Clinical Trial

Feasibility and Expansion Trial of Transcutaneous Vagus Nerve Stimulation (tVNS) for Immune-Related Fatigue in Patients Receiving Immune Checkpoint Inhibitors

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Summary
This study evaluates whether a non-invasive device called transcutaneous vagus nerve stimulation (tVNS) can be safely and feasibly used to help reduce fatigue in patients receiving immunotherapy for cancer. Fatigue is a common and often severe side effect of immune checkpoint inhibitors, and there are currently limited effective treatment options. In this study, participants will use a small device at home that delivers mild electrical stimulation to the ear for 60 minutes each day over a 6-week period. The study will assess whether patients are able to use the device as prescribed (feasibility), how well it is tolerated, and whether it may improve fatigue and quality of life. The study will also explore changes in biological markers of inflammation and measures of nervous system function to better understand how tVNS may work. The results of this study will help determine whether this approach should be tested in larger future trials.
Trial Details
NCT Number NCT07529431
Lead Sponsor University of Vermont Medical Center
Conditions Cancer-related Fatigue
Enrollment 13 participants
Start Date 2026-07-01
Primary Completion 2030-07-01 (estimated)
Study Completion 2035-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-14