Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting---A Randomized Single Center Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of Participants Receiving HEC With Complete Response in Overall Phase
研究概览
简要总结
The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.
详细描述
Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,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
- Prevention
- 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 malignant disease
- •Accept chemotherapy for the first time
- •Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide>=1500mg/m2,adriamycin>60mg/m2,epirubicin>90mg/m2,dacarbazine，ifosfamide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)
- •Written informed consent
排除标准
- •Pregnant 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
Olanzapine regimen
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
干预措施: Olanzapine (Drug)
Olanzapine regimen
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
干预措施: Aprepitant (Drug)
Olanzapine regimen
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
干预措施: Palonosetron (Drug)
Olanzapine regimen
Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.
干预措施: Dexamethasone (Drug)
Control regimen
Aprepitant in combination with palonosetron and dexamethasone
干预措施: Aprepitant (Drug)
Control regimen
Aprepitant in combination with palonosetron and dexamethasone
干预措施: Palonosetron (Drug)
Control regimen
Aprepitant in combination with palonosetron and dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Proportion of Participants Receiving HEC With Complete Response in Overall Phase
时间窗: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants Receiving MEC With Complete Response in Overall Phase
时间窗: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
次要结局
- Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase(0 to 120 hours)
- Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase(0 to 24 hours)
- Proportion of Participants Receiving HEC With Complete Response in the Acute Phase(0 to 24 hours)
- Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase(24 to 120 hours)
- Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase(24 to 120 hours)
- Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase(24 to 120 hours)
- Proportion of Participants Receiving MEC With Complete Response in the Acute Phase(0 to 24 hours)
- Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase(0-120 hours)
- Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase(0 to 24 hours)
- Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase(24 to 120 hours)