CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 67 enrolled
Drug / intervention
Combination of Magic Mouthwash Plus Sucralfate +1 moredrug
Likely dose
Combination of Magic Mouthwash Plus Sucralfate 375mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00814359
NCT00814359Phase 3Completed
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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.

Juravinski Cancer Centre Foundation·interventional·Posted Dec 24, 2008·Updated Jan 20, 2011

In Brief

A Phase 3 clinical trial evaluating Combination of Magic Mouthwash Plus Sucralfate and 0.15% Benzydamine HCl for Head and Neck Cancer and Mucositis. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Mucositis
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2008
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.5 years ago

Interventions

Combination of Magic Mouthwash Plus Sucralfatedrug

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.

0.15% Benzydamine HCldrug

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.