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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer

Conditions
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Breast Cancer, Aging

Intervention / Treatment
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* Behavioral: Walk With Ease


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Patients<br>Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment. | Behavioral: Walk With Ease<br>* 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.<br>* Other names: WWE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Information obtained through patient-reported surveys and p16 levels obtained from blood samples between baseline to 6 month post-chemotherapy | One year | 
| Compare changes in p16 between patients who do and do not experience any grade 3/4 toxicities | Information obtained through physician and patient reported surveys. | One year | 
| Predict changes in physical function, fatigue, and quality of life over | 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. | One year | 
| Measure the association of change in physical activity levels with changes in physical function, fatigue, and quality of life measures | Changes will be measured over the course of the study | One year | 
| Measure the association of change in p16 levels with changes in physical function, fatigue, and quality of life measures | Changes will be measured over the course of chemotherapy | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Walk With Ease, Physical Activity, Walking, Younger Women, Cancer, p16, Aging, Biomarkers, Biomarkers of Aging, Chemotherapy, Chemotherapy Treatment, Adjuvant Chemotherapy, Neoadjuvant Chemotherapy