Pilot study to determine the optimal dose of methylphenidate for an n-of-1 trial for fatigue in patients with cancer

Hardy, Janet Rea, Carmont, Sue-Ann S., O'Shea, Angela, Vora, Rohan, Schluter, Philip, Nikles, Catherine Jane and Mitchell, Geoffrey Keith (2010) Pilot study to determine the optimal dose of methylphenidate for an n-of-1 trial for fatigue in patients with cancer. Journal of Palliative Medicine, 13 10: 1193-1197. doi:10.1089/jpm.2010.0185


Author Hardy, Janet Rea
Carmont, Sue-Ann S.
O'Shea, Angela
Vora, Rohan
Schluter, Philip
Nikles, Catherine Jane
Mitchell, Geoffrey Keith
Title Pilot study to determine the optimal dose of methylphenidate for an n-of-1 trial for fatigue in patients with cancer
Journal name Journal of Palliative Medicine   Check publisher's open access policy
ISSN 1096-6218
Publication date 2010-10-14
Sub-type Article (original research)
DOI 10.1089/jpm.2010.0185
Volume 13
Issue 10
Start page 1193
End page 1197
Total pages 5
Place of publication New Rochelle, NY, USA
Publisher Mary Ann Liebert
Collection year 2011
Language eng
Formatted abstract
Purpose: 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.

Method: 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 5mg/d to 15mg 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 (5mg twice daily), with minimal improvement thereafter.

Conclusion: The results indicate a dose of 5mg twice daily for the definitive study. There was little correlation between performance status and maximum tolerated dose. No patient withdrew because of toxicity.
Keyword Placebo controlled trial
Double blind
Scale
Validation
Care
Tool
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Online Ahead of Print: September 11, 2010

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2011 Collection
School of Medicine Publications
 
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Created: Sun, 31 Oct 2010, 00:06:04 EST