• J Pain Symptom Manage · Nov 2016

    EffenDys - Fentanyl buccal tablet for the relief of episodic breathlessness in patients with advanced cancer: a multicenter, open label, randomized, morphine-controlled, crossover, phase II trial.

    • Steffen T Simon, Marianne Kloke, Bernd Alt-Epping, Jan Gärtner, Martin Hellmich, Rebecca Hein, Maren Piel, Oliver A Cornely, Friedemann Nauck, and Raymond Voltz.
    • Department of Palliative Medicine and Clinical Trial Unit in Palliative Care, University Hospital of Cologne, Cologne, Germany; Center for Integrated Oncology (CIO) Cologne/Bonn, University Hospital of Cologne, Cologne, Germany. Electronic address: steffen@steffensimon.de.
    • J Pain Symptom Manage. 2016 Nov 1; 52 (5): 617-625.

    ContextEpisodic breathlessness is a frequent and burdensome symptom in cancer patients but pharmacological treatment is limited.ObjectivesTo determine time to onset, efficacy, feasibility, and safety of transmucosal fentanyl in comparison to immediate-release morphine for the relief of episodic breathlessness.MethodsPhase II, investigator-initiated, multicenter, open-label, randomized, morphine-controlled, crossover trial with open-label titration of fentanyl buccal tablet (FBT) in inpatients with incurable cancer. The primary outcome was time to onset of meaningful breathlessness relief. Secondary outcomes were efficacy (breathlessness intensity difference at 10 and 30 minutes; sum of breathlessness intensity difference at 15 and 60 minutes), feasibility, and safety. Study was approved by local ethics committees.ResultsTwenty-five of 1341 patients were eligible, 10 patients agreed to participate (four female, mean age 58 ± 11, mean Karnofsky score 67 ± 11). Two patients died before final visits and two patients dropped-out because of disease progression leaving six patients for analysis with 61 episodes of breathlessness. Mean time to onset was for FBT 12.7 ± 10.0 and for immediate-release morphine 23.6 ± 15.1 minutes with a mean difference of -10.9 minutes (95% CI = -24.5 to 2.7, P = 0.094). Efficacy measures were predominately in favor for FBT. Both interventions were safe. Feasibility failed because of too much study demands for a very ill patient group.ConclusionThe description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial.Copyright © 2016. Published by Elsevier Inc.

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