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Completed

NCT Number: NCT04222478

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

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan, Brest, Brittany Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specific auriculotherapy

Other

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

Other

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

Primary outcomes

  1. Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)

    Time frame: 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 outcomes

  1. Assess the effect of auriculotherapy on the subjective improvement of salivation

    Time frame: 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).

  2. Assess the effect of auriculotherapy on the subjective improvement of clinical status

    Time frame: 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.

  3. Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations

    Time frame: 3 months

    Simple numerical scales from 0 (best score) to 10 (worst score) at inclusion and at 3 months post-treatment.

  4. Assess the effect of auriculotherapy on anxiety and depression

    Time frame: 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).

  5. Assess the effect of auriculotherapy on quality of life

    Time frame: 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).

  6. Assess the effect of auriculotherapy on the wish to continue treatment

    Time frame: 3 months

    Patient's desire to continue treatment (question to patient - yes/no response)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Interest of Auriculotherapy in the Treatment of Xerostomia.

Acronym: AURICULOXERO

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2020
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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