Interest of Auriculotherapy in the Treatment of Xerostomia

Xerostomia Clinical Trial

— AURICULOXERO  

Official title:

Interest of Auriculotherapy in the Treatment of Xerostomia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222478
• Other study ID #: 2018_0101
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: December 4, 2024

Study information

• Verified date: June 2024
• Source: Hopital Foch
• Contact: Mireille Michel-Cherqui, MD
• Phone: +33(0)146252985
• Email: m.michel-cherqui[@]hopital-foch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 4, 2024
• Est. primary completion date: December 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Xerostomia

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan	Brest	Bretagne
France	Hôpital Forcilles	Férolles-Attilly
France	GHP Saint Joseph	Paris
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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