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

This study has been completed.
Sponsor:
Collaborator:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Sung-Soo Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00845819
First received: February 16, 2009
Last updated: January 20, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Drug: rhEGF + povidone iodine, chlorhexidine, & nystatin
Drug: Placebo + povidone iodine, chlorhexidine, & nystatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0) [ Time Frame: Assessed daily during application of study drugs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Assessed daily during application of study drugs ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO) [ Time Frame: Assessed daily during application of study drugs ] [ Designated as safety issue: No ]
  • Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (WHO) [ Time Frame: Assessed daily during application of study drugs ] [ Designated as safety issue: No ]
  • Incidence, day of onset, and duration of oral mucositis of grade 4 or higher (WHO) [ Time Frame: Assessed daily during application of study drugs ] [ Designated as safety issue: No ]
  • OMDQ (oral mucositis daily questionnaire) score during treatment [ Time Frame: Assessed daily during application of study drugs ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: February 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845819

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Daewoong Pharmaceutical Co. LTD.
Investigators
Principal Investigator: Sung-Soo Yoon, MD, PhD Seoul National University Hospital
  More Information

Publications:

Responsible Party: Sung-Soo Yoon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00845819     History of Changes
Other Study ID Numbers: SNUH-Hema-1001
Study First Received: February 16, 2009
Last Updated: January 20, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
oral mucositis
intensive chemotherapy
stem cell transplantation
epidermal growth factor

Additional relevant MeSH terms:
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Cadexomer iodine
Chlorhexidine
Chlorhexidine gluconate
Iodine
Mitogens
Nystatin
Povidone
Povidone-Iodine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Antifungal Agents
Blood Substitutes
Dermatologic Agents
Disinfectants
Growth Substances
Hematologic Agents
Ionophores
Membrane Transport Modulators
Micronutrients
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 27, 2015