Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting Following High-dose Cisplatin in Nasopharyngeal Carcinoma Patients：a Randomized Phase 3 Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 主要终点
- Complete response
研究概览
简要总结
To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.
详细描述
Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant, palonosetron and dexamethasone .In the other group,patients will accept the same dose of palonosetron and dexamethasone. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years of age or older
- •Histologically or cytologically confirmed nasopharyngeal carcinoma
- •Accept chemotherapy for the first time
- •Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV)
- •Written informed consent
排除标准
- •regnant or breast-feeding
- •Uncontrolled psychosis history
- •Inability or unwillingness to understand or cooperate with study procedures
- •Central nervous system tumors primary or secondary
- •Concurrent abdominal radiotherapy
- •History of uncontrolled diabetes mellitus
- •Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
- •Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
- •Pre-existing nausea or vomiting
- •Inadequate hematological function and abnormal liver and renal function.
- •History of sensitivity to olanzapine
- •Concurrent application of quinolone antibiotic therapy
- •Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
- •Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
- •Concurrent application of systemic corticosteroids
- •Active infection or gastrointestinal dysfunction
研究组 & 干预措施
Aprepitant arm
Aprepitant+palonosetron+dexamethasone
干预措施: Aprepitant+palonosetron+dexamethasone (Drug)
Control arm
palonosetron+dexamethasone
干预措施: palonosetron+dexamethasone (Drug)
结局指标
主要结局
Complete response
时间窗: Up to 10 days
The primary endpoint is the rate of patients achieving a complete response(defined as no emetic episode and no use of rescue medication) during over all time (0 to 120 hours post chemotherapy)
次要结局
- Functional Living Index -Emesis (FLIE)(Up to 10 days)
- Acute Phase Response(0 to 24 hours post chemotherapy)
- Delayed Phase Response(>24 to 10 days post chemotherapy)
- Safety and tolerability as measured by the incidence and severity of adverse(Up to 10 days)
研究者
Ting Hu
MD
Wuhan Union Hospital, China