Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy
试验速览
- 阶段
- 3 期
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- no nausea rate
研究概览
简要总结
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.
详细描述
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •pathologically proved of solid malignancy
- •receive first cycle of cisplatin >= 50 mg/m2 or cyclophosphamide/doxorubicin
排除标准
- •pregnancy
- •patients with episode of vomiting within 24 hours before starting chemotherapy
- •uncontrolled brain/ CNS metastasis
- •gut obstruction
- •receive combination of moderate or high emetogenic chemotherapy during Day 2-5
- •Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone
- •currently receive olanzapine with other indication and plan to continue the drug
研究组 & 干预措施
aprepitant
aprepitant / dexamethasone/ ondansetron
干预措施: aprepitant (Drug)
olanzapine 10 mg
olanzapine 10 mg/dexamethasone/ ondansetron
干预措施: olanzapine 10 mg (Drug)
olanzapine 5 mg
olanzapine 5 mg/dexamethasone/ ondansetron
干预措施: olanzapine 5 mg (Drug)
结局指标
主要结局
no nausea rate
时间窗: Days 1-5 of chemotherapy
proportion of patients report no nausea
次要结局
- complete remission(Days 1-5 of chemotherapy)
- >= grade 3 vomiting(Days 1-5 of chemotherapy)