Universität zu Köln

Simon, Steffen T., Kloke, Marianne, Alt-Epping, Bernd, Gaertner, Jan ORCID: 0000-0002-1176-3164, Hellmich, Martin, Hein, Rebecca, Piel, Maren, Cornely, Oliver A., Nauck, Friedemann and Voltz, Raymond (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. J. Pain Symptom Manage., 52 (5). S. 617 - 626. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1873-6513

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Abstract

Context. Episodic breathlessness is a frequent and burdensome symptom in cancer patients but pharmacological treatment is limited. Objectives. To determine time to onset, efficacy, feasibility, and safety of transmucosal fentanyl in comparison to immediate-release morphine for the relief of episodic breathlessness. Methods. Phase II, investigator-initiated, multicenter, open-label, randomized, morphine-controlled, crossover trial with openlabel 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. Results. Twenty-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. Conclusion. The description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial. (C) 2016 Published by Elsevier Inc. on behalf of American Academy of Hospice and Palliative Medicine.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Simon, Steffen T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kloke, Marianne UNSPECIFIED UNSPECIFIED UNSPECIFIED Alt-Epping, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Gaertner, Jan UNSPECIFIED orcid.org/0000-0002-1176-3164 UNSPECIFIED Hellmich, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Hein, Rebecca UNSPECIFIED UNSPECIFIED UNSPECIFIED Piel, Maren UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nauck, Friedemann UNSPECIFIED UNSPECIFIED UNSPECIFIED Voltz, Raymond UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-257842
DOI:	10.1016/j.jpainsymman.2016.05.023
Journal or Publication Title:	J. Pain Symptom Manage.
Volume:	52
Number:	5
Page Range:	S. 617 - 626
Date:	2016
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1873-6513
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DOUBLE-BLIND; EXERCISE; DYSPNEA; INTENSITY; CITRATE; PAIN Multiple languages Health Care Sciences & Services; Medicine, General & Internal; Clinical Neurology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/25784