Phase II Study of Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting
试验速览
- 阶段
- 2 期
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving complete control of nausea and vomiting
研究概览
简要总结
phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)
详细描述
chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy.
All patients will receive IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3.
Patients will be randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5.
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
- Double (Participant, Investigator)
盲法说明
double blinding
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
- •patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy;
- •18 years or older;
- •Eastern Cooperative Oncology Group < 2
排除标准
- •Nausea or vomiting 24h before randomization
- •aspartate aminotransferase / alanine aminotransferase above 3 times the upper limit
- •Severe cognitive compromise;
- •regular use of corticosteroids, opioid, benzodiazepines, tricyclic antidepressant, or cannabinoids within 30 days before randomization;
- •brain metastasis;
- •chronic alcoholism;
研究组 & 干预措施
Pregabalin
Pregabalin 75mg, twice a day, from the night before chemotherapy to day 5
干预措施: Pregabalin (Drug)
Placebo
Placebo, twice a day, from the night before chemotherapy to day 5
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients achieving complete control of nausea and vomiting
时间窗: five days
次要结局
未报告次要终点
研究者
Felipe Melo Cruz
PhD, Head of Medical Oncology Department
Faculdade de Medicina do ABC