This clinical trial studies how well exercise training works in improving immune activity and treatment response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The use of immunotherapy for the treatment of NSCLC has been rapidly increasing. Although immunotherapy has shown great potential in cancer therapy, not all patients benefit from this therapy and resistance to immunotherapy can occur. This could be due to poor immune activity. It has been shown that exercise can enhance systemic immune activity in various ways. The exercise training used in this study is aerobic interval training. Aerobic interval training increases the heart rate and the body's use of oxygen and alternates short periods of intense aerobic exercise with less intense recovery periods. This may cause biological changes which may improve immune activity and treatment response in patients with NSCLC who are receiving immunotherapy
Additional locations may be listed on ClinicalTrials.gov for NCT06983899.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Dong-Woo Kang
Phone: 206-675-5188
PRIMARY OBJECTIVE:
I. To investigate the effects of exercise on systemic immune function in patients with NSCLC receiving immunotherapy.
SECONDARY OBJECTIVES:
I. To examine the effects of exercise on blood biomarkers in patients with NSCLC receiving immunotherapy.
II. To examine the effects of exercise on physical fitness and function in patients with NSCLC receiving immunotherapy.
III. To examine the effects of exercise on patient-reported outcomes in patients with NSCLC receiving immunotherapy.
EXPLORATORY OBJECTIVE:
I. To explore the effect of exercise on immunotherapy-related adverse events (irAEs) and immunotherapy response rate during post-intervention follow-up period.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete virtual home-based aerobic interval training sessions with a trained exercise specialist via stationary bike over approximately 60 minutes once a week (QW) during weeks 1-4, twice a week (BIW) during weeks 5-8, and three times a week (TIW) during weeks 9-24 in the absence of unacceptable toxicity. Patients also receive a stationary bike, heart rate (HR) monitor, blood pressure (BP) monitor, oxygen saturation (SPO2) monitor, and a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection and dual-energy x-ray absorptiometry (DEXA) throughout the study.
ARM II: Patients receive a general healthy lifestyle guidebook for cancer patients and survivors on study. Patients also undergo blood sample collection and DEXA throughout the study.
After completion of study intervention, patients are followed up at week 26 and then every 3 months up to the completion of ICI treatment.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorDong-Woo Kang