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.

• N = 160
• MEAN AGE = 68.9 years
• MALES: 50%, FEMALES: 50%
• KEY DISEASE CHARACTERISTICS: All patients had non-small cell lung cancer.

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: United Kingdom

Double-blinded, placebo-controlled, randomized, controlled trial

• Functional Assessment of Chronic Illness Treatment–Fatigue (FACIT-F) scale for fatigue
• Epworth Sleepiness Scale (ESS)
• Hospital Anxiety and Depression Scale (HADS)

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.

• Subject withdrawals ≥ 10% 
• Other limitations/explanation: It is not clear what phase of care patients were in and whether receiving active treatment.  

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.