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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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.
Israel: Israeli Health Ministry Pharmaceutical Administration