Boosting the Effects of Immunotherapy Through Exercise Training in Patients With Lung Cancer: The BOOST Trial
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.
Arms & interventions
- OtherAerobic Exercise
Complete virtual home-based aerobic interval training sessions
- OtherExercise Intervention
Receive stationary bike, HR monitor, BP monitor, SPO2 monitor
- OtherEducational Intervention
Receive general healthy lifestyle guidebook
- ProcedureDual X-ray Absorptiometry
Undergo DEXA
- OtherElectronic Health Record Review
Ancillary studies
- OtherCardiopulmonary Exercise Testing
Ancillary studies
- OtherPhysical Performance Testing
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedurePulmonary Function Test
Undergo PFT
Outcome measures
Primary
Mean difference in neutrophil-to-lymphocyte ratio (NLR)
The primary analysis will follow an intention-to-treat approach, using a two-sample t-test to compare changes in NLR from baseline between the groups.
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Secondary
Mean difference in immune parameters
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in inflammatory cytokines
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in fasting glucose (mg/dL)
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in insulin (µIU/mL)
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in lipid profile
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in circulating tumor markers
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body weight (kg), assessed via weight scale
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body mass index (BMI) (kg/m²), calculated from height and weight
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in lean mass (kg), assessed via DEXA
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body fat percentage (%), assessed via DEXA
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in body fat mass (kg), assessed via DEXA
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV (L), assessed via spirometry
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV1 (L), derived from FEV1
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean change in FEV1/FEV, derived from FEV and FEV1A
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in cardiopulmonary fitness
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in timed balance
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in gait speed
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in chair stand
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in health-related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in lung cancer-related quality of life
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in immunotherapy-related symptoms
Time frame: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Mean difference in symptomatic treatment toxicity
Time frame: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Mean difference in anxiety and depression
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in sleep quality
Time frame: Baseline (Week 1) and post-intervention (Week 26)
Mean difference in exercise behavior
Time frame: Baseline (Week 1), mid-point (Week 13), post-intervention (Week 26), and every three months post-intervention up to the completion of immunotherapy.
Eligibility criteria
Study locations (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109