title: Irsogladine maleate reduces the incidence of fluorouracil-based chemotherapy-induced oral mucositis.
abstract: BACKGROUND
  Oral mucositis is one of the most common side-effects of 5-fluorouracil (5-FU)-based chemotherapy. The objective of this study was to evaluate the effects of irsogladine maleate (IM) on fluorouracil-induced oral mucositis through a double-blind, placebo controlled trial.
  
  
  METHODS
  Patients (N = 66) were randomly assigned to receive either placebo or IM (4 mg/day for 14 consecutive days). The incidence and maximum severity of fluorouracil-induced oral mucositis and safety of the irsogladine dosing regimen were evaluated.
  
  
  RESULTS
  A cohort of 33 patients received placebo and 33 patients received IM. The incidence of oral mucositis was significantly lower for IM than for placebo (27% versus 73%; P < 0.001 by chi-square test). Specific adverse events considered related to IM were not found.
  
  
  CONCLUSIONS
  IM significantly reduced the incidence and maximum severity of oral mucositis in patients treated with 5-FU-chemotherapy.
authors.affiliation: Department of Radiology, Kansai Medical University, Hirakata, Japan. excell@hkg.odn.ne.jp
authors.forename: M
authors.initials: M
authors.lastname: Nomura
authors.forename: M
authors.initials: M
authors.lastname: Kamata
authors.forename: H
authors.initials: H
authors.lastname: Kojima
authors.forename: K
authors.initials: K
authors.lastname: Hayashi
authors.forename: S
authors.initials: S
authors.lastname: Sawada
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology*; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage*
chemical_list: D010919:Placebos; D014227:Triazines; C041836:irsogladine; D005472:Fluorouracil