NCT02454777

High-Intensity Interval Training for Stage I-III Breast Cancer Patients

High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot clinical trial studies the feasibility of high-intensity interval training in improving cardiovascular fitness in patients with stage I-III breast cancer undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may cause side effects to the heart. Aerobic exercise may help the heart function better, which may help protect it against side effects from trastuzumab. Exercise may also help reduce fatigue and prevent cancer from coming back. High-intensity interval training involves short bursts of higher intensity efforts with longer periods of recovery. This may also allow patients who cannot exercise for a long period of time to still be physically active. This trial studies whether patients can tolerate high-intensity interval training, and how well it works in improving fitness in patients with breast cancer receiving trastuzumab.

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility (completion of \> 80% exercise sessions) of utilizing high-intensity interval training (HIT). II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed group. III. To examine the effects of HIT on left ventricular function when compared to delayed group. IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular atherosclerosis when compared to delayed group. OUTLINE: Participants are randomized to 1 of 2 groups. ARM I: HIT (High-intensity Interval Training) group - Participants undergo HIT over 30 minutes, thrice weekly for 8 weeks. ARM II: DEL (Delayed/usual care) group - Participants maintain their current sedentary activity level (\< 60 minutes of total exercise per week) for 8 weeks. Participants document their weekly activity in an exercise log. Following completion of all study visits, participants are given the option to complete the HIT exercise program as in Arm I. After completion of study, patients are followed up at weeks 9 and 17.

Conditions

• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	Undergo HIT
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-09-29
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2015-05-27
• Last updated: 2021-04-05

Locations

1 site across 1 country: United States