title: Pilot study to determine the optimal dose of methylphenidate for an n-of-1 trial for fatigue in patients with cancer.
abstract: OBJECTIVE
  In advanced cancer, the prevalence of fatigue is high and can be related to treatment or disease. Methylphenidate hydrochloride (MPH) is a central nervous system stimulant that has been used to palliate fatigue. There is no standard dose for MPH when used for this indication; recommended doses range from 5–20 + mg/d.
  
  
  METHODS
  To identify a dose to test formally in a subsequent n-of-1 trial of fatigue, we recruited patients with advanced cancer and a fatigue score of 4 or more on a 10-point scale. Following a 3-day baseline assessment, each patient titrated MPH at doses ranging from 5 mg/d to 15 mg twice daily at 3-day intervals. In a daily diary, patients recorded measures of fatigue, depression, toxicity, and symptom control.
  
  
  RESULTS
  Ten patients provided consent, 9 completed 8 days and 5 received maximum dose at day 15. Three patients were unwilling to increase the dose to maximum levels as they were satisfied with the response at a lower dose. Across all patients, there was a pattern of rapidly improving fatigue and depression scores to day 9 (5 mg twice daily), with minimal improvement thereafter.
  
  
  CONCLUSIONS
  The results indicate a dose of 5 mg twice daily for the definitive study. There was little correlation between performance status and maximum tolerated dose. No patient withdrew because of toxicity.
authors.affiliation: Department of Palliative Care, Mater Health Services, Mater Adult Hospital, Brisbane, Queensland, Australia.
authors.forename: Janet Rea
authors.initials: JR
authors.lastname: Hardy
authors.forename: Sue-Ann S
authors.initials: SA
authors.lastname: Carmont
authors.forename: Angela
authors.initials: A
authors.lastname: O'Shea
authors.forename: Rohan
authors.initials: R
authors.lastname: Vora
authors.forename: Philip
authors.initials: P
authors.lastname: Schluter
authors.forename: Catherine Jane
authors.initials: CJ
authors.lastname: Nikles
authors.forename: Geoffrey Keith
authors.initials: GK
authors.lastname: Mitchell
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000697:Central Nervous System Stimulants / Q000008:administration & dosage*; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010865:Pilot Projects; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate