All-extremity Exercise During Breast Cancer Chemotherapy

Study Overview
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Brief Summary
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Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.

Official Title
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All-extremity Exercise as a Novel Strategy for Optimizing Cardiovascular Function During Chemotherapy for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III Female 18 to 85 years of age Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane) Absence of contraindications to exercise Study clinician approval Able to give consent Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process Exclusion Criteria: Do not meet inclusion criteria Receiving targeted therapies (CDK4/6 or PARP inhibitors) Receiving radiation therapy concurrent with chemotherapy Lymphedema stage ≥ 2 prior to study enrollment Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent) Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss) Current participation in aerobic exercise training (≥150 min/week of moderate-intensity aerobic exercise)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All-extremity exercise<br> | Behavioral: Exercise training<br>* Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.<br>|
| Active Comparator: Treadmill exercise<br> | Behavioral: Exercise training<br>* Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brachial artery FMD | Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. | 12 weeks | 
| Change in global longitudinal strain | Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction. | 12 weeks | 
| Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy | To evaluate the feasibility, tolerability and safety of all-extremity exercise compared with treadmill exercise in breast cancer patients undergoing chemotherapy, we will collect comprehensive information throughout the exercise intervention: completed vs. planned exercise dose (intensity/session, min/session, sessions/week), reasons for missed/partially completed sessions or study withdrawal, adverse events, and disease- and treatment-related outcomes. To specifically evaluate safety, should an adverse event occur, plans are in place for determination and monitoring according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions. | Monitored throughout the 12 weeks of intervention |