Acupuncture, Taste Disorders, Dysgeusia, Chemotherapy, Cancer
Conditions
Brief 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.
Detailed 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.
Interventions
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysgeusia (Phantogeusia) (NRS - Numeric Rating Scale) | 7 days |
Secondary
| Measure | 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 |
| Impairment (NRS - Numeric Rating Scale) | 7 days |
| Adverse Events (free text) | 7 days |
| Appetite (NRS - Numeric Rating Scale) | 7 days |
Other
| Measure | Time frame |
|---|---|
| Treatment Expectancy and Credibility (TCS - Treatment Credibility Scale + BI - Blining Index) | 7 days |
Countries
Germany
Contacts
Primary ContactHeidemarie Haller, PhD
Backup ContactHolger Cramer, PhD
Outcome results
None listed