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

Vrije Universiteit Brussel

Status: Unknown

Conditions: Lung Cancer, Non-small Cell

Treatments: Device: Sham; Radiation: Radiotherapy; Device: Transcutaneous vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03553485

1.0_09/01/2018

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

taVNS

Experimental group

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.

Treatment:

Device: Transcutaneous vagus nerve stimulation

Radiation: Radiotherapy

Control

Sham Comparator group

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.

Treatment:

Device: Sham

Radiation: Radiotherapy