Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acupuncture, Taste Disorders, Dysgeusia, Chemotherapy, Cancer

Intervention / Treatment
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* Other: Hypoglossal acupuncture
* Other: Sham acupuncture
* Behavioral: Dietary recommendations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypoglossal acupuncture<br>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<br> <br> |
| Sham Comparator: Sham acupuncture<br>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<br> <br> |
| Active Comparator: Dietary recommendations<br>This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society. | Behavioral: Dietary recommendations<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale) |  | 7 days | 
| Xerostomia (NRS - Numeric Rating Scale) |  | 7 days | 
| Stomatitis (NRS - Numeric Rating Scale) |  | 7 days | 
| Appetite (NRS - Numeric Rating Scale) |  | 7 days | 
| Impairment (NRS - Numeric Rating Scale) |  | 7 days | 
| Adverse Events (free text) |  | 7 days |