Interest of Auriculotherapy in the Treatment of Xerostomia

NCT04222478 | Recruiting

• 1 other identifier: 2018_0101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Xerostomia

Keywords

Auriculotherapy; Xerostomia; ENT cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)

  Show that auriculotherapy (treatment of specific points) is effective in the treatment of xerostomia compared to a "sham" treatment (treatment of non-specific points). The relative variation of salivary secretion "after treatment" compared to "before treatment" will be judged on the weight of 3 compresses left 5 minutes in the mouth: 2 in front of the openings of Sténon's canal and 1 on the buccal floor (orifice of Wharton's canal). Salivary secretion is measured by the weight in grams of the compresses left in the mouth. This measurement is performed at inclusion and after 3 months of treatment. The measurement is made with a jeweler-type precision balance.

  3 months

Secondary Outcomes (6)

• Assess the effect of auriculotherapy on the subjective improvement of salivation

  3 months

• Assess the effect of auriculotherapy on the subjective improvement of clinical status

  3 months

• Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations

  3 months

• Assess the effect of auriculotherapy on anxiety and depression

  3 months

• Assess the effect of auriculotherapy on quality of life

  3 months

Study Arms (2)

Real Auriculotherapy

EXPERIMENTAL

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.

Other: Specific auriculotherapy

Sham Auriculotherapy

SHAM COMPARATOR

Patients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points.

Other: Non-specific auriculotherapy

Interventions

Specific auriculotherapy OTHER

3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.

Real Auriculotherapy

Non-specific auriculotherapy OTHER

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

Sham Auriculotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (4)

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Brittany Region, 29600, France

RECRUITING

Hôpital Forcilles

Férolles-Attilly, 77150, France

RECRUITING

GHP Saint Joseph

Paris, 75014, France

NOT YET RECRUITING

Hôpital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mireille Michel-Cherqui, MD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireille Michel-Cherqui, MD

CONTACT

+33(0)146252985; m.michel-cherqui@hopital-foch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 10, 2020
• Study Start: December 4, 2019
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)