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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
The severity of patient-reported symptoms of mucositis as determined by the change in Oral Mucositis Weekly Questionnaire - Head and Neck Cancer (OMWQ-HN) score from baseline to 6 weeks.
Baseline to 6 weeks after the initiation of radiotherapy.
Joda Kuk, MD
Juravinski Cancer Centre
Canada: Ethics Review Committee