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Trial Title:
HIIT Following Breast Cancer Chemotherapy
NCT ID:
NCT05913713
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
12-week Intervention Period
Description:
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.
Arm group label:
High Intensity Interval Training (HIIT)
Arm group label:
Moderate Intensity Continuous Training (MICT)
Arm group label:
Usual Care (UC)
Intervention type:
Behavioral
Intervention name:
12-week Observation Period
Description:
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.
Arm group label:
High Intensity Interval Training (HIIT)
Arm group label:
Moderate Intensity Continuous Training (MICT)
Arm group label:
Usual Care (UC)
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.
Criteria for 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)
Gender:
Female
Gender based:
Yes
Gender description:
Women who received chemotherapy for breast cancer
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Integrative Cardiovascular Physiology Laboratory, University of Florida
Address:
City:
Gainesville
Zip:
32611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Demetra Christou, PhD
Phone:
352-294-1746
Email:
ddchristou@ufl.edu
Start date:
March 7, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
University of Florida
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Source:
University of Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05913713
