Benzydamine for Radiation-Induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy

This single-center, open-label, randomized clinical trial evaluates the effect of 0.15% benzydamine hydrochloride (Difflam) oral spray on the severity of radiation-induced oral mucositis in patients with head and neck cancer receiving high-dose radiotherapy (≥50 Gy) without concurrent chemotherapy. Oral mucositis is a common and clinically significant complication of radiotherapy that can cause pain, difficulty swallowing, nutritional impairment, and treatment interruption. Participants are randomly assigned to receive either standard oral care alone or standard oral care plus benzydamine oral spray for 6 weeks. Oral mucositis severity is assessed weekly using the World Health Organization (WHO) oral mucositis grading scale. The study aims to determine whether benzydamine reduces the progression and severity of oral mucositis in this patient population.

NCT Number	NCT07467759
Lead Sponsor	Tishreen University
Conditions	Radiation-induced Oral Mucositis
Enrollment	35 participants
Start Date	2025-07-20
Primary Completion	2025-12-25 (estimated)
Study Completion	2025-12-25 (estimated)
Updated on ClinicalTrials.gov	2026-03-17