Lievens, Y., Haustermans, K., Van den Weyngaert, D., Van den Bogaert, W., Scalliet, P., Hutsebaut, L., . . . Lambin, P. (1998). Does sucralfate reduce the acute side-effects in head and neck cancer treated with radiotherapy? A double-blind randomized trial. Radiotherapy and Oncology, 47, 149–153.

To determine the efficacy of oral sucralfate in reducing radiation (RT)-induced acute complications in the treatment of patients with head and neck cancer. This study looked at mucositis and dermatitis.

Patients were given oral sucralfate at a dose of 1 gm six times a day from the onset of RT and continued during the entire treatment.

• The sample was comprised of 83 patients.
• Age and gender were not provided.
• Patients had head and neck cancer.
• Patients were treated to 55 Gy in five weeks.

Two sites in Belgium

The study was a randomized, placebo-controlled, double-blind trial.

Dermatitis scoring scale:

• 0 = none
• 1 = slight erythema
• 2 = deep erythema
• 3 = dry desquamation
• 4 = spotted epidermolysis
• 5 = confluent epidermolysis
• 6 = necrosis

Other variables analyzed were weight, tumor site, and stage; subjective tolerance; dysphagia; nausea and vomiting; dermatitis; mucositis; total dose; and daily fractionation schedule.

Of the initial 102 patients randomized, only 83 were evaluable due to issues of patient nonadherence to the protocol. Compliance was worse in the sucralfate group. There were no differences in mean scores for dermatitis or other symptoms measured between the two study groups.

No clinical evidence indicated that sucralfate reduces acute RT-induced side effects.

• Patients were given local anesthetics and systemic painkillers when needed, so it would be difficult to determine what actually worked.
• Patients were not evaluated at the end of treatment.
• Many participants did not follow protocol.
• Use of a nonstandard tool makes comparison to other studies difficult.
• No data were provided on gender and age.
• No data were shown regarding total RT dose and fractionation schedule.