ClinicalTrials.gg
RecruitingNCT02304913OralAcuUpdated Apr 14, 2026

Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

An interventional study of Hypoglossal acupuncture and Sham acupuncture in Acupuncture, Taste Disorders and Dysgeusia, sponsored by Universität Duisburg-Essen. Recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Primary conditionDysgeusiaRegistry: Taste DisordersReclassifiedWhy we changed it
Registry
Taste Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Dysgeusia
Why
  1. The study's listed conditions name Dysgeusia, a narrower term within Taste Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2015; still recruiting 11 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acupuncture
  • Taste Disorders
  • Dysgeusia
  • Chemotherapy
  • Cancer

Browse trials for

03

In context

Dysgeusia Reclassified

52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.

This study's planned enrollment of 75 is above the median of 49 across 28 interventional studies indexed under Dysgeusia.

Browse Dysgeusia studies →

Lead sponsor

Universität Duisburg-Essen is the lead sponsor of 85 studies on the registry; 14 are open to participants now.

Compared within Dysgeusia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Taste Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Hypoglossal acupuncture

  • Sham comparator
    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.

    Other: Sham acupuncture

  • Active comparator
    Dietary recommendations

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

    Behavioral: Dietary recommendations

Interventions

  • OtherHypoglossal acupuncture
  • OtherSham acupuncture
  • BehavioralDietary recommendations
06

What researchers measure

Primary outcomes

  1. Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)

    Time frame: 7 days

Secondary outcomes

  1. Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)

    Time frame: 7 days

  2. Xerostomia (NRS - Numeric Rating Scale)

    Time frame: 7 days

  3. Stomatitis (NRS - Numeric Rating Scale)

    Time frame: 7 days

  4. Appetite (NRS - Numeric Rating Scale)

    Time frame: 7 days

  5. Impairment (NRS - Numeric Rating Scale)

    Time frame: 7 days

  6. Adverse Events (free text)

    Time frame: 7 days

Other outcomes

  1. Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)

    Time frame: 7 days

07

Study locations

1 of 3 sites recruiting
  • Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte
    Essen, North Rhine-Westphalia 45136, Germany
    Active, not recruiting

    Not enrolling at this site.

  • Universitätsklinikum Mannheim, Internistische Onkologie
    Mannheim, 68167, Germany
    Recruiting
  • Robert Bosch Krankenhaus Stuttgart
    Stuttgart, 70376, Germany
    Not yet recruiting
08

References and documents

Publications

  • 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. PubMed 31272494 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2015 (actual). Primary completion is estimated for Dec 2027, 155 months after the start.

Of 18 interventional studies with no phase under Dysgeusia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 16. This study's planned 155 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2014
First posted
Dec 2, 2014
StartActual
Jan 1, 2015
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Apr 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02304913
Lead sponsor
Universität Duisburg-Essen
Responsible party
Heidemarie Haller (Postdoctoral Research Fellow, Universität Duisburg-Essen) — Principal investigator
First posted
Dec 2, 2014
Start date
Jan 1, 2015
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 14, 2026

Study contacts

Heidemarie Haller, PhD
Contact
heidemarie.haller@uk-essen.de
+4920172377382
Holger Cramer, PhD
Contact
holger.cramer@med.uni-tuebingen.de
Gustav Dobos, Prof., MD
study director · Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion