Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

NCT ID: NCT02304913

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acupuncture Taste Disorders Dysgeusia Chemotherapy Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypoglossal acupuncture

Single 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.

Group Type EXPERIMENTAL

Hypoglossal acupuncture

Intervention Type OTHER

Sham acupuncture

Single 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.

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type OTHER

Dietary recommendations

This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society.

Group Type ACTIVE_COMPARATOR

Dietary recommendations

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hypoglossal acupuncture

Intervention Type OTHER

Sham acupuncture

Intervention Type OTHER

Dietary recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heidemarie Haller

Postdoctoral Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gustav Dobos, Prof., MD

Role: STUDY_DIRECTOR

Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Mannheim, Internistische Onkologie

Mannheim, , Germany

Site Status RECRUITING

Robert Bosch Krankenhaus Stuttgart

Stuttgart, , Germany

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Heidemarie Haller, PhD

Role: CONTACT

+4920172377382

Holger Cramer, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ralf-Dieter Hofheinz, MD

Role: primary

Simone Weingärtner, MD

Role: backup

Marcela Winkler, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31272494 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-5953-BO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.