A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: J-SUPPORT 1604 - J-FORCE STUDY: J-SUPPORT and the Fourth agent Olanzapine Resist Cisplatin Emetogenesity.

AMED (Japan Agency for Medical Research and Development)0 个研究点目标入组 690 人开始时间: 2016年11月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. History of hypersensitivity or allergy for study drugs or similar compounds. 2. Patients who need antiemetics at the enrollment. 3. Patients who start taking opioids within 48 hours prior to enrollment. 4. Patient who suffered from ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenum ulcer within 6 months prior to enrollment. 5. Patients who has a convulsive disorders that need anticonvulsants therapy. 6. Patients with symptomatic ascites that need therapeutic drainage. 7. Patients with gastro-intestinal stenosis or obstruction. 8. Pregnant, breastfeeding or expecting woman. 9. Psychotic patients using antipsychotic drug. 10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment or patients who receive abdominal or pelvic concurrent chemoradiotherapy. 11. Patients who had diabetes mellitus with use of antidiabetics and patients with HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. 12. Patients who cannot be hospitalized during 6 days (0-120 h post-cisplatin administration). 13. Habitual smoker at the enrollment. 14. Patients judged by the investigator to be inappropriate for this study.

发起方

AMED (Japan Agency for Medical Research and Development)