search
Back to results

Interest of Auriculotherapy in the Treatment of Xerostomia (AURICULOXERO)

Primary Purpose

Xerostomia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific auriculotherapy
Non-specific auriculotherapy
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Auriculotherapy, Xerostomia, ENT cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital MorvanRecruiting
  • Hôpital ForcillesRecruiting
  • GHP Saint Joseph
  • Hôpital FochRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real Auriculotherapy

Sham Auriculotherapy

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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).
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).
Assess the effect of auriculotherapy on the wish to continue treatment
Patient's desire to continue treatment (question to patient - yes/no response)

Full Information

First Posted
December 31, 2019
Last Updated
June 13, 2023
Sponsor
Hopital Foch
search

1. Study Identification

Unique Protocol Identification Number
NCT04222478
Brief Title
Interest of Auriculotherapy in the Treatment of Xerostomia
Acronym
AURICULOXERO
Official Title
Interest of Auriculotherapy in the Treatment of Xerostomia.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
December 4, 2024 (Anticipated)
Study Completion Date
December 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
Auriculotherapy, Xerostomia, ENT cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real Auriculotherapy
Arm Type
Experimental
Arm 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.
Arm Title
Sham Auriculotherapy
Arm Type
Sham Comparator
Arm Description
Patients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points.
Intervention Type
Other
Intervention Name(s)
Specific auriculotherapy
Intervention Description
3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
Intervention Type
Other
Intervention Name(s)
Non-specific auriculotherapy
Intervention Description
3 sessions of auriculotherapy with semi-permanent needles on non-specific points.
Primary Outcome Measure Information:
Title
Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assess the effect of auriculotherapy on the subjective improvement of salivation
Description
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).
Time Frame
3 months
Title
Assess the effect of auriculotherapy on the subjective improvement of clinical status
Description
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.
Time Frame
3 months
Title
Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations
Description
Simple numerical scales from 0 (best score) to 10 (worst score) at inclusion and at 3 months post-treatment.
Time Frame
3 months
Title
Assess the effect of auriculotherapy on anxiety and depression
Description
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).
Time Frame
3 months
Title
Assess the effect of auriculotherapy on quality of life
Description
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).
Time Frame
3 months
Title
Assess the effect of auriculotherapy on the wish to continue treatment
Description
Patient's desire to continue treatment (question to patient - yes/no response)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mireille Michel-Cherqui, MD
Phone
+33(0)146252985
Email
m.michel-cherqui@hopital-foch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coralie Clodic, MD
Email
coralie.clodic@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Pauline Cam
Phone
02 98 22 33 32
Email
promotion.externe@chu-brest.fr
Facility Name
Hôpital Forcilles
City
Férolles-Attilly
ZIP/Postal Code
77150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David GUIGOU, MD
Email
dguigou@cognacq-jay.fr
First Name & Middle Initial & Last Name & Degree
David GUIGOU, MD
Facility Name
GHP Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David EBBO, MD
Email
debbo@hpsj.fr
First Name & Middle Initial & Last Name & Degree
David EBBO, MD
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireille MICHEL-CHERQUI, MD
Phone
+33(0)146252985
Email
m.michel-cherqui@hopital-foch.org
First Name & Middle Initial & Last Name & Degree
Mireille MICHEL-CHERQUI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Interest of Auriculotherapy in the Treatment of Xerostomia

We'll reach out to this number within 24 hrs