NCT07467759

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

The Effect of 0.15% Benzydamine Hydrochloride (Difflam) Oral Spray on the Severity of Radiation-induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy: An Open-Label Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Tishreen University · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Radiation-induced Oral Mucositis

Interventions

Type	Name	Description
DRUG	benzydamine hydrochloride	Benzydamine hydrochloride 0.15% oral spray administered as 4 to 8 sprays, 4 to 6 times daily, for 6 weeks, in addition to standard oral care
OTHER	saline mouth rinse	standard oral care consisted of routine oral hygiene measures and saline mouth rinses.

Timeline

• Start date: 2025-07-20
• Primary completion: 2025-12-25
• Completion: 2025-12-25
• First posted: 2026-03-12
• Last updated: 2026-03-17

Locations

1 site across 1 country: Syria