Interest of Auriculotherapy in the Treatment of Xerostomia

NCT ID: NCT04222478

Last Updated: 2025-02-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2025-12-04

Brief Summary

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The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia

Detailed Description

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Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Specific auriculotherapy

Intervention Type OTHER

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.

Group Type SHAM_COMPARATOR

Non-specific auriculotherapy

Intervention Type OTHER

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.

Intervention Type OTHER

Non-specific auriculotherapy

3 sessions of auriculotherapy with semi-permanent needles on non-specific points.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years old;
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Hôpital Forcilles

Férolles-Attilly, , France

Site Status RECRUITING

GHP Saint Joseph

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Foch

Suresnes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mireille Michel-Cherqui, MD

Role: CONTACT

+33(0)146252985

Facility Contacts

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Coralie Clodic, MD

Role: primary

Pauline Cam

Role: backup

02 98 22 33 32

David GUIGOU, MD

Role: primary

David EBBO, MD

Role: primary

Mireille MICHEL-CHERQUI, MD

Role: primary

+33(0)146252985

Other Identifiers

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2018_0101

Identifier Type: -

Identifier Source: org_study_id

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