Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

Overview

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.

Full Title of Study: “Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2019

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.

Interventions

  • Other: Hypoglossal acupuncture
  • Other: Sham acupuncture
  • Behavioral: Dietary recommendations

Arms, Groups and Cohorts

  • 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.
  • 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.
  • Active Comparator: Dietary recommendations
    • This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society.

Clinical Trial Outcome Measures

Primary Measures

  • Dysgeusia (Phantogeusia) (NRS – Numeric Rating Scale)
    • Time Frame: 7 days

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universität Duisburg-Essen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heidemarie Haller, Postdoctoral Research Fellow – Universität Duisburg-Essen
  • Overall Official(s)
    • Gustav Dobos, Prof., MD, Study Director, Department of Internal and Integrative Medicine | Kliniken Essen-Mitte | Faculty of Medicine | University of Duisburg-Essen
  • Overall Contact(s)
    • Heidemarie Haller, PhD, 004920117425044, h.haller@kem-med.com

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