Actively Recruiting
Interest of Auriculotherapy in the Treatment of Xerostomia
Led by Hopital Foch · Updated on 2025-02-12
68
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of auriculotherapy, a treatment involving semi-permanent needles applied to specific points on the ear, for people experiencing xerostomia, or dry mouth. This condition occurs after cervical irradiation therapy for ENT cancer. The study aims to see if this therapy improves saliva production and related symptoms. It is a randomized, single-blind clinical trial sponsored by Hopital Foch. Participants are divided into two groups: one receives auriculotherapy with needles placed on six specific points based on the "protocol of Alimi," and the other receives sham auriculotherapy with needles placed on non-specific points. Each participant undergoes three treatment sessions spaced one month apart. This allows comparison between the effects of the targeted treatment and the sham procedure. During the study, researchers will assess saliva production improvement after three months, as well as subjective symptoms like dry mouth, taste changes, swallowing difficulties, pain, burning sensations, anxiety, depression, and overall quality of life. Participants will also be asked about their willingness to continue treatment. The study tracks these measures over three months of treatment and monitoring.
CONDITIONS
Brief Title
Interest of Auriculotherapy in the Treatment of Xerostomia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Experiencing xerostomia after cervical irradiation for ENT cancer
- Completed radiotherapy more than 3 months ago
- Covered by a national healthcare insurance
- Signed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Local contraindication to auriculotherapy
- Taking anticoagulant treatment
- History or presence of hemophilia
- Presence of valvular prosthesis
- Infection of the ear's pavilion
- Received auriculotherapy or acupuncture for this condition in the past 12 months
- Started new xerostomia treatments within 48 hours before the first auriculotherapy session
- Difficulty complying with treatment, questionnaires, or study protocol
- Deprived of liberty or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive 3 sessions of auriculotherapy with semi-permanent needles on specific or non-specific points, each session spaced one month apart.
3 visits (in-person, monthly)
Trial Site Locations
Total: 4 locations
1
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Brittany Region, France, 29600
Actively Recruiting
2
Hôpital Forcilles
Férolles-Attilly, France, 77150
Actively Recruiting
3
GHP Saint Joseph
Paris, France, 75014
Not Yet Recruiting
4
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
M
Mireille Michel-Cherqui, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here