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临床试验/EUCTR2005-002699-13-DE
EUCTR2005-002699-13-DE进行中(未招募)1 期

Modafinil in der Behandlung von Müdigkeit bei Tumorpatienten - eine randomisierte doppelblinde N=1 Studie - Modafinil for treatment of fatigue in cancer patients

Department of Palliative Medicine, RWTH Aachen0 个研究点目标入组 20 人开始时间: 2005年9月30日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • patients with advanced cancer
  • treated in the paliative care unit
  • palliative prognostic index <= 6 (indicating high probability of survival >= 3 weeks
  • severe fatigue on a 4-step categorical scale for self-assessment of the patient
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • nonmalignant disease
  • patients not able to complete self-assessment
  • palliative prognostic index >6
  • patient refuses to participate
  • pregnancy or lactation
  • impaired organ function from liver, renal or cardiac disease or hypertonus that does not allow treatment with modafinil in the opinion of the investigator
  • investigator finds burden for the patient to high

研究者

发起方
Department of Palliative Medicine, RWTH Aachen

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