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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Brussels, Belgia
- Rekruttering
- UZ Brussels
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Ta kontakt med:
- Reijmen, Dra
- Telefonnummer: +32498254615
- E-post: eva.nina.reijmen@vub.be
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Reijmen, Dra, VUB
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1.0_09/01/2018
Plan for individuelle deltakerdata (IPD)
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