Jatoi, A., Kahanic, S.P., Frytak, S., Schaefer, P., Foote, R.L., Sloan, J., & Petersen, R.C. (2005). Donepezil and vitamin E for preventing cognitive dysfunction in small cell lung cancer patients: Preliminary results and suggestions for future study designs. Supportive Care in Cancer, 13(1), 66–69.doi: 10.1007/s00520-004-0696-0
The study was conducted to test oral donepezil and oral vitamin E in patients with small-cell lung cancer after completion of all cancer therapy and prophylactic cranial irradiation.
A randomization procedure was conducted after participant stratification in the following ways.
The treatment group received 5 mg/day of oral donepezil, which increased to 10 mg/day after one month of therapy if tolerated well. Treatment group participants also received 1000 IU/day of oral vitamin E. The control group was given an identical oral placebo. Assessments were performed at study enrollment, one month, and every three months until cancer recurrence or treatment failure.
The study took place at the North Central Cancer Treatment Group and the Mayo Clinic.
The study was a double-blind, placebo-controlled trial.
There were no notable differences in cognitive stability, adverse events, or quality of life between treatment arms. Only one patient, who received donepezil and vitamin E, manifested a three-point drop in cognitive scores as measured by the MMSE. There was a slight trend of increased gastrointestinal side effects among patients treated with donepezil and vitamin E.
The median time spent in the study was 42 or 69 days for the treatment or control group, respectively.
Due to low enrollment and retention, the effect of oral doses of vitamin E and donepezil on cognitive function could not be determined.