Document Detail


Validation of the Phase II Feasibility Study in a Palliative Care Setting: Gastrografin in Malignant Bowel Obstruction.
MedLine Citation:
PMID:  23277632     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background: Malignant bowel obstruction (MBO) is common in patients with advanced cancer. Aim: To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO. METHODS: Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo. RESULTS: Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment). CONCLUSIONS: It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.
Authors:
Cindy Lee; Ryash Vather; Anne O'Callaghan; Jackie Robinson; Briar McLeod; Michael Findlay; Ian Bissett
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-31
Journal Detail:
Title:  The American journal of hospice & palliative care     Volume:  -     ISSN:  1938-2715     ISO Abbreviation:  Am J Hosp Palliat Care     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2013-1-1     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9008229     Medline TA:  Am J Hosp Palliat Care     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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