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

NCT04584164 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-01-03

No results posted yet for this study

Summary

Xerostomia is defined as the subjective sensation of dry mouth, and may be associated with a reduction in saliva secretion and composition. It is one of the most common complaints found in patients after irradiation in the head and neck area. This complaint is found in a large majority of patients during radiotherapy, continuing for several years after stopping radiotherapy (93% during radiotherapy and 40 to 60% after two years post-radiotherapy). The advent of IMRT (Intensity-Modulated Radiation Therapy) has reduced this complaint, but it still concerns 40% of patients undergoing post-radiotherapy affecting the head and neck. Xerostomia is responsible for pronunciation difficulties, dysphagia, dysgeusia, alteration of the oral condition leading to a significant alteration of the quality of life. This complaint is maximal in the first six months following radiotherapy, then stabilizes or even regresses in the year following radiotherapy but can persist well beyond the end of the irradiation. At present, there are few treatments that have been shown to be truly effective. Systemic treatments (sialogues, cholinergic agonists, parasympathomimetic and muscarinic agonists, corticosteroids, etc.) allow partial improvement with delayed and not prolonged effectiveness. Many studies evaluating the efficacy of these therapies have shown contradictory and insufficient results (less than half of the patients present an improvement under treatment), without ever allowing a complete cure. Surgical treatments by submaxillary gland transfer have also been studied, but at the price of significant morbidity (cervicotomy, risk to the chin nerve in post-radial areas, etc.). Conformational radiotherapy with intensity modulation has made it possible to reduce the severity of xerostomia but does not make it possible to free oneself from this complication. Patients often find themselves reduced to symptomatic adjunctive treatments (gland massage, sprays, hydration, acupuncture...) without curative treatment. There is therefore a real need to respond to the complaint expressed by many patients by proposing an effective and long-lasting therapy.

Conditions

  • Xerostomia

Interventions

DEVICE

sialendoscopy

The patients applying the hygiene rule and benifiting in addition a sialendoscopy treatment with a local injection of corticostéroïdes (at the end of the procedure) in the treatment for Xerostomia.

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Elisabeth SAUVAGET, MD · Fondation Hôpital Saint-Joseph

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2023-12-06
Completion
2025-12-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584164 on ClinicalTrials.gov