NCT07217600招募中4 期
Efficacy and Safety of Ondansetron Orodispersible Film in Preventing Vomiting Induced by Moderately Emetogenic Risk Radiotherapy in Pediatric Patients With Malignant Tumors
Chongqing University Cancer Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月25日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy in preventing vomiting between the two groups, as per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
研究概览
简要总结
The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused by moderate emetic risk radiation in children with malignant tumor.
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
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with malignant tumors diagnosed by histopathology
- •Age range: 1-14 years old (calculated from the day of signing the informed consent form)
- •Weight >= 8Kg;
- •Lansky functional status (LPS) score >= 50 (excluding posterior fossa syndrome)
- •Be planned to undergo upper abdominal or craniospinal radiation therapy, and the upper abdominal irradiation should cover the anatomical area from the upper edge of the 11th thoracic vertebra to the lower edge of the third lumbar vertebra
- •Radiotherapy is administered once daily, and the fractional dose is 1.8Gy, except for 1.5 Gy for whole abdominal radiotherapy
- •The blood routine test must meet the following criteria: ANC >= 1.0 × 10^9/L (after discontinuation of G-CSF), PLT >= 50 × 10^9/L (without drug support or transfusion therapy), HGB >= 80g/L
- •Biochemical tests must meet the following standards: total bilirubin <= 1.5 times ULN (upper limit of normal), ALT <= 2.5 times ULN, AST <= 2.5 times ULN, alkaline phosphatase ≤ 1.5 times ULN, serum albumin >= 2.5 g/dL, BUN and CRE <= 1.5 × ULN
- •Expected survival period >= 3 months;
- •The guardian of the child understands and signs the informed consent form, has good compliance, and cooperates with follow-up.
排除标准
- •The nausea and vomiting caused by the surgery have not fully recovered if the subject has undergone a major surgery
- •The patient has symptoms of central nervous system tumors such as cerebral edema and requires intervention with adrenal cortex hormones
- •Participants who have participated in or are currently participating in other clinical studies within 4 weeks prior to the first use of the investigational drug (calculated based on the time of the last use of the investigational drug for those who have entered the follow-up period)
- •Individuals allergic to 5-HT3 receptor antagonists or other excipients
- •Joint use of apomorphine
- •Congenital QT prolongation syndrome
- •Severe gastrointestinal obstruction
- •Other observers who affect the efficacy and adverse reactions
- •Used other 5-HT3 receptor antagonists in the first 3 days of enrollment
- •According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data.
研究组 & 干预措施
group QD
Experimental
干预措施: Ondansetron orodispersible film once (Drug)
group BID
Active Comparator
干预措施: Ondansetron orodispersible film twice (Drug)
结局指标
主要结局
Efficacy in preventing vomiting between the two groups, as per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
时间窗: From the first day of radiotherapy to 7 days after the end of radiotherapy
Vomiting was divided into 5 grades according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
次要结局
- Adverse reaction rate(From the first day of radiotherapy to 7 days after the end of radiotherapy)
- The frequency of rescue treatments(From the first day of radiotherapy to 7 days after the end of radiotherapy)
研究者
Yue Xie
Deputy Director
Chongqing University Cancer Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency DepartmentSedation and AnalgesiaSide Effect of DrugNCT01477242Seoul National University Hospital266
已完成
2 期
Evaluation the efficacy of oral ondansetron on gag reflex in soft palate and palatine tonsilgag reflex.Nausea and vomitingIRCT201010254224N8Vice Chancellery for Research of Isfahan Dental College, Isfahan University of Medical Sciences88
招募中
3 期
The effect of ondansetron in patients with residual schizophreniaSchizophrenia with residual symptoms.Residual schizophreniaF20.5IRCT20120314009297N7Mazandaran University of Medical Sciences30
已完成
4 期
Ondansetron vs. Dexamethasone for Postoperative NauseaNCT06886230Hafiz Muhammad Hamza105
Unknown
4 期
Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical TrialVomiting in Infants and/or ChildrenNCT04318847Lizar Aguirre Pascasio220