Status:
COMPLETED
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
Lead Sponsor:
Izun Pharma Ltd
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 chemothe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01400620
Start Date
March 1 2012
End Date
January 1 2017
Last Update
March 13 2018
Active Locations (10)
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1
UF Health Cancer Center
Gainesville, Florida, United States, 32610
2
University of Miami-Sylvester CCC Clinical Research Services
Miami, Florida, United States, 33136
3
Mount Sinai Beth Israel - Phillips Ambulatory Care Center
New York, New York, United States, 10003
4
NYU Clinical Cancer Center
New York, New York, United States, 10016