Clinical trial · Interventional
Feasibility and Expansion Trial of Transcutaneous Vagus Nerve Stimulation (tVNS) for Immune-Related Fatigue in Patients Receiving Immune Checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Participants will self-administer transcutaneous vagus nerve stimulation (tVNS) at home using a non-invasive auricular stimulation device for 60 minutes per day over a 6-week period. Participants will | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transcutaneous Vagus Nerve Stimulation (tVNS)
- description
- Participants will self-administer transcutaneous vagus nerve stimulation (tVNS) at home using a non-invasive auricular stimulation device for 60 minutes per day over a 6-week period. Participants will continue standard cancer therapy, including immune checkpoint inhibitors, during the study. Study assessments will include adherence monitoring, adverse event evaluation, patient-reported outcomes, and collection of blood samples and physiologic data.
- interventionNames
- Device: Participants will self-administer transcutaneous vagus nerve stimulation (tVNS) at home using a non-invasive auricular stimulation device for 60 minutes per day over a 6-week period. Participants will
Primary outcomes (1)
- measure
- Feasibility of Daily tVNS Use
- timeFrame
- Up to 6 weeks
- description
- Feasibility will be assessed based on adherence to the prescribed tVNS regimen. Feasibility is defined as the proportion of participants who complete at least 80% of prescribed tVNS sessions over the 6-week intervention period, as measured by concordance between participant-reported use and device-recorded usage.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available