Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.

Official Title
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Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: IZN-6N4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of head and neck cancer planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy able to eat at least soft solids normal cardiac function able to perform oral rinse Exclusion Criteria: Induction chemotherapy regimen life threatening allergic reaction to food and/or drugs history of any other primary malignancy diagnosed within the past 5 years prior radiation to the sites to be treated active infections of the oral cavity

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active oral rinse<br>Oral rinse containing botanical extracts | Drug: IZN-6N4<br>* Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks<br>|
| Placebo Comparator: Placebo rinse<br> | Drug: IZN-6N4<br>* Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups | Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial | Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure |  | Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral mucositis, chemoradiation, head and neck cancer