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Interest of Auriculotherapy in the Treatment of Xerostomia (AURICULOXERO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04222478
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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

Condition or disease Intervention/treatment Phase
Xerostomia Other: Specific auriculotherapy Other: Non-specific auriculotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Interest of Auriculotherapy in the Treatment of Xerostomia.
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : April 4, 2023
Estimated Study Completion Date : April 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: Real 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.
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.

Sham Comparator: Sham Auriculotherapy
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
3 sessions of auriculotherapy with semi-permanent needles on non-specific points.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222478


Contacts
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Contact: Mireille Michel-Cherqui, MD +33(0)146252985 m.michel-cherqui@hopital-foch.org

Locations
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France
Hôpital Forcilles Not yet recruiting
Férolles-Attilly, France, 77150
Contact: David GUIGOU, MD       dguigou@cognacq-jay.fr   
Principal Investigator: David GUIGOU, MD         
GHP Saint Joseph Not yet recruiting
Paris, France, 75014
Contact: David EBBO, MD       debbo@hpsj.fr   
Principal Investigator: David EBBO, MD         
Hôpital Foch Recruiting
Suresnes, France, 92150
Contact: Mireille MICHEL-CHERQUI, MD    +33(0)146252985    m.michel-cherqui@hopital-foch.org   
Principal Investigator: Mireille MICHEL-CHERQUI, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Mireille Michel-Cherqui, MD Hopital Foch
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT04222478    
Other Study ID Numbers: 2018_0101
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hopital Foch:
Auriculotherapy
Xerostomia
ENT cancer
Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases