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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02167932
First received: June 17, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Aging
Behavioral: Walk With Ease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Compare changes in p16 between patients who do and do not experience any grade 3/4 toxicities [ Time Frame: One year ] [ Designated as safety issue: No ]
    Information obtained through physician and patient reported surveys.

  • Predict changes in physical function, fatigue, and quality of life over [ Time Frame: One year ] [ Designated as safety issue: No ]
    This objective will use the surveys that measure physical function, fatigue and quality of life to see if they can make any predictions about how these domains may change over the course of chemotherapy.

  • Measure the association of change in physical activity levels with changes in physical function, fatigue, and quality of life measures [ Time Frame: One year ] [ Designated as safety issue: No ]
    Changes will be measured over the course of the study

  • Measure the association of change in p16 levels with changes in physical function, fatigue, and quality of life measures [ Time Frame: One year ] [ Designated as safety issue: No ]
    Changes will be measured over the course of chemotherapy


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 48
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast Cancer Patients
Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment.
Behavioral: 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.
Other Name: WWE

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 21-59 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.

  Eligibility

Ages Eligible for Study:   21 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast Cancer Patients age 21-59

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02167932

Contacts
Contact: Shan M Alston, MPH 919-843-1906 shani_alston@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Shani M Alston, MPH    919-843-1906    shani_alston@med.unc.edu   
Principal Investigator: Hyman B Muss, MD         
Principal Investigator: William A Wood, MD         
Principal Investigator: Kirsten A Nyrop, PhD         
Principal Investigator: Bryce Reeve, PhD         
Principal Investigator: Ethan Basch, MD         
Sub-Investigator: Lisa A Carey, MD         
Sub-Investigator: E. Claire Dees, MD, MSc         
Sub-Investigator: Carey K Anders, MD         
Sub-Investigator: Katie Reeder-Hayes, MD         
Sub-Investigator: Trevor A Jolly, MD         
Sub-Investigator: Norman E Sharpless, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Breast Cancer Research Foundation
Investigators
Principal Investigator: Hyman B Muss, MD University of North Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02167932     History of Changes
Other Study ID Numbers: LCCC1334
Study First Received: June 17, 2014
Last Updated: June 17, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Breast Cancer
Walk With Ease
Physical Activity
Walking
Younger Women
Cancer
p16
Aging
Biomarkers
Biomarkers of Aging
Chemotherapy
Chemotherapy Treatment
Adjuvant Chemotherapy
Neoadjuvant Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014