title: Placebo-controlled trial of sucralfate for inhibiting radiation-induced esophagitis.
abstract: OBJECTIVE
  To determine whether a sucralfate oral solution can prevent/alleviate radiation-induced esophagitis.
  
  
  METHODS
  Patients included on this clinical trial were beginning thoracic radiation therapy to the mediastinum. Following stratification, they were randomized, in a double-blind manner, to receive a sucralfate solution or an identical-appearing placebo solution. Esophagitis was measured by physicians who used standard criteria and also by patients who used short questionnaires completed weekly during the course of the trial.
  
  
  RESULTS
  A total of 97 assessable patients were entered onto this clinical trial. During the first 2 weeks of the study, two placebo patients (4%) stopped their study medication, compared with 20 sucralfate patients (40%). This was related to substantially increased incidences of gastrointestinal toxicity (58% of sucralfate patients v 14% of placebo patients; P > .0001). There was no substantial benefit from the sucralfate in terms of esophagitis scores.
  
  
  CONCLUSIONS
  This oral sucralfate solution does not appear to inhibit radiation-induced esophagitis and is associated with disagreeable gastrointestinal side effects in this patient population.
authors.affiliation: Iowa Oncology Research Association Community Clinical Oncology Program (CCOP), Des Moines, USA.
authors.forename: W L
authors.initials: WL
authors.lastname: McGinnis
authors.forename: C L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: S J
authors.initials: SJ
authors.lastname: Buskirk
authors.forename: J A
authors.initials: JA
authors.lastname: Sloan
authors.forename: R G
authors.initials: RG
authors.lastname: Drummond
authors.forename: A R
authors.initials: AR
authors.lastname: Frank
authors.forename: T G
authors.initials: TG
authors.lastname: Shanahan
authors.forename: S P
authors.initials: SP
authors.lastname: Kahanic
authors.forename: R L
authors.initials: RL
authors.lastname: Moore
authors.forename: S E
authors.initials: SE
authors.lastname: Schild
authors.forename: S L
authors.initials: SL
authors.lastname: Humphrey
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004941:Esophagitis / Q000188:drug therapy* / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries / Q000188:drug therapy* / Q000517:prevention & control; D013392:Sucralfate / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D013392:Sucralfate