Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis
|Head and Neck Cancer Mucositis||Drug: Combination of Magic Mouthwash Plus Sucralfate Drug: 0.15% Benzydamine HCl||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||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.|
- 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. [ Time Frame: Baseline to 6 weeks after the initiation of radiotherapy. ]
- The severity of patient-reported symptoms of mucositis throughout the course radiotherapy as determined by the area under the curve for mean change in OMWQ-HN scores from baseline. [ Time Frame: Baseline to 10 weeks after initiating radiotherapy. ]
- Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy. [ Time Frame: 4 weeks after initiating radiotherapy ]
|Study Start Date:||May 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Experimental: Magic Mouthwash Plus Sucralfate||
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.
|Active Comparator: Benzydamine HCl||
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.
Other Name: Tantum
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814359
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Principal Investigator:||Joda Kuk, MD||Juravinski Cancer Centre|