NCT Number: NCT02304913
Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
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.
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte, Essen, North Rhine-Westphalia, Germany
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sham Acupuncture
OtherDietary recommendations
BehavioralPrimary outcomes
-
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
Time frame: 7 days
Secondary outcomes
-
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
Other outcomes
-
Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)
Time frame: 7 days
Study contacts
Contact information is provided by the study sponsor or research team.
Heidemarie Haller, PhD
CONTACT
Holger Cramer, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Universität Duisburg-Essen
Other
Registry information
Official study title
Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Acronym: OralAcu
Important dates
- Study start
- 2015
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Dec 2, 2014
- Registry last updated
- Apr 14, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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