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Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy (OralAcu)

Primary Purpose

Acupuncture, Taste Disorders, Dysgeusia

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypoglossal acupuncture
Sham acupuncture
Dietary recommendations
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte
  • Universitätsklinikum Mannheim, Internistische OnkologieRecruiting
  • Robert Bosch Krankenhaus Stuttgart

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Hypoglossal acupuncture

Sham acupuncture

Dietary recommendations

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)

Secondary Outcome Measures

Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
Xerostomia (NRS - Numeric Rating Scale)
Stomatitis (NRS - Numeric Rating Scale)
Appetite (NRS - Numeric Rating Scale)
Impairment (NRS - Numeric Rating Scale)
Adverse Events (free text)

Full Information

First Posted
November 19, 2014
Last Updated
December 5, 2022
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT02304913
Brief Title
Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
Acronym
OralAcu
Official Title
Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Taste Disorders, Dysgeusia, Chemotherapy, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoglossal acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Dietary recommendations
Arm Type
Active Comparator
Arm Description
This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society.
Intervention Type
Other
Intervention Name(s)
Hypoglossal acupuncture
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Type
Behavioral
Intervention Name(s)
Dietary recommendations
Primary Outcome Measure Information:
Title
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
Time Frame
7 days
Title
Xerostomia (NRS - Numeric Rating Scale)
Time Frame
7 days
Title
Stomatitis (NRS - Numeric Rating Scale)
Time Frame
7 days
Title
Appetite (NRS - Numeric Rating Scale)
Time Frame
7 days
Title
Impairment (NRS - Numeric Rating Scale)
Time Frame
7 days
Title
Adverse Events (free text)
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidemarie Haller, PhD
Phone
+4920172377382
Email
heidemarie.haller@uk-essen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Holger Cramer, PhD
Email
holger.cramer@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof., MD
Organizational Affiliation
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte
City
Essen
State/Province
NRW
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Mannheim, Internistische Onkologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf-Dieter Hofheinz, MD
Email
ralf-dieter.hofheinz@medma.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Simone Weingärtner, MD
Email
simone.weingaertner@umm.de
Facility Name
Robert Bosch Krankenhaus Stuttgart
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcela Winkler, MD
Email
Marcela.Winkler@rbk.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
31272494
Citation
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.
Results Reference
derived

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Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

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