CompletedNot Applicable

Interest of Auriculotherapy in the Treatment of Xerostomia

France65 participantsStarted 2019-12-04

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 months

Trial details

NCT IDNCT04222478

SponsorHopital Foch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-15

View on ClinicalTrials.gov More Xerostomia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.