Interest of Auriculotherapy in the Treatment of Xerostomia
NCT ID: NCT04222478
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2019-12-04
2025-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Real Auriculotherapy
Patients benefit from 3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
Specific auriculotherapy
3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
Sham Auriculotherapy
Patients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points.
Non-specific auriculotherapy
3 sessions of auriculotherapy with semi-permanent needles on non-specific points.
Interventions
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Specific auriculotherapy
3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
Non-specific auriculotherapy
3 sessions of auriculotherapy with semi-permanent needles on non-specific points.
Eligibility Criteria
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Inclusion Criteria
* Complain about xerostomia after cervical irradiation in the context of ENT cancer;
* End of radiotherapy\> 3 months
* Covered by a national healthcare insurance
* Consent form signed.
* Pregnant or breastfeeding women;
* Local counterindication to auriculotherapy;
* With anticoagulant treatment;
* History or existing of hemophilia;
* Valvular prosthesis;
* Ear's pavilion infection;
* Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
* Having started in the 48 hours preceding the first auriculotherapy session, any new management of xerostomia and likely to interfere with the study (specific medication and/or complementary therapeutic management);
* Difficulty to comply with the treatment, questionnaires or study protocol;
* Being deprived of liberty or under guardianship.
18 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Mireille Michel-Cherqui, MD
Role: PRINCIPAL_INVESTIGATOR
Hopital Foch
Locations
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Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Brittany Region, France
Hôpital Forcilles
Férolles-Attilly, , France
GHP Saint Joseph
Paris, , France
Hôpital Foch
Suresnes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018_0101
Identifier Type: -
Identifier Source: org_study_id
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