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

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ClinicalTrials.gov Identifier: NCT02167932
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment
Breast Cancer Aging Behavioral: Walk With Ease

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 21-64 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.

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Study Type : Observational
Actual Enrollment : 127 participants
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
Study Start Date : March 2014
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 [ Time Frame: One Year ]
    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 :
  1. 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 ]
    Information obtained through patient-reported surveys and p16 levels obtained from blood samples between baseline to 6 month post-chemotherapy

  2. Compare changes in p16 between patients who do and do not experience any grade 3/4 toxicities [ Time Frame: One year ]
    Information obtained through physician and patient reported surveys.

  3. Predict changes in physical function, fatigue, and quality of life over [ Time Frame: One year ]
    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.

  4. Measure the association of change in physical activity levels with changes in physical function, fatigue, and quality of life measures [ Time Frame: One year ]
    Changes will be measured over the course of the study

  5. Measure the association of change in p16 levels with changes in physical function, fatigue, and quality of life measures [ Time Frame: One year ]
    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.


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Ages Eligible for Study:   21 Years to 59 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167932


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Breast Cancer Research Foundation
Investigators
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Principal Investigator: Hyman B Muss, MD University of North Carolina

Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02167932     History of Changes
Other Study ID Numbers: LCCC1334
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

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

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