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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglossal acupuncture | Experimental | 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 acupuncture | Sham Comparator | 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. |
|
| Dietary recommendations | Active Comparator | This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal acupuncture | Other |
| ||
| Sham acupuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) | 7 days |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index) | 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidemarie Haller, PhD | Contact | +4920172377382 | heidemarie.haller@uk-essen.de | |
| Holger Cramer, PhD | Contact | holger.cramer@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof., MD | Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte | Active, not recruiting | Essen | North Rhine-Westphalia | 45136 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31272494 | Derived | 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. |
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| ID | Term |
|---|---|
| D013651 | Taste Disorders |
| D004408 | Dysgeusia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| Dietary recommendations | Behavioral |
|
| 7 days |
| Appetite (NRS - Numeric Rating Scale) | 7 days |
| Impairment (NRS - Numeric Rating Scale) | 7 days |
| Adverse Events (free text) | 7 days |
| Universitätsklinikum Mannheim, Internistische Onkologie | Recruiting | Mannheim | 68167 | Germany |
|
| Robert Bosch Krankenhaus Stuttgart | Not yet recruiting | Stuttgart | 70376 | Germany |
|
| D013568 | Pathological Conditions, Signs and Symptoms |