
• Status Verified: 2019-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Cohort	Walk with Ease Program	Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.

Primary Outcome Measures

Name	Time	Method
To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group	12 months	The comparison group will be taken from another study
To measure the changes in the level of p16 expression from baseline and end of chemotherapy.	2 - 6 months	The study will look at the change of p16 expression within patients on this study.

Secondary Outcome Measures

Name	Time	Method
To measure change in physical function over the course of the study	12 months	As measured by the Short Physical Performance Battery
To measure changes in body compositional aspects of lean body mass (LBM)	12 months	As measured by DEXA
To measure changes in body compositional aspects of fat tissue mass (FM)	12 months	As measured by DEXA
To measure changes in body compositional aspects of percentage body fat (BF)	12 months	As measured by DEXA
To measure change in physical activity over the course of the study	12 months	As measured by engagement in walking survey
To measure retention during the study	12 months	• Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.
To measure safety of the walking program	12 months	• Safety will be defined as any adverse events potentially related to the intervention, including falls, which are reported by study participants to the Study Team.
To measure change in fatigue over the course of the study	12 months	As measured by the FACIT-F
To measure change in self-efficacy over the course of the study	12 months	As measured by the PSEFSM and OEE
To average the number of daily and weekly steps per participant	12 months	As measure via an continuous accelerometer.
To measure change in quality of life over the course of the study	12 months	As measured by the FACT-B
To measure overall satisfaction with the program	12 months	As measured by a satisfaction questionnaire

Trial Locations

Locations (1)

Amy Garrett; 🇺🇸 Chapel Hill, North Carolina, United States