NCT07476209Recruiting
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)
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 12 Mar 2026
- Start date
- Apr 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Alexandria University
- Diseases
- Head and neck cancer
- NCT number
- NCT07476209
What you commit to
- Study type: Interventional
- Planned participants: 42
- From Apr 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with history of using drugs such as (pilocarpine ), oral humidifiers or herbs that prevent or treat xerostomia 2 months prior to study inclusion.
Other illness
- Patients suffering from uncontrolled systemic diseases (such as diabetes, hypertension, cardiovascular, liver or renal dysfunction).
- Patients diagnosed with Sjögren's disease or other underlying systemic illness that is known to cause xerostomia.
Other
- Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Dentistry, Alexandria University Coordinator of this site? Confirm its status | Alexandria | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.