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

Izun Pharma

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis

Treatments: Drug: IZN-6N4

Study type: Interventional

Funder types: Industry

Identifiers

NCT01400620

IOM-HNC-201-IL

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Active oral rinse

Experimental group

Description:

Oral rinse containing botanical extracts

Treatment:

Drug: IZN-6N4

Placebo rinse

Placebo Comparator group

Treatment:

Drug: IZN-6N4