Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Inflammation

Lung Neoplasms

Carcinoma

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Treatment will be carried out twice a day (once before the RT session and 8h later) during 7 weeks. Each treatment takes 30 minutes.

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.

Transcutaneous vagus nerve stimulation

Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.

Sham

Radiotherapy

Reijmen, Dra

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.

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

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.

Kom Op Tegen Kanker

Vrije Universiteit Brussel

Principal Investigator

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Fatigue

Breast Neoplasms

Lymphopenia

Neoplasms, Second Primary

Quality of Life

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

The participants under conventional radiotherapy were applied with sham taVNS at the left tragus with the power off for 30min. The intervention would last until to the end of conventional radiotherapy.

For taVNS group, the electrodes were attached to the tragus of left ear after skin preparation with an alcohol pad. The stimulation current was a single-phase rectangular pulse with the following stimulation parameters: duty circle: 60 s "on" periods and 10 s "off" periods; frequency: 30 Hz; pulse width: 200 μs; pulse amplitude of 0.5 mA to 1.5 mA; stimulation time:30 min.

the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.

Li-Na Zhao, Doctor

Wei Qin, Doctor

Patients diagnosed with breast cancer who received assisted radiotherapy were recruited and the transcutaneous auricular vagus nerve stimulation (taVNS) was applied. The aim of of study is : 1) to study whether taVNS could improve the patient's fatigue, quality of life under radiotherapy or chemotherapy; 2) to investigate the effects of taVNS on the levels of patients' lymphocyte subsets and proinflammatory cytokines.

A prospective, randomized, double-blind, parallel controlled trial was conducted. This trail is to recruit 261 patients. Patients were randomly assigned in 2:1 ratio to two groups: 1) taVNS with conventional radiotherapy(intervention group); 2)sham taVNS with conventional radiotherapy (control group). taVNS was conducted at every radiotherapy day. taVNS stimulation method: for taVNS group, the electrodes were attached to the tragus of left ear after skin preparation with an alcohol pad, the stimulation current was a single-phase rectangular pulse with the following stimulation parameters: duty circle: 60 s "on" periods and 10 s "off" periods; frequency: 30 Hz; pulse width: 200 μs; pulse amplitude of 0.5 mA to 1.5 mA; stimulation time:30 min. For staVNS group, the clip electrodes were also placed on the left tragus but with no current output. The Fatigue Scale (BFI), the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30), Pittsburgh sleep quality index (PSQI) and Hospital Anxiety and Depression Scale (HADS) assessment, lymphocyte subpopulations,level of proinflammatory factors, blood routine testing and electrocardiogram testing were performed within 2 weeks before treatment (baseline), 4 weeks after intervention, end of chemoradiation and 1 month after the end of chemoradiation; weekly blood routine testing during intervention under radiotherapy and chemotherapy; the incidence of side effects and sleep quality score were evaluated at baseline, 2 weeks and 4 weeks after the intervention, at the end of radiotherapy and chemotherapy, and 1 month after the end of radiotherapy. The number of recruited participants met the statistical requirements.

Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients

Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients' Fatigue, Quality of Life and Lymphopenia After Radiotherapy or Chemotherapy

the data will be available by the publication of articles

For fatigue degree evaluation, the Brief Fatigue Inventory (BFI) was used. The score of fatigue in two groups will be evaluated by BFI and will be compared. The scale uses the 11-point scoring method, whereby 0 points indicates no fatigue and 10 points the most severe fatigue. A higher score indicates more severe fatigue. The BFI included three fatigue severity items and six fatigue interference items. Three fatigue severity items ask patients to rate the severity of their fatigue at its "worst", "usual" and "now" during the past 24 h and another six fatigue interference items describe how much fatigue has interfered with different aspects of the patient's life during past 24 h, including general activity, mood, walking ability, normal work, relationships with other people and enjoy of life.

For depression and anxiety degree evaluation, the Hospital Anxiety and Depression Scale (HADS) was used. The HADS is a brief 14-item scale, with seven items in each of the anxiety and depression dimension scored from 0 to 3, resulting in scale scores ranging from 0 to 21.

For sleep evaluation, the Pittsburgh Sleep Quality Index (PSQI) was used. The PSQI was a 19-item self-report instrument that includes seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction.

The quality of life was evaluated by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). It included a total of 30 entries, which were divided into 15 domains; among these, there were 5 functional domains (body, role, cognition, mood, and social function), 3 symptom domains (fatigue, pain, and nausea and vomiting), 1 overall health status/quality of life area and 6 single entries (each as a domain). The higher the score for the functional domains and overall health status, the better the functional status and quality of life. The final standardized score ranges from 0 to 100, with higher scores indicating better quality of life.

Clinical and laboratory parameters, including the cell counts of white blood cell, lymphocyte, neutrophil, platelet, the value of hemoglobin, were extracted from the electronic medical record for all patients.

The levels of interleukin-6 (IL-6) was extracted from the electronic medical record for all patients.

The levels of C-reactive protein (CRP) was extracted from the electronic medical record for all patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC	NCT03553485	Lung Cancer, No...	Transcutaneous ... Sham Radiotherapy	18 Years -	Vrije Universiteit Brussel
Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients	NCT04563013	Breast Cancer Cancer, Therapy... Cancer-related ... Quality of Life	Transcutaneous ...	18 Years - 65 Years	Xidian University
Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC	NCT03553485	Lung Cancer, No...	Transcutaneous ... Sham Radiotherapy	18 Years -	Vrije Universiteit Brussel

Spots Global Cancer Trial Database for transcutaneous vagus nerve stimulation