Exercise Training for the Improvement of Immune Activity and Treatment Outcomes During Immunotherapy for Non-small Cell Lung Cancer, BOOST Trial
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- Fred Hutchinson Cancer Center
- Study ID
- NCT06983899
- Status
- Recruiting
Conditions
- Lung Non-Small Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aerobic Exercise — OTHERComplete virtual home-based aerobic interval training sessions
- Exercise Intervention — OTHERReceive stationary bike, HR monitor, BP monitor, SPO2 monitor
- Educational Intervention — OTHERReceive general healthy lifestyle guidebook
- Dual X-ray Absorptiometry — PROCEDUREUndergo DEXA
- Electronic Health Record Review — OTHERAncillary studies
- Cardiopulmonary Exercise Testing — OTHERAncillary studies
- Physical Performance Testing — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Pulmonary Function Test — PROCEDUREUndergo PFT
Study Details
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.
Key Dates
- First listed
- May 21, 2025
- Start date
- Jan 28, 2026
- Status verified
- Jun 2026
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm I (aerobic training sessions, equipment, guidebook)Patients complete virtual home-based aerobic interval training sessions with a trained exercise specialist via stationary bike over approximately 60 minutes QW during weeks 1-4, BIW during weeks 5-8, and TIW during weeks 9-24 in the absence of unacceptable toxicity. Patients also receive a stationary bike, HR monitor, BP monitor, 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.
- Active Comparator: Arm II (guidebook)Patients receive 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.
Primary Outcome Measure
Mean difference in neutrophil-to-lymphocyte ratio (NLR) [ Time Frame: Baseline (Week 1) and post-intervention (Week 26) ]
Central Contacts
- Dong-Woo Kang, PhD206-667-5188
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | Dong-Woo Kang, PhD (PRINCIPAL_INVESTIGATOR) |
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