NCT00814359

Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Juravinski Cancer Centre Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. This study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.

Detailed description

Sixty patients with head and neck cancer being treated with 6 or more weeks of radiotherapy, will be randomly assigned to receive either a combination of magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate or benzydamine. Patients randomized to receive magic mouthwash plus sucralfate will rinse first with 5ml of the magic mouthwash for 2 minutes then swallow, followed by rinsing with 5ml of the 1g/5ml sucralfate for 2 minutes before swallowing, 4 times daily. Patients randomized to receive 0.15% benzydamine HCl will be instructed to rinse with 15ml of the solution for 2 minutes before expectorating, 4 times daily. Patients will start the mouthwash regimens prior to the initiation of radiotherapy, and stop 2 weeks after the completion of radiotherapy.

Conditions

• Head and Neck Cancer
• Mucositis

Interventions

Type	Name	Description
DRUG	Combination of Magic Mouthwash Plus Sucralfate	Magic mouthwash will contain diphenhydramine powder 375mg, dexamethasone injection 2.8mg, and nystatin suspension 50ml (1000 units/ml) diluted to a total volume of 250ml with sterile water. The concentration of the sucralfate suspension will be 1g/5ml. Patients will be instructed to rinse first with 5ml of the magic mouthwash solution for 2 minutes then swallow, followed by rinsing with 5ml of the sucralfate suspension for 2 minutes before swallowing, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.
DRUG	0.15% Benzydamine HCl	Patients will rinse with 15ml of 1.5mg/ml benzydamine HCl for 2 minutes then expectorate the solution, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-12-24
• Last updated: 2011-01-20

Locations

1 site across 1 country: Canada