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 人开始时间: 待定最近更新: 2023年10月16日

研究概览

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•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

•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
•History of sensitivity or intolerance to the drugs under study
•Pregnant or lactating women
•History of drug or alcohol abuse in the past year
•Involved in another clinical trial

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