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

Phase 2

Completed

• Conditions: Oral Mucositis
• Interventions: Drug: IZN-6N4

• Registration Number: NCT01400620
• Lead Sponsor: Izun Pharma Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Study Start: 2012-03
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active oral rinse	IZN-6N4	Oral rinse containing botanical extracts
Placebo rinse	IZN-6N4	-

Primary Outcome Measures

Name	Time	Method
Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups	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.	Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

Soroka Medical Center; 🇮🇱 Beer Sheba, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel

Mount Sinai Beth Israel - Phillips Ambulatory Care Center; 🇺🇸 New York, New York, United States

University of Miami-Sylvester CCC Clinical Research Services; 🇺🇸 Miami, Florida, United States

UF Health Cancer Center; 🇺🇸 Gainesville, Florida, United States

NYU Clinical Cancer Center; 🇺🇸 New York, New York, United States

Rabin Medical Center - Beilinson Campus; 🇮🇱 Petach Tikva, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel