Clinical trial NCT02304913: Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
Official title: Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acupuncture
Taste Disorders
Dysgeusia
Chemotherapy
Cancer
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
timeFrame: 7 days
Secondary outcomes:
measure: Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
timeFrame: 7 days
measure: Xerostomia (NRS - Numeric Rating Scale)
timeFrame: 7 days
measure: Stomatitis (NRS - Numeric Rating Scale)
timeFrame: 7 days
measure: Appetite (NRS - Numeric Rating Scale)
timeFrame: 7 days
measure: Impairment (NRS - Numeric Rating Scale)
timeFrame: 7 days
measure: Adverse Events (free text)
timeFrame: 7 days
Other outcomes:
measure: Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)
timeFrame: 7 days
Locations:
city: Essen
country: Germany
facility: Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte
state: NRW
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim, Internistische Onkologie
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus Stuttgart
Study officials:
affiliation: Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
name: Gustav Dobos, Prof., MD
role: STUDY_DIRECTOR
References:
citation: Haller H, Wang T, Lauche R, Choi KE, Voiss P, Felber S, Cramer H, Ataseven B, Kummel S, Paul A, Dobos G. Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial. Trials. 2019 Jul 4;20(1):398. doi: 10.1186/s13063-019-3525-y.