HIIT Following Breast Cancer Chemotherapy

Breast Cancer Clinical Trial

Official title:

High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913713
• Other study ID #: IRB202300460 -N
• Secondary ID: 1R21AG078995-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: University of Florida
• Contact: Demetra Christou, PhD
• Phone: 352-294-1746
• Email: ddchristou[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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 12 months prior to study enrollment
• absence of contraindications to exercise or to participate in study
• study clinician approval

Exclusion Criteria:

• do not meet inclusion criteria
• completed chemotherapy and/or other cancer treatment (i.e., surgery or radiation) within past 6 months. 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
• scheduled to receive surgery, radiation therapy, or chemotherapy during the study period. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed during study participation.
• 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)
• are pregnant
• current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
• consistent participation over the past 6 months in moderate-intensity aerobic exercise training for =150 min/week

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 12-week Intervention Period
Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.
• 12-week Observation Period
After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brachial 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.	Baseline, Following a 12-week intervention period, Following a 12-week observation period
Primary	Change in cardiac function (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.	Baseline, Following a 12-week intervention period, Following a 12-week observation period
Primary	Percent completed vs. planned exercise frequency	The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.	Throughout the 12 weeks of supervised home-based exercise training
Primary	Percent completed vs. planned exercise duration	The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.	Throughout the 12 weeks of supervised home-based exercise training
Primary	Percent completed vs. planned exercise intensity	The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.	Throughout the 12 weeks of supervised home-based exercise training
Primary	Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention	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.	Throughout the 12 weeks of supervised home-based exercise training