Interest of Auriculotherapy in the Treatment of Xerostomia (AURICULOXERO)

Interest of Auriculotherapy in the Treatment of Xerostomia.

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

Study Overview

• Status: Recruiting
• Conditions: Xerostomia
• Intervention / Treatment: Other: Specific auriculotherapy; Other: Non-specific auriculotherapy

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireille Michel-Cherqui, MD; Phone Number: +33(0)146252985; Email: m.michel-cherqui@hopital-foch.org

Study Locations

• France
  • Férolles-Attilly, France, 77150
    • Recruiting
    • Hôpital Forcilles
    • Principal Investigator: David GUIGOU, MD
    • Contact: David GUIGOU, MD; Email: dguigou@cognacq-jay.fr
  • Paris, France, 75014
    • Not yet recruiting
    • GHP Saint Joseph
    • Contact: David EBBO, MD; Email: debbo@hpsj.fr
    • Principal Investigator: David EBBO, MD
  • Suresnes, France, 92150
    • Recruiting
    • Hopital FOCH
    • Contact: Mireille Michel-Cherqui, MD; Phone Number: +33(0)146252985; Email: m.michel-cherqui@hopital-foch.org
    • Principal Investigator: Mireille MICHEL-CHERQUI, MD
  • Bretagne
    • Brest, Bretagne, France, 29600
      • Recruiting
      • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
      • Contact: Coralie Clodic, MD; Email: coralie.clodic@chu-brest.fr
      • Contact: Pauline Cam; Phone Number: 02 98 22 33 32; Email: promotion.externe@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Non inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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 Comparator: Sham Auriculotherapy; 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; 3 sessions of auriculotherapy with semi-permanent needles on non-specific points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the effect of auriculotherapy on the subjective improvement of salivation	Specific xerostomia questionnaire at inclusion and 3 months post-treatment (11 questions with 5 response levels (1 = never / 2 = very rarely / 3 = occasionally / 4 = quite often / 5 = very often) to evaluate Xerostomia symptoms).	3 months
Assess the effect of auriculotherapy on the subjective improvement of clinical status	Global Patient Change Impression (GPCI) questionnaire at 3 months post-inclusion. This questionnaire evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status.	3 months
Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations	Simple numerical scales from 0 (best score) to 10 (worst score) at inclusion and at 3 months post-treatment.	3 months
Assess the effect of auriculotherapy on anxiety and depression	Hospital Anxiety and Depression questionnaire at inclusion and 3 months post-treatment. The HADS consists of 14 items, scored from 0 to 3, with seven questions relating to anxiety and seven questions relating to depression, allowing 2 scores to be obtained. The highest scores indicating more severe symptoms: "normal" cases (0-7 points); doubtful case (8-10 points); certain cases (11-21 points).	3 months
Assess the effect of auriculotherapy on quality of life	EuroQoL five Dimension questionnaire at inclusion and 3 months post-treatment. This questionnaire is designed for the patient to judge the impact of his state of health on his quality of life according to 5 dimensions (mobility, personal autonomy, daily activities, pain / discomfort and anxiety / depression). Each item has 3 response levels (1, 2 and 3) and the combination of the five digits will represent the patient's state of health. It is supplemented by a quality of life thermometer graduated from 0 (worst quality of life) to 100 (best quality of life).	3 months
Assess the effect of auriculotherapy on the wish to continue treatment	Patient's desire to continue treatment (question to patient - yes/no response)	3 months

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Mireille Michel-Cherqui, MD, Hopital FOCH

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Estimated): December 4, 2024
• Study Completion (Estimated): December 4, 2024

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Xerostomia; Auriculotherapy; ENT cancer
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: 2018_0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No