A phase II, multi-site, double blind, randomised placebo-controlled feasibility trial of crushed oral famotidine for management of Inoperable Malignant Bowel Obstruction (IMBO)
- Conditions
- Bowel ObstructionMalignant Bowel ObstructionBowel cancerCancer - Bowel - Small bowel (duodenum and ileum)Cancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12621001403820
- Lead Sponsor
- niversity of Technology Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 4
•Advanced cancer;
•Clinically confirmed bowel obstruction at any level with vomiting that precipitates a hospital admission or change in clinical care;
•Deemed by two consultant level medical practitioners that this person has a bowel obstruction (partial or complete) for which immediate surgery is not indicated;
•Disease-modifying therapy (surgery, chemotherapy, radiotherapy, hormone therapy; biological/targeted therapies) is deemed by relevant practitioners unlikely to change the bowel obstruction;
•If participant has a nasogastric tube (NGT), final decompression must be at least 12 hours before treatment start;
•Participant is capable of completing assessments and complying with the study procedures;
•Record a St Louis Mental Status Exam Score (SLUMS) of greater than or equal to 23 or as deemed suitable by the site principal investigator; and
•Participant is able to give fully informed, written consent.
•Previous adverse reaction to any of the study medications;
•Calculated creatinine clearance <10 mL / min using the Modification of Diet in Renal Disease Study (MDRD) formula;
•Venting or feeding gastrostomy or jejunostomy;
•Participant has a NGT that, in the investigator’s opinion, cannot be clamped for the duration of treatment; and
•Oral food intake that cannot be reduced to clear fluids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is whether this study is feasible to extend to a fully powered phase III clinical trial. <br><br>Feasibility is defined as:<br>1.An average of one participant identified per site every eight weeks using recruitment tracking data bases;<br>2.One participant recruited per site every 12 weeks using recruitment racking databases; and<br>3.Collect data for >80% of people randomised, to the primary endpoint of 120 hours or study exit assessed by reviewing the data entry into the study data base..<br>[ On completion of the study<br><br>]
- Secondary Outcome Measures
Name Time Method