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

Seoul National University Hospital138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

138

Conditions

Oral Mucositis

Interventions

rhEGF + povidone iodine, chlorhexidine, & nystatinDRUG

Topical application of 50 µg/mL rhEGF solution twice daily + oral gargling with povidone iodine (1%), chlorhexidine (0.5%) \& nystatin (5,000IU/mL) three times a day. Application of drugs begins with start of intensive chemotherapy and ends at the time of recovery from neutropenia (ANC\>1000/µL for 3 days) or disappearance of oral mucositis. For each application of rhEGF, spray total 6 times at palate, oropharynx, both buccal mucosa, tongue, and gingiva.

Placebo + povidone iodine, chlorhexidine, & nystatinDRUG

Topical application of placebo drug twice daily + oral gargling with povidone iodine (1%), chlorhexidine (0.5%), and nystatin (5,000IU/mL) three times a day. Application of drugs begins with start of intensive chemotherapy and ends at the time of recovery from neutropenia (ANC\>1000/µL for 3 days) or disappearance of oral mucositis. For each application of placebo drug, spray total 6 times at palate, oropharynx, both buccal mucosa, tongue, and gingiva.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea