Donepezil for cancer fatigue: a double-blind, randomized, placebo-controlled trial.
OBJECTIVE
To evaluate the effectiveness of donepezil compared with placebo in cancer patients with fatigue as measured by the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F).


METHODS
Patients with fatigue score >or= 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) for more than 1 week were included. Patients were randomly assigned to receive donepezil 5 mg or placebo orally every morning for 7 days. A research nurse contacted the patients by telephone daily to assess toxicity and fatigue level. All patients were offered open-label donepezil during the second week. FACIT-F and/or the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 11, and 15. The FACIT-F fatigue subscale score on day 8 was considered the primary end point.


RESULTS
Of 142 patients randomly assigned to treatment, 47 patients in the donepezil group and 56 in the placebo group were assessable for final analysis. Fatigue intensity improved significantly on day 8 in both donepezil and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .57) or ESAS (P = .18) between groups. In the open-label phase, fatigue intensity continued to be low as compared with baseline. No significant toxicities were observed.


CONCLUSIONS
Donepezil was not significantly superior to placebo in the treatment of cancer-related fatigue.
Bruera
Eduardo
E
Department of Palliative Care and Rehabilitation Medicine, Unit 008, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA. ebruera@mdanderson.org
El Osta
Badi
B
Valero
Vicente
V
Driver
Larry C
LC
Pei
Be-Lian
BL
Shen
Loren
L
Poulter
Valerie A
VA
Palmer
J Lynn
JL
D000368:Aged; D018450:Disease Progression; D000077265:Donepezil; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D018697:Nootropic Agents / Q000627:therapeutic use*; D010880:Piperidines / Q000627:therapeutic use*; D010919:Placebos; D017216:Telemedicine; D013997:Time Factors; D016896:Treatment Outcome
D007189:Indans; D018697:Nootropic Agents; D010880:Piperidines; D010919:Placebos; D000077265:Donepezil