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

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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

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE August 8, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
  • Cancer prognosis: tumor marker [ Time Frame: 7 weeks ]
    CEA (µg/mL)
  • Cancer prognosis: inflammatory level [ Time Frame: 7 weeks ]
    CRP (mg/mL)
  • Cancer prognosis: inflammatory level [ Time Frame: 7 weeks ]
    cytokines: IL1, IL2, IL6 and IL8 (pg/mL)
  • Cancer prognosis: immunological factors [ Time Frame: 7 weeks ]
    neutrophil count (x10³/mm³)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03553485 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
Official Title  ICMJE Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer, Non-small Cell
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Transcutaneous vagus nerve stimulation
    • Radiation: Radiotherapy
  • 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.
    Interventions:
    • Device: Sham
    • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reijmen, Dra +32498254615 eva.nina.reijmen@vub.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553485
Other Study ID Numbers  ICMJE 1.0_09/01/2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Reijmen Eva, Vrije Universiteit Brussel
Study Sponsor  ICMJE Vrije Universiteit Brussel
Collaborators  ICMJE Kom Op Tegen Kanker
Investigators  ICMJE
Principal Investigator: Reijmen, Dra VUB
PRS Account Vrije Universiteit Brussel
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP