All-extremity Exercise During Breast Cancer Chemotherapy
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Exercise training
- Registration Number
- NCT04914663
- Lead Sponsor
- University of Florida
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 68
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treadmill exercise Exercise training - All-extremity exercise Exercise training -
- Primary Outcome Measures
Name Time Method Change in brachial artery FMD 12 weeks 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.
Change in global longitudinal strain 12 weeks 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.
Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy Monitored throughout the 12 weeks of intervention 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Integrative Cardiovasculal Physiology Laboratory, University of Florida
🇺🇸Gainesville, Florida, United States