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

LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Physical Activity; Aging
• Intervention / Treatment: Behavioral: Walk with Ease Program

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Amy Garrett

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Cohort; Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure changes in body compositional aspects of lean body mass (LBM)	As measured by DEXA	12 months
To measure changes in body compositional aspects of fat tissue mass (FM)	As measured by DEXA	12 months
To measure changes in body compositional aspects of percentage body fat (BF)	As measured by DEXA	12 months
To measure change in physical activity over the course of the study	As measured by engagement in walking survey	12 months
To measure change in physical function over the course of the study	As measured by the Short Physical Performance Battery	12 months
To measure change in fatigue over the course of the study	As measured by the FACIT-F	12 months
To measure change in quality of life over the course of the study	As measured by the FACT-B	12 months
To measure change in self-efficacy over the course of the study	As measured by the PSEFSM and OEE	12 months
To measure retention during the study	• Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.	12 months
To measure safety of the walking program	• 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.	12 months
To measure overall satisfaction with the program	As measured by a satisfaction questionnaire	12 months
To average the number of daily and weekly steps per participant	As measure via an continuous accelerometer.	12 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Hyman Muss, MD, University of North Carolina

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): January 16, 2019
• Study Completion (Actual): January 16, 2019

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Breast Cancer; Cancer; Chemotherapy; Geriatric; p16; Breast Cancer Treatment; Advance Age; Genetic Marker
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LCCC1410; 14-2074 (Other Identifier: UNC IRB)