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

January 20, 2015 updated by: Sung-Soo Yoon, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: EGF
rhEGF + povidone iodine, chlorhexidine, & nystatin
Drug: rhEGF + povidone iodine, chlorhexidine, & nystatin

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.

Other Names:
  • Nepidermin
  • Easyef(R)
PLACEBO_COMPARATOR: Placebo
Placebo + povidone iodine, chlorhexidine, & nystatin
Drug: Placebo + povidone iodine, chlorhexidine, & nystatin

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.

Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)
Time Frame: Assessed daily during application of study drugs
Assessed daily during application of study drugs

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Daewoong Pharmaceutical Co. LTD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

February 16, 2009

First Submitted That Met QC Criteria

February 16, 2009

First Posted (ESTIMATE)

February 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 20, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-Hema-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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