Boost immune activity and treatment response with guided interval bike exercise during immunotherapy

Boosting the Effects of Immunotherapy Through Exercise Training in Patients With Lung Cancer: The BOOST Trial

We will test if a home-based, guided interval cycling program can boost immune activity and help people with non-small cell lung cancer tolerate and respond better to immunotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fred Hutchinson Cancer Center (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06983899 on ClinicalTrials.gov

What this trial studies

Patients are randomized to either a home-based aerobic interval training program delivered virtually on a stationary bike with monitoring and equipment provided, or to a control group receiving a healthy lifestyle guidebook. The exercise program ramps from once-weekly supervised sessions to three times weekly over 24 weeks, with heart rate and safety monitoring and oversight by an exercise specialist. All participants undergo blood sampling, DEXA scans, pulmonary function tests, physical fitness and function assessments, and questionnaires to measure immune markers, fitness, body composition, and treatment tolerance. After the intervention participants are followed at week 26 and then every three months while on immunotherapy.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed non-small cell lung cancer who are already receiving immunotherapy, have ECOG performance status 0–2, plan to continue immunotherapy for at least 24 weeks, and are not already doing ≥150 minutes/week of moderate-to-vigorous aerobic exercise are ideal candidates.

Not a fit: Patients who are already meeting high levels of aerobic exercise, have unstable or uncontrolled medical conditions that make exercise unsafe, or cannot perform or monitor home cycling are unlikely to benefit from the intervention.

Why it matters

Potential benefit: If successful, the program could improve systemic immune activity, help patients better tolerate immunotherapy, and possibly increase treatment responses.

How similar studies have performed: Prior research shows exercise can boost systemic immune activity and improve fitness and quality of life in cancer patients, but combining aerobic interval training specifically with immunotherapy for NSCLC is relatively novel and has limited direct evidence to date.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 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.

Where this trial is running

Seattle, Washington

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Dong-Woo Kang, PhD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Dong-Woo Kang, PhD

Conditions Lung Non-Small Cell Carcinoma