Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy (OralAcu)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    75
  • sponsor
    Universität Duisburg-Essen
Updated on 30 May 2022
cancer
breast cancer
chemotherapy regimen
primary cancer
taxane

Summary

This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.

Description

Taste disorders are frequent side effects in patients undergoing chemotherapy (CTX). Dysguesia has prevalence rates of 16% to 1000% during CTX with sometimes also persistent courses. Impact of dysguesia on appetite, body weight as well as health-related quality of life was shown. Until now, evidence for adequate treatment options is limited to specific diary recommendations. Acupuncture in the treatment of side effects of chemotherapy was investigated for nausea and xerostomia, but not for dysguesia. Therefore, this randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.

Details
Condition Acupuncture, Taste Disorders, Dysgeusia, Chemotherapy, Cancer
Treatment Sham acupuncture, Hypoglossal acupuncture, Dietary recommendations
Clinical Study IdentifierNCT02304913
SponsorUniversität Duisburg-Essen
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Initial treatment with platinum-containing or taxane-based CTX (regardless of the the length of the CTX cycle)
Senological, gynecological or internistic tumors
Phantogeusia (on average ≥4 NRS)
Willingness to participate in the study and written informed consent

Exclusion Criteria

Severe stomatitis
Dysgeusia before the CTX based on neurological diseases, diabetes, or the ingestion of drugs with taste disorders as side effects
Leucopenia/neutropenia
Intake of anticoagulants
Smoking
Severe physical or mental comorbidity (due to which the patient is unable to participate in the study)
Participation in other CAM treatments within the integrative oncology care
Participation in other studies on the effectiveness of interventions for oral complications
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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