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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active oral rinse | Experimental | Oral rinse containing botanical extracts |
|
| Placebo rinse | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IZN-6N4 | Drug | Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health Cancer Center | Gainesville | Florida | 32610 | United States | ||
| University of Miami-Sylvester CCC Clinical Research Services |
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| Miami |
| Florida |
| 33136 |
| United States |
| Mount Sinai Beth Israel - Phillips Ambulatory Care Center | New York | New York | 10003 | United States |
| NYU Clinical Cancer Center | New York | New York | 10016 | United States |
| Soroka Medical Center | Beersheba | Israel |
| Rambam Medical Center | Haifa | Israel |
| Rabin Medical Center - Beilinson Campus | Petah Tikva | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Assuta Medical Center | Tel Aviv | Israel |
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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