The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
- Registration Number
- NCT01099891
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - EGF rhEGF -
- Primary Outcome Measures
Name Time Method Incidence of severe oral mucositis (RTOG garde 3 or 4) 5 weeks(at the point of receiving 50 Gy radiation)
- Secondary Outcome Measures
Name Time Method Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis 5 weeks(at the point of receiving 50 Gy radiation) Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis 5 weeks(at the point of receiving 50 Gy radiation)
Trial Locations
- Locations (2)
Asan medical center
🇰🇷Seoul, Korea, Republic of
Seoul National Colleage & Hospital
🇰🇷Seoul, Korea, Republic of