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临床试验/ACTRN12612000650897
ACTRN12612000650897已完成2 期

A double-blind, placebo-controlled cross-over study of the effect of corticosteroids on sleep quality- a pilot study in patients with advanced cancer

Mater Misericordiae Health Services Brisbane Ltd0 个研究点目标入组 53 人开始时间: 2012年6月19日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
53

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
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • a diagnosis of cancer
  • -on a stable dose of corticosteroid (CS) for the previous 48hours for any indication
  • -likely to remain on a stable dose of CS for the next 10 days
  • -patients on another CS other than dexamethasone must be prepared to convert to an equivalent dose of dexamethasone
  • - likely to remain on a stable doses of sedatives, hypnotics and analgesics throughout study period.
  • - likely to remain at home or in hospital (ie in a stable environment) for the duration of the study period
  • - life expectancy> 1 month
  • - able to swallow tablets
  • - ability to understand the patient information sheet, sign a fully informed consent and comply with trial requirements

排除标准

  • -patients prescribed dexamethasone for emergency management, eg. spinal cord compression, superior vena cava syndrome, raised intracranial pressure (ICP)
  • -patients being weaned off steroids not willing to remain on a stable dose for 1 0 days
  • -a history of psychosis
  • -concurrent medication likely to cause insomnia eg psychostimulants
  • -uncontrolled diabetes mellitus

研究者

发起方
Mater Misericordiae Health Services Brisbane Ltd

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