This clinical trial compares the effect of high-intensity interval training (HIIT) to moderate-intensity continuous training (MICT) on cardiovascular rehabilitation following chemotherapy in patients with breast cancer. Chemotherapy is an effective breast cancer treatment but can be associated with acute and long term cardiovascular toxicities leading to an increase in the risk for developing cardiovascular disease. Aerobic exercise is recommended by the National Comprehensive Cancer Network as a way to combat the adverse effects of treatment in cancer survivors, however the guidelines are not specific. Currently information concerning the frequency, intensity, duration or type of exercise to preserve or improve heart function is limited. HIIT is a type of cardiovascular exercise that alternates short periods of intense anaerobic exercise with less intense recovery periods. MICT is exercise that raises the heart rate. Participating in HIIT may improve physical function and quality of life following chemotherapy in patients with breast cancer
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05913713.
Locations matching your search criteria
United States
Florida
Gainesville
UF Health Cancer Institute - GainesvilleStatus: Active
Contact: Demetra Christou
Phone: 352-294-1715
Tampa
Moffitt Cancer CenterStatus: Approved
Contact: Mohammed Al-Jumayli
PRIMARY OBJECTIVES:
I. To investigate the short-term and prolonged effects of HIIT-all extremity non-weight-bearing exercise (ANE), MICT-ANE and usual care (UC) on endothelial function (flow-mediated dilation; FMD) assessed by high-resolution ultrasonography in women who have recently completed chemotherapy for primary non-metastatic breast cancer.
II. To investigate the durability of the endothelial effects of HIIT-ANE versus (vs.) MICT-ANE.
SECONDARY OBJECTIVES:
I. To investigate the short-term and prolonged effects of HIIT-ANE, MICT-ANE and UC on cardiac function (global longitudinal strain; GLS) assessed by speckle tracking echocardiography in women who have recently completed chemotherapy for primary non-metastatic breast cancer.
II. To investigate the durability of the cardiac effects of HIIT-ANE vs. MICT-ANE.
III. Examine the feasibility, tolerability, and safety of HIIT-ANE and MICT-ANE in this patient population.
EXPLORATORY OBJECTIVE:
I. To gain preliminary mechanistic insight on the impact of HIIT-ANE and MICT-ANE on circulating factors associated with cancer, cancer therapy and exercise including biomarkers of cardiac damage, endothelial dysfunction, inflammation, oxidative stress.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients are provided an all-extremity stationary bicycle and participate in an at-home based supervised HIIT cycling sessions over 40 minutes 3 days a week for 12 weeks. Additionally, patients wear an accelerometer to monitor activity and undergo blood sample collection, echocardiography, dual X-ray absorptiometry (DXA) scan and ultrasonography throughout study.
GROUP II: Patients are provided an all-extremity stationary bicycle and participate in an at-home based supervised MICT cycling sessions over 47 minutes 3 days a week for 12 weeks. Additionally, patients wear an accelerometer to monitor activity and undergo blood sample collection, echocardiography, DXA scan and ultrasonography throughout study.
GROUP III: Patients continue to participate in usual habitual physical activity during 12 week intervention period and 12 week observation period then may optionally participate in supervised HIIT or MICT exercise programs 3 days a week for 12 weeks after completion of all study assessments. Additionally, patients wear an accelerometer to monitor activity and undergo blood sample collection, echocardiography, DXA scan and ultrasonography throughout study.
After completion of study intervention, patients are followed up for 12 weeks observation period, then at 2 visits within 1-2 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUF Health Cancer Institute - Gainesville
Principal InvestigatorDemetra Christou