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

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ClinicalTrials.gov Identifier: NCT00845819

Recruitment Status : Completed

First Posted : February 18, 2009

Last Update Posted : January 21, 2015

Sponsor:

Collaborator:

Daewoong Pharmaceutical Co. LTD.

Information provided by (Responsible Party):

Sung-Soo Yoon, Seoul National University Hospital

Study Description

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.

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

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	138 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	February 2009
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorhexidine Chlorhexidine acetate Nystatin Chlorhexidine hydrochloride Iodine Povidone Chlorhexidine gluconate Povidone-iodine Urogastrone Hibiclens

U.S. FDA Resources

Arms and Interventions

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 Name: Placebo

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 Name: Placebo

Outcome Measures

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 ]

Secondary Outcome Measures :

Adverse events [ Time Frame: 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 ]
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 ]
Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO) [ Time Frame: 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 ]
Incidence, day of onset, and duration of oral mucositis of grade 4 or higher (WHO) [ Time Frame: Assessed daily during application of study drugs ]
OMDQ (oral mucositis daily questionnaire) score during treatment [ Time Frame: Assessed daily during application of study drugs ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845819

Locations

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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

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Principal Investigator:	Sung-Soo Yoon, MD, PhD	Seoul National University Hospital

More Information

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.

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.

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.

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.

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.

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.

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Responsible Party:	Sung-Soo Yoon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00845819
Other Study ID Numbers:	SNUH-Hema-1001
First Posted:	February 18, 2009 Key Record Dates
Last Update Posted:	January 21, 2015
Last Verified:	January 2015

Keywords provided by Sung-Soo Yoon, Seoul National University Hospital:


oral mucositis intensive chemotherapy stem cell transplantation epidermal growth factor

Additional relevant MeSH terms:

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Hematologic Neoplasms Mucositis Stomatitis Neoplasms Neoplasms by Site Hematologic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases Iodine Chlorhexidine Chlorhexidine gluconate Cadexomer iodine	Povidone-Iodine Nystatin Povidone Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Plasma Substitutes Blood Substitutes Anti-Bacterial Agents

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