Efficacy and Dosage of Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis in Women With Gynecologic Cancers Receiving Carboplatin-based Regimen : a Double-blind, Placebo-controlled, Randomized Crossover Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
研究概览
简要总结
To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo
详细描述
A double-blind, placebo-controlled, randomized crossover trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with gynecological cancer receiving carboplatin-based chemotherapeutic regimen
- •ECOG performance status 0-1
- •Normal bone marrow, liver, and renal functions
- •Can speak and write in Thai language
排除标准
- •Women with nausea or vomiting prior to chemotherapeutic administration
- •Pregnant women
- •Women with active infection
- •Women with bowel obstruction
- •Women with symptomatic brain metastases
- •Women who received dopamine receptor antagonists within 1 week before chemotherapeutic administration
- •Women who received corticosteroid within 1 week before chemotherapeutic administration
- •Women with past history of chemotherapy or radiotherapy
- •Women with psychiatric disorders
- •Women with poor controlled diabetes mellitus
- •Women who received anticonvulsant medication
- •Women with history of neuroleptic malignant syndrome
- •Women with history of olanzapine allergy
- •Women with history of lactose intolerance
研究组 & 干预措施
OLN 0-5-10
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
干预措施: Olanzapine 10 Mg ORAL TABLET (Drug)
OLN 0-5-10
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
干预措施: Olanzapine 5 Mg ORAL TABLET (Drug)
OLN 0-5-10
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
干预措施: Placebo ORAL TABLET (Drug)
OLN 5-10-0
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
干预措施: Olanzapine 10 Mg ORAL TABLET (Drug)
OLN 5-10-0
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
干预措施: Olanzapine 5 Mg ORAL TABLET (Drug)
OLN 5-10-0
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
干预措施: Placebo ORAL TABLET (Drug)
OLN 10-0-5
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
干预措施: Olanzapine 10 Mg ORAL TABLET (Drug)
OLN 10-0-5
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
干预措施: Olanzapine 5 Mg ORAL TABLET (Drug)
OLN 10-0-5
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
干预措施: Placebo ORAL TABLET (Drug)
结局指标
主要结局
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
时间窗: 5 days after chemotherapeutic administration
No breakthrough vomiting and no using rescue therapy
次要结局
- Episodes of vomiting(5 days after chemotherapeutic administration)
- Use of rescue drug(5 days after chemotherapeutic administration)
- Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)(5 days after chemotherapeutic administration)
- Severity of nausea(5 days after chemotherapeutic administration)