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

NCT07467759 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tishreen University

    lead OTHER

Principal Investigators

  • Rama Ibrahim, PhD · Latakia university, Latakia, Syria

  • Bassam Saad, PhD · Latakia university, Latakia, Syria

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-20
Primary Completion
2025-12-25
Completion
2025-12-25

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07467759 on ClinicalTrials.gov