Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Nausea Complete Response Rate
研究概览
简要总结
This is a longitudinal, one arm, prospective phase II study, designed to evaluate the efficacy of Olanzapine Netupitant and Palonosetron in the controll of nausea and vomiting induced by highly emetogenic chemotherapy.
详细描述
The population of the study is women diagnosed with breast cancer, who will start chemotherapy (Doxorubicine and Cyclophosfamide). We will evaluate the control of nausea and vomiting in the first cycle of chemotherapy, utilizing Netupitant (300mg) + palonosetron (0,56mg) in day 1 and Olanzapine 5mg starting on Day 0, given once a day for five days. The primary endpoint of this study is complete response rate (no nausea, no emesis no use of rescue medication).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer hitologically confirmed
- •18 Years and older (Adult, Older Adult)
- •Patients about to start use of Doxorubicine 60mg/m2 + Cyclophosfamide 600mg/m2
- •No previous chemotherapy for breast cancer
排除标准
- •Patients not capable of completing the questionnaire
- •Patients with other condition that could cause nausea and emesis
- •Use of opioids
- •Use of antipsychotic medications
- •Patients not capable of taking medications orally
研究组 & 干预措施
Olanzapine + Netupitanto + Palonosetron
Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;
干预措施: Olanzapine (Drug)
Olanzapine + Netupitanto + Palonosetron
Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;
干预措施: Netupitant (Drug)
Olanzapine + Netupitanto + Palonosetron
Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;
干预措施: Palonesetron (Drug)
结局指标
主要结局
Nausea Complete Response Rate
时间窗: 5 days after chemotherapeutic administration
Defined as no nausea and no rescue medication
次要结局
- Complete Emesis Control(For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall))
- Complete Control(For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall))
研究者
Camilla Vieira de Rebouças
MD
Instituto Brasileiro de Controle do Cancer