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

NCT00845819 | Completed Phase 2

• 1 other identifier: SNUH-Hema-1001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

oral mucositis; intensive chemotherapy; stem cell transplantation; epidermal growth factor

Outcome Measures

Primary Outcomes (1)

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

  Assessed daily during application of study drugs

Secondary Outcomes (7)

• Adverse events

  Assessed daily during application of study drugs

• Day of onset and duration of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)

  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)

  Assessed daily during application of study drugs

• Incidence, day of onset, and duration of oral mucositis of grade 2 or higher (WHO)

  Assessed daily during application of study drugs

• Incidence, day of onset, and duration of oral mucositis of grade 3 or higher (WHO)

  Assessed daily during application of study drugs

Study Arms (2)

EGF

ACTIVE COMPARATOR

rhEGF + povidone iodine, chlorhexidine, \& nystatin

Drug: rhEGF + povidone iodine, chlorhexidine, & nystatin

Placebo

PLACEBO COMPARATOR

Placebo + povidone iodine, chlorhexidine, \& nystatin

Drug: Placebo + povidone iodine, chlorhexidine, & nystatin

Interventions

rhEGF + povidone iodine, chlorhexidine, & nystatin DRUG

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.

Also known as: Nepidermin, Easyef(R)

EGF

Placebo + povidone iodine, chlorhexidine, & nystatin DRUG

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.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients having previous history of hypersensitivity to this drug or similar drugs
• Patients received chemotherapy, radiotherapy, or surgery within 3 weeks
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (7)

• 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.

  PMID: 17236223 BACKGROUND

• 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.

  PMID: 11304772 BACKGROUND

• 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.

  PMID: 3486247 BACKGROUND

• 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.

  PMID: 1488231 BACKGROUND

• 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.

  PMID: 11147596 BACKGROUND

• 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.

  PMID: 19456848 BACKGROUND

• 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.

  PMID: 19514089 BACKGROUND

MeSH Terms

Conditions

Stomatitis

Interventions

Povidone-Iodine; Chlorhexidine; Nystatin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines; Macrolides; Lactones

Study Officials

• Sung-Soo Yoon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

KR (1)