The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The scores of Rhodes Index of Nausea, Vomiting and Retching.
研究概览
简要总结
The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy;
- •Right-handed and aged 18 to 75 years;
- •Karnosky performance status (KPS) ≥ 70;
- •Life expectancy ≥ 6 months.
排除标准
- •Had brain metastases or other concurrent life-threatening diseases;
- •Nausea and/or vomiting were present 24h before chemotherapy treatment;
- •Suffered from or had a history of gastrointestinal diseases;
- •Had a history of head trauma, serious neurological or psychiatric disorders;
- •Participating in other clinical trials currently;
- •Had any contraindication to exposure to a high magnetic field or receive acupuncture
研究组 & 干预措施
Waitinglist control
In this group, patients received no electroacupuncture
Acupuncture 1
In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy.
干预措施: acupuncture (Huatuo) (Device)
Acupuncture 2
In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy.
干预措施: acupuncture (Huatuo) (Device)
Sham acupuncture
In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy.
干预措施: acupuncture (Huatuo) (Device)
结局指标
主要结局
The scores of Rhodes Index of Nausea, Vomiting and Retching.
时间窗: 24 hours
次要结局
- Content of 5-hiaa in urine(12 hours)
- Heart Rate Variability(1 hour)
- Tachygastria percentage(1 hour)
- Dosage of antiemetic drugs(24 hours)