HIIT Following Breast Cancer Chemotherapy

NCT05913713 | Recruiting DMC

• 2 other identifiers: IRB202300460 -N1R21AG078995-01A1
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

High Intensity Interval Training (HIIT)

EXPERIMENTAL

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; Behavioral: 12-week Observation Period

Moderate Intensity Continuous Training (MICT)

EXPERIMENTAL

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; Behavioral: 12-week Observation Period

Usual Care (UC)

OTHER

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; Behavioral: 12-week Observation Period

Interventions

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.

High Intensity Interval Training (HIIT); Moderate Intensity Continuous Training (MICT); Usual Care (UC)

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.

High Intensity Interval Training (HIIT); Moderate Intensity Continuous Training (MICT); Usual Care (UC)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Women who received chemotherapy for breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients based on biological sex
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Integrative Cardiovascular Physiology Laboratory, University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Demetra Christou, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Demetra Christou, PhD

CONTACT

352-294-1746; ddchristou@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: March 7, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)