Radiation-induced Oral MucositisPhase 4NCT07467759
Benzydamine for Radiation-Induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy
A Phase 4 study testing benzydamine hydrochloride and saline mouth rinse in people with Radiation-induced Oral Mucositis, run by Latakia University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Radiation-induced Oral Mucositis
- What is being tested?
- benzydamine hydrochloride and saline mouth rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSyria
- Study dates
- 20 Jul 2025to 25 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Use of concurrent treatments affecting OM
- Incomplete follow-up
- Other conditions influencing its progression
- patient withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- benzydamine hydrochloride, saline mouth rinse
- Keywords
- Benzydamine, Radiation-induced oral mucositis, Head and neck cnacer, Supportive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzydamine hydrochlorideDrug
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 rinseOther
standard oral care consisted of routine oral hygiene measures and saline mouth rinses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: saline mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly for 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: During the 6-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start20 Jul 2025
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rama Ibrahim, PhD, Study director, Latakia university, Latakia, SyriaBassam Saad, PhD, Principal investigator, Latakia university, Latakia, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467759
- Sponsor's protocol ID
- LATAKIA-ONC-BENZ-2025-1
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07467759
- Acronym / sponsor ID
- LATAKIA-ONC-BENZ-2025-1
- Conditions
- Radiation-induced Oral Mucositis
- Keywords
- Benzydamine, Radiation-induced oral mucositis, Head and neck cnacer, Supportive care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Benzydamine plus standard oral care | Experimental | Drug: benzydamine hydrochloride, Other: saline mouth rinseparticipants 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. |
| Standard oral care alone | Active comparator | Other: saline mouth rinseparticipants in this arm received standard oral care alone, including routine oral hygiene measures and saline mouth rinses, without benzydamine oral spray. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Use of concurrent treatments affecting OM
- Incomplete follow-up
- Other conditions influencing its progression
- patient withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benzydamine hydrochlorideBenzydamine 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 | Drug | Benzydamine plus standard oral care |
| saline mouth rinsestandard oral care consisted of routine oral hygiene measures and saline mouth rinses. | Other | Benzydamine plus standard oral care, Standard oral care alone |
Primary outcome
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.
2 secondary outcomes
Between-group difference in oral mucositis severity at weeks 4 and 6
Time frame: Week 4 and week 6
Proportion of patients who developed grade 3 oral mucositis
Time frame: During the 6-week follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rama Ibrahim, PhD study director
Latakia university, Latakia, Syria
Bassam Saad, PhD principal investigator
Latakia university, Latakia, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing benzydamine hydrochloride and saline mouth rinse in people with Radiation-induced Oral Mucositis, run by Latakia University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly severity of oral mucositis (time frame: Weekly for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.