Radiation-induced Oral Mucositis
Conditions
Keywords
Benzydamine, Radiation-induced oral mucositis, Head and neck cnacer, Supportive care
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.
Interventions
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
OTHERsaline mouth rinse
standard oral care consisted of routine oral hygiene measures and saline mouth rinses.
Sponsors
Tishreen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly severity of oral mucositis | 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
| Measure | Time frame | Description |
|---|---|---|
| Between-group difference in oral mucositis severity at weeks 4 and 6 | 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. |
| Proportion of patients who developed grade 3 oral mucositis | 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. |
Countries
Syria
Contacts
STUDY_DIRECTORRama Ibrahim, PhD
Latakia university, Latakia, Syria
PRINCIPAL_INVESTIGATORBassam Saad, PhD
Latakia university, Latakia, Syria
Outcome results
None listed