NCT06983899

Exercise Training for the Improvement of Immune Activity and Treatment Outcomes During Immunotherapy for Non-small Cell Lung Cancer, BOOST Trial

Boosting the Effects of Immunotherapy Through Exercise Training in Patients With Lung Cancer: The BOOST Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies how well exercise training works in improving immune activity and treatment tolerance and response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Immunotherapy may induce changes in the 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 have shown great potential in cancer therapy, not all patients benefit from this therapy and resistance to it 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.

Detailed description

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, dual-energy x-ray absorptiometry (DEXA), pulmonary function test (PFT), physical fitness and function tests, and questionnaires 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, DEXA, PFT, physical fitness and function tests, and questionnaires 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 immunotherapy.

Conditions

• Lung Non-Small Cell Carcinoma

Interventions

Type	Name	Description
OTHER	Aerobic Exercise	Complete virtual home-based aerobic interval training sessions
OTHER	Exercise Intervention	Receive stationary bike, HR monitor, BP monitor, SPO2 monitor
OTHER	Educational Intervention	Receive general healthy lifestyle guidebook
PROCEDURE	Dual X-ray Absorptiometry	Undergo DEXA
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Cardiopulmonary Exercise Testing	Ancillary studies
OTHER	Physical Performance Testing	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Pulmonary Function Test	Undergo PFT

Timeline

• Start date: 2026-01-28
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2025-05-21
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States