Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
OralAcu
1 other identifier
interventional
75
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 14, 2026
April 1, 2026
13 years
November 19, 2014
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
7 days
Secondary Outcomes (6)
Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
7 days
Xerostomia (NRS - Numeric Rating Scale)
7 days
Stomatitis (NRS - Numeric Rating Scale)
7 days
Appetite (NRS - Numeric Rating Scale)
7 days
Impairment (NRS - Numeric Rating Scale)
7 days
- +1 more secondary outcomes
Other Outcomes (1)
Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)
7 days
Study Arms (3)
Hypoglossal acupuncture
EXPERIMENTALSingle treatment of hypoglossal needle acupuncture during the chemotherapy administration: Treated points will be Jinjin (Golden Liquid/EX-HN12) left beside the lingual frenulum and Yuye (Jade Fluid/EX-HN13) right beside the lingual frenulum. Both points are treated in quick succession with immediate removal of the needle.
Sham acupuncture
SHAM COMPARATORSingle treatment of hypoglossal sham acupuncture uring the chemotherapy administration: Treated points will be 1 to 1.5 cun (a cun is defined as the width of the patient's thumb at the knuckle) beside the verum acupuncture points Jinjin and Yuye using the dull side of the needle.
Dietary recommendations
ACTIVE COMPARATORThis group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45136, Germany
Universitätsklinikum Mannheim, Internistische Onkologie
Mannheim, 68167, Germany
Robert Bosch Krankenhaus Stuttgart
Stuttgart, 70376, Germany
Related Publications (1)
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.
PMID: 31272494DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gustav Dobos, Prof., MD
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Research Fellow
Study Record Dates
First Submitted
November 19, 2014
First Posted
December 2, 2014
Study Start
January 1, 2015
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04