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Clinical Trial
. 2008 Nov 10;26(32):5248-53.
doi: 10.1200/JCO.2008.17.1546. Epub 2008 Sep 2.

Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA

James A Martenson  1 , Michele Y Halyard, Jeff A Sloan, Gary M Proulx, Robert C Miller, Richard L Deming, Stephen J Dick, Harold A Johnson, T H Patricia Tai, Angela W Zhu, Joan Keit, Kathy J Stien, Pamela J Atherton
Affiliations
Clinical Trial

Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA

James A Martenson et al. J Clin Oncol. .

Abstract

Purpose: To assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy.

Patients and methods: Patients receiving pelvic radiation therapy (planned minimum dose, 45 Gy; 1.7 to 2.1 Gy daily) were eligible for the study. From May 10, 2002, through October 14, 2005, 125 patients were randomly allocated in a double-blind fashion to receive octreotide (100 microg, administered subcutaneously on day 1, followed by depot octreotide, 20 mg, administered intramuscularly on days 2 and 29; n = 62) or to receive a placebo (n = 63).

Results: Grade 0, 1, 2, and 3 diarrhea were observed in 18%, 31%, 31%, and 21% of patients in the octreotide arm, respectively, and in 25%, 32%, 22%, and 21% of patients in the placebo arm, respectively (P = .64). Grade 0, 1, 2, and 3 abdominal cramps were observed in 32%, 45%, 21%, and 2% of patients receiving octreotide, respectively, and in 51%, 24%, 21%, and 5% of patients receiving the placebo, respectively (P = .053). Some patient-reported symptoms were worse in the octreotide group, including nocturnal bowel movements (70% v 45%; P = .004), clustering of bowel movements (90% v 69%; P = .004), and bleeding with bowel movements (57% v 35%; P = .01).

Conclusion: As administered in this study, octreotide did not decrease diarrhea during pelvic radiation therapy. Some gastrointestinal symptoms were worse in patients treated with octreotide. Octreotide is not indicated for prevention of diarrhea during pelvic radiation therapy.

Trial registration: ClinicalTrials.gov NCT00033605.

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Figures

Fig 1.
Fig 1.
Study flow diagram.
Fig 2.
Fig 2.
Mean diarrhea grade during pelvic radiation therapy. No significant differences were observed between patients treated with octreotide and patients treated with the placebo.
See this image and copyright information in PMC

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References

    1. Kozelsky TF, Meyers GE, Sloan JA, et al: North Central Cancer Treatment Group: Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. J Clin Oncol 21:1669-1674, 2003 - PubMed
    1. Martenson JA, Bollinger JW, Sloan JA, et al: 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. J Clin Oncol 18:1239-1245, 2000 - PubMed
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    1. Miller RC, Martenson JA, Sargent DJ, et al: Acute treatment-related diarrhea during postoperative adjuvant therapy for high-risk rectal carcinoma. Int J Radiat Oncol Biol Phys 41:593-598, 1998 - PubMed

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