NCT04914663 · University of Florida
All-extremity Exercise During Breast Cancer Chemotherapy
What this study is about
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.
View original scientific description
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
BEHAVIORAL
Exercise training
Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.
Primary outcome measures
Change in brachial artery FMD
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
- 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)
Where
- Gainesville, Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2025 · Source of record for eligibility and locations