Spots Global Cancer Trial Database for Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC

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Trial Identification

Brief Title: Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC

Official Title: Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer

Study ID: NCT03553485

Conditions

Lung Cancer, Non-small Cell

Interventions

Transcutaneous vagus nerve stimulation

Sham

Radiotherapy

Study Description

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.

Detailed Description: