XerostomiaAURICULOXERONCT04222478
Interest of Auriculotherapy in the Treatment of Xerostomia
A study testing Specific auriculotherapy and Non-specific auriculotherapy in people with Xerostomia, run by Hopital Foch at 4 sites in France.
Trial summary
The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Specific auriculotherapy and Non-specific auriculotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Dec 2019to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Brittany Region, 29600
Hôpital Forcilles
Férolles-Attilly, 77150
GHP Saint Joseph
Paris, 75014
Hôpital Foch
Suresnes, 92150
About this study
Official title: 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
- Conditions
- Xerostomia
- Being tested
- Specific auriculotherapy, Non-specific auriculotherapy
- Keywords
- Auriculotherapy, Xerostomia, ENT cancer
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific auriculotherapyOther
3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
Non-specific auriculotherapyOther
3 sessions of auriculotherapy with semi-permanent needles on non-specific points.
| Study group | Role | What they receive |
|---|---|---|
| Real Auriculotherapy | Experimental | 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. Receives: Other: Specific auriculotherapy |
| Sham Auriculotherapy | Sham comparator | Patients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points. Receives: Other: Non-specific auriculotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
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).
Measured: 3 months
Assess the effect of auriculotherapy on the wish to continue treatment
Patient's desire to continue treatment (question to patient - yes/no response)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start4 Dec 2019
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222478
- Sponsor's protocol ID
- 2018_0101
- Acronym
- AURICULOXERO
- Status last verified
- Jun 2026
- First submitted
- 31 Dec 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Auriculotherapy in the Treatment of Xerostomia.
- ClinicalTrials.gov ID
- NCT04222478
- Acronym / sponsor ID
- AURICULOXERO / 2018_0101
- Conditions
- Xerostomia
- Keywords
- Auriculotherapy, Xerostomia, ENT cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Auriculotherapy | Experimental | Other: Specific auriculotherapyPatients benefit from 3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals. |
| Sham Auriculotherapy | Sham comparator | Other: Non-specific auriculotherapyPatients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific auriculotherapy3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals. | Other | Real Auriculotherapy |
| Non-specific auriculotherapy3 sessions of auriculotherapy with semi-permanent needles on non-specific points. | Other | Sham Auriculotherapy |
Primary outcome
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.
6 secondary outcomes
Assess the effect of auriculotherapy on the subjective improvement of salivation
Time frame: 3 months
Assess the effect of auriculotherapy on the subjective improvement of clinical status
Time frame: 3 months
Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations
Time frame: 3 months
Assess the effect of auriculotherapy on anxiety and depression
Time frame: 3 months
Assess the effect of auriculotherapy on quality of life
Time frame: 3 months
Assess the effect of auriculotherapy on the wish to continue treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireille Michel-Cherqui, MD principal investigator
Hopital Foch
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific auriculotherapy and Non-specific auriculotherapy in people with Xerostomia, run by Hopital Foch at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.