Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 主要终点
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea
研究概览
简要总结
The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.
详细描述
This study was designed to evaluate efficacy and safety of olanzapine compared with 5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •no severe cognitive compromise
- •Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
- •Confirmed histology
排除标准
- •European Cooperative Oncology Group (ECOG) performance status of 3 and 4
- •Nausea or vomiting in the 24 hours before enrollment
- •History of Nausea or vomiting Grade 3 before previous chemotherapy
- •Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
- •Bowel obstruction
- •Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more
- •Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range
- •Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment
- •Treatment with another antiemetic agent before 48 hours before enrollment
- •Uncontrolled severe infection or uncontrolled severe comorbidity
- •Concurrent abdominal radiotherapy
- •Known hypersensitivity to olanzapine, palonosetron
- •Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month
研究组 & 干预措施
Olanzapine group
Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group
干预措施: Olanzapine (Drug)
Olanzapine group
Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group
干预措施: Palonosetron (Drug)
结局指标
主要结局
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea
时间窗: the overall assessment period (0 to 72 hours)
次要结局
- Quality of life was evaluated according to MDASI-K(the overall assessment period (0 to 72 hours))
研究者
Hee Jun Kim
Associate Professor,Division of Hemato-oncology
Chung-Ang University Hosptial, Chung-Ang University College of Medicine