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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer, Non-small Cell
• Intervention / Treatment: Device: Transcutaneous vagus nerve stimulation; Radiation: Radiotherapy; Device: Sham

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • UZ Brussels
    • Contact: Reijmen, Dra; Phone Number: +32498254615; Email: eva.nina.reijmen@vub.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taVNS; Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.	Device: Transcutaneous vagus nerve stimulation; The transcutaneous auricular vagus nerve stimulator Parasym consists of a stimulation unit and a dedicated ear electrode. The stimulation unit, having approximately the size of a common mobile phone, sends out the electrical impulses. It is connected with the ear electrode, which patients wear like an earphone. The patient can regulate and adapt the intensity of the stimulation (current intensity) according to his/her individual sensitivity, which can vary from day to day or even over the period of the therapy.; Radiation: Radiotherapy; Standard treatment for included patients
Sham Comparator: Control; Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.	Radiation: Radiotherapy; Standard treatment for included patients; Device: Sham; Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer prognosis: tumor marker	CEA (µg/mL)	7 weeks
Cancer prognosis: inflammatory level	CRP (mg/mL)	7 weeks
Cancer prognosis: inflammatory level	cytokines: IL1, IL2, IL6 and IL8 (pg/mL)	7 weeks
Cancer prognosis: immunological factors	neutrophil count (x10³/mm³)	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related Quality of Life	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.	7 weeks

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: Kom Op Tegen Kanker
• Investigators: Principal Investigator: Reijmen, Dra, VUB

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Inflammation
• Other Study ID Numbers: 1.0_09/01/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No