Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000125325
Ethics application status
Approved
Date submitted
19/01/2017
Date registered
24/01/2017
Date last updated
2/07/2019
Date data sharing statement initially provided
2/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study trialling the drug Gastrografin for use in patients with a bowel obstruction due to cancer.
Scientific title
An open label pilot study of oral water soluble contrast (Gastrografin)in addition to conservative medical management for the resolution of malignant bowel obstruction in adult patients.
Secondary ID [1] 290974 0
None
Universal Trial Number (UTN)
Trial acronym
Gastrografin for MBO
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
cancer 301726 0
malignant bowel obstruction 301727 0
Condition category
Condition code
Cancer 301422 301422 0 0
Any cancer
Oral and Gastrointestinal 301429 301429 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open label
Drug - Gastrografin - 10g sodium diatrizoate and 66g meglumine diatrizoate per 100mls
Dose - 100mls orally
Dose - Single dose
Intervention code [1] 296926 0
Treatment: Drugs
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300809 0
Composite Outcome: Percentage of patients who progress to complete study (feasibility to proceed to phase III will be defined as at least 60% completion of the protocol requirements and study measurements), and recruitment of 20 patients over a 12-month period.
Timepoint [1] 300809 0
12 months since the recruitment of the first participant.
Secondary outcome [1] 330930 0
To assess the ability of Gastrografin 'Registered Trademark' use to predict resolution of inoperable MBO (diagnostic) (presence of Gastrografin 'Registered Trademark' in the rectum)

This outcome is assessed with an x-ray of the abdomen
Timepoint [1] 330930 0
24 hours post dose of study drug
Secondary outcome [2] 330931 0
Composite outcome: Frequency of and time to clinical resolution of bowel obstruction by passage of stool, and ability to tolerate oral intake for more than 48 hours without vomiting (including time after administration of Gastrografin 'Registered Trademark').
Timepoint [2] 330931 0
5 days post study drug dose
Secondary outcome [3] 330936 0
Assessment of adverse effects of Gastrografin

known and possible adverse reactions: (assessed by research nurse review of clinical file and adverse event interview questions)
1.hypersensitivity reaction
2.nausea
3 vomiting
4 diarrhoea
5 dehydration
6 aspiration
7 headache
8 dizziness
9 tachycardia
10 hypotension
11 fever
12 abdominal pain
13 oral blisters
14 rash
15 itchiness
Timepoint [3] 330936 0
Daily assessment of adverse events from day 1-5 post study drug dose and also at
Follow-up on Day 12.
Secondary outcome [4] 330939 0
Correlation of Gastrografin 'Registered Trademark' in rectum (x-ray at 24 hours post dose)with resolution of symptoms (passage of stool-bowel chart, and ability to tolerate oral intake for more than 48 hours without vomiting - interview and progress notes).
Timepoint [4] 330939 0
5 days post study dose (x-ray at 24hrs plus resolution of symptoms for 48hrs up to 5 days post dose).
Secondary outcome [5] 330940 0
Overall survival from start of study
Timepoint [5] 330940 0
6 months post the completion of follow-up on the last recruited participant.

Eligibility
Key inclusion criteria
-Age > 18 years old
-Admitted to Mater Misericordiae Ltd, Brisbane or St Vincent’s Private Hospital, Brisbane
-Meeting criteria for MBO
a) Clinical evidence of bowel obstruction – history, physical examination, and/or
b) Radiographic evidence of bowel obstruction distal to ligament of Treitz (at the junction of the duodenum and jejunum) and
c) Known intra-abdominal/pelvic primary cancer with incurable disease or non-intra-abdominal cancer with intra-peritoneal disease
-MBO with no indication for any acute intervention (surgery, endoscopy, chemotherapy, radiotherapy)
-Have received standard conservative management for at least 24 hours with no resolution of MBO
-Capacity to provide consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients with sepsis, signs of perforation or acute abdomen on examination
-Pregnancy
-Known allergy to Gastrografin 'Registered Trademark' or iodine
-Evidence of gross gastric distension on radiologic examination.
-Presence of a venting or feeding gastrostomy or jejunostomy (presence of an NG tube does not exclude patients and may be advisable in patients with frequent large volume vomits)
-Biochemically proven thyrotoxicosis
-Diagnosed with faecal loading ONLY
-Known oesophageal or gastrointestinal fistula
-Swallowing deficit (clinician discretion)
-Patient whom are clinically dehydrated (clinician discretion)
-Clinician judgement that patient is at high risk of aspiration

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
open label Gastrografin
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The aim is to recruit 20 participants across the two sites over a 12-month recruitment period. (feasibility pilot).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
18/05/2017
Date of last participant enrolment
Anticipated
31/07/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
20
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7349 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 7350 0
Mater Private Hospital - South Brisbane
Recruitment hospital [3] 7351 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment postcode(s) [1] 15141 0
4101 - South Brisbane
Recruitment postcode(s) [2] 15142 0
4101 - South Brisbane
Recruitment postcode(s) [3] 15143 0
4169 - Kangaroo Point

Funding & Sponsors
Funding source category [1] 295388 0
Hospital
Name [1] 295388 0
Mater Misericordiae Ltd
Country [1] 295388 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Ltd
Address
Raymond Terrace
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 294210 0
None
Name [1] 294210 0
Address [1] 294210 0
Country [1] 294210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296723 0
Mater Misericordiae Ltd Human Research Ethics Committee (MML HREC)
Ethics committee address [1] 296723 0
Raymond Tce
South Brisbane, QLD, 4101
Ethics committee country [1] 296723 0
Australia
Date submitted for ethics approval [1] 296723 0
19/12/2016
Approval date [1] 296723 0
18/01/2017
Ethics approval number [1] 296723 0
HREC/16/MHS99

Summary
Brief summary
The primary purpose of this pilot trial is to evaluate whether a full-scale clinical trial for gastrografin is feasible, and to provide an initial estimate of the efficacy of gastrografin for the resolution of malignant bowel obstruction (MBO).

Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with MBO.

Study details
All participants enrolled in this pilot trial will receive the same treatment. This involves a single oral dose of gastrografin administered as a 100ml solution. Participants will then be followed up for 5 days to assess whether the treatment has reached the bowel, whether it has been effective in clearing the obstruction and any side effects which may have occurred.

It is hoped that the findings from this trial can be used to inform future clinical trials on the use of gastrografin in palliative care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71890 0
A/Prof Phillip Good
Address 71890 0
Mater Misericordiae Ltd, Raymond Terrace South Brisbane, QLD, 4101
Country 71890 0
Australia
Phone 71890 0
+617 3163 3884
Fax 71890 0
Email 71890 0
phillip.good@mater.org.au
Contact person for public queries
Name 71891 0
Miss Georgie Cupples
Address 71891 0
Mater Misericordiae Ltd, Raymond Terrace South Brisbane QLD 4101
Country 71891 0
Australia
Phone 71891 0
+617 3163 3884
Fax 71891 0
+617 3163 1588
Email 71891 0
Georgie.Cupples@mater.org.au
Contact person for scientific queries
Name 71892 0
A/Prof Phillip Good
Address 71892 0
Mater Health Services
Raymond Tce
South Brisbane, QLD
4101
Country 71892 0
Australia
Phone 71892 0
+617 3163 3884
Fax 71892 0
Email 71892 0
phillip.good@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
currently still recruiting to trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.