Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia

March 22, 2026 updated by: Basma Morsy, Alexandria University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of Dentistry, Alexandria University
        • Contact:
        • Principal Investigator:
          • Basma Morsy, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I: Sialendoscopy
Patients in this group will receive sialendoscopic management using an all-in-one 1.3-mm Marchal sialendoscope.
Procedure: Sialendoscopy
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
Active Comparator: Group II: Photobiomodulation
Patients in this group will receive laser photobiomodulation sessions (twice/week) for 6 weeks (total of 12 sessions)
Procedure: Photobiomodulation
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.
No Intervention: Group III: Control
patients in this group will receive Basic oral care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xerostomia grade
Time Frame: from baseline to two months following the end of radiation

Xerostomia grade will be assessed based on clinical implications and activity impact from Common Terminology Criteria for Adverse Events (CTCAE) v5.0. at baseline, 3 weeks (during RT) and 8 weeks (after the end of RT).

Xerostomia is graded from 1 to 3 based on symptom severity and dietary impact.
from baseline to two months following the end of radiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of patients
Time Frame: From baseline to two months after the end of Radiation
Using Multidisciplinary Salivary Gland Society (MSGS) questionnaire It includes 20 questions with scores from 0 to 10. where 0 indicates normal condition and 10 indicates maximum severity.
From baseline to two months after the end of Radiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1205-12/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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