All-extremity Exercise During Breast Cancer Chemotherapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Exercise training

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Demetra Christou, PhD; Phone Number: 3522941746; Email: ddchristou@ufl.edu
• Study Contact Backup: Name: Eileen Handberg; Phone Number: 352-273-9082; Email: handbem@medicine.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • Integrative Cardiovasculal Physiology Laboratory, University of Florida
      • Contact: Demetra Christou, PhD; Phone Number: 352-294-1746; Email: ddchristou@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: All-extremity exercise	Behavioral: Exercise training; Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.
Active Comparator: Treadmill exercise	Behavioral: Exercise training; Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brachial artery FMD	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.	12 weeks
Change in global longitudinal strain	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.	12 weeks
Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy	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.	Monitored throughout the 12 weeks of intervention

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Demetra Christou, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: IRB202100182 -N; 1R21HL152264-01A1 (U.S. NIH Grant/Contract); PRO00031309 (Other Identifier: University of Florida); OCR40536 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No