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

INTERVENTION: A phase III randomised, double blind, placebo controlled trial of octreotide (600mcg) delivered by continuous subcutaneous infusion used in conjunction with bolus daily parenteral (subcutaneous or intravenous) dexamethasone (8mg), ranitidine (200mg per 24 hours, either as bolus or continuous subcutaneous infusion) and parenteral hydration (continous subcutaneous or intravenous infusion) of(10mls/kg/24hours) over a maximum of 72 hours. CONDITION: Bowel obstruction in the setting of advanced cancer PRIMARY OUTCOME: The primary outcome is number of days without an episode of vomiting in the first 72 hours of the study. SECONDARY OUTCOME: Adverse events Global measures will be; ; the Australian ‐ modified Karnofsky performance status (AKPS), ; Quality of life using the Functinal Assessment of Chronic Illness Therapy ‐ Palliative Care (FACIT‐PAL) and the European Organisation Research Therapy Cancer Quality of Life questionnaire (EORTC QLQC15), ; The caregiver quality of life using the Caregiver Quality of LIfe INdex ‐ Cancer (CQOLC), ; The brief pain inventory (BPI) average pain score, and ; survival days Health service utilisation and long term outcomes using participant data regarding use of health services (inpatient admissions, home health care visits, general practitioner visits), use of medications, medication compliance, days of survival without vomiting, caregiver impact via quality of life, patient preference for place of care. Restoration of (limited) bowel function will be measured by collecting patient data on the number of patients who maintain oral intake, the number of people for whom flatus occurs, and the number of people for whom bowel function resumes during the study period. Treatment failure. This will be assessed by collecting patient data on the number of episodes of vomiting, the number of breakthrough doses of hyoscine butylbromide, the number of doses of opioid breakthrough, the number of people proceding to surgery, and the number of people proceding to insertion of venting gastrostomy. 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