A randomised, controlled study of oral olanzapine versus oral haloperidol in patients with cancer and nausea not related to anticancer therapy (Nausea study 4 pilot)

The University of Technology Sydney0 个研究点目标入组 24 人开始时间: 2019年5月20日最近更新: 2022年9月26日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 24

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 o limit（—）
性别: All

入选标准

•Patients who:
•- are 18 years or over
•- have a clinical diagnosis of cancer
•- have nausea with an average score over the last 24 hours of greater than or equal to 3 on an 11 point numerical rating scale (NRS) anchored at 0 (no nausea) and 10 (worst possible nausea)
•- are able to tolerate oral medications
•- are able to comply with all trial requirements
•- are able to provide fully informed consent

排除标准

•Patients who:
•-have nausea related to the treatment of cancer (i.e. surgery, chemotherapy, radiotherapy) within 5 days of anticancer therapy
•-have nausea for which a specific antiemetic is indicated and randomisation to study medications alone would not be appropriate (dexamethasone for acutely raised ICP, 5HT3 antagonists for chemotherapy induced nausea/vomiting)
•-are to undergo a procedure or intervention with the potential to affect nausea during the 3 day study period (e.g. chemotherapy or radiotherapy to a site likely to cause nausea)
•-have received ondansetron, olanzapine or haloperidol at doses equivalent to dose level 1 per day within the previous 48 hours
•-have had uncontrolled nausea despite treatment with ondansetron, olanzapine or haloperidol at study doses within the previous 2 weeks
•-if on corticosteroids, the dose has changed within 48 hours prior to study or is likely to change during the 3 day study period
•-have a definite contraindication to haloperidol (Parkinson’s disease, movement disorders, severe hepatic impairment*)
•-documented congenital or acquired (drug induced#) QTc prolongation (QTc>440sec in men and >0.46sec in women, calculated manually as per Bazett’s formula^) or factors that exacerbate QT prolongation i.e. untreated hypokalaemia, hypothyroidism or bradyarrythmias
•-uncontrolled epilepsy or glaucoma
•-concurrent treatment with monoamine oxidase inhibitors
•-have had a previous adverse reaction to the study medications
•-are pregnant or breastfeeding
•-have participated in a trial of a new clinical entity within the last 28 days
•* this applies to AST, ALT or bilirubin but not to ALP or GGT
•# see appendix for drugs with the potential to prolong QT
•^ QTc=QT interval/square root of the RR interval (in sec)

研究者

发起方

The University of Technology Sydney

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