title: 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.
abstract: OBJECTIVE
  To assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA. jmartenson@mayo.edu
authors.forename: James A
authors.initials: JA
authors.lastname: Martenson
authors.forename: Michele Y
authors.initials: MY
authors.lastname: Halyard
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
authors.forename: Gary M
authors.initials: GM
authors.lastname: Proulx
authors.forename: Robert C
authors.initials: RC
authors.lastname: Miller
authors.forename: Richard L
authors.initials: RL
authors.lastname: Deming
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Dick
authors.forename: Harold A
authors.initials: HA
authors.lastname: Johnson
authors.forename: T H Patricia
authors.initials: TH
authors.lastname: Tai
authors.forename: Angela W
authors.initials: AW
authors.lastname: Zhu
authors.forename: Joan
authors.initials: J
authors.lastname: Keit
authors.forename: Kathy J
authors.initials: KJ
authors.lastname: Stien
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Atherton