Bruera, E., El Osta, B., Valero, V., Driver, L.C., Pei, B.L., Shen, L., . . . Palmer, J.L. (2007). Donepezil for cancer fatigue: A double-blind, randomized, placebo-controlled trial. Journal of Clinical Oncology, 25, 3475–3481.

Patients received either donepezil or placebo (5 mg) orally every morning for seven days. A research nurse contacted patients by daily telephone calls to assess symptoms and treatment toxicity. Patients were evaluated at the clinic on day 8. Patients returned for a final assessment on day 15, and those who chose to continue taking donepezil were provided with a two-week supply of the drug. Fatigue outcomes were assessed at baseline, day 8, and day 15.

• N = 142; 103 patients were assessable for the final analysis
• MEAN AGE = 56 years
• FEMALES: 65%
• KEY DISEASE CHARACTERISTICS: Patients with advanced cancer, defined as locally recurrent or metastatic; the primary cancer site was most often breast.
• EXCLUSION CRITERIA: Women who were pregnant or lactating, use of tube feeding, cardiac complications, urinary incontinence, presence of concurrent nausea, vomiting, diarrhea, major contraindication to donepezil, major changes expected in the next seven days, administration of anticholinergic agents, hemoglobin less than 1 g/dL within four weeks before enrollment

• Patients were recruited from palliative care or pain clinics at the MD Anderson Cancer Center and the Lyndon B. Johnson General Hospital.

• Active treatment

• Prospective, open-label, pilot, double-blind, randomized, placebo-controlled trial
  • Donepezil intervention (N = 47)
  • Placebo (N = 56)

• Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F)

The donepezil intervention did not show any improvement in fatigue in comparison to the placebo, as no significant difference was seen between groups at baseline and on day 8 for FACIT-F fatigue intensity scores.

• Small sample size
• Intervention only lasted a week, so long-term effects of donepezil remain unknown.