Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy (OralAcu)

April 2, 2024 updated by: Heidemarie Haller, Universität Duisburg-Essen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • NRW
      • Essen, NRW, Germany, 45136
        • Active, not recruiting
        • Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
Time Frame: 7 days
7 days
Xerostomia (NRS - Numeric Rating Scale)
Time Frame: 7 days
7 days
Stomatitis (NRS - Numeric Rating Scale)
Time Frame: 7 days
7 days
Appetite (NRS - Numeric Rating Scale)
Time Frame: 7 days
7 days
Impairment (NRS - Numeric Rating Scale)
Time Frame: 7 days
7 days
Adverse Events (free text)
Time Frame: 7 days
7 days

Other Outcome Measures

Outcome Measure
Time Frame
Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Investigators

  • Study Director: Gustav Dobos, Prof., MD, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimated)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-5953-BO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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