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NCT Number: NCT04914663

All-extremity Exercise During Breast Cancer Chemotherapy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

Location contact

Demetra Christou, PhD

CONTACT

[email protected]

352-294-1746

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise Training

Behavioral

Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Demetra Christou, PhD

CONTACT

[email protected]

3522941746

Eileen Handberg

CONTACT

[email protected]

352-273-9082

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2021
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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