ISRCTN79478762已完成未知
Methylphenidate versus placebo for fatigue in advanced cancer (MePFAC)
niversity College London0 个研究点目标入组 162 人开始时间: 2017年8月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 162
研究概览
简要总结
2024 Results article in https://doi.org/10.1200/jco.23.02639 (added 04/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 28/10/2018 (updated 27/07/2023):
- •1. Aged 18 years or over
- •2. Participant is willing and able to give informed consent for participation
- •3. Advanced incurable cancer of all tumour types
- •4. Moderate or severe fatigue (>3/10 on a numerical rating scale)
- •5. Able and willing to comply with all study requirements, including ability to participate in study for ten weeks
- •6. Participant is receiving generalist or specialist palliative care
- •7. Willing to allow his or her General Practitioner to be notified of participation in the study
- •Previous inclusion criteria:
- •1. Aged 18 years or over
- •2. Participant is willing and able to give informed consent for participation
- •3. Advanced incurable cancer of all tumour types
- •4. Moderate or severe fatigue (>3/10 on a numerical rating scale)
- •5. Prognosis 2-12 months (as estimated by clinician)
- •6. Able and willing to comply with all study requirements, including ability to participate in study for nine weeks
- •7. Under the care of a specialist palliative care team
- •8. Willing to allow his or her General Practitioner to be notified of participation in the study
排除标准
- •Current exclusion criteria as of 28/10/2018 (updated 27/07/2023):
- •1. Pregnancy
- •2. Females of childbearing potential and males who have sexual partners with child-bearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until six weeks after treatment discontinuation and inform the trial if pregnancy occurs. For the purpose of clarity, true abstinence is when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception)
- •3. Females of childbearing potential must have a negative pregnancy test seven days or fewer prior to first dose administration and must be willing to have a pregnancy test at every physical visit during the study
- •4. Females must not be breastfeeding
- •5. Known sensitivity to methylphenidate or to any of the excipients
- •6. History of glaucoma
- •7. Known phaechromocytoma
- •8. Planned general anaesthesia in the next nine weeks
- •9. During treatment with non-selective, irreversible MAO inhibitors, or within a minimum of 14 days of discontinuing those drugs
- •10. Clinical hyperthyroidism or thyrotoxicosis. Patients must have a thyroid function test (T4 and TSH) showing no evidence of hyperthyroidism in three months prior to first dose administration of study medication
- •11. Known diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
- •12. Known diagnosis or history of severe and episodic (Type 1) bipolar (affective) disorder (that is not well controlled)
- •13. Known pre-existing cardiovascular disorders including severe hypertension (BP >160/100mmHg), uncontrolled heart failure, uncontrolled angina, arterial occlusive disease, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction (within last one year), potentially life-threatening arrhythmias and channelopathies
- •14. Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke (within last 1 year) or known high-risk factors for cerebrovascular disorders
- •15. Current or previous psycho-stimulant use in the last month
- •16. Severe anaemia (haemoglobin <80g/L)
- •17. Platelets <50 × 10e3/µL
- •18. White blood count less than 1.5 x 109/litre
- •19. Any evidence of severe or uncontrolled infection that in the view of the investigator makes it undesirable for the patient to participate in the trial
- •20. Estimated glomerular filtration rate [eGFR] <45 ml/minute per 1·73 m²
- •21. ALT > 2 x ULN or bilirubin > 1.5 x ULN
- •22. Participating in another research study involving any investigational agents within four weeks prior to registration
- •23. Insufficient English language skills to understand study documentation and complete assessments
- •24. Current treatment with clonidine, warfarin, monoamine oxidase inhibitors or modafinil
- •25. History of previous or current substance or alcohol dependency within the last 1 year
- •26. Unable to swallow tablets/capsules
- •27. History of poorly controlled epilepsy, or seizures related to underlying brain tumour
- •28. Any other significant disease or disorder which, in the
研究者
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