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

NCT01400620 | Completed Phase 2

• 1 other identifier: IOM-HNC-201-IL
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 10

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.

Conditions

Oral Mucositis

Keywords

oral mucositis; chemoradiation; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Active oral rinse

EXPERIMENTAL

Oral rinse containing botanical extracts

Drug: IZN-6N4

Placebo rinse

PLACEBO COMPARATOR

Drug: IZN-6N4

Interventions

IZN-6N4 DRUG

Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks

Active oral rinse; Placebo rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izun Pharma Ltd: lead

Study Sites (10)

UF Health Cancer Center

Gainesville, Florida, 32610, United States

Location

University of Miami-Sylvester CCC Clinical Research Services

Miami, Florida, 33136, United States

Location

Mount Sinai Beth Israel - Phillips Ambulatory Care Center

New York, New York, 10003, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Rabin Medical Center - Beilinson Campus

Petah Tikva, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Assuta Medical Center

Tel Aviv, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: March 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

US (4); IL (6)