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Modafinil zur Behandlung der Tumorfatigue

Eine Interventionsstudie

Modafinil for the treatment of cancer-related fatigue

An intervention study

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Zusammenfassung

Ziel

Die Autoren führten eine Open-label-Untersuchung durch, um den Effekt von Modafinil zur Behandlung der Tumorfatigue bei Patienten mit einer Tumorerkrankung, antiproliferativen Therapie und Opioidgabe zu evaluieren.

Methoden

Nach Genehmigung durch die örtliche Ethikkommission und Patienteneinwilligung wurden Tumorpatienten mit Fatigue, definiert als anhaltende Schwäche sowie eingeschränkte Fähigkeit zu körperlicher und geistiger Arbeit, in die Studie eingeschlossen. Die Patienten erhielten „open-label“ 100 mg/Tag Modafinil. Vor (t1), 7 Tage (t2) und 28 Tage (t3) nach Beginn der Medikation wurden Fatigue Severity Score (FSS), Epworth Sleeping Scale (ESS) und eine Visuelle Analogskala (Müdigkeit; VAS; 0–10) durchgeführt. Zusätzlich wurden der d2-Aufmerksamkeitstest nach Brickenkamp, die Hamilton Depression Scale (HAMD), der Eastern-Cooperative-Oncology-Group-Score (ECOG), Nebenwirkungen und Therapiezufriedenheit dokumentiert.

Ergebnisse

Von 37 eingeschlossenen Patienten lagen bei Studienende komplette Daten von 29 Patienten vor. Modafinil verbesserte signifikant die Werte von FSS (t1 44,6±12,2, t2 39±12,4, t3 35,3±13,8; p=0,015) und VAS (Müdigkeit; VAS t1 6±3,1, t2 4,5±2,8, t3 3,7±2,8; p=0,005) und nicht signifikant Parameter des d2-Tests und ESS. Die Werte des ECOG und der Patientenzufriedenheit wiesen keine Veränderung auf. Schwerwiegende Nebenwirkungen wurden nicht beobachtet

Schlussfolgerungen

Bei Patienten mit einer Tumorschmerztherapie steigerte Modafinil Wachheit und kognitive Fähigkeiten. Trotz der Vorläufigkeit der Ergebnisse weist dies möglicherweise auf eine Verbesserung der Lebensqualität durch Modafinil bei dieser Patientengruppe hin. Dennoch müssen der Off-label-Status einer solchen Therapie und die Notwendigkeit einer sorgfältigen Fatiguediagnostik beachtet werden. Randomisierte kontrollierte Studien stehen zur Verbesserung der Evidenzlage aus.

Abstract

Aim

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.

Conclusion

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.

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Danksagung

Die Autoren bedanken sich bei den Ambulanzschwestern der Schmerzambulanz der Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin der Universitätskliniken Bonn, Marta Dederichs, Annette Dahlhaus, Christiane Statz und Kathleen Wolf, die diese Untersuchung unterstützt haben. Dank an Sonja Vater für die sorgfältige Datenerhebung. Dank an Sonja Vater, Uwe Junker und Amelie Wirz für die Datenanalyse. Dank an Ronel Kranz für die Sichtung des englischen Abstracts.

Interessenkonflikt

Der korrespondierende Autor weist auf folgende Beziehungen hin: Herr Dr. Stefan Wirz war in den vergangenen Jahren als Referent für die Firmen Cephalon, Lilly, Mundipharma und Grünenthal tätig.

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Authors and Affiliations

  1. Abteilung für Anästhesie, Interdisziplinäre Intensivmedizin, Schmerztherapie, Palliativmedizin, CURA - katholisches Krankenhaus im Siebengebirge, Schülgenstr. 15, 53604, Bad Honnef, Deutschland

    S. Wirz

  2. Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin, Universitätskliniken Bonn, Bonn, Deutschland

    J. Nadstawek & S. Vater

  3. Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum des Saarlandes, Homburg/Saar, Deutschland

    K.U. Kühn

  4. Abteilung Anästhesie, Spezielle Schmerztherapie und Palliativmedizin, Sana-Klinikum Remscheid, akademisches Lehrkrankenhaus der Ruhruniversität Bochum, Remscheid, Deutschland

    U. Junker

  5. Afdeling Anesthesiologie, Academisch Medisch Centrum (AMC), Amsterdam, Niederlande

    H.C. Wartenberg

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  1. S. Wirz
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  4. S. Vater
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Correspondence to S. Wirz.

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Wirz, S., Nadstawek, J., Kühn, K. et al. Modafinil zur Behandlung der Tumorfatigue. Schmerz 24, 587–595 (2010). https://doi.org/10.1007/s00482-010-0987-y

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