NCT07476209 Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia
| NCT ID | NCT07476209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexandria University |
| Condition | Radiation Induced Xerostomia |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2026-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07476209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation Induced Xerostomia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07476209 currently recruiting?
Yes, NCT07476209 is actively recruiting participants. Contact the research team at basma.mohamed.dent@alexu.edu.eg for enrollment information.
Where is the NCT07476209 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT07476209 clinical trial?
NCT07476209 is sponsored by Alexandria University. The trial plans to enroll 42 participants.