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Donepezil for Cancer Fatigue: A Double-Blind, Randomized, Placebo-Controlled Trial

Eduardo Bruera, Badi El Osta, Vicente Valero, Larry C. Driver, Be-Lian Pei, Loren Shen, Valerie A. Poulter, J. Lynn Palmer

From the Department of Palliative Care and Rehabilitation Medicine, Department of Breast Medical Oncology, and Department of Cancer Pain Management, The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Eduardo Bruera, MD, Department of Palliative Care and Rehabilitation Medicine, Unit 008, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: ebruera{at}mdanderson.org

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 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.

Supported in part by National Institutes of Health Grants No. R01NRO10162-01A1 and RO1CA122292-01 (E.B.).

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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