Martenson, J.A., Bollinger, J.W., Sloan, J.A., Novotny, P.J., Urias, R.E., Michalak, J.C., … Levitt, R. (2000). 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. Journal of Clinical Oncology, 18(6), 1239–1245.

Patients receiving pelvic external beam radiation therapy were randomly assigned to receive sulcrafate (2 gm four times per day) or placebo.

The study reported on 123 evaluable patients. The treatment group consisted of 62 patients, and the placebo group consisted of 61 patients. The two groups were balanced in terms of factors such as diagnosis, functional status, radiation dosage, and tumor status. 

This was a double-blind, randomized controlled trial.

• Patients reported the number bowel movements, use of protective clothing, and symptoms of cramping, blood, nocturnal bowel movements, and fecal incontinence weekly via a questionnaire.
• Physicians assessed diarrhea, tenesmus, cramping, bleeding, nausea, and constipation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

More patients in the treatment group reported fecal incontinence and a need for protective clothing than in the control group (34% versus 16%, p = 0.04). Physician-reported severity of nausea was worse in the treatment group compared to the control group (p = 0.3), although this was not a specific study endpoint.

Sulcrafate did not decrease pelvic radiation therapy-related bowel toxicity by any of the endpoints measured and seems to have aggravated some gastrointestinal symptoms.

Although the patient questionnaire approximated the physician scale, provider assessments of subjective data such as cramping and straining can be unreliable if not obtained directly from the subject.