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临床试验/IRCT20150302021307N6
IRCT20150302021307N6
招募中
3 期

Efficacy of palliative pharmacotherapy with Methylphenidate, Bupropion, Ginseng, and Amantadine to improve fatigue in people with advanced cancer (5-EPIFAT)

Ahvaz University of Medical Sciences0 个研究点目标入组 255 人待定

概览

阶段
3 期
干预措施
未指定
疾病 / 适应症
Cancer-related fatigue.
发起方
Ahvaz University of Medical Sciences
入组人数
255
状态
招募中
最后更新
2年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Interventional
性别
All

研究者

入排标准

入选标准

  • Age over 18 years with advanced cancer diagnosis undergoing active anticancer treatment
  • Participants with all types of cancer except patients with central nervous system tumor or hormone\-sensitive cancers or Pheochromocytoma
  • Report of moderate to severe fatigue in the last week (score \= 4 on a scale of 0 to 10\)
  • Diagnosis of cancer\-related fatigue based on International Classification of Diseases 10th edition (ICD\-10\) criteria
  • Hemoglobin level above 9 g/dL in 2 weeks before enrollment
  • Ability to swallow and absorb medications
  • Females who are likely to become pregnant should use contraceptive methods during treatment and up to 6 weeks after.
  • Ability to read and write

排除标准

  • A known fatigue disorder not related to cancer
  • Presence of cognitive disorders, mental disorders (severe anxiety, major depression, schizophrenia, bipolar syndrome), neurological or brain disorders (dementia, delirium, Tourette syndrome, motor tics, epilepsy, history of stroke, aneurysm)
  • Diabetes, untreated severe anemia or anemia requiring blood transfusion, severe and uncontrolled pain and insomnia, serious cardiac disorders, uncontrolled arrhythmia or hypertension, history of long QT syndrome, glaucoma, intestinal obstruction, uncontrolled hypothyroidism, respiratory disorders limiting participation, autoimmune diseases, bleeding disorders
  • Abnormal liver or kidney function
  • History of a major surgery in the month before enrollment
  • Taking erythropoietin, psychostimulants, antidepressants, nutritional supplements, or other medications to control fatigue currently or in the 4 weeks before participating in the study
  • Simultaneous use of drugs (warfarin, anticonvulsants, tricyclic antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline, caffeine and pseudoephedrine)
  • Major dose change (more than 25%) of opioids within 48 hours before enrollment.
  • Hypersensitivity to sympathomimetic amines
  • Planned surgery within 2 months of screening

结局指标

主要结局

未指定

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