Spathis, A., Fife, K., Blackhall, F., Dutton, S., Bahadori, R., Wharton, R., . . . Wee, B. (2014). Modafinil for the treatment of fatigue in lung cancer: Results of a placebo-controlled, double-blind, randomized trial. Journal of Clinical Oncology, 32, 1882–1888.
To establish the safety and efficacy of modafinil for the treatment of fatigue in patients with non-small cell lung cancer
Patients were randomized to take either oral modafinil 100 mg or a matched placebo capsule. Patients took the medication on a fixed-dose titration schedule of one capsule daily for 14 days and then two capsules daily for the next 14 days. Assessments were done at baseline and on days 14 and 28.
Double-blinded, placebo-controlled, randomized, controlled trial
Fatigue declined in all patients with no significant differences between groups. Modafinil appeared to be well-tolerated with no difference between groups in adverse events; however, more patients in the modafinil group withdrew from the study (p = .02). 42% of those receiving modafinil and 23% of those on the placebo reported that the treatment was not helpful.
Modafinil was not shown to be effective in reducing fatigue in this study.
The findings of this study do not show the efficacy of modafinil in the treatment of cancer-related fatigue. Nurses should be aware that there is insufficient evidence to support effectiveness of modafinil for fatigue and should advocate for the use of interventions that have demonstrated effectiveness.