IRB #

STUDY00018644

Title

Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EC-18 in altering the severity and course of oral mucositis in patients being treated with concomitant chemoradiation therapy for cancers of the mouth, oropharynx, hypopharynx, and nasopharynx

Principal Investigator

John Holland

Study Purpose

To determine the effects of oral investigational medication EC-18 on oral mucositis in patients being treated with chemotherapy and radiation therapy for squamous cell carcinoma of the oral cavity or oropharynx.

Medical Condition(s)

Squamous cell cancer of the head and neck (SCCHN)

Eligibility Criteria

Patients with diagnosis of squamous cell carcinoma of the head and neck who are 18 years of age and older. Patients must not have received prior chemotherapy or radiation therapy but plan to be treated this way.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

15 months, including screening and long-term follow-up.

Minors Included

No

Contact

John Minger
Sr. Research Assistant
Oregon Health & Science University
Department of Radiation Medicine
mingerj@ohsu.edu
503-418-3247

Sponsor

Enzychem Lifescience Corporation

Recruitment End

12/31/2019

Compensation Provided

No


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