Clinical trial NCT05913713: HIIT Following Breast Cancer Chemotherapy
Official title: High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-06-22
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Change in brachial FMD
timeFrame: Baseline, Following a 12-week intervention period, Following a 12-week observation period
measure: Change in cardiac function (global longitudinal strain)
timeFrame: Baseline, Following a 12-week intervention period, Following a 12-week observation period
measure: Percent completed vs. planned exercise frequency
timeFrame: Throughout the 12 weeks of supervised home-based exercise training
measure: Percent completed vs. planned exercise duration
timeFrame: Throughout the 12 weeks of supervised home-based exercise training
measure: Percent completed vs. planned exercise intensity
timeFrame: Throughout the 12 weeks of supervised home-based exercise training
measure: Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention
timeFrame: Throughout the 12 weeks of supervised home-based exercise training
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Integrative Cardiovascular Physiology Laboratory, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra Christou, PhD
role: PRINCIPAL_INVESTIGATOR
References: