Clinical trial · Interventional
Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies
NCT00845819CI-TRIAL-00016658EGFOMcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo + povidone iodine, chlorhexidine, & nystatin | Drug | — | UNRESOLVED |
| rhEGF + povidone iodine, chlorhexidine, & nystatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EGF
- description
- rhEGF + povidone iodine, chlorhexidine, \& nystatin
- interventionNames
- Drug: rhEGF + povidone iodine, chlorhexidine, & nystatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo + povidone iodine, chlorhexidine, \& nystatin
- interventionNames
- Drug: Placebo + povidone iodine, chlorhexidine, & nystatin
Primary outcomes (1)
- measure
- Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0)
- timeFrame
- Assessed daily during application of study drugs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDKeefe 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
- BACKGROUNDSonis 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
- BACKGROUNDBrown 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
- BACKGROUNDSonis 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
- BACKGROUNDEpstein 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
- BACKGROUNDHong 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.