A randomised double blind placebo controlled trial of infusional subcutaneous octreotide in the management of malignant bowel obstruction in people with advanced cancer.

Palliative Care Clinical Studies Collaborative (PaCCSC)

Dataset description

Data set includes individual participant data for 112 consenting participants. The dataset includes CSV files for: the number of days free of vomiting as reported by patients daily, measured 72 hours after the first administration of study medication; Patient-rated Global Impression of Change; the number of patient-reported episodes of vomiting; survival as date of death; nausea and Pain scores using NCI CTCAE criteria and Brief Pain Inventory; functional status (Australian modified Karnofsky Performance Scale (AKPS); and; protocol defined “as needed” symptom control medications (hyoscine butylbromide for colicky pain, morphine for pain, haloperidol for nausea). Quality of Life measures used the EORTC C15, Facit Pal and caregiver Quality of life was measured using the Caregiver Quality of Life Index. Data is available for screening, baseline, each day of intervention and 4 weeks of follow-up. Health Service Utilisation data was collected for up to 4 weeks post intervention.
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Source Study



Scientific enquiries

Prof Meera Agar

Brief Summary

The aim of this study is to determine whether it is feasible to conduct a study of crushed oral dexamethasone, at a dose of at least 8 mg daily, either with or without daily crushed oral famotidine in the management of inoperable bowel obstruction. Who is it for? You may be eligible for this study if you are aged 18 years or older, have advanced cancer, and have a clinically confirmed inoperable bowel obstruction at any level with vomiting that requires a hospital admission or a change in clinic ....
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Key Inclusion Criteria

• 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 obs ....
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Key Exclusion Criteria

• 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

Can healthy volunteers participate?




Sample Size    4

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Bowel Obstruction , Bowel cancer , Malignant Bowel Obstruction

Condition code    Cancer


Intervention code Treatment: Drugs

Crushed Famotidine tablet for oral consumption, 40 mg every 24 hours for 5 days, within 24 hours of baseline assessments, administered in a thick fluid such as yoghurt or apple puree. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence. Crushed Dexamethasone for oral consumption, 8mg once per day in the morning for 5 days and to be commenced before midday on the first day or the next morning ....
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Control group Placebo

Crushed oral placebo for oral consumption every 24 hours for a total of 5 days, within 24 hours of baseline assessments. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence. The placebo contains PROSOLV® EASYTab SP which contains: Microcrystalline Cellulose, Colloidal Silicon Dioxide, Sodium Starch Glycolate and Sodium Stearyl Fumarate. Crushed Dexamethasone for oral consumption, 8mg once per ....
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Outcome: The primary outcome is whether this study is feasible to extend to a fully powered phase III clinical trial. Feasibility is defined as: 1. An average of one participant identified per site every eight weeks using recruitment tracking data bases; 2. One participant recruited per site every 12 weeks using recruitment racking databases; and 3. Collect data for >80% of people randomised, to the primary endpoint of 120 hours or study exit assessed by reviewing the data ent ....
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The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see