Olanzapine versus Aprepitant for prevention of chemotherapy induced nausea and vomiting in children receiving highly emetogenic chemotherapy: A Randomized Open Label Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- To compare the efficacy of olanzapine versus aprepitant when combined with ondansetron and dexamethasone in control of chemotherapy induced vomiting for the acute period
研究概览
简要总结
Chemotherapy induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. In current practice, pediatric patients receiving highly emetogenic chemotherapy are recommended to receive triple regimen prophylaxis with Neurokinin 1 receptor antagonist, dexamethasone and 5 HT3 receptor antagonist for prevention of CINV. Compared to aprepitant the cost and drug interaction profile of olanzapine is minimal with equivalent efficacy for CINV control as noted in adult population studies. Recent research establishes safety and efficacy of olanzapine for CINV control in pediatric population. To the best of our knowledge, there are no prospective studies in children comparing the efficacy of olanzapine versus aprepitant for CINV prophylaxis.
Thus, our research hypothesis is that among pediatric patients with cancer 3 to 18 years age who receive highly emetogenic chemotherapy, olanzapine combined with dexamethasone and ondansetron is non inferior as compared to aprepitant with dexamethasone and ondansetron for chemotherapy induced nausea and vomiting control. This would provide us with a cheaper alternative and comparable efficacy in CINV prophylaxis.
This will be a randomized, open label non inferiority trial to be conducted at Department of Pediatrics, AIIMS Delhi for a period of 2 years from July 2024 to July 2026. The primary objective will be to compare between study and control groups the complete response rates for vomiting in the acute period ( upto 24 hours after chemotherapy block completion). The secondary objectives will be to compare between the study and control groups the complete response rates for vomiting in delayed and overall period ( upto 120 hours after chemotherapy block completion), the no nausea rates, the need of rescue antiemetics and hospital visits and the incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of malignancy
- •Scheduled for highly emetogenic chemotherapy
- •Should be able to swallow the drug
- •Written informed consent.
排除标准
- •Have had treatment within 14 days prior to study enrolment with olanzapine or 30 days prior with another antipsychotic agent 2.Planned to receive quinolone antibiotics or other antipsychotic agents, citalopram, amifostine, CYP1A2 inducers or inhibitors
- •History of seizure disorder
- •History of hypersensitivity to olanzapine
- •Vomited in the prior 24 hours to first dose of chemotherapy 6.Abnormal lab values (absolute neutrophil count less than 1000/mm3, total leucocyte count less than 3000/mm3, platelet count less than 100,000mm3, AST/ALT more than 2.5 times of upper limit of normal, total serum bilirubin more than 1.5 times of upper limit of normal and serum creatinine more than 1.5 times of upper limit of normal) 7.
结局指标
主要结局
To compare the efficacy of olanzapine versus aprepitant when combined with ondansetron and dexamethasone in control of chemotherapy induced vomiting for the acute period
时间窗: Upto 24 hours after completion of the chemotherapy block
次要结局
- 1. To compare between the study and control groups the efficacy of control in chemotherapy induced vomiting for delayed and overall period(Upto 120 hours after completion of the chemotherapy block)
- 2.To compare between the study and control groups the no nausea rates for acute, delayed and overall period(Upto 120 hours after completion of the chemotherapy block)
- 3.To compare between the study and control groups the need for rescue antiemetic medications(Upto 120 hours after completion of the chemotherapy block)
- 4. To compare between the study and control groups the need for hospital visits(Upto 120 hours after completion of the chemotherapy block)
- 5.To compare between the study and control groups the incidence of adverse events(Upto the scheduled next cycle of chemotherapy)
研究者
Dr Nikita Jakhar
AIIMS Delhi