Clinical trial NCT02167932: The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer
Official title: Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Aging
Keywords: Breast Cancer
Walk With Ease
Physical Activity
Walking
Younger Women
Cancer
p16
Aging
Biomarkers
Biomarkers of Aging
Chemotherapy
Chemotherapy Treatment
Adjuvant Chemotherapy
Neoadjuvant Chemotherapy
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2014-06-19
Enrollment: 127
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer Patients age 21-59

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: One Year
Secondary outcomes:
measure: 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.
timeFrame: One year
measure: Compare changes in p16 between patients who do and do not experience any grade 3/4 toxicities
timeFrame: One year
measure: Predict changes in physical function, fatigue, and quality of life over
timeFrame: One year
measure: Measure the association of change in physical activity levels with changes in physical function, fatigue, and quality of life measures
timeFrame: One year
measure: Measure the association of change in p16 levels with changes in physical function, fatigue, and quality of life measures
timeFrame: One year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Hyman B Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: