title: Sucralfate in the treatment of chemotherapy-induced stomatitis: a double-blind, placebo-controlled pilot study.
abstract: BACKGROUND
  The study was a double-blind, placebo-controlled, randomised pilot study to assess the efficacy of sucralfate gel in the treatment of chemotherapy-induced mucositis.
  
  
  METHODS
  At the onset of stomatitis, forty patients received sucralfate gel (1 gr.) or placebo and were instructed to apply the gel over oral mucosas, 3 times daily.
  
  
  RESULTS
  Objective response was observed in 14 patients (11 complete response+3 partial response) and in 15 patients (10 CR+5 PR), in the sucralfate and placebo arms, respectively; (p = NS). Analysis of VAS (visual analogue scale) scoring of pain did not detect any statistical difference between the two groups. No important side-effects were observed. Twelve out 21 patients who obtained a complete resolution of stomatitis (5 out of 11 and 7 out of 10 in the sucralfate and in placebo arms, respectively) received further treatment at the subsequent course of chemotherapy; prevention of mucositis was observed in 4 patients in the sucralfate arm and in 6 patients in the placebo arm, respectively.
  
  
  CONCLUSIONS
  In the present pilot study, sucralfate did not demonstrate a significant advantage in comparison to the placebo in the treatment of chemotherapy-induced stomatitis.
authors.affiliation: Department of Medical Oncology, National Institute for Cancer Research, Genova, Italy. schiara@hp380.ist.unige.it
authors.forename: S
authors.initials: S
authors.lastname: Chiara
authors.forename: M T
authors.initials: MT
authors.lastname: Nobile
authors.forename: M
authors.initials: M
authors.lastname: Vincenti
authors.forename: A
authors.initials: A
authors.lastname: Gozza
authors.forename: I
authors.initials: I
authors.lastname: Pastrone
authors.forename: M
authors.initials: M
authors.lastname: Rosso
authors.forename: R
authors.initials: R
authors.lastname: Rosso
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D010865:Pilot Projects; D010919:Placebos; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy*; D013392:Sucralfate / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D000970:Antineoplastic Agents; D010919:Placebos; D013392:Sucralfate