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Trial registered on ANZCTR


Registration number
ACTRN12608000211369
Ethics application status
Approved
Date submitted
4/04/2008
Date registered
18/04/2008
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised double blind placebo controlled trial of infusional subcutaneous octreotide in the management of malignant bowel obstruction at the end of life.
Scientific title
A randomised double blind placebo controlled trial of infusional subcutaneous octreotide in the management of malignant bowel obstruction in people with advanced cancer.
Secondary ID [1] 251759 0
003/07
Universal Trial Number (UTN)
Trial acronym
Octreotide for bowel obstruction
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel obstruction in the setting of advanced cancer 2998 0
Condition category
Condition code
Cancer 3149 3149 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2740 0
Treatment: Drugs
Comparator / control treatment
Normal saline in 10mls, via subcutaneous infusion over 72 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 4032 0
The primary outcome is number of days without an episode of vomiting in the first 72 hours of the study.
Timepoint [1] 4032 0
72 hours from the start of treatment
Secondary outcome [1] 6794 0
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.
Timepoint [1] 6794 0
72 hours from the start of treatment.
Secondary outcome [2] 6795 0
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.
Timepoint [2] 6795 0
72 hours from the start of treatment and for 28 days post treatment.
Secondary outcome [3] 6796 0
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
Timepoint [3] 6796 0
Australian - modified Karnofsky performance status (AKPS) at baseline, end of treatment and 28 days.
Quality of life at baseline, end of treatment and at 28 days post treatment
Brief pain inventory at start of days 1 to 4
and survival at 28 dys post treatment.
Secondary outcome [4] 6797 0
Adverse events
Timepoint [4] 6797 0
72 hours
Secondary outcome [5] 6798 0
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.
Timepoint [5] 6798 0
28 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous adverse reaction to any of the study medications
Australian-modified Karnofsky performance score less than 30 at the beginning of the study
participants who have participated in a clinical study of a new chemical entity within the month prior to study entry.
calculated creatinine clearance <10ml/min
documented cirrhosis
venting or feeding gastrostomy or jejunostomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At each centre, people referred to the study will be sequentially allocated an ID number. This ID number will be used for all subsequent study documentation for that participant. The procedures outlined in the Allocation of ID number Standard Operating Procedure are to be followed.

All people with suspected bowel obstruction secondary to malignancy presenting to hospital because of vomiting, or inpatients who develop evidence of bowel obstruction will be referred to the study. The study nurse will ask the consultant in charge for permission to approach potentially eligible participants. This referral will be recorded within both the Case Report Form and the participant’s clinical file.

If participants are suitable for entry and prepared to consent to the study, they will undergo baseline assessments and assessment of eligibility criteria and commence study the following morning. A screening log will be kept of all potentially eligible participants including the reasons for non-entry.

On notification of a participant, the pharmacist at each site will consult the schedule, and will allocate the next code available and prepare one or the other of the treatment arms delivered in a labeled syringe. The participant ID, allocation code, dates of request, preparation, and dispensing will be recorded in a log maintained by the pharmacist.

All syringes will be prepared by the site clinical trial pharmacist according to the randomisation schedule. Each syringe will be numbered according to the pre-determined randomisation code and labeled as 003/07 study - octreotide 600mcg/placebo normal saline 10mls according to the prescription from the investigator (or 400mcg in the case of severe renal impairment). All syringes will look identical in volume and colour to preserve the blinding irrespective of the contents.

At all times, from eligibility screening to completion of the study, all study staff are unaware of the treatment allocation. Allocation is concealed from the investigator at the time of the participant inclusion in the trial; the allocation is determined by contacting the site pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedules will be developed for each site using random number tables, generated at an independent centre (central registry). Treatment for each participant will be allocated according to a block randomisation schedule held by the central registry in a 1:1 ratio. Block randomisation will ensure even allocation to each code. The central registry will supply site randomisation schedules to each site pharmacy. There will be no stratification at the randomisation level for this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pre-Consent
In some cases it is possible that participants will offered pre-consent, as in the case where the participant have an episode of partial or complete bowel obstruction that is not operable, or has known malignancy within the peritoneum and is therefore at risk of subsequent bowel obstruction.
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA
Recruitment postcode(s) [1] 643 0
8006, 1435, 6014, 6009, 3004, 3353.

