Status:
RECRUITING
Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 inhibi...
Detailed Description
This single-center, two-armed, pilot randomized controlled research study will assess feasibility and compare immune activities, cardiorespiratory fitness, physical function, and immunotherapy-related...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Histologically diagnosed with advanced 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06026111
Start Date
February 1 2024
End Date
December 31 2025
Last Update
January 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215