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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, X-rays, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Patients also undergo blood sample collection, DEXA, PFT, physical fitness and function tests, and questionnaires throughout the study."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The BOOST trial tests whether exercise can help the immune system work better and improve how patients handle and respond to immunotherapy. It is for adults with non-small cell lung cancer who are receiving immunotherapy, a treatment that helps the immune system fight cancer. The exercise alternates short periods of harder activity with easier recovery periods.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • A tissue test has confirmed non-small cell lung cancer.
  • You are receiving immunotherapy and have completed at least 1 month of treatment.
  • You plan to continue immunotherapy for at least 24 weeks when you join.
  • Your ability to do daily activities meets the study's rating of 0–2, and you can complete physical fitness and movement tests.
  • You can understand the study and are willing to give consent to join.

Who can't join

  • You have done 150 minutes or more of moderate-to-hard aerobic exercise each week over the past month.
  • The study team and your cancer doctor find that unstable health problems or medicines make exercise unsafe. Examples include a heart attack within 6 months, uncontrolled heart rhythms, worsening heart failure, unstable chest pain, or severe heart valve narrowing with symptoms.
  • You have uncontrolled blood pressure of 180/110 or higher, or uncontrolled diabetes with an A1c above 10% and symptoms. A1c measures average blood sugar.
  • You have severe COPD, a long-term lung disease, that required a hospital stay in the past 3 months, or cancer in your bones with a high risk of a bone breaking soon.
  • The team finds a high risk that you cannot follow study steps, such as visits, blood tests after fasting, video exercise sessions, or using monitoring devices. Signs include 3 or more missed cancer visits without notice in 6 months, 3 or more unanswered study calls or emails, trouble following instructions, or concerns from your provider.
  • You do not speak enough English to take part in the study survey.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

WA