Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553485
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Kom Op Tegen Kanker
Information provided by (Responsible Party):
Reijmen Eva, 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.


Condition or disease Intervention/treatment Phase
Lung Cancer, Non-small Cell Device: Transcutaneous vagus nerve stimulation Device: Sham Radiation: Radiotherapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.
Device: 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




Primary Outcome Measures :
  1. Cancer prognosis: tumor marker [ Time Frame: 7 weeks ]
    CEA (µg/mL)

  2. Cancer prognosis: inflammatory level [ Time Frame: 7 weeks ]
    CRP (mg/mL)

  3. Cancer prognosis: inflammatory level [ Time Frame: 7 weeks ]
    cytokines: IL1, IL2, IL6 and IL8 (pg/mL)

  4. Cancer prognosis: immunological factors [ Time Frame: 7 weeks ]
    neutrophil count (x10³/mm³)


Secondary Outcome Measures :
  1. Health related Quality of Life [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553485


Contacts
Layout table for location contacts
Contact: Reijmen, Dra +32498254615 eva.nina.reijmen@vub.be

Locations
Layout table for location information
Belgium
UZ Brussels Recruiting
Brussels, Belgium
Contact: Reijmen, Dra    +32498254615    eva.nina.reijmen@vub.be   
Sponsors and Collaborators
Vrije Universiteit Brussel
Kom Op Tegen Kanker
Investigators
Layout table for investigator information
Principal Investigator: Reijmen, Dra VUB

Layout table for additonal information
Responsible Party: Reijmen Eva, Principal Investigator, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03553485     History of Changes
Other Study ID Numbers: 1.0_09/01/2018
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Inflammation
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms