Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

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.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis
• Intervention / Treatment: Drug: IZN-6N4

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Beer Sheba, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Rambam Medical Center
  • Petach Tikva, Israel
    • Rabin Medical Center - Beilinson Campus
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center
  • Tel Aviv, Israel
    • Assuta Medical Center
  • Tel Hashomer, Israel, 52621
    • Sheba Medical Center
• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health Cancer Center
    • Miami, Florida, United States, 33136
      • University of Miami-Sylvester CCC Clinical Research Services
  • New York
    • New York, New York, United States, 10016
      • Nyu Clinical Cancer Center
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel - Phillips Ambulatory Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active oral rinse; Oral rinse containing botanical extracts	Drug: IZN-6N4; Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks
Placebo Comparator: Placebo rinse	Drug: IZN-6N4; Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure	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.

Collaborators and Investigators

• Sponsor: Izun Pharma Ltd

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: head and neck cancer; chemoradiation; oral mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis
• Other Study ID Numbers: IOM-HNC-201-IL