Hardy, J. R., Carmont, S. A., O'Shea, A., Vora, R., Schluter, P., Nikles, C. J., . . . Mitchell, G. K. (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, 1193–1197.
DOI Link
Study Purpose
To identify a dose of methylphenidate to test formally in a subsequent N-of-one trial of fatigue.
Intervention Characteristics/Basic Study Process
Patients with fatigue 4/10 or more at baseline received titrated doses of methylphenidate beginning at 5 mg/day up to 15 mg twice daily (BID) at three-day intervals.
Sample Characteristics
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In total, nine patients (20% male, 80% female) were included.
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Age ranged from 56 to 86 years.
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Patients had breast, ovarian, and other cancers.
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No demographic information was available.
Setting
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Single site
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Outpatient
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Queensland, Australia
Phase of Care and Clinical Applications
Patients were undergoing the transition phase on “stable treatment,” not on chemotherapy.
Study Design
The study was a prospective trial.
Measurement Instruments/Methods
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Wu Cancer Fatigue Scale
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Functional Assessment of Cancer Treatment–Fatigue (FACT-F)
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Edinburgh Depression Scale
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Daily toxicity and symptom diaries
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Karnofsky Performance Status (KPS)
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Global Impression of Change
Results
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Nine patients began taking 5 mg of methylphenidate daily; seven patients increased to 5 mg BID; six patients increased to 10 mg BID; five patients received the maximum dose of 15 mg BID, and three patients were unwilling to increase the dose to the maximum because they were satisfied with the response at a lower dose.
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No statistical information was provided; overall, fatigue and depression improved until day 9 of the study (5 mg BID dose of methylphenidate) after which the rate of improvement was slower.
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There was little correlation between performance status and maximum tolerated dose.
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Although toxicity was difficult to measure due to small numbers and side effects at baseline, no patient discontinued due to toxicity.
Conclusions
Methylphenidate 5 mg BID was chosen as the ideal dose to test against placebo.
Limitations
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The study had a small sample size, with less than 100 patients.
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The study lacked a control group.
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There was significant attrition.
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There was one treatment site in one country.
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The study lacked racial/ethnic diversity.
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The aim of the study was not to determine if methylphenidate was effective in managing fatigue but rather to find an ideal dose to use for a future randomized, controlled trial.
Nursing Implications
Nurses in research can use a 5-mg BID dose of methylphenidate to test against placebo.