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

  • In total, nine patients (20% male, 80% female) were included.   
  • Age ranged from 56 to 86 years.
  • Patients had breast, ovarian, and other cancers.
  • No demographic information was available.

Setting

  • Single site  
  • Outpatient  
  • 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

  • Wu Cancer Fatigue Scale
  • Functional Assessment of Cancer Treatment–Fatigue (FACT-F)
  • Edinburgh Depression Scale
  • Daily toxicity and symptom diaries
  • Karnofsky Performance Status (KPS)
  • Global Impression of Change
     

Results

  • 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.
  • 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.
  • There was little correlation between performance status and maximum tolerated dose.
  • 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

  • The study had a small sample size, with less than 100 patients.
  • The study lacked a control group.
  • There was significant attrition.
  • There was one treatment site in one country.
  • The study lacked racial/ethnic diversity.
  • 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.