Using auriculotherapy to treat dry mouth after cancer treatment
Interest of Auriculotherapy in the Treatment of Xerostomia.
This study is testing if auriculotherapy can help adults with dry mouth after cancer treatment feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hopital Foch Academic / other |
| Locations | 4 sites (Brest, Brittany Region and 3 other locations) |
| Trial ID | NCT04222478 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of auriculotherapy in alleviating xerostomia, a condition characterized by dry mouth, particularly in patients who have undergone cervical irradiation due to ENT cancer. Participants will receive specific and non-specific auriculotherapy treatments to assess their impact on symptoms. The study will include patients who are at least 18 years old and have experienced xerostomia for more than three months following their radiotherapy. The goal is to determine if this alternative therapy can provide relief for those suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have xerostomia resulting from cervical irradiation for ENT cancer.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to auriculotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-invasive treatment option for patients suffering from dry mouth after cancer treatment.
How similar studies have performed: While there is limited data on the effectiveness of auriculotherapy specifically for xerostomia, similar alternative therapies have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brest, Brittany Region and 3 other locations
- Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan — Brest, Brittany Region, France (Recruiting)
- Hôpital Forcilles — Férolles-Attilly, France (Recruiting)
- GHP Saint Joseph — Paris, France (Not_yet_recruiting)
- Hôpital Foch — Suresnes, France (Recruiting)
Study contacts
- Principal investigator: Mireille Michel-Cherqui, MD — Hopital Foch
- Study coordinator: Mireille Michel-Cherqui, MD
- Email: m.michel-cherqui@hopital-foch.org
- Phone: +33(0)146252985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.