The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients

Daewoong Pharmaceutical Co. LTD.300 enrolled

Overview

The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy

Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Stomatitis

Interventions

rhEGFDRUG

rhEGF 50 μg/ml, spray type, twice a day

PlaceboDRUG

Placebo, Spray type, Twice a day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, aged at least 18 years Exclusion Criteria: * Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential * Have oral mucositis or other oral conditions at study entry

Locations (2)

Asan medical center

Seoul, South Korea

Seoul National Colleage & Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of severe oral mucositis (RTOG garde 3 or 4)

Time frame: 5 weeks(at the point of receiving 50 Gy radiation)

Secondary Outcomes

Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis

Time frame: 5 weeks(at the point of receiving 50 Gy radiation)

Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis

Time frame: 5 weeks(at the point of receiving 50 Gy radiation)

Data from ClinicalTrials.gov

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