Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
Conditions
Oral Mucositis
Conditions: official terms
Head and Neck Neoplasms - Mucositis - Stomatitis
Conditions: Keywords
oral mucositis, chemoradiation, head and neck cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: IZN-6N4
Type: Drug
Overall Status
Recruiting
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 chemotherapy and radiation therapy for head and neck cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Sourasky Medical Center
Tel Aviv, Israel
Status: Recruiting
Start Date
March 2012
Sponsors
Izun Pharma Ltd
Source
Izun Pharma Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page