Palonosetron Hydrochloride Capsules (Ruoshan ®) Used to Prevent and Control Chemotherapy for Tumor Patients Real World Study on the Safety of Nausea and Vomiting Reduction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,060
- 试验地点
- 1
- 主要终点
- Any adverse event after treatment
研究概览
简要总结
To observe and evaluate the safety and effectiveness of Palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; The characteristics of the applicable population, clinical medication and clinical benefits of Palonosetron Hydrochloride Capsules were analyzed.
详细描述
At present, as the mainstream antiemetics of CINV, oral administration is the most commonly used method of drug therapy. Clinical studies showed that there was no difference in the efficacy of 5-HT3 receptor antagonist between different administration routes (oral and intravenous). At the same time, because the oral route is the most convenient, oral preparations provide more and more convenient choices for clinicians and patients. To observe and evaluate the safety and effectiveness of Palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; The characteristics of the applicable population, clinical medication and clinical benefits of Palonosetron Hydrochloride Capsules were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients with malignant tumors who can accept chemotherapy, the disease type is not limited. The specific chemotherapy scheme is the chemotherapy scheme with moderate risk of vomiting (for the risk level of vomiting, refer to the 2019 CSCO anti-tumor treatment related nausea and vomiting prevention and treatment guidelines);
- •18-75 years old, KPS score ≥ 70, and the expected survival time is more than 3 months;
- •Before treatment, ECG, blood routine test, liver and kidney functions and electrolytes were basically normal;
- •All patients signed the informed consent form
排除标准
- •Patients with chemotherapy contraindications, patients allergic to 5-HT3RA, pregnant women and lactating women;
- •People with digestive tract obstruction; Patients with serious heart disease, liver and kidney disease and metabolic disorder; Patients suffering from epilepsy or using psychotropic and sedative drugs;
- •Used antiemetic drugs or chemicals within 24 hours.Those who have vomited before treatment may have brain metastasis, intracranial hypertension, gastrointestinal obstruction, psychological abnormalities, etc.Patients with factors causing nausea and vomiting.
研究组 & 干预措施
Palonosetron hydrochloride capsules
The recommended dose for adults is 0.5mg (1 capsule) for a single oral dose about 1 hour before chemotherapy.
干预措施: Palonosetron hydrochloride capsules (Drug)
结局指标
主要结局
Any adverse event after treatment
时间窗: 1 year
次要结局
未报告次要终点