Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial.
Heidemarie Haller, Taige Wang, Romy Lauche...
https://pubmed.ncbi.nlm.nih.gov/31272494Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02304913
Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Led by Universität Duisburg-Essen · Updated on 2026-04-14
75
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating hypoglossal acupuncture as a treatment for dysgeusia, a taste disorder commonly experienced by cancer patients undergoing chemotherapy. The study compares hypoglossal acupuncture with sham acupuncture and standard dietary recommendations. Dysgeusia can affect appetite, body weight, and quality of life, and currently, treatment options are limited mainly to dietary advice. This trial aims to provide evidence on whether acupuncture can help manage this side effect during chemotherapy. Participants will receive one of three interventions during chemotherapy administration: a single hypoglossal needle acupuncture treatment targeting specific points beside the lingual frenulum, a sham acupuncture treatment using blunt needles near the acupuncture points, or follow specific dietary recommendations for dysgeusia provided by the German Cancer Society. Each treatment is given once during chemotherapy sessions. Throughout the study, participants' taste disturbances will be assessed using a numeric rating scale over seven days, focusing on phantogeusia as the primary outcome. Secondary outcomes include other taste changes, dry mouth, mouth inflammation, appetite, and overall impairment, also rated over seven days. Adverse events will be monitored. Participants' involvement includes consenting to treatment allocation and completing assessments related to taste and oral symptoms during chemotherapy.
CONDITIONS
Brief Title
Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Initial treatment with platinum-containing or taxane-based chemotherapy regardless of cycle length
- Diagnosis of breast, gynecological, or internal medicine tumors
- Phantom taste sensation with an average rating of 4 or higher on the Numeric Rating Scale
- Willingness to participate and provide written informed consent
You will not qualify if you...
- Severe stomatitis
- Taste disorders before chemotherapy caused by neurological diseases, diabetes, or medications
- Low white blood cell count (leucopenia/neutropenia)
- Use of anticoagulant medications
- Current smoking
- Severe physical or mental health conditions preventing study participation
- Participation in other complementary and alternative medicine treatments within integrative oncology care
- Participation in other studies on oral complication treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - Single treatment on chemotherapy administration day
Participants receive a single treatment of hypoglossal acupuncture, sham acupuncture, or dietary recommendations during chemotherapy administration to address dysguesia.
1 visit (in-person) during chemotherapy administration
Follow-up
Duration - 7 days
Participants are monitored for dysguesia, xerostomia, stomatitis, appetite, impairment, and adverse events for 7 days after treatment.
1 follow-up visit within 7 days after treatment
Trial Site Locations
Total: 3 locations
1
Department of Gynecology & Gynecologic Oncology, Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany, 45136
Active, Not Recruiting
2
Universitätsklinikum Mannheim, Internistische Onkologie
Mannheim, Germany, 68167
Actively Recruiting
3
Robert Bosch Krankenhaus Stuttgart
Stuttgart, Germany, 70376
Not Yet Recruiting
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Research Team
H
Heidemarie Haller, PhD
H
Holger Cramer, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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