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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 : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen

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.

Condition or disease Intervention/treatment Phase
Acupuncture Taste Disorders Dysgeusia Chemotherapy Cancer Other: Hypoglossal acupuncture Other: Sham acupuncture Behavioral: Dietary recommendations Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Hypoglossal acupuncture
Following acupuncture points will be engraved: Jinjin (EX-HN12) and Yuye (EX-HN13).
Other: Hypoglossal acupuncture
Sham Comparator: Sham acupuncture
The sham acupuncture will also carried out twice, each time after the CTX cycle. But the needle will be applied 1-1,5 cun beside the real acupuncture points in the palate 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



Primary Outcome Measures :
  1. Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index) [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304913


Contacts
Contact: Heidemarie Haller, PhD 004920117425044 h.haller@kem-med.com
Contact: Holger Cramer, PhD h.cramer@kem-med.com

Locations
Germany
Department of Gynecology & Gynecologic Oncology, Kliniken Essen-Mitte Recruiting
Essen, NRW, Germany, 45136
Contact: Heidemarie Haller, MSc    004920117425044    h.haller@kem-med.com   
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Study Director: Gustav Dobos, Prof., MD Department of Internal and Integrative Medicine | Kliniken Essen-Mitte | Faculty of Medicine | University of Duisburg-Essen

Responsible Party: Heidemarie Haller, PhD, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02304913     History of Changes
Other Study ID Numbers: 14-5953-BO
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Dysgeusia
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms