Interest of Auriculotherapy in the Treatment of Xerostomia

Study Overview
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Brief Summary
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The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia

Official Title
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Interest of Auriculotherapy in the Treatment of Xerostomia.

Conditions
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Xerostomia

Intervention / Treatment
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* Other: Specific auriculotherapy
* Other: Non-specific auriculotherapy


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real Auriculotherapy<br>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<br>* 3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the protocol of Alimi at one month intervals.<br>|
| Sham Comparator: Sham Auriculotherapy<br>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<br>* 3 sessions of auriculotherapy with semi-permanent needles on non-specific points.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auriculotherapy, Xerostomia, ENT cancer