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Recruiting NCT02304913

Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

No phase Interventional Acupuncture Taste Disorders Dysgeusia Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypoglossal acupuncture, Sham acupuncture, Dietary recommendations.
Who it may be relevant to
Registry conditions: Acupuncture, Taste Disorders, Dysgeusia, Chemotherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

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.

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

Primary outcome measures

  • Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) [Time frame: 7 days]
Secondary outcome measures (6)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Germany · 3 centers
  • Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte — Essen
  • Universitätsklinikum Mannheim, Internistische Onkologie — Mannheim
  • Robert Bosch Krankenhaus Stuttgart — Stuttgart

Publications

  • 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. PMID 31272494

Identifiers

NCT: NCT02304913 · 14-5953-BO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