Mouth spray may soothe painful sores from cancer radiation
NCT ID NCT07467759
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a benzydamine hydrochloride (Difflam) oral spray can reduce the severity of mouth sores caused by high-dose radiation in head and neck cancer patients. Thirty-five adults receiving radiation without chemotherapy were randomly assigned to standard mouth care or standard care plus the spray for six weeks. Researchers tracked soreness weekly using a standard scale to see if the spray helped.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- benzydamine hydrochloride (Difflam) oral spray
- What this could lead to
- If it works, this spray could become a standard way to reduce painful mouth sores during radiation therapy for head and neck cancer.
- What could go wrong
- This is a small, single-center trial with only 35 participants, so results may not apply to everyone. The spray may not work better than standard care alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
35 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
22 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Pharmacy, Latakia university
Latakia, Syria
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer