Evaluation of the efficacy and safety of 5mg olanzapine combined with aprepitant, granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in gynecologic cancer patients: a multicenter phase 2 study. - J-TOP-G : Japan, combination of Triplet therapy and Olanzapine for Prevention of carboplatin-induced nausea and vomiting in Gynecologic cancer patients

Gifu University0 个研究点目标入组 60 人开始时间: 2018年4月5日最近更新: 2023年10月17日

适应症

试验速览

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•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 with unstable angina, ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenal ulcer within 6 months prior to enrollment. 5. Patients who have convulsive disorders requiring anticonvulsants therapy 6. Patients with ascites effusion requiring paracentesis 7. Patients who have gastrointestinal obstruction 8.Pregnant, breastfeeding or expecting women or who do not wish to use contraception 9. Patients who have psychosis or psychiatric symptoms that interferes with daily life 10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment 11. Patients who had diabetes mellitus 12. Habitual smoker at enrollment 13. Other patients who are judged to be inappropriate for the study by the investigator

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