NCT06850454招募中3 期
A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- total protection rate of nausea and vomiting
研究概览
简要总结
A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy
详细描述
A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •histologically confirmed cancer patients who will be started on first dose of oxaliplatin, irinotecan or carboplatin
- •age of >18 years old
排除标准
- •pregnancy or breast feeding
- •has emetic episode within 24 hours
- •gut obstruction
- •uncontrolled brain metastasis
- •allergy to or current use of olanzapine
- •concomittant moderate or high emetogenic chemotherapy on day 2-5
- •Total bilirubin > 2 mg/dl or creatinine clearance < 30 ml/min
- •unable to swallow drug
研究组 & 干预措施
olanzapine
Experimental
olanzapine 5 mg on day 1-4
干预措施: olanzapine (Drug)
placebo
Placebo Comparator
placebo 5 mg day 1-4
干预措施: Placebo (Drug)
结局指标
主要结局
total protection rate of nausea and vomiting
时间窗: 5 days
Proportion of patients without vomiting or requiring rescue therapy and VAS nausea score of less than 25 mm
次要结局
- no nausea rate(5 days)
- severity of nausea and vomiting(5 days)
- adverse events(5 days)
- rescue therapy(5 days)
- quality of life score(5 days)
- Cost(5 days)
研究者
suthinee ithimakin
Associate professor
Mahidol University
研究点 (1)
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