Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2012 |
| End Date: | January 2017 |
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
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.
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.
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
We found this trial at
5
sites
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Gainesville, Florida 32610
Principal Investigator: Robert Amdur, MD
Phone: 352-265-0680
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Miami, Florida 33136
Principal Investigator: Michael Samuels, MD, FACR
Phone: 305-243-0974
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