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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Oral Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active oral rinse

Oral rinse containing botanical extracts

Group Type EXPERIMENTAL

IZN-6N4

Intervention Type DRUG

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

Placebo rinse

Group Type PLACEBO_COMPARATOR

IZN-6N4

Intervention Type DRUG

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

Interventions

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IZN-6N4

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No