A phase II study of methylphenidate for the treatment of fatigue.
BACKGROUND
Cancer-related fatigue (CRF) is one of the most distressing symptoms patients experience and is seen well after the completion of treatment. Methylphenidate (Ritalin) use includes the treatment of opiate-induced somnolence, depression, and reduced cognition. This phase II study was performed to evaluate the effects of methylphenidate on CRF.


METHODS
The criteria for the eligibility of patients included the following: a history of breast cancer, absence of disease for greater than 6 months but less than 5 years, a hemoglobin level of >12 g%, less than moderate depression on the Brief Zung Self-administered Depression Scale, and a score of > or =4 on the Brief Fatigue Inventory (BFI). Patients received methylphenidate, 5 mg, orally, twice daily, for 6 weeks, with a dose escalation on week 2 if the BFI score remained > or =4 and no significant toxicities were reported. A response was defined as a decrease in the BFI score of at least two points on weeks 4 and 6 as compared to baseline.


RESULTS
Between May 2001 and May 2003, 37 patients were entered and treated. On weeks 4 and 6, 20 of 37 (54%) responded with a decreased BFI score greater than two points, averaging a decrease of 3.5. Although six patients (19%) withdrew due to adverse events, these were reported as grade 1.


CONCLUSIONS
This study suggests that women with breast cancer who are suffering from moderate to severe fatigue may benefit from methylphenidate.
Hanna
Amy
A
Division of Hematology/Oncology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, IN 46202, USA. amynasser@sbcglobal.net
Sledge
George
G
Mayer
Mary Lou
ML
Hanna
Nasser
N
Einhorn
Lawrence
L
Monahan
Patrick
P
Daggy
Joanne
J
Bhatia
Sumeet
S
D000328:Adult; D000368:Aged; D001943:Breast Neoplasms; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D005221:Fatigue / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007196:Indiana; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D011795:Surveys and Questionnaires
D000697:Central Nervous System Stimulants; D008774:Methylphenidate