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 | Unknown

• 1 other identifier: SIALORAD
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

xerostomia; sialendoscopy; corticosteroids; ENT

Outcome Measures

Primary Outcomes (1)

• Superiority of sialendoscopy combined with local injection of corticosteroids (intervention group) in improving the symptoms of post-radial xerostomia, compared to the usual HDR-based treatment

  Difference in mean scores of the Xerostomia Questionnaire (XQ) 6 months after the start of treatment between the 2 groups of patients.

  6 months

Secondary Outcomes (8)

• To compare the efficacy of sialendoscopy associated with local corticosteroid injection compared to the usual HDR-based treatment on the early improvement of patient-reported symptoms of post-radial xerostomia

  1 month

• To compare the efficacy of sialendoscopy associated with a local corticosteroid injection compared to usual HDR-based treatment on the prolonged improvement of post-radial xerostomy symptoms reported by patients.

  1 year

• To compare the effectiveness of sialendoscopy associated with a local corticosteroid injection compared to that of standard HHR-based treatment in improving quality of life.

  1 month

• To compare the effectiveness of sialendoscopy associated with a local corticosteroid injection compared to the usual HDR-based treatment on the improvement of stimulated and non-stimulated saliva production.

  1 month

• To compare the efficacy of sialendoscopy associated with local corticosteroid injection compared to usual HDR-based treatment on the improvement of post-radial xerostomy symptoms reported by patients according to the rate of salivary gland irradiation.

  1 month

Study Arms (2)

Control arm

NO INTERVENTION

This arm involves patients applying the basic hygiene rules (with mouthwashes) without the sialendoscopy method.

Sialendoscopy arm

EXPERIMENTAL

This arm involves 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.

Device: sialendoscopy

Interventions

sialendoscopy DEVICE

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.

Sialendoscopy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

RECRUITING

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Elisabeth SAUVAGET, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth SAUVAGET, MD

CONTACT

01 44 12 74 92; esauvaget@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study aims at comparing the sialendoscopy associated with a local injection of corticosteroids to the basic hygiene rules in the treatment of Xerostomia.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 12, 2020
• Study Start: October 19, 2020
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2025
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

FR (1)