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

Intervention

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 .... 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 (if baseline assessments are completed in the afternoon), 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. Isotonic fluid administered as a parenteral infusion, at 10 – 20 mL / kg / 24-hours, commenced on on completion of the baseline assessments (unless dehydrated at the time the study is commenced where the treating clinician’s discretion may be used in the first 24 hours).
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Comparison

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 .... 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 day in the morning for 5 days and to be commenced before midday on the first day or the next morning (if baseline assessments are completed in the afternoon), 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. Isotonic fluid administered as a parenteral infusion, at 10 – 20 mL / kg / 24-hours, commenced on on completion of the baseline assessments (unless dehydrated at the time the study is commenced where the treating clinician’s discretion may be used in the first 24 hours).
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Outcomes

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 .... 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 entry into the study data base..
Timepoint: On completion of the study
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