Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Vrije Universiteit Brussel
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Cancer prognosis: tumor marker
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Transcutaneous vagus nerve stimulation (Device)
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.
Intervention: Radiotherapy (Radiation)
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.
Intervention: Sham (Device)
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.
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Cancer prognosis: tumor marker
Time Frame: 7 weeks
CEA (µg/mL)
Cancer prognosis: immunological factors
Time Frame: 7 weeks
neutrophil count (x10³/mm³)
Cancer prognosis: inflammatory level
Time Frame: 7 weeks
CRP (mg/mL)
Secondary Outcomes
- Health related Quality of Life(7 weeks)
Investigators
Reijmen Eva
Principal Investigator
Vrije Universiteit Brussel