Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of 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.

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Key information

Conditions

Oral Mucositis Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Soroka Medical Center, Beersheba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IZN-6N4

Drug

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

Primary outcomes

Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups

Time frame: 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 outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Izun Pharma Ltd

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Jul 22, 2011
Registry last updated: Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed