Status:
COMPLETED
Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Oral Mucositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine efficacy and toxicity of recombinant human epidermal growth factor (rhEGF) as a preventive drug of oral mucositis during intensive chemotherapy with stem cell...
Detailed Description
Oral mucositis is one of the most common adverse events during chemotherapy and affects quality of life of patients receiving chemotherapy in relation to the dose of drugs. However, there is only one ...
Eligibility Criteria
Inclusion
- Patients with confirmed diagnosis of hematologic malignancies including acute \& chronic leukemia, lymphoma, plasma cell dyscrasia, myelodysplastic syndrome, aplastic anemia, etc.
- Patients who are planned to receive high-dose chemotherapy with SCT
- ECOG performance status 0-2
- Informed consent
Exclusion
- Patients having previous history of hypersensitivity to this drug or similar drugs
- Patients having oral ulcer or herpes or severe dental disease at the time of inclusion
- Patients received chemotherapy, radiotherapy, or surgery within 3 weeks
- Patients who had finished clinical trials which could affect the results of this trial within 4 weeks or are attending one at the time of inclusion
- Patients having another diseases which have worse prognosis than patients' hematologic malignancy
- Patients with major psychotic disorder or drug/alcohol abuser
- Women who are pregnant or breastfeeding
- Refusal at patients' will
- Inappropriate patients according to the investigators' opinion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00845819
Start Date
February 1 2009
End Date
October 1 2014
Last Update
January 21 2015
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744