NCT01895010Unknown2 期
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Classification of nausea and vomiting
研究概览
简要总结
Observation on acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting and improving the patient's appetite after TACE for primary or metastatic liver cancer patients.
详细描述
- Classification of nausea and vomiting, as measured by NCI CTC-AE version 3
- The improvement of appetite, as measure by the classification of Appetite in accordance with NCI CTC-AE version 3.
- Quality of life: use M. D. Anderson symptom scale (the m. d. Anderson Symptom Inventory,MDASI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •ECOG physical status 0,1,2
- •would accept the transcatheter hepatic arterial chemoembolization of primary or metastatic liver cancer patients;
- •Adult male and female 3, age 18 years old;
- •the chem-scheme of arterial infusion chemotherapy based on oxaliplatin dosage of 200mg;
- •signed the informed consent and understand the study design;
- •Organ function examination in patients must meet the following laboratory indexes: Neutrophil>500/Ul, hemoglobin > 8 gm/dL, platelet >100000/uL,Creatinine < 2 mg/dL bilirubin < 1.5 mg/dL, , alanine aminotransferase < 3 times the normal value, albumin >30g/L
- •understand and complete quality of life scale ;
- •women of childbearing age urine pregnancy test was negative.
排除标准
- •The combined use of other venous chemotherapy within 5 days after TACE;
- •skin infection on or near the points;
- •skin hyperalgesia, unable to withstand electrical stimulation;
- •other confounding factors may cause nausea and vomiting (such as intestinal obstruction, anorexia, etc.);
- •heart, cerebrovascular accident history or the history of spinal cord injury;
- •intestinal obstruction lead to nausea and vomiting
- •installing pacemaker;
- •cognitive dysfunction, unable to finish Scale;
- •currently using acupuncture therapy.
研究组 & 干预措施
Acupoint and tropisetron
Experimental
acupoint electric stimulation combined with tropisetron 6mg before TACE
干预措施: acupoint electric stimulation (Device)
tropisetron
Active Comparator
treated with tropisetron 6mg before TACE
干预措施: tropisetron (Drug)
结局指标
主要结局
Classification of nausea and vomiting
时间窗: 12 month
次要结局
- The improvement of appetite(12 month)
研究者
zhu xiao yan
Attending doctor
Fudan University
研究点 (1)
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