Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
NCT ID: NCT03553485
Last Updated: 2019-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2018-08-08
2019-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
Radiotherapy
Standard treatment for included patients
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.
Sham
Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.
Radiotherapy
Standard treatment for included patients
Interventions
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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.
Radiotherapy
Standard treatment for included patients
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Kom Op Tegen Kanker
OTHER
Vrije Universiteit Brussel
OTHER
Responsible Party
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Reijmen Eva
Principal Investigator
Principal Investigators
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Reijmen, Dra
Role: PRINCIPAL_INVESTIGATOR
VUB
Locations
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UZ Brussels
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1.0_09/01/2018
Identifier Type: -
Identifier Source: org_study_id
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