A Pilot Study on Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Emesis control
研究概览
简要总结
Oral olanzapine showed superior antiemetic efficacy to metoclopramide as rescue treatment to control breakthrough emesis induced by chemotherapy. This study aims to evaluate safety and efficacy of olanzapine for nausea and vomiting in advanced cancer patients.
详细描述
This will be a pilot study; open-label prospective clinical trial. Oral olanzapine 5 mg tablet will be given to patients who fail two standard treatment medications for nausea and vomiting within 30 minutes after the first vomiting episode. Other doses of olanzapine will be given at 12, 24, and 36 hours following the first dose concurrently with standard regimen.
Patients with emesis will be followed up after receiving olanzapine every 12 hour for 48 hours. We will record the frequency of vomiting, nausea, and retching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Diagnosis of advanced malignancy.
- •Failed two standard medications for nausea/vomiting (after 6 hours from last dose).
- •Adequate organ function, including the following:
- •Hepatic: bilirubin ≤1.5 times the upper limit of normal (x ULN); aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤3.0 x ULN (AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement), alkaline phosphatase (AP) ≤5.0 x ULN.
- •Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula.
- •Expected life expectancy > 1 month.
- •Patients must be able to read Thai.
- •Patients must sign an informed consent document.
排除标准
- •Patients with history of abdominal radiotherapy.
- •Patients who receive chemotherapy within 1 week.
- •Patients who take fluoxetine.
- •Patients with heart failure or myocardial infarction in the past 6 months.
- •Patients with QTc prolongation from baseline ECG.
- •Known hypersensitivity to olanzapine.
- •Patients who are unwilling to participate in the study.
研究组 & 干预措施
Olanzapine
Olanzapine 5 mg at 0, 12, 24 and 36 hours
干预措施: Olanzapine (Drug)
结局指标
主要结局
Emesis control
时间窗: 48 hours
Percentage of patients without emesis
次要结局
未报告次要终点
研究者
Jarin Chindaprasirt
Assistant professor
Khon Kaen University