(HealthDay)—The central nervous system stimulant modafinil is not effective in treating non-small-cell lung cancer-related fatigue, according to a study published online April 28 in the Journal of Clinical Oncology.
Anna Spathis, M.B., B.Chir.,from Cambridge University Hospitals National Health Service Foundation Trust in the United Kingdom, and colleagues randomly assigned adults with advanced non-small-cell lung cancer, who were not treated with chemotherapy or radiotherapy within the last four weeks, to receive either daily modafinil (75 patients) or matched placebo (85 patients). Questionnaires were completed at baseline and day 28.
The researchers found that, from baseline to day 28, Functional Assessment of Chronic Illness Therapy-Fatigue scores improved in both groups (mean score change: modafinil, 5.29; placebo, 5.09), with no difference between treatment groups (mean score change difference: 0.20; 95 percent confidence interval, −3.56 to 3.97). Secondary outcomes of patient-reported measures of depression, daytime sleepiness, and quality of life were not different between treatment groups. Forty-seven and 23 percent of the modafinil and placebo groups, respectively, stated that the intervention was not helpful.
"Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting," the authors write. "Its use was associated with a clinically significant placebo effect."
Matched modafinil and placebo capsules were provided by Bilcare Global Clinical Supplies Europe.