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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Patients | Breast Cancer patients undergoing chemotherapy will participate in the Walk with Ease program during their treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk With Ease | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Breast Cancer Patients age 21-59
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| Name | Affiliation | Role |
|---|---|---|
| Hyman B Muss, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38153568 | Derived | Nyrop KA, Page A, Deal AM, Wagoner C, Kelly EA, Kimmick GG, Copeland A, Speca J, Wood WA, Muss HB. Association of self-directed walking with toxicity moderation during chemotherapy for the treatment of early breast cancer. Support Care Cancer. 2023 Dec 28;32(1):68. doi: 10.1007/s00520-023-08275-4. |
| Label | URL |
|---|---|
| UNC Geriatric Oncology Program | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016138 | Walking |
| C034430 | methyl hydroxyethyl cellulose |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Blood samples will be taken collect p16 levels, CBC + Differential and senescence markers.
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| 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 |
| D001519 |
| Behavior |
| D015444 | Exercise |
| D009043 | Motor Activity |