Exercise Training for the Improvement of Immune Activity and Treatment Outcomes During Immunotherapy for Non-small Cell Lung Cancer, BOOST Trial
NCT ID: NCT06983899
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-23
2028-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Aerobic Exercise
Complete virtual home-based aerobic interval training sessions
Exercise Intervention
Receive stationary bike, HR monitor, BP monitor, SPO2 monitor
Educational Intervention
Receive general healthy lifestyle guidebook
Dual X-ray Absorptiometry
Undergo DEXA
Electronic Health Record Review
Ancillary studies
Cardiopulmonary Exercise Testing
Ancillary studies
Physical Performance Testing
Ancillary studies
Questionnaire Administration
Ancillary studies
Biospecimen Collection
Undergo blood sample collection
Pulmonary Function Test
Undergo PFT
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.
Educational Intervention
Receive general healthy lifestyle guidebook
Dual X-ray Absorptiometry
Undergo DEXA
Electronic Health Record Review
Ancillary studies
Cardiopulmonary Exercise Testing
Ancillary studies
Physical Performance Testing
Ancillary studies
Questionnaire Administration
Ancillary studies
Biospecimen Collection
Undergo blood sample collection
Pulmonary Function Test
Undergo PFT
Interventions
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Aerobic Exercise
Complete virtual home-based aerobic interval training sessions
Exercise Intervention
Receive stationary bike, HR monitor, BP monitor, SPO2 monitor
Educational Intervention
Receive general healthy lifestyle guidebook
Dual X-ray Absorptiometry
Undergo DEXA
Electronic Health Record Review
Ancillary studies
Cardiopulmonary Exercise Testing
Ancillary studies
Physical Performance Testing
Ancillary studies
Questionnaire Administration
Ancillary studies
Biospecimen Collection
Undergo blood sample collection
Pulmonary Function Test
Undergo PFT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically diagnosed with NSCLC.
* Currently receiving immunotherapy with a minimum of one month of treatment completed.
* Having a plan to continue immunotherapy for at least 24 weeks (i.e., study intervention period) at the time of recruitment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.
* Able to understand and willingness to provide study consent.
Exclusion Criteria
* Having medical conditions clinically unstable or uncontrollable, with medications that are deemed high-risk for exercise participation by the study team in consultation with the treating oncologist, using the electric medical record (EMR) and Physical Activity Readiness Questionnaire (PAR-Q). This includes but is not limited to: recent (\< 6 months) myocardial infarction, uncontrolled arrhythmias, decompensated heart failure, unstable angina, symptomatic severe aortic stenosis, uncontrolled hypertension (≥ 180/110 mmHg), uncontrolled diabetes (hemoglobin A1c \[HbA1c\] \> 10% with symptoms), severe chronic obstructive pulmonary disease requiring hospitalization in past 3 months, and bone metastases with imminent fracture risk. These exclusions are based on the American College of Sports Medicine (ACSM)'s Guidelines for Exercise Testing and Prescription and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR)'s Guidelines for Cardiac Rehabilitation Programs for safe exercise in clinical populations.
* Having a high risk for noncompliance with study procedures, including but not limited to: informed consent, participation in outcome assessments, completion of fasting blood draws, attendance at scheduled sessions, adherence to supervised virtual exercise sessions, and appropriate use of provided monitoring equipment (e.g., heart rate monitor, blood pressure monitor, SpO2 monitor). This determination will be based on a composite assessment of the following factors: history of missed oncology appointments (i.e., three or more uninformed no-shows in the prior six months) and poor responsiveness to study communications (i.e., three or more repeated unreturned calls or emails during the recruitment stage). We will also consider any demonstrated difficulty following instructions during initial scheduling or onboarding, or clinical concern raised by the referring provider. Participants meeting one or more of these criteria likely to impair participation will be considered ineligible.
* Patients who are non-English speaking that would prevent their participation in the participant survey.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dong-Woo Kang, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Dong-Woo Kang, PhD
Role: primary
Other Identifiers
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NCI-2025-02781
Identifier Type: REGISTRY
Identifier Source: secondary_id
20819
Identifier Type: OTHER
Identifier Source: secondary_id
RG1125289
Identifier Type: -
Identifier Source: org_study_id