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

Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies

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.

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 drug (palifermin) approved by the US FDA for the prevention of oral mucositis and the other methods to prevent or treat oral mucositis are just empirical and lack evidences. The results of recent study demonstrated promising efficacy and minimal toxicity of recombinant human epidermal growth factor (rhEGF) as a preventive drug of oral mucositis in head and neck cancer patients undergoing radiotherapy (Wu HG, et al. Cancer 2009;115(16):3699-3708). This clinical trial is a double-blind randomized prospective single-institutional phase II study to evaluate 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.

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