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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01400620

Enrollment

110

Registered

2011-07-22

Start date

2012-03-31

Completion date

2017-01-31

Last updated

2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Mucositis

Keywords

oral mucositis, chemoradiation, head and neck cancer

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.

Interventions

DRUGIZN-6N4

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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.

Countries

Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026