Lung Cancer, Non-small Cell
Conditions
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.
Interventions
DEVICETranscutaneous 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.
DEVICESham
Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.
RADIATIONRadiotherapy
Standard treatment for included patients
Sponsors
Kom Op Tegen Kanker
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer prognosis: tumor marker | 7 weeks | CEA (µg/mL) |
| Cancer prognosis: inflammatory level | 7 weeks | CRP (mg/mL) |
| Cancer prognosis: immunological factors | 7 weeks | neutrophil count (x10³/mm³) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related Quality of Life | 7 weeks | 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. |
Countries
Belgium
Contacts
Primary ContactReijmen, Dra
Outcome results
None listed