Feasibility and Expansion Trial of Transcutaneous Vagus Nerve Stimulation (tVNS) for Immune-Relat… (NCT07529431) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility and Expansion Trial of Transcutaneous Vagus Nerve Stimulation (tVNS) for Immune-Related Fatigue in Patients Receiving Immune Checkpoint Inhibitors
13 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.