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临床试验/NCT00528554
NCT00528554Unknown不适用

Laser Acupuncture to Alleviate Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy. A Prospective, Double-Blinded, Placebo-Controlled Clinical Trial

University Children Hospital Homburg2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年9月1日最近更新:
适应症
干预措施

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 Comparator

Active laser acupuncture

干预措施: laser acupuncture (Procedure)

B

Placebo Comparator

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))

研究者

发起方
University Children Hospital Homburg
申办方类型
Other

研究点 (2)

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