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

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EGF

Group Type EXPERIMENTAL

rhEGF

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, Spray type, Twice a day

Interventions

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rhEGF

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

Intervention Type DRUG

Placebo

Placebo, Spray type, Twice a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No