Universität zu Köln

Haller, Heidemarie ORCID: 0000-0001-7973-4071, Wang, Taige, Lauche, Romy ORCID: 0000-0002-4171-7935, Choi, Kyung-Eun, Voiss, Petra, Felber, Sabine, Cramer, Holger, Ataseven, Beyhan, Kuemmel, Sherko, Paul, Anna and Dobos, Gustav (2019). Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial. Trials, 20. LONDON: BMC. ISSN 1745-6215

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Abstract

BackgroundDistortion of taste sensations is a common chemotherapy-induced side effect; however, treatment evidence is limited. Pilot data indicated that acupuncture might be able to improve symptoms of dysgeusia. Thus, the aim of this study is to investigate the effects and side effects of hypoglossal acupuncture in the treatment of dysgeusia in patients with breast cancer undergoing chemotherapy.Methods/designThe study is a randomized controlled trial comparing a single verum acupuncture treatment with two active comparators: sham acupuncture and dietary recommendations. Sample size calculation revealed a total of 75 patients pending an alpha of 0.05, a power of 0.8, and an estimated effect size of 0.80. Patients with breast cancer undergoing platinum- or taxane-based chemotherapy will be included if they present with phantogeusia (abnormal taste sensations without an external oral stimulus) with an intensity of 4 points or above on an 11-point numeric rating scale (NRS). The primary outcome is phantogeusia; secondary outcomes include parageusia (abnormal taste of food), hypogeusia (reduced taste sensations), hypergeusia (increased taste sensations), xerostomia (dry mouth), stomatitis, appetite, and functional impairment. All outcomes will be assessed at baseline and prior to the next chemotherapy administration using an 11-point NRS for each. All adverse events will be recorded.DiscussionThe results of this study will demonstrate the extent to which hypoglossal acupuncture may influence the intensity of and functional impairment due to chemotherapy-induced dysgeusia.Trial registrationClinical Trials.gov, NCT02304913. Registered on 19 November 2014.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Haller, Heidemarie UNSPECIFIED orcid.org/0000-0001-7973-4071 UNSPECIFIED Wang, Taige UNSPECIFIED UNSPECIFIED UNSPECIFIED Lauche, Romy UNSPECIFIED orcid.org/0000-0002-4171-7935 UNSPECIFIED Choi, Kyung-Eun UNSPECIFIED UNSPECIFIED UNSPECIFIED Voiss, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Felber, Sabine UNSPECIFIED UNSPECIFIED UNSPECIFIED Cramer, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Ataseven, Beyhan UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuemmel, Sherko UNSPECIFIED UNSPECIFIED UNSPECIFIED Paul, Anna UNSPECIFIED UNSPECIFIED UNSPECIFIED Dobos, Gustav UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-135462
DOI:	10.1186/s13063-019-3525-y
Journal or Publication Title:	Trials
Volume:	20
Date:	2019
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PLACEBO-CONTROLLED TRIAL; TASTE ALTERATIONS; DOUBLE-BLIND; HEAD; AMIFOSTINE; ZINC; CARE Multiple languages Medicine, Research & Experimental Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/13546