Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cancer prognosis: inflammatory level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Cancer prognosis: inflammatory level
时间窗: 7 weeks
CRP (mg/mL)
Cancer prognosis: tumor marker
时间窗: 7 weeks
CEA (µg/mL)
Cancer prognosis: immunological factors
时间窗: 7 weeks
neutrophil count (x10³/mm³)
次要结局
- Health related Quality of Life(7 weeks)
研究者
Reijmen Eva
Principal Investigator
Vrije Universiteit Brussel