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

NCT06983899 | Recruiting

• 4 other identifiers: RG1125289NCI-2025-0278120819R00CA287050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 1) and post-intervention (Week 26)

Secondary Outcomes (25)

• Mean difference in immune parameters

  Baseline (Week 1) and post-intervention (Week 26)

• Mean difference in inflammatory cytokines

  Baseline (Week 1) and post-intervention (Week 26)

• Mean change in fasting glucose (mg/dL)

  Baseline (Week 1) and post-intervention (Week 26)

• Mean change in insulin (µIU/mL)

  Baseline (Week 1) and post-intervention (Week 26)

• Mean change in lipid profile

  Baseline (Week 1) and post-intervention (Week 26)

Study Arms (2)

Arm I (aerobic training sessions, equipment, guidebook)

EXPERIMENTAL

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.

Other: Aerobic Exercise; Other: Exercise Intervention; Other: Educational Intervention; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing; Other: Physical Performance Testing; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Procedure: Pulmonary Function Test

Arm II (guidebook)

ACTIVE COMPARATOR

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.

Other: Educational Intervention; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing; Other: Physical Performance Testing; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Procedure: Pulmonary Function Test

Interventions

Aerobic Exercise OTHER

Complete virtual home-based aerobic interval training sessions

Also known as: Aerobic Activity

Arm I (aerobic training sessions, equipment, guidebook)

Exercise Intervention OTHER

Receive stationary bike, HR monitor, BP monitor, SPO2 monitor

Arm I (aerobic training sessions, equipment, guidebook)

Educational Intervention OTHER

Receive general healthy lifestyle guidebook

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Dual X-ray Absorptiometry PROCEDURE

Undergo DEXA

Also known as: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Cardiopulmonary Exercise Testing OTHER

Ancillary studies

Also known as: CPET, CPX

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Questionnaire Administration OTHER

Ancillary studies

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Pulmonary Function Test PROCEDURE

Undergo PFT

Also known as: PFT

Arm I (aerobic training sessions, equipment, guidebook); Arm II (guidebook)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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.

You may not qualify if:

• Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.
• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Exercise; Early Intervention, Educational; Educational Status; Methods; Absorptiometry, Photon; Bone Density; Exercise Test; Clostridium perfringens epsilon-toxin; Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Dong-Woo Kang, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Woo Kang, PhD

CONTACT

206-667-5188; dkang@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 21, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)