Actively Recruiting
Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia
Led by Alexandria University · Updated on 2026-03-25
42
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients planning to receive intensity-modulated radiation therapy (IMRT) for head and neck cancer as postoperative or definitive therapy
- Radiation therapy planned with parotid mean dose bilaterally not exceeding 25 Gy
- Male and female patients aged 18 years or older
You will not qualify if you...
- Uncontrolled systemic diseases such as diabetes, hypertension, cardiovascular, liver, or kidney dysfunction
- Use of drugs like pilocarpine, oral humidifiers, or herbs for xerostomia prevention or treatment within 2 months prior to study
- Physical or mental abnormalities interfering with study procedures
- Diagnosis of Sj�f6gren's disease or other systemic illnesses known to cause xerostomia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Actively Recruiting
Research Team
B
Basma Morsy, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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