This clinical trial evaluates the effectiveness of a 12-week, home-based, virtually supervised exercise in improving various health outcomes among patients with lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic) undergoing immunotherapy. In lung cancer, exercise is an effective intervention to maintain/improve cardiopulmonary fitness before and after surgery and manage treatment-related symptoms and quality of life; however, the effects of exercise during lung cancer immunotherapy are unknown. High-intensity interval training (HIIT) evokes greater physiological stimuli (e.g., immune activities, cardiopulmonary conditioning) verse moderate-intensity continuous exercise (MICT); however, it is unknown which type of exercise would be more effective in lung cancer immunotherapy settings. Information gathered from this study may help researchers determine whether participating in HIIT and MICT exercise is tolerable during immunotherapy and exert health benefits among patients with lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06026111.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Christina Dieli-Conwright
Phone: 617-582-8321
PRIMARY OBJECTIVE:
I. To examine the feasibility of 12-weeks of different modes (i.e., HIIT and MICT) of virtually supervised, aerobic exercise training in patients with lung cancer undergoing immunotherapy.
SECONDARY OBJECTIVES:
I. To examine the preliminary effects of HIIT and MICT on immune parameters (i.e., immune phenotypes) in patients with lung cancer undergoing immunotherapy.
II. To examine the preliminary effects of HIIT and MICT on cardiorespiratory fitness and physical function in patients with lung cancer undergoing immunotherapy.
III. To examine the preliminary effects of HIIT and MICT on immunotherapy-related adverse events and patient-reported outcomes in patients with lung cancer undergoing immunotherapy.
EXPLORATORY OBJECTIVE:
I. To explore the biological mechanisms of exercise on cancer progression as correlative studies, including cancer-related biomarkers (e.g., metabolic and inflammatory biomarkers) and tumor markers (e.g., circulating tumor cell [CTC], alpha-fetoprotein [AFP], and cell-free deoxyribonucleic acid [DNA][cfDNA]).
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP A: Patients participate in a home-based, virtually supervised, exercise training over 60 minutes three times per week (TIW) for 12 weeks. Patients perform alternating high-intensity exercise and recovery aerobic exercise intervals on a home stationary bike. Patients also receive home-based exercise-related equipment (i.e., home stationary, bike, heart rate monitor, blood pressure monitor) on study. Patients also undergo blood sample collection during screening and post-intervention.
GROUP B: Patients participate in a home-based, virtually supervised, exercise training over 60 minutes TIW for 12 weeks. Patients perform continuous moderate-intensity exercise on a home stationary bike. Patients also receive home-based exercise-related equipment (i.e., home stationary, bike, heart rate monitor, blood pressure monitor) on study. Patients also undergo blood sample collection during screening and post-intervention.
GROUP C: Patients undergo usual care and will not participate in any of the exercise intervention components or structured exercise program during the 12 weeks. Patients may optionally participate in the HIIT exercise program upon the completion of post-intervention assessments after the initial 12 weeks. Patients also undergo blood sample collection during screening and post-intervention.
After completion of study intervention, patients are followed up using medical records until the completion of their immunotherapy.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorChristina Dieli-Conwright
