All-extremity Exercise During Breast Cancer Chemotherapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914663
• Other study ID #: IRB202100182 -N
• Secondary ID: 1R21HL152264-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: University of Florida
• Contact: Demetra Christou, PhD
• Phone: 3522941746
• Email: ddchristou[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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)
• Current participation in aerobic exercise training (=150 min/week of moderate-intensity aerobic exercise)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Integrative Cardiovasculal Physiology Laboratory, University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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