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Exercise During Breast Cancer Chemotherapy

This study is looking at whether a special exercise program can help protect the heart of women with breast cancer (stages I-III) who are receiving chemotherapy. The exercise training is done at home with remote supervision over 12 weeks. Researchers want to see if this exercise can improve how blood vessels work (brachial artery FMD) and how well the heart pumps (global longitudinal strain). They will also check if the exercise program is practical, well-tolerated, and safe. You may be able to join if you are a woman between 18 and 85 years old, have primary invasive non-metastatic breast cancer, and are about to start certain types of chemotherapy (anthracycline, alkylating agent, and/or taxane). The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 68 women. It is not specified if it is randomized or blinded.
What's involved
You would participate in a 12-week exercise training program performed at home under remote live supervision while undergoing chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Changes in heart and blood vessel function will be measured at 12 weeks. Safety and tolerability will be monitored throughout the 12 weeks of intervention.

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NCT04914663

All-extremity Exercise During Breast Cancer Chemotherapy

Recruiting
NAAges 18–85InterventionalPrevention
University of Florida
~68 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:Exercise training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in brachial artery FMD
Measured over 12 weeks
+2 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Demetra Christou, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Demetra Christou, PhD
[email protected]
3522941746
Email the study team

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Eligibility criteria

Inclusion

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
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)

What this trial measures

  • Change in brachial artery FMD12 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 strain12 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 chemotherapyMonitored 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.