Examining exercise training effects during immunotherapy in lung cancer patients
Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
This study is testing whether a 12-week exercise program can help people with advanced lung cancer feel better while they are receiving immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06026111 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial investigates the feasibility and effects of a 12-week exercise training program at varying intensities for patients with advanced lung cancer undergoing immune checkpoint inhibitor therapy. Participants will be randomly assigned to one of three groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or usual care. The study aims to compare immune activities, cardiorespiratory fitness, physical function, immunotherapy-related adverse events, and patient-reported outcomes among the groups. The exercise interventions will be conducted virtually, with participants engaging in three sessions per week for the duration of the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced non-small cell lung cancer receiving anti-PD-1 or anti-PD-L1 therapy.
Not a fit: Patients who regularly engage in more than 60 minutes of moderate-to-vigorous aerobic exercise per week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the physical fitness and immune response of lung cancer patients undergoing immunotherapy.
How similar studies have performed: Other studies have shown promising results with exercise interventions in cancer patients, suggesting potential benefits of this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Histologically diagnosed with non-small cell lung cancer (NSCLC). * Having been receiving anti-PD-1 or anti-PD-L1 antibodies (i.e., single agent or combination) for at least one month with a plan to continue for at least 12 weeks prospectively at the time of recruitment. * Medical clearance to perform exercise intervention and testing by their treating oncologist. * No uncontrolled medical conditions that could be exacerbated with exercise (e.g., uncontrolled hypertension or diabetes). * Ability to communicate and complete written forms in English. * Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. * Ability to understand and the willingness to sign informed consent prior to any study-related procedures. * Willing to travel to DFCI for necessary data collection. Exclusion Criteria: * Participate in more than 60 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. * Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. * Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. * Development of second malignancy (except for basal cell carcinoma or squamous cell carcinoma of the skin) that requires concurrent treatment, which would interfere with this study.
Where this trial is running
Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, PhD, MPH
- Email: christinam_dieli-conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.