RecruitingNot ApplicableNCT06026111

Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial

Sponsor

Dana-Farber Cancer Institute

Enrollment

30 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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:

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria4

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.