Interest of Auriculotherapy in the Treatment of Xerostomia (AURICULOXERO)

Hopital Foch

Status: Enrolling

Conditions: Xerostomia

Treatments: Other: Non-specific auriculotherapy; Other: Specific auriculotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04222478

2018_0101

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Real Auriculotherapy

Experimental group

Description:

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.

Treatment:

Other: Specific auriculotherapy

Sham Auriculotherapy

Sham Comparator group

Description:

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

Treatment:

Other: Non-specific auriculotherapy