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Published (Version of record)CC BY V4.0, Open Access
Journal article
Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial
Trials, Vol.20(1), pp.398-398
2019
PMCID: PMC6610893
PMID: 31272494
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Source: InCites
Abstract
Distortion 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. The 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. The 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. Clinical Trials.gov, NCT02304913 . Registered on 19 November 2014.
Details
- Title
- Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial
- Creators
- Heidemarie Haller (Author) - University of Duisburg-EssenTaige Wang (Author) - Kliniken Essen-MitteRomy Lauche (Author) - University of Technology SydneyKyung-Eun Choi (Author) - University of ColognePetra Voiß (Author) - Kliniken Essen-MitteSabine Felber (Author) - Kliniken Essen-MitteHolger Cramer (Author) - University of Duisburg-EssenBeyhan Ataseven (Author) - Kliniken Essen-MitteSherko Kümmel (Author) - Kliniken Essen-MitteAnna Paul (Author) - University of Duisburg-EssenGustav Dobos (Author) - University of Duisburg-Essen
- Publication Details
- Trials, Vol.20(1), pp.398-398
- Publisher
- BioMed Central
- Identifiers
- 991012854698802368
- Academic Unit
- Faculty of Health; National Centre for Naturopathic Medicine
- Language
- English
- Resource Type
- Journal article