Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Patients With Complete Response During Chemotherapy Course 1
研究概览
简要总结
Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis.
The purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.
详细描述
This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent.
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, Investigator)
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
- •First course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per square meter)
- •Written informed consent must be obtained before initiating the protocol procedures
排除标准
- •Nausea and vomiting within the past 1 day
- •Gastrointestinal obstruction
- •Concurrent use of opioid
- •Patients with brain metastases
- •History of allergic or other adverse reaction to gabapentin
研究组 & 干预措施
Control group
Placebo:
- Five and four days before chemotherapy (day -5 and day -4): 1x daily
- Three and two days before chemotherapy (day -3 and day -2): 2x daily
- One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
干预措施: Placebo (Drug)
Gabapentin
Gabapentin 300mg:
- Five and four days before chemotherapy (day -5 and day -4): 1x daily
- Three and two days before chemotherapy (day -3 and day -2): 2x daily
- One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
干预措施: Gabapentin (Drug)
结局指标
主要结局
Number of Patients With Complete Response During Chemotherapy Course 1
时间窗: 5 days
The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)
Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
时间窗: 6 days
Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy
次要结局
未报告次要终点
研究者
Felipe Melo Cruz
MsC
Faculdade de Medicina do ABC