The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Complete Response(CR) within 24-120 hours after chemotherapy
研究概览
简要总结
This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
- •The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
- •Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
- •Life expectancy ≥ 3 months;
- •Adequate hematologic function;
- •Adequate hepatic function;
- •Adequate renal function;
- •At least 2 weeks away from the last chemotherapy;
- •Patients signed written informed consent.
排除标准
- •Pregnant or lactating women;
- •History of anticipatory vomiting;
- •Radiation therapy on the abdomen or pelvis within one week prior to study entry;
- •Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
- •Patients with gastrointestinal obstruction;
- •Patients with severe heart disease, liver or renal disease, or metabolism disorders;
- •Patients with epilepsy or using sedative or psychotropic drugs;
- •Patients with diabetes or with contraindication for corticosteroids;
- •Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;
- •Patients with brain metastasis or intracranial hypertension;
- •Hypersensitivity to 5-HT3 receptor antagonist;
- •Patients with active infection;
- •Other conditions that the investigator considered as unsuitable for chemotherapy;
- •Subjects participating in other clinical trials.
研究组 & 干预措施
Arm1
1st cycle Palonosetron, 2nd cycle Granisetron
干预措施: Palonosetron (Drug)
Arm1
1st cycle Palonosetron, 2nd cycle Granisetron
干预措施: Granisetron (Drug)
Arm1
1st cycle Palonosetron, 2nd cycle Granisetron
干预措施: Dexamethasone (Drug)
Arm1
1st cycle Palonosetron, 2nd cycle Granisetron
干预措施: Cisplatin (Drug)
Arm2
1st cycle Granisetron, 2nd cycle Palonosetron
干预措施: Palonosetron (Drug)
Arm2
1st cycle Granisetron, 2nd cycle Palonosetron
干预措施: Granisetron (Drug)
Arm2
1st cycle Granisetron, 2nd cycle Palonosetron
干预措施: Dexamethasone (Drug)
Arm2
1st cycle Granisetron, 2nd cycle Palonosetron
干预措施: Cisplatin (Drug)
结局指标
主要结局
Complete Response(CR) within 24-120 hours after chemotherapy
时间窗: 24-120 hours
次要结局
- CR within 0-120 hours after chemotherapy(0-120 hours)
- CR within 0-24 hours after chemotherapy(0-24 hours)
- Incidence of Adverse events(up to 3 months)