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NCT Number: NCT07476209

Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location status: Recruiting

Location contact

Basma Morsy, MSc

PRINCIPAL_INVESTIGATOR

Fatma Amin, professor

CONTACT

[email protected]

+201550142760

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sialendoscopy

Procedure

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

Photobiomodulation

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Basma Morsy, MSc

CONTACT

[email protected]

+201018222678

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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