This trial studies how well cardiac rehabilitation exercise program works for the improvement of heart-related side effects in patients with thoracic cancers receiving standard of care radiation therapy. One of the side effects of radiation to the chest can be radiation-induced heart disease, or specific heart problems such as narrowing of the arteries, heart attack, fluid around the heart, inflammation of the heart, heart muscle disease, and irregular heartbeat. Aerobic exercise may positively affect heart health in patients with thoracic cancers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04072393.
PRIMARY OBJECTIVE:
I. To determine the feasibility of completing home-based cardiac rehabilitation (CR) after definitive radiation therapy in patients with thoracic cancer who have started the CR program.
SECONDARY OBJECTIVE:
I. To determine the feasibility of home-based CR in all enrolled patients after definitive radiation therapy in patients with thoracic cancer.
EXPLORATORY OBJECTIVES:
I. To determine rates of hospital admission up to 6 months following completion of radiation therapy (RT) in patients undergoing home-based CR.
II. To explore tolerability of home-based CR based on type of cancer and stage of cancer.
III. To determine the effect of radiation therapy and CR on cardiorespiratory fitness as measured by 6 minute walk test.
IV. To determine the effect of radiation therapy and CR on muscle strength as measured by Biodex isokinetic testing.
V. To determine the effect of radiation therapy and CR on plasma ceramide species.
VI. To assess patient-reported quality of life outcomes in patients undergoing CR after definitive radiation therapy.
VII. To evaluate whether serum inflammatory markers/other biomarkers levels pre-and post-treatment are prognostic and/or correlate with development of toxicities and/or dose to targets and organs at risk and other patient characteristics.
OUTLINE:
Within 6 weeks of completion of standard of care radiation therapy or cytotoxic chemotherapy (whichever is last), patients complete a home-based cardiac rehabilitation program consisting of 36 exercise sessions, 3 times a week, 1 hour each, over a period of 12 weeks.
After completion of study treatment, patients are followed up at 0-4 weeks and 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorCarmen R. Bergom
