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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

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.

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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


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




Primary Outcome Measures :
  1. 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 :
  1. Adverse events [ Time Frame: Assessed daily during application of study drugs ]
  2. 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 ]
  3. 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 ]
  4. Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO) [ Time Frame: Assessed daily during application of study drugs ]
  5. Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (WHO) [ Time Frame: Assessed daily during application of study drugs ]
  6. Incidence, day of onset, and duration of oral mucositis of grade 4 or higher (WHO) [ Time Frame: Assessed daily during application of study drugs ]
  7. OMDQ (oral mucositis daily questionnaire) score during treatment [ Time Frame: Assessed daily during application of study drugs ]


Information from the National Library of Medicine

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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

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
Publications:

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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