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Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy (OralAcu)

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ClinicalTrials.gov Identifier: NCT02304913
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen

Tracking Information
First Submitted Date  ICMJE November 19, 2014
First Posted Date  ICMJE December 2, 2014
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2014)
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
Change History Complete list of historical versions of study NCT02304913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2014)
  • Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
  • Xerostomia (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
  • Stomatitis (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
  • Appetite (NRS - Numeric Rating Scale) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
  • Adverse Events (free text) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
Current Other Pre-specified Outcome Measures
 (submitted: July 21, 2015)
Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index) [ Time Frame: 7 days ]
Original Other Pre-specified Outcome Measures
 (submitted: November 27, 2014)
Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index) [ Time Frame: 7 days (CTX A) / 21 days (CTX B) ]
 
Descriptive Information
Brief Title  ICMJE Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
Official Title  ICMJE Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acupuncture
  • Taste Disorders
  • Dysgeusia
  • Chemotherapy
  • Cancer
Intervention  ICMJE
  • Other: Hypoglossal acupuncture
  • Other: Sham acupuncture
  • Behavioral: Dietary recommendations
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Sham acupuncture
  • Active Comparator: Dietary recommendations
    This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society.
    Intervention: Behavioral: Dietary recommendations
Publications * Haller H, Wang T, Lauche R, Choi KE, Voiß P, Felber S, Cramer H, Ataseven B, Kümmel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2014)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Initial treatment with platinum-containing or taxane-based CTX (regardless of the the length of the CTX cycle)
  • Breast cancer
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heidemarie Haller, PhD 004920117425044 h.haller@kem-med.com
Contact: Holger Cramer, PhD h.cramer@kem-med.com
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02304913
Other Study ID Numbers  ICMJE 14-5953-BO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heidemarie Haller, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gustav Dobos, Prof., MD Department of Internal and Integrative Medicine | Kliniken Essen-Mitte | Faculty of Medicine | University of Duisburg-Essen
PRS Account Universität Duisburg-Essen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP