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OralAcu: Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

Sponsor
Universität Duisburg-Essen (Other)
Overall Status
Recruiting
CT.gov ID
NCT02304913
Collaborator
(none)
75
Enrollment
2
Locations
3
Arms
107
Anticipated Duration (Months)
37.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypoglossal acupuncture
  • Other: Sham acupuncture
  • Behavioral: Dietary recommendations
 N/A

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 Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) [7 days]

Secondary Outcome Measures

  1. Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale) [7 days]

  2. Xerostomia (NRS - Numeric Rating Scale) [7 days]

  3. Stomatitis (NRS - Numeric Rating Scale) [7 days]

  4. Appetite (NRS - Numeric Rating Scale) [7 days]

  5. Impairment (NRS - Numeric Rating Scale) [7 days]

  6. Adverse Events (free text) [7 days]

Other Outcome Measures

  1. Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index) [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte Essen NRW Germany 45136
2 Universitätsklinikum Mannheim, Internistische Onkologie Mannheim Germany 68167

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heidemarie Haller, Postdoctoral Research Fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT02304913
Other Study ID Numbers:
  • 14-5953-BO
First Posted:
Dec 2, 2014
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Additional relevant MeSH terms:
Taste Disorders
Dysgeusia

Study Results

No Results Posted as of May 18, 2022