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

Starting soon · Not applicable

Conditions studied: Cancer-related Fatigue

In brief

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.

Key facts

Study ID

NCT07529431

Run by

University of Vermont Medical Center

People needed

13

Starts

2026-07-01

Expected to finish

2035-07-01

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Histologically confirmed advanced or metastatic solid tumor
• Receiving immune checkpoint inhibitor therapy and completed at least two cycles
• Clinically significant fatigue (FACIT-F score ≤ 34)
• ECOG performance status 0-2
• Life expectancy of at least 3 months
• Ability to provide informed consent
• Access to a smartphone or tablet

You may not qualify if…

• Current or planned chemotherapy, targeted therapy, or radiation during the 4-week intervention period.
• Have received targeted therapy in the last 2 weeks
• Have received chemotherapy or radiation therapy in the last 4 weeks
• Symptomatic brain metastases defined as active neurologic complaint (headache, blurry vision, neurologic deficits or other symptom requiring treatment with steroids)
• Long term steroid use >10 mg prednisone equivalent daily
• Active autoimmune disease requiring systemic immunosuppression
• Implanted electronic medical devices (e.g., pacemakers, defibrillators)
• History of epilepsy or vagal hypersensitivity
• Known arrhythmia or bradycardia (Baseline HR < 50 bpm)
• Open wounds or dermatologic issues at the stimulation site
• Pregnancy or breastfeeding
• Participation in other fatigue-focused intervention trials
• Severe uncontrolled psychiatric illness (PHQ-9 >20)

Full record on ClinicalTrials.gov

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