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A randomised double blind placebo controlled trial of infusional subcutaneous octreotide in the management of malignant bowel obstruction at the end of life.

Phase 3
Completed
Conditions
Bowel obstruction in the setting of advanced cancer
Cancer - Other cancer types
Registration Number
ACTRN12608000211369
Lead Sponsor
Flinders University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
94
Inclusion Criteria

age >18 years
advanced cancer
disease-modifying therapy (chemotherapy, radiotherapy, hormone therapy, biological/targeted therapies) is deemed by relevant practitioners unlikely to change the bowel obstruction or the course of cancer.
presents with clinically confirmed bowel obstruction at any level and vomiting that precipitates a hospital admission or change in clinical care for those already in-patients
deemed by two consultant level medical practitioners that this person has a bowel obstruction (partial or complete) for which immediate surgery is not indicated
participant is capable of completing assessments and complying with the study procedures
participant is able to give fully informed written consent
Mini Mental State of >23
Not currently on octreotide

Exclusion Criteria

previous adverse reaction to any of the study medications
Australian-modified Karnofsky performance score less than 30 at the beginning of the study
participants who have participated in a clinical study of a new chemical entity within the month prior to study entry.
calculated creatinine clearance <10ml/min
documented cirrhosis
venting or feeding gastrostomy or jejunostomy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome is number of days without an episode of vomiting in the first 72 hours of the study.[ 72 hours from the start of treatment]
Secondary Outcome Measures
NameTimeMethod
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