Bruera, E., Driver, L., Barnes, E. A., Willey, J., Shen, L., Palmer, J. L., . . . Escalante C. (2003). Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. Journal of Clinical Oncology, 21, 4439–4443.

The study involved patient-controlled administration of immediate-release methylphenidate 5 to 20 mg per day, taken as often as every two hours based on the hypothesis that treatment with a psychostimulant (methylphenidate) would reduce perceived fatigue.

• In total, 30 patients with a median age of 51 years (range 24–79) were included. 
• Most patients were women. 
• The sample included a mix of primary cancer diagnoses, including head and neck, gynecologic, and hematologic cancers.
• All patients had normal thyroid function and a hemoglobin level of 10 mg/dL or greater at study inception.
• Patients with central nervous system disease, a history of seizures, or significant hepatic, renal, or cardiac dysfunction were excluded.

Patients were recruited from a palliative care outpatient clinic or a pain clinic of a large university cancer center.

Unspecified

The study used a single-center pilot study prospective, open-label design; no comparison group was included.

• Functional Assessment for Chronic Illness Therapy–Fatigue (FACIT-F)
• Edmonton Symptom Assessment Score (ESAS)
• Patients rated their drowsiness, ability to sleep at night, pain, depression, and nervousness using a numeric scale from 0 to 10.

Of the patients, 93% (n = 28) reported improvements in fatigue from baseline to day 7 of study participation (as measured by the fatigue item on the ESAS and FACIT-F). Of the patients, 93% took three or more methylphenidate tablets daily. All patients chose to continue methylphenidate for at least four weeks beyond the initial study period of seven days. The following side effects were reported by two or less participants:  restlessness, dizziness, anorexia, skin rash, and self-limited vertigo and tachycardia.

• This was an open-label study, with no randomization, control, or comparison group.
• A small convenience sample was used.
• No stratification existed for the presence or absence of depression.
• Safety was not evaluated in patients with central nervous system disease, a history of seizures, or significant hepatic, renal, or cardiac dysfunction.

No special training is required to deliver the intervention; the costs are related to drug acquisition.