A Randomized, Open Label Trial to Compare Efficacy and Safety of Olanzapine 10mgand 5mg for the prophylaxis of emesis in patients receiving highly emetogenic cancer chemotherapy
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- primary outcome- complete response of vomiting in early(0- 24hrs), delayed(24-120 hrs) in both groups
研究概览
简要总结
Study lies in its specific focus on comparing the efficacy and safety of two different doses of olanzapine (10mg and 5mg) for the prophylaxis of emesis in patients receiving highly emetogenic cancer chemotherapy. Olanzapine 10mg (control arm) as well as 5mg (test arm) have shown efficacious role in the prophylaxis of CINV while used in combination with other antiemetic drugs (Palonosetron, Dexamethasone etc.) due to its action on multiple receptors involved in emesis (D1, D2, D3, and D4, 5-HT2a, 5-HT2c, 5-HT3, and 5-HT6 receptors). While olanzapine has been shown to be an effective antiemetic agent, there is currently limited research comparing different dosages of the medication for this specific indication. As such, this study aims to provide valuable insight into whether a higher dose of olanzapine provides greater prophylaxis against emesis than a lower dose, and to identify any potential safety concerns associated with each dosage level. By filling this gap in the literature, this study has the potential to inform clinical practice and improve the management of emesis in patients receiving highly emetogenic cancer chemotherapy.
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
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1-18 years of age or older patients who had not received previous chemotherapy 2-Patients going to receive 1st cycle of highly emetogenic cancer chemotherapy 3-Written informed consent.
- •4-Able to understand and describe patient-reported outcomes.
排除标准
- •1-History of hypersensitivity or allergy to any of antiemetic drugs we are going to use in study 2-Received any chemotherapy in last 3 weeks.
- •3-Multiday chemotherapy regimen, concurrent radiotherapy 4-brain metastasis.
结局指标
主要结局
primary outcome- complete response of vomiting in early(0- 24hrs), delayed(24-120 hrs) in both groups
时间窗: early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs)
Secondary outcome- to record different grades of chemotherapy induced nausea and vomiting in all three periods
时间窗: early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs)
次要结局
- To record different grades of chemotherapy induced nausea and vomiting (CINV) in all three periods: - Acute (0- 24 hrs), Delayed (24 -120hrs), overall(0-120hrs).(early(0- 24hrs), delayed(24-120 hrs) and overall period (0-120hrs))
研究者
Dr Abhay Pratap Singh
UPUMS, Saifai