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

Lung Cancer, Non-small Cell Clinical Trial

Official title:

Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553485
• Other study ID #: 1.0_09/01/2018
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: December 2019

Study information

• Verified date: June 2019
• Source: Vrije Universiteit Brussel
• Contact: Reijmen, Dra
• Phone: +32498254615
• Email: eva.nina.reijmen[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Inflammation
• Lung Cancer, Non-small Cell
• Lung Neoplasms

Intervention

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.
• Sham
Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.

Radiation:
• Radiotherapy
Standard treatment for included patients

Locations

Country	Name	City	State
Belgium	UZ Brussels	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Kom Op Tegen Kanker

Country where clinical trial is conducted

Belgium, 

Outcome

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