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

Tishreen University35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Radiation-induced Oral Mucositis

Interventions

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Use of concurrent treatments affecting OM * Incomplete follow-up * Other conditions influencing its progression * patient withdrawal

Outcomes

Primary Outcomes

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.

Time frame: Weekly for 6 weeks

Secondary Outcomes

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

Between-group differences in oral mucositis severity were assessed at week 4 and week 6 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.

Time frame: Week 4 and week 6

Proportion of patients who developed grade 3 oral mucositis

The proportion of patients who developed grade 3 oral mucositis during the 6-week follow-up period was assessed using the World Health Organization (WHO) oral mucositis grading scale.

Time frame: During the 6-week follow-up period