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

Phase 2

Completed

• Conditions: Oral Mucositis
• Interventions: Drug: rhEGF + povidone iodine, chlorhexidine, & nystatin; Drug: Placebo + povidone iodine, chlorhexidine, & nystatin

• Registration Number: NCT00845819
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-16
• Study First Submitted QC: 2009-02-16
• Study First Posted: 2009-02-18
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGF	rhEGF + povidone iodine, chlorhexidine, & nystatin	rhEGF + povidone iodine, chlorhexidine, \& nystatin
Placebo	Placebo + povidone iodine, chlorhexidine, & nystatin	Placebo + povidone iodine, chlorhexidine, \& nystatin

Primary Outcome Measures

Name	Time	Method
Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)	Assessed daily during application of study drugs

Secondary Outcome Measures

Name	Time	Method
Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (WHO)	Assessed daily during application of study drugs
Adverse events	Assessed daily during application of study drugs
Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (NCI CTCAE 3.0)	Assessed daily during application of study drugs
OMDQ (oral mucositis daily questionnaire) score during treatment	Assessed daily during application of study drugs
Day of onset and duration of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)	Assessed daily during application of study drugs
Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO)	Assessed daily during application of study drugs
Incidence, day of onset, and duration of oral mucositis of grade 4 or higher (WHO)	Assessed daily during application of study drugs

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of