Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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 transplantation in patients with hematologic malignancies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Daewoong Pharmaceutical Co. LTD.
• Treatments: Cadexomer iodine; Chlorhexidine; Chlorhexidine gluconate; Iodine; Mitogens; Nystatin; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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