Does sucralfate reduce the acute side-effects in head and neck cancer treated with radiotherapy? A double-blind randomized trial.
OBJECTIVE
We evaluated sucralfate, well-known in the treatment of gastric ulcers, in relation to its possible reduction of radiation-induced acute complications in the treatment of head and neck cancers.


METHODS
One hundred two patients were randomized in a double-blind placebo-controlled prospective setting. All patients were treated to a minimum dose of 55 Gy in 5 weeks. Oral intake of sucralfate was started at the beginning of radiotherapy and continued during the whole treatment at a dose of 1 g six times a day. All patients were scored according to a scoring system developed in our department. Weight was checked once a week.


RESULTS
Comparing the time course of the mean scores for subjective intolerance, mucositis, dysphagia, dermatitis and nausea, no statistically significant differences between the two treatment arms (sucralfate, n = 38; placebo, n = 45) were observed. The mean weight loss in the sucralfate arm was 1.6 +/- 3.4 kg while it was 1.3 +/- 2.0 kg in the placebo arm. Apart from gastrointestinal upset, the administration of sucralfate did not cause any side-effects.


CONCLUSIONS
This trial produced no clinical evidence indicating that the oral intake of sucralfate reduces the acute radiation-induced side-effects. Therefore, we do not recommend the prophylactic use of sucralfate in patients with head and neck cancer treated by radiotherapy.
Lievens
Y
Y
Department of Radiotherapy, UZ Gasthuisberg, Leuven, Belgium.
Haustermans
K
K
Van den Weyngaert
D
D
Van den Bogaert
W
W
Scalliet
P
P
Hutsebaut
L
L
Fowler
J
J
Lambin
P
P
D000208:Acute Disease; D000284:Administration, Oral; D003680:Deglutition Disorders / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D009092:Mucous Membrane / Q000187:drug effects; D009325:Nausea / Q000209:etiology / Q000517:prevention & control; D011446:Prospective Studies; D011832:Radiation Injuries / Q000517:prevention & control*; D011855:Radiodermatitis / Q000517:prevention & control; D011879:Radiotherapy Dosage; D013392:Sucralfate / Q000008:administration & dosage / Q000627:therapeutic use*
D013392:Sucralfate