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Sucralfate in the Prevention of Treatment-Induced Diarrhea in Patients Receiving Pelvic Radiation Therapy: A North Central Cancer Treatment Group Phase III Double-Blind Placebo-Controlled Trial

From the Mayo Clinic and Mayo Foundation, Rochester; Duluth Community Clinical Oncology Program (CCOP), Duluth, MN; Grand Forks, Ltd, Grand Forks; Meritcare Hospital CCOP, Fargo, ND; Siouxland Hematology-Oncology Associates, Sioux City, IA; Carle Cancer Center CCOP, Urbana, IL; and Missouri Valley Cancer Consortium, Omaha, NE.

Address reprint requests to James A. Martenson, MD, Division of Radiation Oncology, Mayo Clinic, 200 First St SW, Rochester, MN 55905.

PURPOSE: Randomized studies have suggested that sucralfate is effective in mitigating diarrhea during pelvic radiation therapy (RT). This North Central Cancer Treatment Group study was undertaken to confirm the antidiarrheal effect of sucralfate. Several other measures of bowel function were also assessed.

PATIENTS AND METHODS: Patients receiving pelvic RT to a minimum of 45 Gy at 1.7 to 2.1 Gy/d were eligible for the study. Patients were assigned randomly, in double-blind fashion, to receive sucralfate (1.5 g orally every 6 hours) or an identical looking placebo during pelvic RT.

RESULTS: One hundred twenty-three patients were randomly assigned and found assessable. Overall, there was no significant difference in patient characteristics between those receiving sucralfate and those receiving placebo. Moderate or worse diarrhea was observed in 53% of patients receiving sucralfate versus 41% of those receiving placebo. Compared with patients receiving placebo, more sucralfate-treated patients reported fecal incontinence (16% v 34%, respectively; P = .04) and need for protective clothing (8% v 23%, respectively; P = .04). The incidence and severity of nausea were worse among those taking sucralfate (P = .03). Analysis of patient-reported symptoms 10 to 12 months after RT showed a nonsignificant trend toward more problems in patients taking sucralfate than in those taking placebo (average, 2.3 v 1.9 problems, respectively; P = .34).

CONCLUSION: Sucralfate did not decrease pelvic RT-related bowel toxicity by any of the end points measured and seems to have aggravated some gastrointestinal symptoms.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and was supported in part by Public Health Service grants no. CA-25224, CA-37404, CA-35269, CA-35103, CA-35195, CA-63849, CA-37417, CA-63848, CA-35448, CA-35415, CA-35101, CA-35113, CA-52352, and CA-35272 from the National Cancer Institute Department of Health and Human Services, Bethesda, MD.

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