Head and neck cancer/mucositis Cancer Malignant neoplasm of other and ill-defined sites
Conditions
Interventions
Patients will be randomised in two groups (placebo and benzydamine). Subjects were encouraged to brush their teeth at least twice daily, floss once daily, rinse as necessary with bland oral rinses (e.
Sponsors
Imam Hossein Hospital (Iran)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant female subjects aged 18 - 80 years 2. Diagnoses of head and neck malignancy 3. Total external beam radiotherapy (RT) dose of at least 5000 cGy via a megavoltage treatment with either a cobalt-60 or a linear accelerator 4. At least two oral mucosal sites included in the planned RT treatment volume
Exclusion criteria
Exclusion criteria: 1. Karnofsky performance status less than 80% 2. Hypersensitivity to benzydamine or typical nonsteroidal anti-inflammatory drugs (NSAIDs) 3. Had taken experimental drugs within 30 days of study start 4. Chronically took steroids, NSAIDs, or other analgesics for other medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reducing mucositis, measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to grade III mucositis 2. Time to grade IV mucositis Measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy). | — |
Countries
Iran
Outcome results
None listed