[Modafinil for the treatment of cancer-related fatigue : an intervention study].
OBJECTIVE
the authors conducted an open-label investigation examining the effects of modafinil in reducing fatigue in patients with cancer, undergoing cancer treatment, and receiving opioid therapy.


METHODS
after approval by the local Ethics Committee and informed consent cancer patients who reported fatigue - defined as persistent tiredness interfering with usual functioning - were enrolled in the study. Once daily, patients received 100 mg open-label modafinil. The Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), and a visual analogue scale (VAS, 0-10) were performed at baseline (t1), day 7 (t2), and day 28 (t3). Further assessment comprised the d2 Test of Attention (d2), the Hamilton Depression Scale (HAMD), the Eastern Cooperative Oncology Group-Score (ECOG), side effects, and patients' satisfaction with modafinil treatment.


RESULTS
of the 37 patients who were enrolled, 29 completed all assessments in the study. Modafinil had a significant effect on the FSS (t1 44.6+/-12.2, t2 39+/-12.4, t3 35.3+/-13.8 (p=0.015), on the VAS (t1 6+/-3.1), t2 4.5+/-2.8, t3 3.7+/-2.8 (p=0.005), and an insignificant effect on d2 parameters of neurophysiological functioning and ESS. No differences were seen for ECOG and patients' satisfaction. No severe adverse effects were detected.


CONCLUSIONS
modafinil improved alertness and cognitive skills in patients receiving cancer pain treatment by enhancing vigilance and cognitive performance. Although confirmation of this preliminary result is needed, these findings suggest that modafinil may improve quality of life in this patient population. However, in Germany the use of modafinil for fatigue is off-label and careful assessment of fatigue is needed prior to treatment. Randomized controlled trials are needed to confirm this evidence.
Abteilung für Anästhesie, Interdisziplinäre Intensivmedizin, Schmerztherapie, Palliativmedizin, CURA - katholisches Krankenhaus im Siebengebirge, Schülgenstr. 15, 53604 Bad Honnef, Deutschland. stefan.wirz@cura.org
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Wirz
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Nadstawek
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Kühn
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Vater
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Junker
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Wartenberg
D000203:Activities of Daily Living / Q000523:psychology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy / Q000523:psychology; D004185:Disability Evaluation; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009369:Neoplasms / Q000150:complications* / Q000503:physiopathology* / Q000523:psychology; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D010147:Pain Measurement / Q000706:statistics & numerical data; D010552:Personality Assessment / Q000706:statistics & numerical data; D011594:Psychometrics; D011788:Quality of Life / Q000523:psychology; D012307:Risk Factors; D011795:Surveys and Questionnaires
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil