Interest of Auriculotherapy in the Treatment of Xerostomia

Not Applicable

Recruiting

• Conditions: Xerostomia
• Interventions: Other: Non-specific auriculotherapy; Other: Specific auriculotherapy

• Registration Number: NCT04222478
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-04
• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-12-04
• Study Completion: 2024-12-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Auriculotherapy	Non-specific auriculotherapy	Patients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points.
Real Auriculotherapy	Specific 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.

Primary Outcome Measures

Name	Time	Method
Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Assess the effect of auriculotherapy on the subjective improvement of salivation	3 months	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).
Assess the effect of auriculotherapy on the subjective improvement of clinical status	3 months	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.
Assess the effect of auriculotherapy on quality of life	3 months	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).
Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations	3 months	Simple numerical scales from 0 (best score) to 10 (worst score) at inclusion and at 3 months post-treatment.
Assess the effect of auriculotherapy on anxiety and depression	3 months	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).
Assess the effect of auriculotherapy on the wish to continue treatment	3 months	Patient's desire to continue treatment (question to patient - yes/no response)

Trial Locations

Locations (4)

Hôpital Forcilles; 🇫🇷 Férolles-Attilly, France

Hôpital Foch; 🇫🇷 Suresnes, France

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan; 🇫🇷 Brest, Bretagne, France

GHP Saint Joseph; 🇫🇷 Paris, France