Efficacy and safety of mirtazapine combined with granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in thoracic cancer patients: A multi-institution phase II study

Endo Junki0 个研究点目标入组 51 人开始时间: 2022年7月13日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) Thoracic cancer patients
•2) Patients received CBDCA (AUC 4) based chemotherapy
•3) 20 age old over and less than 80 age old at time of enrolment
•4) Eastern Cooperative Oncology Group performance status of 0, 1 or 2
•5) No history of administration of moderate-to-high emetogenic chemotherapy drugs
•6) Within 48 hours prior to enrolment, no current use of any drugs with antiemetic or somnolent activity, including 5-HT3RA, NK1RA, corticostroids, dopamine receptor antagonists, phenothiazine tranquillisers, antihistamine drugs (paclitaxel administra
•tion allowed during premedication) and benzodiazepine agents
•7) Within a month prior to enrolment, within the following standard ranges for general clinical test T-bil: 2.0 mg/dL and less than, AST: 100 U/L and less than, ALT: 100 U/L and less than, Ccr: 40 mL/min and over
•8) Provided written informed consent

•1) History of hypersensitivity or allergy to study drugs or similar compounds
•2) Need for antiemetics at the time of enrolment
•3) Started opopod intake within 48 hours prior to enrolment
•4) Presence of unstable angina, ischemic heart disease, cerebral hemorrahage or
•apoplexy, or active gastric or duodental ulcer within 6 months prior to enrolment
•5) Presence of convulsive disorders requiring anticonvulsant therapy
•6) Presence of gastrointestinal obstruction
•7) Breastfeeding or pregnant women or those not willing to use contraception
•8) Presence of psychosis or psychiatric symptoms that interfere with daily life
•9) Being a habitual smoker at the time of enrolment
•10) Patients deemed inappropriate for the study by the investigator

发起方

Endo Junki