Kazemian, A., Kamian, S., Aghili, M., Hashemi, F. A., & Haddad, P. (2009). Benzydamine for prophylaxis of radiation-induced oral mucositis in head and neck cancers: A double-blind placebo-controlled randomized clinical trial. European Journal of Cancer Care, 18(2), 174–178.

To evaluate the efficacy of benzydamine oral rinse for prevention of radiation-induced mucositis

Patients rinsed for 2 minutes four times a day with 15 mL study medication (0.15% benzydamine oral rinse) or identical placebo (in appearance and taste) from the first day of radiation therapy (RT) to the end of treatment. Patients were encouraged to brush their teeth at least twice daily and rinse as necessary with normal saline or sodium bicarbonate. Commercial mouthwashes were prohibited.

• The study reported on a sample of 81 patients with a mean age 56.
• There were 54 females and 27 males.
• All patients had been diagnosed with head and neck cancer and were scheduled to receive a total external beam RT dose of at least 50 Gy in standard fractions and at least 2 oral or oropharyngeal sites were included in the planned RT treatment volume.

The study was conducted at the Radiation Oncology Department of the Cancer Institute at Tehran University of Medical Sciences in 2004-2005.

This was a double-blind, randomized, placebo-controlled trial.

• Patients oral hygiene before and during RT (number of tooth brushing per day) was recorded.
• The Radiation Therapy Oncology Group (RTOG) grading system was used.
• Patients were visited once.

• The statistical analysis revealed that three variables significantly affected the grade of mucositis at the end of the treatment: smoking before and during RT (p = 0.008), chemoradiation (p = 0.002), and receiving benzydamine (p = 0.001).
• Benzydamine produced a statistically significant reduction in mucositis during RT (p < 0.001).
• An increase in the grade of mucositis in the first three weeks of treatment was found in both groups, but, after that time, a remarkable difference was found in this parameter in the two groups. Overall, mucositis scores increased rapidly in severity between the third and seventh week of treatment, with a plateau occurring near the end of RT in the placebo group. In the benzydamine group, the plateau appeared from the third week to the end of therapy.

Benzydamine 0.15% oral rinse was safe and well tolerated. It significantly reduced RT-induced mucositis, which also decreased the interruption of treatment.

• The study was conducted at a single institution.
• The sample size was small, with fewer than 100 patients.
• The authors did not address who conducted the mucositis assessment, opening up the possibility for discrepancy between the evaluators.

Nurses will need to know how to effectively teach patients to use the oral rinse. This study also highlights the importance of daily oral hygiene, which is another good teaching point.