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Mayo-led study: Drug fails to reduce diarrhea in patients receiving radiation therapy
Date:9/24/2013

ROCHESTER, Minn. -- Sulfasalazine, a drug commonly prescribed to reduce diarrhea in patients with inflammatory bowel disease, does not reduce diarrhea in patients receiving radiation therapy for cancers in the pelvic area a Mayo Clinic-led study has found. The study also found that the medication may be associated with a higher risk of diarrhea than a placebo when used during radiation therapy to the pelvis. The results were presented today at the American Society of Radiation Oncology's (ASTRO's) 55th Annual Meeting in Atlanta.

"Patients receiving radiation therapy in the pelvic region can experience diarrhea which is a negative side effect of the therapy," says the study's lead author Robert Miller, M.D., a radiation oncologist at Mayo Clinic. Dr. Miller says that in previous trials sulfasalazine, which treats bowel inflammation, had been shown to decrease diarrhea in patients during pelvic radiation therapy.

Dr. Miller led a two-year, randomized, double-blind, placebo-controlled phase III clinical trial through the Alliance for Clinical Trials in Oncology to evaluate the effectiveness of sulfasalazine versus placebo in inflammation of the bowel during pelvic radiation therapy. The trial included 87 patients, with 78 patients evaluated for the primary endpoint, which was maximal severity of diarrhea up to six weeks after therapy, based on commonly accepted criteria. Patients enrolled in the study came from 24 institutions in the United States.

Patients received 1,000 milligrams of sulfasalazine or placebo orally, twice each day during radiation therapy and for four weeks after therapy. Patients completed bowel function questionnaires weekly during therapy, afterward for six weeks and at 12 and 24 months after therapy. Health care providers graded each patient on the maximum severity and the duration of maximum severity of diarrhea, rectal bleeding, abdominal cramping, constipation and tenesmus, the sensation of incomplete defec
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Contact: Joe Dangor
newsbureau@mayo.edu
504-284-5005
Mayo Clinic
Source:Eurekalert

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