NCT06026111 Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
| NCT ID | NCT06026111 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to examine the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors. The names of the study interventions involved in this study are: * High-intensity interval training (HIIT) * Moderate-intensity continuous training (MICT) * Usual care (UC)
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years. * Histologically diagnosed with non-small cell lung cancer (NSCLC). * Having been receiving immunotherapy 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.
Contact & Investigator
Christina Dieli-Conwright, PhD, MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06026111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06026111 currently recruiting?
Yes, NCT06026111 is actively recruiting participants. Contact the research team at christinam_dieli-conwright@dfci.harvard.edu for enrollment information.
Where is the NCT06026111 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06026111 clinical trial?
NCT06026111 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Christina Dieli-Conwright, PhD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 30 participants.
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