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NCT Number: NCT02304913

Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte, Essen, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoglossal acupuncture

Other

Sham Acupuncture

Other

Dietary recommendations

Behavioral

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

Study contacts

Contact information is provided by the study sponsor or research team.

Heidemarie Haller, PhD

CONTACT

[email protected]

+4920172377382

Holger Cramer, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

Acronym: OralAcu

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2014
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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