Treatment for dry mouth after head and neck radiation using sialendoscopy and corticosteroids
Interest of the Sialendoscopy Associated With a Local Injection of Corticosteroids in the Treatment of Radio-induced Xerostomia in Comparison With the Hygiene Rules: a Prospective Randomized and Controlled Study
This study is testing if a new treatment using a special procedure and steroid injections can help adults with dry mouth after radiation for head and neck cancer feel better compared to regular mouth care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Drugs / interventions | Radiation, chemotherapy |
| Locations | 1 site (Paris, Ile-de-France) |
| Trial ID | NCT04584164 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of sialendoscopy combined with a local injection of corticosteroids to treat xerostomia, a common side effect experienced by patients after radiation therapy for head and neck cancer. The study aims to compare this intervention with standard hygiene practices to assess improvements in saliva production and overall quality of life. Eligible participants include adults who have received significant radiation doses to their salivary glands and are experiencing persistent dry mouth symptoms. The trial will monitor changes in salivary function and patient-reported outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone radiation therapy for head and neck cancer and are experiencing xerostomia.
Not a fit: Patients who have had prior surgeries on their salivary glands or those currently experiencing acute infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate dry mouth symptoms and improve the quality of life for patients recovering from head and neck cancer.
How similar studies have performed: While there have been studies on xerostomia treatments, the specific combination of sialendoscopy and corticosteroids in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris, Ile-de-France
- Groupe Hospitalier Paris Saint Joseph — Paris, Ile-de-France, France (Recruiting)
Study contacts
- Principal investigator: Elisabeth SAUVAGET, MD — Fondation Hôpital Saint-Joseph
- Study coordinator: Elisabeth SAUVAGET, MD
- Email: esauvaget@ghpsj.fr
- Phone: 01 44 12 74 92
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.