RecruitingNot ApplicableNCT07476209

Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia

Sialendoscopic Management Versus Photobiomodulation in Prevention of Radiation-induced Xerostomia in Head and Neck Cancer Patients (Randomized Clinical Trial)


Sponsor

Alexandria University

Enrollment

42 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Radiation induced xerostomia (RIX) represents a common debilitating side effect for (RT), adversely affecting oral health and hindering head and neck cancer (HNC) patients' quality of life (QOL). To date, managing (RIX) is mainly symptomatic, while the only FDA-approved preventive therapeutic agent is Amifostine, with associated systemic toxicities. Sialendoscopic management is a minimally invasive technique that can help in restoring ductal patency, decreasing inflammation and improving salivary flow. Laser Photobiomodulation (PBM) is a noninvasive approach that enhances salivary gland function by stimulating cellular activity, increasing blood flow and attenuating oxidative stress. Aim: The present study aims to evaluate and compare the efficacy of sialendoscopic management and photobiomodulation in managing (RIX) in (HNC) patients. Materials and Methods: A randomized clinical trial will be carried out on 42 (HNC) patients. Directly prior to the first (RT) session, Group I (n= 14 patients) will receive sialendoscopic management. Group II (n=14 patients) will receive (PBM) sessions. Group III (n= 14 patients) will receive basic oral care (BOC). Xerostomia will be evaluated at baseline, at 3 weeks and after 8 weeks from the end of (RT), clinically using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and objectively using unstimulated salivary flow. Quality of life will be assessed using Multidisciplinary Salivary Gland Society (MSGS) questionnaire. Salivary amylase will be assessed at baseline and after 8 weeks from the end of (RT).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches to prevent or reduce dry mouth (xerostomia) caused by radiation therapy for head and neck cancer: a procedure called sialendoscopy (a tiny camera inserted into the salivary gland ducts to clear or protect them) versus light therapy applied to the salivary glands (photobiomodulation). **You may be eligible if...** - You are 18 years or older - You are scheduled to receive a type of radiation called IMRT for head and neck cancer (either after surgery or as the main treatment) - Your planned radiation dose to the parotid (cheek) glands is not expected to exceed 25 Gy on both sides **You may NOT be eligible if...** - You have uncontrolled conditions like diabetes, high blood pressure, or serious heart, liver, or kidney disease - You have been using pilocarpine, mouth moisturizers, or herbal dry mouth remedies in the past 2 months - You have Sjögren's syndrome or another condition known to cause dry mouth - You have a physical or mental condition that would interfere with the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESialendoscopy

Patients will receive sialendoscopic management using an all-in-one 1.3-mm Marchal sialendoscope. The Endoscope will be introduced in the duct lumen after dilation of papilla under microscopic magnification, using salivary dilators and a conical probe. The ductal system will be irrigated with a steroid (Triamcinolone acetonide-40mg/ml) diluted in 9mL of sterile saline solution41. The procedure will be done for all patients, directly before their 1st radiotherapy session

PROCEDUREPhotobiomodulation

Patients will receive laser photobiomodulation sessions (twice/week) for 6 weeks (total of 12 sessions), directly before their 1st (RT) session, using (980nm) diode laser.


Locations(1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

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NCT07476209


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