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Oral MucositisPhase 2EGFOMNCT00845819

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

A Phase 2 study testing rhEGF + povidone iodine, chlorhexidine, & nystatin in people with Oral Mucositis, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Oral Mucositis
What is being tested?
rhEGF + povidone iodine, chlorhexidine, & nystatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteSouth Korea
Study dates
Feb 2009to Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Women who are pregnant or breastfeeding
  • Refusal at patients' will
  • Inappropriate patients according to the investigators' opinion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: Randomized Phase II Study of Recombinant Human Epidermal Growth Factor (rhEGF) on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies

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.

Read the 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.

Conditions
Oral Mucositis
Being tested
rhEGF + povidone iodine, chlorhexidine, & nystatin, Placebo + povidone iodine, chlorhexidine, & nystatin
Keywords
oral mucositis, intensive chemotherapy, stem cell transplantation, epidermal growth factor
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhEGF + povidone iodine, chlorhexidine, & nystatinDrug

    Also called Nepidermin, Easyef(R)

    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.

  • Placebo + povidone iodine, chlorhexidine, & nystatinDrug

    Also called Placebo

    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.

Study groups in NCT00845819
Study groupRoleWhat they receive
EGFActive comparatorrhEGF + povidone iodine, chlorhexidine, \& nystatin
Receives: Drug: rhEGF + povidone iodine, chlorhexidine, & nystatin
PlaceboPlacebo comparatorPlacebo + povidone iodine, chlorhexidine, \& nystatin
Receives: Drug: Placebo + povidone iodine, chlorhexidine, & nystatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Assessed daily during application of study drugs

Secondary outcomes (7)

  1. Adverse events

    Measured: 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)

    Measured: 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)

    Measured: Assessed daily during application of study drugs

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

    Measured: Assessed daily during application of study drugs

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

    Measured: Assessed daily during application of study drugs

  6. Incidence, day of onset, and duration of oral mucositis of grade 4 or higher (WHO)

    Measured: Assessed daily during application of study drugs

  7. OMDQ (oral mucositis daily questionnaire) score during treatment

    Measured: Assessed daily during application of study drugs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00845819
Sponsor's protocol ID
SNUH-Hema-1001
Acronym
EGFOM
Status last verified
Jan 2015
First submitted
16 Feb 2009
Last updated
21 Jan 2015
Results posted
No
Data monitoring committee
No

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. doi: 10.1002/cncr.22484.

    PubMed 17236223

  • 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.

    PubMed 11304772

  • 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.

    PubMed 3486247

  • 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.

    PubMed 1488231

  • 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.

    PubMed 11147596

  • 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.

    PubMed 19456848

  • 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.

    PubMed 19514089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhEGF + povidone iodine, chlorhexidine, & nystatin in people with Oral Mucositis, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of oral mucositis of grade 2 or higher (NCI CTCAE 3.0) (time frame: Assessed daily during application of study drugs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00845819, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.

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