Clinical trial · Interventional
Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
- 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)
Lung cancer (LC) remains a leading cause of death among cancers worldwide. Though radiotherapy is one of the most frequently used treatments, it increases side-effects (pain, fatigue) and inflammation, possibly leading to further tumorigenesis of surviving cancer cells. The purpose of this study is to test the effects of transcutaneous auricular VNS vagal nerve stimulation (taVNS), known to reduce inflammation, on radiotherapy-induced inflammation and other side-effects in LC patients undergoing radiotherapy. In this feasibility study 12 patients with NSCLC stage III (A/B) receiving radiotherapy will be enrolled. Our primary endpoint is the effect of vagus nerve stimulation (VNS) on inflammatory levels (such as CRP and cytokines), immunological factors (neutrophils, monocytes, lymphocytes) and the tumor marker CEA. Our secondary endpoint is the psychological well-being and quality of life of the patients during their radiotherapy treatment.
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 |
|---|---|---|---|
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Sham | Device | — | UNRESOLVED |
| Transcutaneous vagus nerve stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- taVNS
- description
- Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.
- interventionNames
- Device: Transcutaneous vagus nerve stimulation
- Radiation: Radiotherapy
- type
- SHAM_COMPARATOR
- label
- Control
- description
- Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.
- interventionNames
- Device: Sham
- Radiation: Radiotherapy
Primary outcomes (4)
- measure
- Cancer prognosis: tumor marker
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>18 years old * Patients with non-small cell lung cancer stage III (A or B) * Patients receiving radiotherapy or chemoradiotherapy * Patients with an HRV \< 70 msec Exclusion Criteria: * Patients with an active implantable medical device, such as a pacemaker, hearing aid implant or any other implanted electronic device * Patients with an implanted or wearable defibrillator. * Patients with myocardial disease * Patients with arrhythmias * Patients with an implanted metallic or electronic device in their head. * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available