AcupunctureOralAcuNCT02304913
Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
A study testing Hypoglossal acupuncture and Dietary recommendations in people with Acupuncture and Taste Disorders, run by Universität Duisburg-Essen at 3 sites in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acupuncture, Taste Disorders, Dysgeusia
- What is being tested?
- Hypoglossal acupuncture and Dietary recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Jan 2015to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Holger Cramer, PhD contact
Germany3 sites, 2 recruiting
- Active, not recruiting
Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45136
- Recruiting
Universitätsklinikum Mannheim, Internistische Onkologie
Mannheim, 68167
Ralf-Dieter Hofheinz, MD, ralf-dieter.hofheinz@medma.uni-heidelberg.de
Simone Weingärtner, MD, simone.weingaertner@umm.de
- Not yet recruiting
Robert Bosch Krankenhaus Stuttgart
Stuttgart, 70376
Marcela Winkler, MD, Marcela.Winkler@rbk.de
About this study
Official title: Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
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.
- Conditions
- Acupuncture, Taste Disorders, Dysgeusia, Chemotherapy, Cancer
- Being tested
- Hypoglossal acupuncture, Sham acupuncture, Dietary recommendations
- Medical subject headings
- Taste Disorders, Dysgeusia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal acupunctureOther
Sham acupunctureOther
Dietary recommendationsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal acupuncture | Experimental | 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. Receives: Other: Hypoglossal acupuncture |
| Sham acupuncture | Sham comparator | 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. Receives: Other: Sham acupuncture |
| Dietary recommendations | Active comparator | This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society. Receives: Behavioral: Dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
Measured: 7 days
Secondary outcomes (6)
Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
Measured: 7 days
Xerostomia (NRS - Numeric Rating Scale)
Measured: 7 days
Stomatitis (NRS - Numeric Rating Scale)
Measured: 7 days
Appetite (NRS - Numeric Rating Scale)
Measured: 7 days
Impairment (NRS - Numeric Rating Scale)
Measured: 7 days
Adverse Events (free text)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof., MD, Study director, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304913
- Sponsor's protocol ID
- 14-5953-BO
- Acronym
- OralAcu
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2014
- Last updated
- 14 Apr 2026
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02304913
- Acronym / sponsor ID
- OralAcu / 14-5953-BO
- Conditions
- Acupuncture, Taste Disorders, Dysgeusia, Chemotherapy, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypoglossal acupuncture | Experimental | Other: Hypoglossal acupunctureSingle 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 comparator | Other: Sham acupunctureSingle 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 comparator | Behavioral: Dietary recommendationsThis group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglossal acupuncture | Other | Hypoglossal acupuncture |
| Sham acupuncture | Other | Sham acupuncture |
| Dietary recommendations | Behavioural | Dietary recommendations |
Primary outcome
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
Time frame: 7 days
6 secondary outcomes
Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
Time frame: 7 days
Xerostomia (NRS - Numeric Rating Scale)
Time frame: 7 days
Stomatitis (NRS - Numeric Rating Scale)
Time frame: 7 days
Appetite (NRS - Numeric Rating Scale)
Time frame: 7 days
Impairment (NRS - Numeric Rating Scale)
Time frame: 7 days
Adverse Events (free text)
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 31272494Haller 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.
Related trials for Acupuncture
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Recruiting
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
Recruiting
Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
Psychological Distress, Insomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holger Cramer, PhD contact
Gustav Dobos, Prof., MD study director
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglossal acupuncture and Dietary recommendations in people with Acupuncture and Taste Disorders, run by Universität Duisburg-Essen at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidemarie Haller, PhD (+4920172377382, heidemarie.haller@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.