Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00814359|
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : January 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Mucositis||Drug: Combination of Magic Mouthwash Plus Sucralfate Drug: 0.15% Benzydamine HCl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|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.|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814359
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Principal Investigator:||Joda Kuk, MD||Juravinski Cancer Centre|