title: Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study.
abstract: OBJECTIVE
  To compare granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwashes with sucralfate mouthwashes in the prevention of radiation-induced mucositis.
  
  
  METHODS
  Forty patients with radically operated head-and-neck cancer were randomly allocated to use either GM-CSF (n = 21) or sucralfate (n = 19) mouthwashes during postoperative radiotherapy (RT). All patients received conventionally fractionated RT to a total dose of 50-60 Gy in 2-Gy daily fractions during 5-6 weeks to the primary site and regional lymphatics. A minimum of 50% of the oral cavity and oropharyngeal mucosa was included in the clinical target volume. GM-CSF mouthwashes consisted of 37.5 microg GM-CSF and sucralfate mouthwashes of 1.0 g of sucralfate distilled in water. Both washes were used 4 times daily, beginning after the first week of RT and continued to the end of the RT course. Symptoms related to radiation mucositis and body weight, serum prealbumin level, and blood cell counts were monitored weekly.
  
  
  RESULTS
  Oral mucositis tended to be less severe in the GM-CSF group (p = 0.072). Complete (n = 1) or partial (n = 4) healing of mucositis occurred during the RT course in 5 patients (24%) in the GM-CSF group and in none of the patients in the sucralfate group (p = 0.049). Patients who received GM-CSF had less mucosal pain (p = 0.058) and were less often prescribed opioids for pain (p = 0.042). Three patients in the sucralfate group needed hospitalization for mucositis during RT compared with none in the GM-CSF group. Four patients (21%) in the sucralfate group and none in the GM-CSF group required an interruption in the RT course (p = 0.042). No significant differences in weight, prealbumin level, or blood cell count were found between the groups, and both mouthwashes were well tolerated.
  
  
  CONCLUSIONS
  GM-CSF mouthwashes may be moderately more effective than sucralfate mouthwashes in preventing radiation-induced mucositis and mucositis-related pain, and their use may lead to less frequent RT course interruptions from mucositis. The present findings need to be confirmed before adopting GM-CSF mouthwashes in routine clinical use.
authors.affiliation: Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland. kauko.saarilahti@hus.fi
authors.forename: Kauko
authors.initials: K
authors.lastname: Saarilahti
authors.forename: Mikael
authors.initials: M
authors.lastname: Kajanti
authors.forename: Timo
authors.initials: T
authors.lastname: Joensuu
authors.forename: Mauri
authors.initials: M
authors.lastname: Kouri
authors.forename: Heikki
authors.initials: H
authors.lastname: Joensuu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000532:radiotherapy / Q000601:surgery; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000528:radiation effects; D009067:Mouthwashes / Q000627:therapeutic use*; D009504:Neutrophils; D011446:Prospective Studies; D011832:Radiation Injuries / Q000517:prevention & control*; D013280:Stomatitis / Q000517:prevention & control*; D013392:Sucralfate / Q000627:therapeutic use*; D015431:Weight Loss
chemical_list: D000897:Anti-Ulcer Agents; D009067:Mouthwashes; D013392:Sucralfate; D016178:Granulocyte-Macrophage Colony-Stimulating Factor