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

PHASE2CompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Oral Mucositis
Interventions
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."

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."

Trial Locations (1)

110-744

Seoul National University Hospital, Seoul

Sponsors
All Listed Sponsors
collaborator

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

lead

Seoul National University Hospital

OTHER