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

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Dong-Woo Kang, PhD
206-667-5188
Dong-Woo Kang, PhD (PRINCIPAL_INVESTIGATOR)

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