Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
18 Years
80 Years
Both
Oral Mucositis
Trial Information
Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)
Outcome Time Frame:
Assessed daily during application of study drugs
Safety Issue:
No
Principal Investigator
Sung-Soo Yoon, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
SNUH-Hema-1001
NCT ID:
NCT00845819
Start Date:
February 2009
Completion Date:
February 2012
Related Keywords:
- Oral Mucositis
- oral mucositis
- intensive chemotherapy
- stem cell transplantation
- epidermal growth factor
- Stomatitis
- Mucositis
- Hematologic Neoplasms
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