A multi-site, fixed dose, parallel arm, double-blind, placebo controlled, block randomised trial of the addition of infusional octreotide or placebo to regular ranitidine and dexamethasone for the evaluation of vomiting associated with bowel obstruction at the end of life

Background: Bowel obstruction due to advanced cancer that is surgically inoperable is a major management problem. Studies to date have either been underpowered or have used comparators that may not draw on the best available evidence. Methods: This double-blind, block randomised, placebo controlled, set dose, parallel arm study was conducted across 12 sites in Australia. Eligibility included inoperable bowel obstruction secondary to cancer or its treatments. The intervention was the addition of infusional octreotide or placebo in addition to 200mg ranitidine per 24 hours parenterally and 4mg per 24 hours parenterally of dexamethasone. The primary outcome measure was the numbers of days free of vomiting up to 72 hours after all medications were administered the first time. Participants were also administered between 10-20mls per hour of subcutaneous isotonic fluid over the 72 hour period. Results: This study will close to recruitment in March 2012. To date 89 of 92 required participants have been randomised. Conclusions: This adequately powered study will define the additional net clinical benefit derived from octreotide over placebo in people who have an anti-secretary agent (ranitidine) and glucocorticoids (dexamethasone).