Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Head and Neck Cancer, Mucositis

Intervention / Treatment
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* Drug: Combination of Magic Mouthwash Plus Sucralfate
* Drug: 0.15% Benzydamine HCl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magic Mouthwash Plus Sucralfate<br> | Drug: Combination of Magic Mouthwash Plus Sucralfate<br>* 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.<br>* Other names: Sulcrate;|
| Active Comparator: Benzydamine HCl<br> | Drug: 0.15% Benzydamine HCl<br>* 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.<br>* Other names: Tantum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Baseline to 10 weeks after initiating radiotherapy. | 
| Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy. |  | 4 weeks after initiating radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mucositis, radiation, magic mouthwash, sucralfate, benzydamine, diphenhydramine, dexamethasone, nystatin