Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis
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ClinicalTrials.gov Identifier: NCT00814359 |
Recruitment Status :
Completed
First Posted : December 24, 2008
Last Update Posted : January 20, 2011
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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 |
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. |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
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. Other Names:
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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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the head and neck.
- Receiving 6 or more weeks of external beam radiotherapy to a treatment volume that includes mucosal surfaces of the head and neck.
Exclusion Criteria:
- Age less than 18 years
- ECOG Performance Score 2 or higher
- Patient is unable to understand the protocol and/or unable to provide informed consent
- Patient is unable or unwilling to complete the questionnaires which are written in English.
- Prior radiation to the head and neck region that would result in overlap of fields for the current study.
- Plan to receive a radiation treatment volume that only includes the larynx and or hypopharynx with no planned treatment of locoregional lymph nodes.
- Plan to receive a concurrent chemotherapy agent other than cisplatin.
- Plan to receive other investigational agents (eg. panitumumab).
- Investigational agent of any kind within 30 days prior to randomization.
- Concurrent administration of any other experimental intervention given for the purpose of preventing oral mucositis.
- History of allergic or hypersensitivity reactions to any of the possible agents to be administered in the study.
- Patients who are pregnant or lactating.

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
Canada, Ontario | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 |
Principal Investigator: | Joda Kuk, MD | Juravinski Cancer Centre |
Responsible Party: | Dr. Joda Kuk, Principal Investigator, Juravinski Cancer Centre |
ClinicalTrials.gov Identifier: | NCT00814359 |
Other Study ID Numbers: |
MUCOSA-PROTECT |
First Posted: | December 24, 2008 Key Record Dates |
Last Update Posted: | January 20, 2011 |
Last Verified: | May 2009 |
mucositis radiation magic mouthwash sucralfate |
benzydamine diphenhydramine dexamethasone nystatin |
Head and Neck Neoplasms Mucositis Neoplasms by Site Neoplasms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Mouth Diseases Stomatognathic Diseases Benzydamine Sucralfate Anti-Inflammatory Agents Anti-Ulcer Agents Gastrointestinal Agents |