RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 help the body's immune system attack the cancer 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.

Official Title

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

Quick Facts

Study Start:2025-07-01

Study Completion:2028-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06983899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years. * Histologically diagnosed with NSCLC. * Newly receiving immunotherapy for one to three months. * 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 0-1, indicating the ability to fulfill physical fitness and function assessments. * Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.	* 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 deem 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, 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.

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years.
* Histologically diagnosed with NSCLC.
* Newly receiving immunotherapy for one to three months.
* 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 0-1, indicating the ability to fulfill physical fitness and function assessments.
* Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

* 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 deem 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, 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.

Contacts and Locations

Study Contact

Dong-Woo Kang, PhD

CONTACT

206-675-5188

dkang@fredhutch.org

Principal Investigator

Dong-Woo Kang, PhD

PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

Dong-Woo Kang, PhD, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01

Study Completion Date2028-05-31

Study Record Updates

Study Start Date2025-07-01

Study Completion Date2028-05-31

Terms related to this study

Additional Relevant MeSH Terms

Lung Non-Small Cell Carcinoma