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Phase III Double-Blind Study of Glutamine Versus Placebo for the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

Timothy F. Kozelsky, Gregory E. Meyers, Jeff A. Sloan, Thomas G. Shanahan, Stephen J. Dick, Randy L. Moore, George P. Engeler, Albert R. Frank, Timothy K. McKone, Rodolfo E. Urias, Miljenko V. Pilepich, Paul J. Novotny, James A. Martenson

From the Mayo Clinic, Rochester; Duluth CCOP, Duluth, MN; Carle Cancer Center Community Clinical Oncology Program [CCOP], Urbana, IL; Siouxland Hematology-Oncology Associates, Sioux City; Iowa Oncology Research Association CCOP, Des Moines, IA; Meritcare Hospital CCOP, Fargo, ND; Toledo Community Hospital Oncology Program CCOP, Toledo, OH; Missouri Valley Cancer Consortium, Omaha, NE; and Ann Arbor Regional CCOP, Ann Arbor, MI.

Address reprint requests to James A. Martenson, MD, Mayo Clinic, 200 First St, SW, Rochester, MN 55905; email: jmartenson{at}mayo.edu.

Purpose: A phase III, randomized, double-blind study was conducted by the North Central Cancer Treatment Group to determine the efficacy and toxicity of oral glutamine for the prevention of acute diarrhea in patients receiving pelvic radiation therapy (RT).

Patients and Methods: All 129 patients enrolled from 14 institutions between February 1998 and October 1999 were eligible. Patients received 4 g of glutamine or placebo orally, twice a day, beginning with the first or second day of RT and continuing for 2 weeks after RT. During treatment, patients were assessed weekly for toxicity, and a bowel function questionnaire was administered. The primary measures of treatment efficacy were diarrhea levels measured by maximum grade of diarrhea, incidence of diarrhea, and average diarrhea score. After completion of RT, the bowel function questionnaire was administered weekly for 4 weeks and at 12 and 24 months. Toxicity was measured by National Cancer Institute common toxicity criteria.

Results: The median age of patients was 69 years (range, 34 to 86 years). The two treatment arms were balanced with respect to all baseline factors. There were no significant differences in toxicity by treatment. Quality-of-life scores and the mean number of problems reported on the bowel function questionnaire were virtually identical for both treatment groups. The incidence of grade 3 or higher diarrhea was 20% for the glutamine arm and 19% for the placebo arm (P = .99). The maximum number of stools per day was 5.1 for the glutamine arm and 5.2 for the placebo arm (P = .99).

Conclusion: There is no evidence of a beneficial effect of glutamine during pelvic RT.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grant nos. CA-25224, CA-37404, CA-15083, CA-63826, CA-35195, CA-35103, CA-37417, CA-35415, CA-63849, CA-35101, CA-35269, and CA-63848.

Presented, in part, at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 13, 2001.

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