NCT03553485

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

May 11, 2018

Last Update Submit

June 24, 2019

Conditions

Lung Cancer, Non-small Cell

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Health related Quality of Life

    7 weeks

Study Arms (2)

taVNS

EXPERIMENTAL

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 stimulationRadiation: Radiotherapy

Control

SHAM COMPARATOR

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: ShamRadiation: Radiotherapy

Interventions

Transcutaneous vagus nerve stimulationDEVICE

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.

taVNS
ShamDEVICE

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

Control
RadiotherapyRADIATION

Standard treatment for included patients

ControltaVNS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussels

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Reijmen, Dra

    VUB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reijmen, Dra

CONTACT

+32498254615eva.nina.reijmen@vub.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2018

First Posted

June 12, 2018

Study Start

August 8, 2018

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)