HIIT Following Breast Cancer Chemotherapy

April 25, 2024 updated by: University of Florida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • Integrative Cardiovascular Physiology Laboratory, University of Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Interval Training (HIIT)
Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
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.
Behavioral: 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.
Experimental: Moderate Intensity Continuous Training (MICT)
Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
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.
Behavioral: 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.
Other: Usual Care (UC)
Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brachial FMD
Time Frame: 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.
Baseline, Following a 12-week intervention period, Following a 12-week observation period
Change in cardiac function (global longitudinal strain)
Time Frame: 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.
Baseline, Following a 12-week intervention period, Following a 12-week observation period
Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention
Time Frame: 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.
Throughout the 12 weeks of supervised home-based exercise training
Percent completed vs. planned exercise frequency
Time Frame: 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.
Throughout the 12 weeks of supervised home-based exercise training
Percent completed vs. planned exercise duration
Time Frame: 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.
Throughout the 12 weeks of supervised home-based exercise training
Percent completed vs. planned exercise intensity
Time Frame: 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.
Throughout the 12 weeks of supervised home-based exercise training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Demetra Christou, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202300460 -N
  • 1R21AG078995-01A1 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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