Laser Acupuncture to Alleviate Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy. A Prospective, Double-Blinded, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- episodes of retching/vomiting per day during 1 chemotherapy course
研究概览
简要总结
To investigate whether nonthermal low level laser acupuncture has beneficial effects on nausea and vomiting in children receiving highly emetogenic chemotherapy for a malignant solid tumor. In a previous crossover study comparing needle acupuncture to no intervention in an otherwise similar setting we found beneficial effects, but this trial was not even single-blinded and therefore the results are questionable. The hypothesis is that active laser acupuncture is more effective than placebo laser acupuncture concerning episodes of retching/vomiting (primary outcome measure) and rescue antiemetic medication (secondary outcome measure) with a fix standard antiemetic medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-17,
- •Highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages)
排除标准
- •Age older than 17 years,
- •Participation in another clinical trial on supportive care
研究组 & 干预措施
A
Active laser acupuncture
干预措施: laser acupuncture (Procedure)
B
Placebo laser acupuncture
干预措施: placebo laser acupuncture (Procedure)
结局指标
主要结局
episodes of retching/vomiting per day during 1 chemotherapy course
时间窗: 1 chemotherapy course (5 days)
次要结局
- rescue antiemetic medication during 1 chemotherapy course(1 chemotherapy course (5 days))
