Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

Cancer Clinical Trial

— OralAcu  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02304913
• Other study ID #: 14-5953-BO
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Universität Duisburg-Essen
• Contact: Heidemarie Haller, PhD
• Phone: +4920172377382
• Email: heidemarie.haller[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Cancer
• Chemotherapy
• Dysgeusia
• Taste Disorders

Intervention

Other:
• Hypoglossal acupuncture

• Sham acupuncture

Behavioral:
• Dietary recommendations

Locations

Country	Name	City	State
Germany	Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte	Essen	NRW
Germany	Universitätsklinikum Mannheim, Internistische Onkologie	Mannheim
Germany	Robert Bosch Krankenhaus Stuttgart	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)		7 days
Primary	Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)		7 days
Secondary	Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)		7 days
Secondary	Xerostomia (NRS - Numeric Rating Scale)		7 days
Secondary	Stomatitis (NRS - Numeric Rating Scale)		7 days
Secondary	Appetite (NRS - Numeric Rating Scale)		7 days
Secondary	Impairment (NRS - Numeric Rating Scale)		7 days
Secondary	Adverse Events (free text)		7 days