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.
Conditions:
🦠 Breast Cancer
🗓️ Study Start (Actual) 7 March 2024
🗓️ Primary Completion (Estimated) 31 May 2026
✅ Study Completion (Estimated) 31 May 2026
👥 Enrollment (Estimated) 158
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Gainesville, Florida, United States

📋 Eligibility Criteria

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 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)
    • * consistent participation over the past 6 months in moderate-intensity aerobic exercise training for ≥150 min/week
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 13 June 2023
  • First Submitted that Met QC Criteria 13 June 2023
  • First Posted 22 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified July 2024