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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Brussels, Belgien
- Rekrytering
- UZ Brussels
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Kontakt:
- Reijmen, Dra
- Telefonnummer: +32498254615
- E-post: eva.nina.reijmen@vub.be
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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 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.
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cancer prognosis: tumor marker
Tidsram: 7 weeks
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CEA (µg/mL)
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7 weeks
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Cancer prognosis: inflammatory level
Tidsram: 7 weeks
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CRP (mg/mL)
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7 weeks
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Cancer prognosis: inflammatory level
Tidsram: 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
Tidsram: 7 weeks
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neutrophil count (x10³/mm³)
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7 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Health related Quality of Life
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Reijmen, Dra, VUB
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1.0_09/01/2018
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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