[Efficacy of sucralfate in the prophylaxis of diarrhea secondary to acute radiation-induced enteritis. Preliminary results of a double-blind randomized trial].

Background: Pelvic radiation therapy is usually associated with intestinal symptoms, especially diarrhea. Sucralfate has been demonstrated to be effective in peptic ulcers, and seems to provide some benefits in chemotherapy induced mucositis and radiogenic rectitis and enteritis.

Methods: Thirty-four patients between 20-80 years of age, without diarrea and with a Karnofsky index greater than 60%, undergoing whole pelvic irradiation (46 Gy total dose, 2 Gy/day, 5 days/week) have been randomized to receive: sucralfate (1g/6h) (18 patients) or placebo (16 patients) during the treatment period and 3 weeks later.

Results: The statistical analysis of the clinical records show that patients receiving sucralfate do better during the whole treatment period (p = 0.03), and they need other complementary measures against diarrhea, as diet (p = 0.03) or pharmacologic support (p = 0.002), later in the course of the radiotherapy. Nevertheless, the incidence and severity of diarrea and other associated simptoms show no differences between both groups.

Conclusions: Sucralfate increases the enteric tolerance during pelvic irradiation in cancer patients.