Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent Nausea and Vomiting Induced by Chemotherapy: A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- 0-120h Complete Remission Rate
研究概览
简要总结
Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older with malignant disease；
- •Life expectancy ≥ 3 months;
- •Scheduled to receive highly emetogenic chemotherapy；
- •Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
排除标准
- •There are contraindications to chemotherapy(Absolute number of neutrophils ≤ 1,500/uL, hemoglobin ≤ 90g/L, platelet count ≤ 10000/uL, serum creatinine level ≥ 2.0mg/dl (177 μmol/L), ALT and AST ≥ 2.5 times the upper normal limit, bilirubin ≥ 1.5 times the upper normal limit);
- •History of central nervous system disease (e.g., brain metastases or a seizure disorder);
- •Severe cognitive impairment；
- •Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period;
- •Concurrent use of pharyngeal or abdominal radiotherapy;
- •Concurrent use of quinolone antibiotics;
- •Concurrent use of Amifostine;
- •Chronic alcoholism;
- •Known hypersensitivity to olanzapine;
- •Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
- •Known uncontrolled diabetes mellitus;
- •Vomiting or retching 24 hours before chemotherapy;
- •Use of anti-emesis drugs 48 hours before chemotherapy;
- •Patients who require medication with dexamethasone for pretreatment.
研究组 & 干预措施
5HT3RA+Olanzapine
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.
干预措施: 5HT3RA+Olanzapine (Drug)
5HT3RA+Olanzapine+Dexamethasone
Using one of the 5-HT3 receptor antagonists within 30 minutes before cisplatin/adriamycin/cyclophosphamide.On day 1-4, Olanzapine is delivered orally after dinner.On first day, dexamethasone is given orally within 30 minutes before cisplatin/adriamycin/cyclophosphamide administered.
干预措施: 5HT3RA+Olanzapine+Dexamethasone (Drug)
结局指标
主要结局
0-120h Complete Remission Rate
时间窗: 24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy
The ratio of patients who have no vomiting and apply no anti-nausea drugs during the whole observation period.
次要结局
- 25-120 hours Complete Remission Rate(24 hours ,48 hours, 72 hours, 96 hours, 120 hours after chemotherapy)
- 0-120h No Nausea Rate(24 hours, 48 hours, 72 hours, 96 hours, 120 hours after chemotherapy)
研究者
Xingchen Peng
Ph.D,Professor
West China Hospital