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Recruiting NCT05913713

HIIT Following Breast Cancer Chemotherapy

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 12-week Intervention Period, 12-week Observation Period.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in brachial FMD [Time frame: 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]
  • Percent completed vs. planned exercise frequency [Time frame: 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]
  • Percent completed vs. planned exercise intensity [Time frame: 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 [Time frame: Throughout the 12 weeks of supervised home-based exercise training]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Integrative Cardiovascular Physiology Laboratory, University of Florida — Gainesville

Identifiers

NCT: NCT05913713 · IRB202300460 -N · 1R21AG078995-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