Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Brussels, Belgien
- Rekruttering
- UZ Brussels
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Kontakt:
- Reijmen, Dra
- Telefonnummer: +32498254615
- E-mail: eva.nina.reijmen@vub.be
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
Standard treatment for included patients
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Sham-komparator: 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.
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Standard treatment for included patients
Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cancer prognosis: tumor marker
Tidsramme: 7 weeks
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CEA (µg/mL)
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7 weeks
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Cancer prognosis: inflammatory level
Tidsramme: 7 weeks
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CRP (mg/mL)
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7 weeks
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Cancer prognosis: inflammatory level
Tidsramme: 7 weeks
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cytokines: IL1, IL2, IL6 and IL8 (pg/mL)
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7 weeks
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Cancer prognosis: immunological factors
Tidsramme: 7 weeks
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neutrophil count (x10³/mm³)
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7 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Health related Quality of Life
Tidsramme: 7 weeks
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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.
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7 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Reijmen, Dra, VUB
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1.0_09/01/2018
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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