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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rhEGF + povidone iodine, chlorhexidine, & nystatin
Placebo + povidone iodine, chlorhexidine, & nystatin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring oral mucositis, intensive chemotherapy, stem cell transplantation, epidermal growth factor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EGF

Placebo

Arm Description

rhEGF + povidone iodine, chlorhexidine, & nystatin

Placebo + povidone iodine, chlorhexidine, & nystatin

Outcomes

Primary Outcome Measures

Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2009
Last Updated
January 20, 2015
Sponsor
Seoul National University Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT00845819
Brief Title
Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
Acronym
EGFOM
Official Title
Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
oral mucositis, intensive chemotherapy, stem cell transplantation, epidermal growth factor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGF
Arm Type
Active Comparator
Arm Description
rhEGF + povidone iodine, chlorhexidine, & nystatin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + povidone iodine, chlorhexidine, & nystatin
Intervention Type
Drug
Intervention Name(s)
rhEGF + povidone iodine, chlorhexidine, & nystatin
Other Intervention Name(s)
Nepidermin, Easyef(R)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo + povidone iodine, chlorhexidine, & nystatin
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)
Time Frame
Assessed daily during application of study drugs
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Assessed daily during application of study drugs
Title
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
Title
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
Title
Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO)
Time Frame
Assessed daily during application of study drugs
Title
Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (WHO)
Time Frame
Assessed daily during application of study drugs
Title
Incidence, day of onset, and duration of oral mucositis of grade 4 or higher (WHO)
Time Frame
Assessed daily during application of study drugs
Title
OMDQ (oral mucositis daily questionnaire) score during treatment
Time Frame
Assessed daily during application of study drugs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Soo Yoon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
17236223
Citation
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.
Results Reference
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PubMed Identifier
11304772
Citation
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.
Results Reference
background
PubMed Identifier
3486247
Citation
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.
Results Reference
background
PubMed Identifier
1488231
Citation
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.
Results Reference
background
PubMed Identifier
11147596
Citation
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.
Results Reference
background
PubMed Identifier
19456848
Citation
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.
Results Reference
background
PubMed Identifier
19514089
Citation
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.
Results Reference
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Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies

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