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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic Exercise

    Other intervention

    Complete virtual home-based aerobic interval training sessions

  • Exercise Intervention

    Other intervention

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

  • Educational Intervention

    Other intervention

    Receive general healthy lifestyle guidebook

  • Dual X-ray Absorptiometry

    Procedure/Surgery

    Undergo DEXA

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Cardiopulmonary Exercise Testing

    Other intervention

    Ancillary studies

  • Physical Performance Testing

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Pulmonary Function Test

    Procedure/Surgery

    Undergo PFT

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Arm I (aerobic training sessions, equipment, guidebook)Experimental treatment 10 interventions
Group B: Arm II (guidebook)Active comparator 8 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Mean difference in immune parameters

To analyze changes in immune parameters (e.g., T-cells, natural killer cells, B-cells) a two-sample t-test will compare changes between the groups.

Time frame
Baseline (Week 1) and post-intervention (Week 26)
2

Mean difference in inflammatory cytokines

To analyze changes in inflammatory cytokines (e.g., IL-6, IL-15) a two-sample t-test will compare changes between the groups.

Time frame
Baseline (Week 1) and post-intervention (Week 26)
3

Mean change in fasting glucose (mg/dL)

Time frame
Baseline (Week 1) and post-intervention (Week 26)
4

Mean change in insulin (µIU/mL)

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

Other outcomes

Sponsors and contacts

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Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator