This clinical trial compares a prescribed home-based high intensity interval training program with counseling about the benefit of physical activity for the reduction of treatment-related cardiotoxicity in patients with ovarian cancer receiving chemotherapy. While standard treatment is effective at dealing with cancer status, there are side effects such as reduced quality of life, increased risk of cardiovascular disease including heart failure and stroke, that are associated with treatment and exercise may lessen these effects. High intensity interval training during chemotherapy may reduce treatment-related cardiotoxicity and improve the well-being and quality of life of patients with ovarian cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05029154.
PRIMARY OBJECTIVE:
I. To estimate the potential impact of a prescribed home-based high intensity interval training program on cardiorespiratory fitness.
SECONDARY OBJECTIVES:
I. To estimate the potential impact of a prescribed home-based high intensity interval training program on cardiovascular function.
II. To estimate the potential impact of a prescribed home-based high intensity interval training program on serum cardiovascular and cancer risk markers.
III. To estimate the potential impact of a prescribed home-based high intensity interval training program on body composition.
IV. To estimate the potential impact of a prescribed home-based high intensity interval training program on quality of life and disease specific and neuropathy specific quality of life.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo high intensity interval exercise (HIIE) over 40 minutes 3 days per week during standard of care (SOC) chemotherapy treatment. Patients' activity is tracked on a Fitbit device.
ARM B: Patients undergo counseling regarding the benefits of physical activity during SOC chemotherapy treatment and are encouraged to exercise over 30 minutes daily and to increase daily step counts by 250-500 steps/day. Patients' activity is tracked on a Fitbit device.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorSiddhartha S. Angadi