Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC

Not Applicable

• Conditions: Lung Cancer, Non-small Cell
• Interventions: Device: Sham; Device: Transcutaneous vagus nerve stimulation; Radiation: Radiotherapy

• Registration Number: NCT03553485
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-12
• Study Start: 2018-08-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-25
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
taVNS	Radiotherapy	Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.
Control	Sham	Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.
Control	Radiotherapy	Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.
taVNS	Transcutaneous vagus nerve stimulation	Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.

Primary Outcome Measures

Name	Time	Method
Cancer prognosis: inflammatory level	7 weeks	cytokines: IL1, IL2, IL6 and IL8 (pg/mL)
Cancer prognosis: immunological factors	7 weeks	neutrophil count (x10³/mm³)
Cancer prognosis: tumor marker	7 weeks	CEA (µg/mL)

Secondary Outcome Measures

Name	Time	Method
Health related Quality of Life	7 weeks	To assess the psychological well-being and quality of life of the patients during their radiotherapy treatment the EORTC QLQ-C30 questionnaire will be used.

Trial Locations

Locations (1)

UZ Brussels; 🇧🇪 Brussels, Belgium