| Validation of the Phase II Feasibility Study in a Palliative Care Setting: Gastrografin in Malignant Bowel Obstruction. | |
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MedLine Citation:
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PMID: 23277632 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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Cindy Lee; Ryash Vather; Anne O'Callaghan; Jackie Robinson; Briar McLeod; Michael Findlay; Ian Bissett |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-12-31 |
Journal Detail:
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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:
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Created Date: 2013-1-1 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9008229 Medline TA: Am J Hosp Palliat Care Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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