Sialendoscopy versus photobiomodulation to prevent radiation‑related dry mouth
Sialendoscopic Management Versus Photobiomodulation in Prevention of Radiation-induced Xerostomia in Head and Neck Cancer Patients (Randomized Clinical Trial)
This trial compares a minimally invasive duct‑clearing procedure (sialendoscopy) with a light‑based laser therapy (photobiomodulation) to try to prevent dry mouth in adults receiving radiation for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07476209 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial will enroll 42 adults with head and neck cancer who are scheduled for IMRT with planned bilateral parotid mean dose ≤25 Gy. Participants are randomized to receive either sialendoscopy performed before the first radiotherapy session or a course of photobiomodulation, with treatments delivered at the Faculty of Dentistry, Alexandria University. Sialendoscopy aims to restore ductal patency and reduce inflammation to improve salivary flow, while photobiomodulation uses low‑level laser light to stimulate glandular cellular activity and blood flow. Outcomes include measures of xerostomia severity and salivary function over follow‑up to determine which approach better prevents radiation‑induced dry mouth.
Who should consider this trial
Good fit: Adults (≥18 years) with head and neck cancer scheduled for IMRT as definitive or adjuvant therapy with planned bilateral parotid mean dose ≤25 Gy and without uncontrolled systemic disease or Sjögren's syndrome.
Not a fit: Patients with Sjögren's syndrome, uncontrolled systemic illness, recent use of xerostomia medications, or those receiving higher parotid radiation doses are unlikely to benefit from these preventive approaches.
Why it matters
Potential benefit: If successful, the intervention could reduce or prevent radiation‑induced dry mouth and improve oral health and quality of life for head and neck cancer patients.
How similar studies have performed: Small studies and case series have suggested that photobiomodulation can reduce xerostomia symptoms and that sialendoscopy can improve salivary flow, but direct randomized comparisons are limited and this head‑to‑head approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are going to receive (IMRT) as a treatment of (HNC) either as postoperative (adjuvant) therapy or definitive therapy. * Patients who are planned to receive (RT) with parotid mean dose bilaterally not exceeding 25 Gy. * Males and females with an age not less than 18 years30 Exclusion Criteria: * Patients suffering from uncontrolled systemic diseases (such as diabetes, hypertension, cardiovascular, liver or renal dysfunction). * Patients with history of using drugs such as (pilocarpine ), oral humidifiers or herbs that prevent or treat xerostomia 2 months prior to study inclusion. * Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure. * Patients diagnosed with Sjögren's disease or other underlying systemic illness that is known to cause xerostomia.
Where this trial is running
Alexandria
- Faculty of Dentistry, Alexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Basma Morsy, MSc
- Email: basma.mohamed.dent@alexu.edu.eg
- Phone: +201018222678
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.