Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Complete Remission Rates in the Acute Phases
研究概览
简要总结
Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy
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
- None
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 4 to 15 years who have been diagnosed with malignant tumor through pathological examination and need to receive chemotherapy, gender is not limited;
- •Receive moderate and low grade emetic chemotherapy;
- •Patients with a score greater than 60 or higher have a life expectancy greater than 3 months;
- •The patients were enrolled voluntarily, and the family members signed the informed consent, and the family members had good compliance and accurately recorded the vomiting diary.
排除标准
- •Children allergic to 5HT3 antagonists;
- •Active infection;
- •Abnormal bone marrow function (absolute neutrophil count <1000/mm3 platelet count <100000/mm3);
- •Abnormal renal function in serum creatinine beyond the upper age limit of normal (ULN);
- •Abnormal liver function of serum aspartate aminotransferase and alanine aminotransferase, age and serum bilirubin are 1.5 times that of ULN;
- •vomiting 24 hours before chemotherapy begins;
- •Start systemic corticosteroid therapy within 72 hours prior to study drug use, or plan to receive corticosteroids as part of a chemotherapy regimen;
- •Patients with benzodiazepines or opioids
研究组 & 干预措施
Ondansetron mouth soluble film
Drug: ondansetron plus dexamethasone Ondansetron oral membrane lysis group, oral administration 30 minutes before chemotherapy, 8 mg bid for children over 12 years old, 4mg/ time for children 4-11 years old, bid; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy
干预措施: Ondansetron oral membrane (Drug)
Ondansetron tablet
Ondansetron tablet group, oral administration 30 minutes before chemotherapy, 5mg/m2 q12h po; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy
干预措施: Ondansetron oral membrane (Drug)
结局指标
主要结局
Complete Remission Rates in the Acute Phases
时间窗: up to 6 months
Complete Remission Rates in the Acute Phases
次要结局
- Complete Remission Rates in the Delayed Phases(up to 6 months)