TerminatedPhase 2ACTRN12621001403820

A phase II, multi-site, double blind, randomised placebo-controlled feasibility trial of crushed oral famotidine for management of Inoperable Malignant Bowel Obstruction (IMBO)

Sponsor

University of Technology Sydney

Enrollment

20 participants

Start Date

Feb 15, 2022

Study Type

Interventional

Conditions

Malignant Bowel Obstruction Bowel Obstruction

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 clinical care. Study details Participants will be randomised (i.e. allocated by chance) to receive 5 days of either 40mg per day of famotidine or placebo as a crushed oral tablet. All participants will also receive a single daily dose of 8mg of dexamethasone for 5 days and intravenous or subcutaneous fluids at 10-20ml/kg/24 hours, as part of standard care. Participants will be assessed daily for the duration of treatment to monitor safety and tolerability, where the study team will visit each day and assess any side effects and improvement. Participants will also complete a number of questionnaires on the last day of treatment, as well as weekly for 4 weeks post-treatment completion. These questionnaires will involve answering questions regarding general well-being and quality of life, vomiting episodes, pain, nausea, side effects, medication use, and use of rescue pain medications. Analysis for cost-effectiveness of the intervention will also occur. It is hoped that this study will help clinicians to further understand the management of of inoperable malignant bowel obstruction.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria8

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.

Exclusion Criteria5

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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).