- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00845819
Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies (EGFOM)
Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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:
|
PLACEBO_COMPARATOR: Placebo
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:
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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
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Assessed daily during application of study drugs
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Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO)
Time Frame: Assessed daily during application of study drugs
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Assessed daily during application of study drugs
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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
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Assessed daily during application of study drugs
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OMDQ (oral mucositis daily questionnaire) score during treatment
Time Frame: Assessed daily during application of study drugs
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Assessed daily during application of study drugs
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Keefe DM, Schubert MM, Elting LS, Sonis ST, Epstein JB, Raber-Durlacher JE, Migliorati CA, McGuire DB, Hutchins RD, Peterson DE; Mucositis Study Section of the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology. Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer. 2007 Mar 1;109(5):820-31. doi: 10.1002/cncr.22484.
- Sonis ST, Oster G, Fuchs H, Bellm L, Bradford WZ, Edelsberg J, Hayden V, Eilers J, Epstein JB, LeVeque FG, Miller C, Peterson DE, Schubert MM, Spijkervet FK, Horowitz M. Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation. J Clin Oncol. 2001 Apr 15;19(8):2201-5. doi: 10.1200/JCO.2001.19.8.2201.
- Brown GL, Curtsinger L 3rd, Brightwell JR, Ackerman DM, Tobin GR, Polk HC Jr, George-Nascimento C, Valenzuela P, Schultz GS. Enhancement of epidermal regeneration by biosynthetic epidermal growth factor. J Exp Med. 1986 May 1;163(5):1319-24. doi: 10.1084/jem.163.5.1319.
- Sonis ST, Costa JW Jr, Evitts SM, Lindquist LE, Nicolson M. Effect of epidermal growth factor on ulcerative mucositis in hamsters that receive cancer chemotherapy. Oral Surg Oral Med Oral Pathol. 1992 Dec;74(6):749-55. doi: 10.1016/0030-4220(92)90402-c.
- Epstein JB, Gorsky M, Guglietta A, Le N, Sonis ST. The correlation between epidermal growth factor levels in saliva and the severity of oral mucositis during oropharyngeal radiation therapy. Cancer. 2000 Dec 1;89(11):2258-65. doi: 10.1002/1097-0142(20001201)89:113.0.co;2-z.
- Hong JP, Lee SW, Song SY, Ahn SD, Shin SS, Choi EK, Kim JH. Recombinant human epidermal growth factor treatment of radiation-induced severe oral mucositis in patients with head and neck malignancies. Eur J Cancer Care (Engl). 2009 Nov;18(6):636-41. doi: 10.1111/j.1365-2354.2008.00971.x. Epub 2009 Apr 23.
- Wu HG, Song SY, Kim YS, Oh YT, Lee CG, Keum KC, Ahn YC, Lee SW. Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial. Cancer. 2009 Aug 15;115(16):3699-708. doi: 10.1002/cncr.24414.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Hematologic Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Hematologic Neoplasms
- Mucositis
- Stomatitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Trace Elements
- Micronutrients
- Anti-Bacterial Agents
- Membrane Transport Modulators
- Antifungal Agents
- Disinfectants
- Plasma Substitutes
- Blood Substitutes
- Ionophores
- Iodine
- Cadexomer iodine
- Chlorhexidine
- Povidone-Iodine
- Povidone
- Chlorhexidine gluconate
- Nystatin
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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