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

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400620
• Other study ID #: IOM-HNC-201-IL
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2011
• Last updated: March 12, 2018
• Start date: March 2012
• Est. completion date: January 2017

Study information

• Verified date: March 2018
• Source: Izun Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• IZN-6N4
Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer Sheba
Israel	Rambam Medical Center	Haifa
Israel	Rabin Medical Center - Beilinson Campus	Petach Tikva
Israel	Assuta Medical Center	Tel Aviv
Israel	Sourasky Medical Center	Tel Aviv
Israel	Sheba Medical Center	Tel Hashomer
United States	UF Health Cancer Center	Gainesville	Florida
United States	University of Miami-Sylvester CCC Clinical Research Services	Miami	Florida
United States	Mount Sinai Beth Israel - Phillips Ambulatory Care Center	New York	New York
United States	NYU Clinical Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Izun Pharma Ltd

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.