A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy.
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.
Butler
Jerome M
JM
Department of Radiation Oncology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA. jebutler@wfubmc.edu
Case
L Douglas
LD
Atkins
James
J
Frizzell
Bart
B
Sanders
George
G
Griffin
Patricia
P
Lesser
Glenn
G
McMullen
Kevin
K
McQuellon
Richard
R
Naughton
Michelle
M
Rapp
Stephen
S
Stieber
Volker
V
Shaw
Edward G
EG
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
D000697:Central Nervous System Stimulants; D008774:Methylphenidate