Breast Cancer
Conditions
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.
Interventions
BEHAVIORALExercise training
Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactDemetra Christou, PhD
Backup ContactEileen Handberg
Outcome results
None listed