Clinical and histopathological evaluation of sucralfate in prevention of oral mucositis induced by radiation therapy in patients with head and neck malignancies

Forty-four patients with head and neck malignancies were included in a prospective, randomized, double-blind, placebo-controlled study for evaluation of sucralfate in prevention of oral mucositis induced by radiation therapy. Patients were randomized to receive oral suspensions of either sucralfate (n = 23) or placebo (n = 21) in six daily doses of 1 g. The primary tumors were treated with portals covering at least one-third of the oral mucosa to a minimum dose of 60 Gy. Drug therapy was not associated with significant adverse effects and compliance: was satisfactory. Daily inspection of the oral mucosa and questionnaires for oral mucositis-related items demonstrated reduction in oral mucositis stores and oral pain scores and biopsies obtained from the buccal mucosa demonstrated reduction in evidence of altered vascular calibration, altered vascular permeability and leukocyte emigration with sucralfate. Clinical and histopathological demonstration of reduction in oral mucositis with sucralfate suggests that sucralfate might be recommended in the prevention of oral mucositis induced by radiation therapy in patients with head and neck malignancies. (C) 2000 Elsevier Science Ltd. All rights reserved.