title: Double blind randomized trial of sucralfate vs placebo during radical radiotherapy for head and neck cancers.
abstract: BACKGROUND
  This study sought to determine whether sucralfate prophylaxis during a course of high dose radiation therapy (RT) for head and neck cancer decreases acute side effects.
  
  
  METHODS
  Patients receiving curative intent RT for advanced head and neck cancers participated in a single institution double-blind randomized trial comparing sucralfate to placebo. Patients were stratified according to fractionation, use of concurrent chemotherapy, Karnofsky performance status (KPS), age, and pretreatment presence of a feeding gastrostomy. Patients were prospectively evaluated during weekly treatment checks, and analyzed with regard to time (measured in terms of dose) until development of the following: weight loss, mucositis, pain, nutritional intake, and need for a treatment break. After completion of RT, time until healing was similarly compared.
  
  
  RESULTS
  Fifty-two patients received sucralfate and 50 received placebo. The mean (+/-SD) prescribed dose was 69 +/- 7 Gy. Sixty-nine patients received BID fractionation and 27 received concurrent chemotherapy. No difference was detected in any outcome measure in the direct comparison between the two groups. On multivariate analysis, weight loss >5% or >10% occurred more frequently in patients receiving chemotherapy (p < 0.01 and p = 0.05, respectively). Grade 3 mucositis was more common in patients receiving chemotherapy (p = 0.05) or BID fractionation (p = 0.04) or having a poor KPS (p = 0.02). Interval to healing was not associated with any of the pretreatment- or treatment-related factors. Sucralfate did not result in any additional toxicity.
  
  
  CONCLUSIONS
  Prophylactic treatment with sucralfate during high-dose head and neck RT did not decrease acute treatment side effects. Other modalities should be investigated.
authors.affiliation: Department of Radiation Oncology, Box 3085, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: D L
authors.initials: DL
authors.lastname: Carter
authors.forename: M E
authors.initials: ME
authors.lastname: Hebert
authors.forename: K
authors.initials: K
authors.lastname: Smink
authors.forename: K A
authors.initials: KA
authors.lastname: Leopold
authors.forename: R L
authors.initials: RL
authors.lastname: Clough
authors.forename: D M
authors.initials: DM
authors.lastname: Brizel
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D004311:Double-Blind Method; D005767:Gastrointestinal Diseases / Q000209:etiology / Q000517:prevention & control*; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D009092:Mucous Membrane; D011446:Prospective Studies; D011832:Radiation Injuries / Q000517:prevention & control*; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control; D013392:Sucralfate / Q000627:therapeutic use*
chemical_list: D013392:Sucralfate