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

NCT07467759 | Completed Phase 4

• 1 other identifier: LATAKIA-ONC-BENZ-2025-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Benzydamine; Radiation-induced oral mucositis; Head and neck cnacer; Supportive care

Outcome Measures

Primary Outcomes (1)

• Weekly severity of oral mucositis

  Oral mucositis severity was assessed weekly for 6 weeks by a specialist using the World Health Organization (WHO) oral mucositis grading scale. The scale ranges from 0 to 4, where 0 indicates no mucositis and 4 indicates sever mucositis. Higher represent worse severity.

  Weekly for 6 weeks

Secondary Outcomes (2)

• Between-group difference in oral mucositis severity at weeks 4 and 6

  Week 4 and week 6

• Proportion of patients who developed grade 3 oral mucositis

  During the 6-week follow-up period

Study Arms (2)

Benzydamine plus standard oral care

EXPERIMENTAL

participants in this arm received standard oral care, including routine oral hygiene measures and saline mouth rinses, in addition to 0.15% benzydamine hydrochloride oral spray for 6 weeks.

Drug: benzydamine hydrochloride; Other: saline mouth rinse

Standard oral care alone

ACTIVE COMPARATOR

participants in this arm received standard oral care alone, including routine oral hygiene measures and saline mouth rinses, without benzydamine oral spray.

Other: saline mouth rinse

Interventions

benzydamine hydrochloride DRUG

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

Benzydamine plus standard oral care

saline mouth rinse OTHER

standard oral care consisted of routine oral hygiene measures and saline mouth rinses.

Benzydamine plus standard oral care; Standard oral care alone

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 years or older
• Pathologically confirmed head and neck cancer
• Currently undergoing RT
• Cumulative total radiation dose exceeding 50 Gy
• Patients were enrolled in the study after their diagnosis of OM was confirmed by a specialist, which occurred approximately two weeks after the initiation of radiotherapy
• All subjects had grade 1 OM according to the WHO criteria at baseline, except for two patients in the intervention group who presented with grade 2 severity at the start of the study
• None of participants received concurrent chemotherapy during the study period

You may not qualify if:

• Use of concurrent treatments affecting OM
• Incomplete follow-up
• Other conditions influencing its progression
• patient withdrawal

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Pharmacy, Latakia university

Latakia, Syria

Location

MeSH Terms

Interventions

Benzydamine

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rama Ibrahim, PhD

  Latakia university, Latakia, Syria

  STUDY DIRECTOR

• Bassam Saad, PhD

  Latakia university, Latakia, Syria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized in a 1:1 ratio to one of two parallel groups: benzydamine oral spray plus standard oral care or standard oral care alone

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: July 20, 2025
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

SY (1)