title: A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy.
abstract: OBJECTIVE
  The quality of life (QOL) and neurocognitive function of patients with brain tumors are negatively affected by the symptoms of their disease and brain radiation therapy (RT). We assessed the effect of prophylactic d-threo-methylphenidate HCl (d-MPH), a central nervous system (CNS) stimulant on QOL and cognitive function in patients undergoing RT.
  
  
  METHODS
  Sixty-eight patients with primary or metastatic brain tumors were randomly assigned to receive d-MPH or placebo. The starting dose of d-MPH was 5 mg twice daily (b.i.d.) and was escalated by 5 mg b.i.d. to a maximum of 15 mg b.i.d. The placebo was administered as one pill b.i.d. escalating three pills b.i.d. The primary outcome was fatigue. Patients were assessed at baseline, the end of radiation therapy, and 4, 8, and 12 weeks after brain RT using the Functional Assessment of Cancer Therapy with brain and fatigue (FACIT-F) subscales, as well as the Center for Epidemiologic Studies Scale and Mini-Mental Status Exam.
  
  
  RESULTS
  The Mean Fatigue Subscale Score at baseline was 34.7 for the d-MPH arm and 33.3 for the placebo arm (p = 0.61). At 8 weeks after the completion of brain RT, there was no difference in fatigue between patient groups. The adjusted least squares estimate of the Mean Fatigue Subscale Score was 33.7 for the d-MPH and 35.6 for the placebo arm (p = 0.64). Secondary outcomes were not different between the two treatment arms.
  
  
  CONCLUSIONS
  Prophylactic use of d-MPH in brain tumor patients undergoing RT did not result in an improvement in QOL.
authors.affiliation: Department of Radiation Oncology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA. jebutler@wfubmc.edu
authors.forename: Jerome M
authors.initials: JM
authors.lastname: Butler
authors.forename: L Douglas
authors.initials: LD
authors.lastname: Case
authors.forename: James
authors.initials: J
authors.lastname: Atkins
authors.forename: Bart
authors.initials: B
authors.lastname: Frizzell
authors.forename: George
authors.initials: G
authors.lastname: Sanders
authors.forename: Patricia
authors.initials: P
authors.lastname: Griffin
authors.forename: Glenn
authors.initials: G
authors.lastname: Lesser
authors.forename: Kevin
authors.initials: K
authors.lastname: McMullen
authors.forename: Richard
authors.initials: R
authors.lastname: McQuellon
authors.forename: Michelle
authors.initials: M
authors.lastname: Naughton
authors.forename: Stephen
authors.initials: S
authors.lastname: Rapp
authors.forename: Volker
authors.initials: V
authors.lastname: Stieber
authors.forename: Edward G
authors.initials: EG
authors.lastname: Shaw
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001932:Brain Neoplasms / Q000523:psychology / Q000532:radiotherapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects*; D004311:Double-Blind Method; D005221:Fatigue / Q000517:prevention & control*; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D010352:Patient Dropouts / Q000706:statistics & numerical data; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate