All-extremity Exercise During Breast Cancer Chemotherapy

NCT04914663 | Recruiting DMC

• 4 other identifiers: IRB202100182 -N1R21HL152264-01A1PRO00031309OCR40536
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

All-extremity exercise

EXPERIMENTAL

Behavioral: Exercise training

Treadmill exercise

ACTIVE COMPARATOR

Behavioral: Exercise training

Usual Care

NO INTERVENTION

Interventions

Exercise training BEHAVIORAL

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

All-extremity exercise; Treadmill exercise

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Women who will receive chemotherapy for breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
• Female
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Demetra Christou, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Demetra Christou, PhD

CONTACT

3522941746; ddchristou@ufl.edu

Eileen Handberg

CONTACT

352-273-9082; handbem@medicine.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 4, 2021
• Study Start: April 5, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)