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NCT Number: NCT07467759

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.

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Key information

Conditions

Radiation-induced Oral Mucositis

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pharmacy, Latakia university

Latakia, Syria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

saline mouth rinse

Other

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

Primary outcomes

  1. Weekly severity of oral mucositis

    Time frame: Weekly for 6 weeks

    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.

Secondary outcomes

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

    Time frame: Week 4 and week 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.

  2. Proportion of patients who developed grade 3 oral mucositis

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

    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.

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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