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
18 Years
N/A
Both
Oral Mucositis
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
Outcome Description:
Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial
Outcome Time Frame:
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.
Safety Issue:
No
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
IOM-HNC-201-IL
NCT ID:
NCT01400620
Start Date:
March 2012
Completion Date:
Related Keywords:
- Oral Mucositis
- oral mucositis
- chemoradiation
- head and neck cancer
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
Name | Location |
|---|
