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

Seoul National University

Status and phase

Completed

Phase 2

Conditions

Oral Mucositis

Treatments

Drug: Placebo + povidone iodine, chlorhexidine, & nystatin

Drug: rhEGF + povidone iodine, chlorhexidine, & nystatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00845819

SNUH-Hema-1001

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

138 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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