Funding & Sponsors
Funding source category [1] 3261 0
Government body
Name [1] 3261 0
Commonwealth Department of Health and Ageing
Address [1] 3261 0
GPO Box 9848
Canberra, ACT 2601.
Country [1] 3261 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 2915 0
Government body
Name [1] 2915 0
Department of Health and Ageing
Address [1] 2915 0
GPO Box 9848
Canberra, ACT 2601.
Country [1] 2915 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5246 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 5246 0
Daws Road
Daw Park SA 5041
Ethics committee country [1] 5246 0
Australia
Date submitted for ethics approval [1] 5246 0
01/05/2008
Approval date [1] 5246 0
27/06/2008
Ethics approval number [1] 5246 0
EC00191
Ethics committee name [2] 5827 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 5827 0
Mater Health Service
Raymond Tce, South Brisbane, QLD, 4101
Ethics committee country [2] 5827 0
Australia
Date submitted for ethics approval [2] 5827 0
15/05/2008
Approval date [2] 5827 0
30/07/2008
Ethics approval number [2] 5827 0
EC00332
Ethics committee name [3] 258964 0
Ballarat Health Services & St John of God Health Care Ethics Committee
Ethics committee address [3] 258964 0
Ballarat Health Services
PO Box 577
BALLARAT VIC 3353
Ethics committee country [3] 258964 0
Australia
Date submitted for ethics approval [3] 258964 0
15/01/2009
Approval date [3] 258964 0
25/03/2009
Ethics approval number [3] 258964 0
EC00326
Ethics committee name [4] 258965 0
Alfred Hospital Ethics Committee
Ethics committee address [4] 258965 0
Alfred Hospital
Commercial Road
MELBOURNE VIC 3004
Ethics committee country [4] 258965 0
Australia
Date submitted for ethics approval [4] 258965 0
16/11/2009
Approval date [4] 258965 0
09/02/2010
Ethics approval number [4] 258965 0
EC00315
Ethics committee name [5] 258966 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [5] 258966 0
Hollywood Private Hospital Ethics Committee
Locked Bag 2002
NEDLANDS WA 6009
Ethics committee country [5] 258966 0
Australia
Date submitted for ethics approval [5] 258966 0
05/05/2008
Approval date [5] 258966 0
07/01/2009
Ethics approval number [5] 258966 0
EC00266
Ethics committee name [6] 258967 0
St John of God Health Care Ethics Committee
Ethics committee address [6] 258967 0
Level 3
St John of God House
177-179 Cambridge Street
WEMBLEY WA 6014
Ethics committee country [6] 258967 0
Australia
Date submitted for ethics approval [6] 258967 0
06/08/2009
Approval date [6] 258967 0
19/03/2010
Ethics approval number [6] 258967 0
EC00286
Ethics committee name [7] 258968 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [7] 258968 0
Cancer Institute NSW
PO Box 41
ALEXANDRIA NSW 1435
Ethics committee country [7] 258968 0
Australia
Date submitted for ethics approval [7] 258968 0
18/06/2008
Approval date [7] 258968 0
16/10/2008
Ethics approval number [7] 258968 0
EC00414
Ethics committee name [8] 258969 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [8] 258969 0
Peter MacCullum Cancer Centre
Locked Bag 1
A'Beckett Street
MELBOURNE VIC 8006
Ethics committee country [8] 258969 0
Australia
Date submitted for ethics approval [8] 258969 0
23/07/2008
Approval date [8] 258969 0
22/05/2009
Ethics approval number [8] 258969 0
EC00235

Summary
Brief summary
This study looks at the effectiveness of the drug octreotide in palliative care management of bowel obstruction caused by cancer in people with advanced cancer.

Who is it for?
You can join this study if you have widespread and advanced cancer and you have a related bowel obstruction which requires hospital admission or a change in care if you are already in hospital, but surgical removal is not currently considered appropriate.

Trial details
Participants will be randomly divided into two groups. One group will receive a continuous infusion of the drugs octreotide and ranitidine under the skin (subcutaneous) in addition to intravenous doses of dexamethasone and intravenous or subcutaneous fluids for 72 hours. The other group (control) will receive fluids under the skin only. Bowel obstruction is a common medical problem in people with advanced cancer. Current treatment options include combinations of surgery (where this is possible), nil by mouth, a feeding tube placed into the stomach, pain relief, and medications that reduce secretions. None of these options has been tested in a study that is large enough to determine which works best. Octreotide can inhibit the release of hormones that cause secretions into the gut that may make the pain of bowel obstruction worse. Inhibiting these secretions with Octreotide may help relieve pain and improve the quality of life.
Trial website
Trial related presentations / publications
David C. Currow · Stephen Quinn · Meera Agar · Belinda Fazekas · Janet Hardy · Nikki McCaffrey · Simon Eckermann · Amy P. Abernethy · Katherine Clark. Double-Blind, Placebo-Controlled, Randomized Trial of Octreotide in Malignant Bowel Obstruction. · Nov 2014 · Journal of Pain and Symptom Management
Public notes

Contacts
Principal investigator
Name 28493 0
Prof David Currow
Address 28493 0
Professor of Palliative and Supportive Services Flinders University Flinders Drive Bedford Park SA 5042
Country 28493 0
Australia
Phone 28493 0
+61 8 8275 1732
Fax 28493 0
Email 28493 0
David.currow@flinders.edu.au
Contact person for public queries
Name 11650 0
Prof Prof David Currow
Address 11650 0
Professor of Palliative and Supportive Services
Flinders University
Flinders Drive
Bedford Park
SA 5042
Country 11650 0
Australia
Phone 11650 0
08 8275 1732
Fax 11650 0
08 8374 0350
Email 11650 0
david.currow@rgh.sa.gov.au
Contact person for scientific queries
Name 2578 0
Prof Prof David Currow
Address 2578 0
Professor of Palliative and Supportive Services
Flinders University
Flinders Drive
Bedford Park
SA 5042
Country 2578 0
Australia
Phone 2578 0
08 8275 1732
Fax 2578 0
08 8374 0350
Email 2578 0
david.currow@rgh.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary