Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Duisburg-Essen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hypoglossal acupuncture
Other interventionSham acupuncture
Other interventionDietary recommendations
Behavioral
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Hypoglossal acupunctureExperimental treatment 1 intervention
Group B: Sham acupunctureSham comparator 1 intervention
Group C: Dietary recommendationsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale)
Time frame
7 daysSecondary outcomes
1
Dysgeusia (Parageusia, Hypogeusia, Hypergeusia) (NRS - Numeric Rating Scale)
Time frame
7 days2
Xerostomia (NRS - Numeric Rating Scale)
Time frame
7 days3
Stomatitis (NRS - Numeric Rating Scale)
Time frame
7 days4
Appetite (NRS - Numeric Rating Scale)
Time frame
7 daysOther outcomes
1
Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index)
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov