HIIT Following Breast Cancer Chemotherapy

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05913713
• Lead Sponsor: University of Florida

Brief Summary

Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Study Start: 2024-03-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 158

Inclusion Criteria

• female patients based on biological sex
• 18 to 85 years of age
• diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer
• completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation
• absence of contraindications to exercise or to participate in study
• study clinician approval

Exclusion Criteria

• do not meet inclusion criteria
• scheduled to receive surgery or radiation therapy during the intervention period
• 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)
• lymphedema stage ≥2 prior to study enrollment
• are pregnant
• current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in brachial FMD	Baseline, Following a 12-week intervention period, Following a 12-week observation period	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.
Percent completed vs. planned exercise duration	Throughout the 12 weeks of supervised home-based exercise training	The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Change in cardiac function (global longitudinal strain)	Baseline, Following a 12-week intervention period, Following a 12-week observation period	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.
Percent completed vs. planned exercise frequency	Throughout the 12 weeks of supervised home-based exercise training	The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Percent completed vs. planned exercise intensity	Throughout the 12 weeks of supervised home-based exercise training	The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention	Throughout the 12 weeks of supervised home-based exercise training	To evaluate safety plans are in place for determination and monitoring of adverse events 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.

Trial Locations

Locations (1)

Integrative Cardiovascular Physiology Laboratory, University of Florida; 🇺🇸 Gainesville, Florida, United States