Shaw, E.G., Rosdhal, R., D'Agostino, R.B., Lovato, J., Naughton, M.J., Robbins, M.E., & Rapp, S.R. (2006). Phase II study of donepezil in irradiated brain tumor patients: Effect on cognitive function, mood, and quality of life. Journal of Clinical Oncology, 24, 1415–1420.

DOI Link

Intervention Characteristics/Basic Study Process

Participants initially were given donepezil 5 mg per day. After 6 weeks, dosage was increased to 10 mg per day for a total of 18 weeks. Treatment then was discontinued for a six-week washout period. Patients, therefore, served as their own control at two points (baseline and post-washout). After week 30, patients were given the choice to continue using donepezil at 10 mg per day. Patient outcomes were assessed at baseline and at week 6, 12, 24, and 30 (following the washout period).

Sample Characteristics

  • N = 35 enrolled (24 patients remained on the study and completed all assessments)
  • MEDIAN AGE = 45 years
  • KEY DISEASE CHARACTERISTICS: All had primary brain tumor, mostly low-grade glioma
  • FEMALES: 46%
  • OTHER KEY SAMPLE CHARACTERISTICS: 92% white, 8% black. Patients who remained on the study did not differ significantly at baseline from the patients who dropped out on the measures of sex, race, mood, and cancer-related quality of life. Patients remaining on the study were significantly younger than those who dropped out.
  • EXCLUSION CRITERIA: Less than 18 years of age, life expectancy of less than 30 weeks, received partial or whole brain radiation less than six months before enrollment, imaging evidence of tumor progression in the previous three months, brain tumor treatment planned during course of study

Setting

  • Wake Forest University School of Medicine in Winston-Salem, NC

Phase of Care and Clinical Applications

  • Active treatment

Study Design

  • Open-label, phase II clinical trial

Measurement Instruments/Methods

  • Profile of Mood States (POMS)

Results

The donepezil intervention group demonstrated a significant improvement in fatigue from baseline to 24 months as shown by the POMS subscale for fatigue (p = 0.03).

Limitations

  • Lack of a neutral comparison group
  • Possible that observed improvement is result of “practice effect,” as participants were required to fill out forms four times over a 7.5-month time period