{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T04:57:59Z","timestamp":1788497879600,"version":"build-2803163510"},"reference-count":49,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["15\/46\/02"],"award-info":[{"award-number":["15\/46\/02"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title>\n<jats:p>Previous meta-analyses suggested methylphenidate may be effective for cancer-related fatigue.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-2\"><jats:title>Trial design<\/jats:title>\n<jats:p>Phase III, parallel-group, randomised, double-blind, placebo-controlled trial.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-3\"><jats:title>Methods<\/jats:title>\n<jats:p>Participants were adults with advanced cancer with cancer-related fatigue receiving palliative care at 17 palliative care services in England between June 2018 and April 2023.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-4\"><jats:title>Principal exclusions<\/jats:title>\n<jats:p>Pregnancy; glaucoma; pheochromocytoma; planned general anaesthesia; hyperthyroidism; severe psychiatric disorders; hypertension; severe cardiovascular disorders; cerebrovascular disorders; anaemia; thrombocytopenia; leucopenia; infection; renal or liver impairment; concomitant clonidine, warfarin, monoamine oxidase inhibitors or modafinil; alcohol or drug dependency; epilepsy.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-5\"><jats:title>Interventions<\/jats:title>\n<jats:p>Methylphenidate 5\u00a0mg tablets or matching placebo. Starting at 1 tablet twice daily, titrated over 6 weeks to a maximum of 12 tablets\/day.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-6\"><jats:title>Objective<\/jats:title>\n<jats:p>To estimate clinical effectiveness of methylphenidate versus placebo for cancer-related fatigue in patients receiving palliative care.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-7\"><jats:title>Primary outcome<\/jats:title>\n<jats:p>Fatigue at 6 (\u00b1\u20052) weeks measured using the Functional Assessment of Chronic Illness Therapy \u2013 Fatigue Scale score. Secondary outcomes were fatigue at other time points; quality of life, adverse events, activities of daily living; appetite; anxiety; depression; patient satisfaction; survival and need for other medication.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-8\"><jats:title>Randomisation<\/jats:title>\n<jats:p>Computer-generated 1\u2005:\u20051 randomisation, stratified by centre, concomitant treatment, depression and initial fatigue score.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-9\"><jats:title>Blinding<\/jats:title>\n<jats:p>Participants and outcome assessors were blinded to group assignment.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10\"><jats:title>Results<\/jats:title>\n<jats:sec id=\"abs1-10-1\"><jats:title>Numbers randomised<\/jats:title>\n<jats:p>Eighty-four were allocated to methylphenidate and 78 to placebo.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10-2\"><jats:title>Recruitment<\/jats:title>\n<jats:p>: Study completed.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10-3\"><jats:title>Numbers analysed<\/jats:title>\n<jats:p>Seventy-five in methylphenidate group and 72 in placebo group were included in analysis of primary outcome.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10-4\"><jats:title>Outcome<\/jats:title>\n<jats:p>There was no statistically or clinically significant difference in primary outcome between groups. Functional Assessment of Chronic Illness Therapy \u2013 Fatigue Scale scores were 1.97 points (95% confidence interval \u22120.95 to 4.90; <jats:italic>p<\/jats:italic>\u2005=\u20050.186) higher (better) on methylphenidate than placebo. Functional Assessment of Chronic Illness Therapy \u2013 Fatigue Scale score was nominally statistically significantly higher (better) in methylphenidate group across duration of study [Diff 2.20 (95% confidence interval 0.39 to 4.01)] but did not reach the minimal clinically important difference (5 points). At 6 weeks, there were no statistically significant differences in quality-of-life or symptom domains except for depression scores [nominally statistically significantly reduced in methylphenidate group: Diff \u22121.35 (95% confidence interval \u22122.41 to \u22120.30)].