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J Palliat Med. 2010 Oct;13(10):1193-7. doi: 10.1089/jpm.2010.0185.

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

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  • 1Department of Palliative Care, Mater Health Services, Mater Adult Hospital, Brisbane, Queensland, Australia.

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 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.

CONCLUSION:

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.

[PubMed - indexed for MEDLINE]
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