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Tytuł:
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Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial.
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Autorzy:
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Haller H; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany. .
Wang T; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.; Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
Lauche R; Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), Faculty of Health, University of Technology Sydney (UTS), Sydney, Australia.
Choi KE; Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR) at the Faculty of Human Sciences and the Faculty of Medicine of the University of Cologne, Cologne, Germany.
Voiß P; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.; Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
Felber S; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.; Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen, Germany.
Cramer H; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.
Ataseven B; Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen, Germany.
Kümmel S; Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
Paul A; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.
Dobos G; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany.
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Źródło:
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Trials [Trials] 2019 Jul 04; Vol. 20 (1), pp. 398. Date of Electronic Publication: 2019 Jul 04.
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Typ publikacji:
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Clinical Trial Protocol; Journal Article
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Język:
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English
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Imprint Name(s):
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Original Publication: [London] : BioMed Central, 2006-
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MeSH Terms:
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Acupuncture Therapy/*methods
Antineoplastic Combined Chemotherapy Protocols/*adverse effects
Breast Neoplasms/*drug therapy
Taste/*drug effects
Tongue/*innervation
Dysgeusia/chemically induced ; Dysgeusia/diagnosis ; Dysgeusia/physiopathology ; Female ; Germany ; Humans ; Randomized Controlled Trials as Topic ; Time Factors ; Treatment Outcome
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Contributed Indexing:
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Keywords: Acupuncture; Cancer; Chemotherapy; Dysgeusia; Randomized controlled trial; Taste disorders
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Molecular Sequence:
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ClinicalTrials.gov NCT02304913
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Entry Date(s):
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Date Created: 20190706 Date Completed: 20200224 Latest Revision: 20200225
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Update Code:
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20240105
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PubMed Central ID:
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PMC6610893
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DOI:
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10.1186/s13063-019-3525-y
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PMID:
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31272494
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Background: 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.
Methods/design: 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.
Discussion: 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.
Trial Registration: Clinical Trials.gov, NCT02304913 . Registered on 19 November 2014.
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