Donepezil for cancer fatigue: a double-blind, randomized, placebo-controlled trial.

Abstract

PURPOSE:

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).

PATIENTS AND 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.

CONCLUSION:

Donepezil was not significantly superior to placebo in the treatment of cancer-related fatigue.

• Authors: Eduardo Bruera, Badi El Osta, Vicente Valero, Larry C Driver, Be-Lian Pei, Loren Shen, Valerie A Poulter, J Lynn Palmer
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 25 Issue 23 Pg. 3475-81 (Aug 10 2007) ISSN: 1527-7755 [Electronic] United States
• PMID: 17687152 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Indans
• Nootropic Agents
• Piperidines
• Placebos
• Donepezil

Topics

• Aged
• Disease Progression
• Donepezil
• Double-Blind Method
• Fatigue (drug therapy)
• Female
• Humans
• Indans (therapeutic use)
• Male
• Middle Aged
• Neoplasms (complications)
• Nootropic Agents (therapeutic use)
• Piperidines (therapeutic use)
• Placebos
• Telemedicine
• Time Factors
• Treatment Outcome