Interest of the Sialendoscopy Associated With a Local Injection of Corticosteroids in the Treatment of Radio-induced Xerostomia in Comparison With the Hygiene Rules

Launched by FONDATION HÔPITAL SAINT-JOSEPH · Oct 6, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients experiencing dry mouth, also known as xerostomia, which often occurs after radiation therapy for head and neck cancers. The researchers want to see if a procedure called sialendoscopy, combined with a local injection of corticosteroids (a type of medication that reduces inflammation), is more effective than just following standard hygiene practices to help relieve this uncomfortable condition. Xerostomia can make it hard to speak and eat, and many patients struggle with it even years after their treatment ends.

To be eligible for the trial, participants should be at least 18 years old, have had radiation to their salivary glands within the last six months, and have been experiencing dry mouth for over a month. They should also be able to understand and give consent to join the study. If eligible, participants can expect to undergo the sialendoscopy procedure and receive the corticosteroid injection, while closely monitored by the research team. This trial aims to find a more effective and lasting solution for those suffering from the impacts of xerostomia, as current treatments often provide only limited relief.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient whose age is ≥ 18 years old
• • Negative pregnancy test for women of childbearing age
• • Patient with head and neck cancer who has had parotid and submaxillary gland irradiation at a received dose greater than or equal to 60 Gy and whose end of treatment by radiotherapy is less than 6 months.
• • Patient with a complaint of xerostomia/dry mouth ≥1 month and wishing to benefit from therapeutic treatment
• • Patient affiliated to a social security system
• • Francophone patient
• • Patient who has given free, informed and written consent.
• Exclusion Criteria:
• • History of surgery of the 4 salivary glands (parotidectomy, under maxillectomy, pelvectomy) or prior sialendoscopy
• • Current episode of submaxillitis or acute infectious parotitis
• • Presence of a lithiasis pathology on the post-radiotherapy control CT scan
• • Patient under guardianship or curatorship
• • Patient deprived of liberty
• • Patient under legal protection
• • Pregnant or nursing patient.