<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10-5\"><jats:title>Harms<\/jats:title>\n<jats:p>There were 25 serious adverse events in 20 participants receiving methylphenidate and 25 serious adverse events among 16 participants receiving placebo. There were no suspected unexpected serious adverse reactions. There were no statistically significant differences in deaths occurring within 75 days of randomisation (2 participants in placebo group and 6 participants in the methylphenidate group; Fisher\u2019s exact <jats:italic>p<\/jats:italic>-value 0.278). Adverse events were similar in the two groups, with no pattern to suggest increased harm with methylphenidate.<\/jats:p>\n<\/jats:sec>\n<\/jats:sec>\n<jats:sec id=\"abs1-11\"><jats:title>Limitations<\/jats:title>\n<jats:p>Participants were highly selected due to multiple exclusion criteria. The choice of 5-point difference in Functional Assessment of Chronic Illness Therapy \u2013 Fatigue Scale score as clinically significant primary outcome may be debated.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-12\"><jats:title>Conclusions<\/jats:title>\n<jats:p>Methylphenidate did not reduce fatigue severity in patients with advanced cancer at 6 (\u00b1\u20052) weeks but was safe and well tolerated.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-13\"><jats:title>Future work<\/jats:title>\n<jats:p>Further trials of methylphenidate for fatigue in patients with advanced cancer receiving palliative care are not recommended. There may be scope for further studies in different populations or for different indications.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-14\"><jats:title>Funding<\/jats:title>\n<jats:p>This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15\/46\/02.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/gjps6321","type":"journal-article","created":{"date-parts":[[2025,8,4]],"date-time":"2025-08-04T07:59:39Z","timestamp":1754294379000},"page":"1-47","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Methylphenidate versus placebo for fatigue in patients with advanced cancer: the MePFAC randomised controlled trial"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5765-9047","authenticated-orcid":true,"given":"Patrick","family":"Stone","sequence":"first","affiliation":[{"name":"Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4258-8995","authenticated-orcid":true,"given":"Ollie","family":"Minton","sequence":"additional","affiliation":[{"name":"University Hospitals Sussex NHS Foundation Trust, Worthing Hospital, Worthing, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3127-5755","authenticated-orcid":true,"given":"Alison","family":"Richardson","sequence":"additional","affiliation":[{"name":"University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8139-2768","authenticated-orcid":true,"given":"Peter","family":"Buckle","sequence":"additional","affiliation":[{"name":"Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4384-9314","authenticated-orcid":true,"given":"Zinat E","family":"Enayat","sequence":"additional","affiliation":[{"name":"Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9973-1131","authenticated-orcid":true,"given":"Louise","family":"Marston","sequence":"additional","affiliation":[{"name":"Department of Primary Care and Population Health, Institute of Epidemiology & Health Care, Faculty of Population Health Sciences, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5807-5740","authenticated-orcid":true,"given":"Nick","family":"Freemantle","sequence":"additional","affiliation":[{"name":"Comprehensive Clinical Trials Unit, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2025,7]]},"reference":[{"key":"key2025080413081000_ref1-bib1","first-page":"2382","article-title":"Methylphenidate versus placebo for treating fatigue in people with advanced cancer: randomized, double-blind, multi-center, placebo-controlled","volume":"42","author":"Stone","year":"2024","journal-title":"J Clin Oncol"},{"key":"key2025080413081000_ref2-bib2","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1016\/j.jpainsymman.2020.07.037","article-title":"Prevalence of fatigue in patients with cancer: a systematic review and meta-analysis","volume":"61","author":"Al Maqbali","year":"2021","journal-title":"J Pain Symptom Manage"},{"key":"key2025080413081000_ref3-bib3","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1007\/s11864-022-01045-0","article-title":"Management of fatigue in patients with advanced cancer","volume":"24","author":"Stone","year":"2023","journal-title":"Curr Treat Options Oncol"},{"key":"key2025080413081000_ref4-bib4","doi-asserted-by":"crossref","first-page":"971","DOI":"10.1023\/A:1008318932641","article-title":"Cancer-related fatigue: inevitable, unimportant and untreatable? 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