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NCT Number: NCT05913713

HIIT 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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Cardiovascular Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

Location contact

Demetra Christou, PhD

CONTACT

[email protected]

352-294-1746

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

12-week Intervention Period

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Demetra Christou, PhD

CONTACT

[email protected]

352-294-1746

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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