Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001172998
Ethics application status
Not yet submitted
Date submitted
28/09/2011
Date registered
9/11/2011
Date last updated
9/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Pancreatic Enzyme Replacement Therapy in Pancreatic Cancer - A Randomized Controlled Trial
Scientific title
Pancreatic Enzyme Replacement Therapy in Patients with Known Unresectable Pancreatic Cancer - A Randomized Controlled Trial to Assess Weight Change, Quality of Life, and Faecal Elastase
Secondary ID [1] 273121 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Enzyme Insufficiency in Pancreatic Cancer 270872 0
Condition category
Condition code
Cancer 279050 279050 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized drug trial of Pancreatic Enzyme Replacement Therapy (Pancreatin)
- Arm 1: Treatment group: 48,000 lipase units (which is equal to two capsules) with meals three times daily (ie. breakfast, lunch and dinner), along with 24,000 units lipase (equal to one capsule) with snacks, (expected 2-3 times daily) in oral capsule form, to be taken daily as described, for a period of four weeks.
- Arm 2: Placebo group: Inert placebo capsules, physically alike to active medication. To be taken in the same way as active medication (ie. one capsule for snacks, 2-3 times daily, along with two capsules with meals, three times daily) also for a period of four weeks.
Intervention code [1] 269463 0
Treatment: Drugs
Comparator / control treatment
Placebo, made from sugar as main component, identical in taste and appearance to active medication, but without active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 279702 0
Weight change in kilograms (kg) - measured with a "weigh-in" at the start and again at the end of the four week trial period. The scales used will be those situated at the Box Hill Hospital outpatient department, and will be consistently used as the only scales throughout the trial period.
Timepoint [1] 279702 0
Four weeks
Secondary outcome [1] 294259 0
Faecal Elastase result - taken from one stool sample taken from the participant at the start of the trial before medication commenced, and again at the end of the trial, just prior to cessation of trial medication. Testing will be done via the Box Hill Hospital Laboratory and Dorevitch pathology service.
Timepoint [1] 294259 0
Four weeks
Secondary outcome [2] 294260 0
Quality Of Life - it is proposed that the Quality Of Life (QOL) Questionnaire will be a combination of the FACT-Hep (Version 4) and the FACIT-D (Version 4). These are validated quality of life questionnaires specific to patients with hepatobiliary cancers, and symptoms of diarrhoea respectively.
Timepoint [2] 294260 0
Four weeks

Eligibility
Key inclusion criteria
- Known, unresectable cancer of the pancreas
- Able to provide informed consent
Minimum age
40 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Resectable or resected pancreatic cancer
- Cannot obtain informed consent
- Chronic pancreatitis, coeliac disease, Chron's disease, previous gastric resections, Zollinger-Ellison syndrome
- Allergy to porcine products

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)
Allocation will be done with blocked randomization strategies, and will involve contacting the holder of the allocation schedule (in this case, a hospital pharmacist) who will not be present during the recruitment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomization by a third party (pharmacy department) not involved in the recruitment process
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269945 0
Hospital
Name [1] 269945 0
Eastern Health
Country [1] 269945 0
Australia
Primary sponsor type
Individual
Name
Dr. Anna McLiesh
Address
c/o Suite 14, Level 3
1 Arnold Street
Box Hill, 3128
Country
Australia
Secondary sponsor category [1] 268942 0
None
Name [1] 268942 0
Address [1] 268942 0
Country [1] 268942 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271914 0
Ethics committee address [1] 271914 0
Ethics committee country [1] 271914 0
Date submitted for ethics approval [1] 271914 0
28/09/2011
Approval date [1] 271914 0
Ethics approval number [1] 271914 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33208 0
Address 33208 0
Country 33208 0
Phone 33208 0
Fax 33208 0
Email 33208 0
Contact person for public queries
Name 16455 0
Dr. Anna McLiesh
Address 16455 0
C/o Suite 14, Level 3
1 Arnold Street
Box Hill
Victoria, 3128
Country 16455 0
Australia
Phone 16455 0
+61 0408527203
Fax 16455 0
Email 16455 0
[email protected]
Contact person for scientific queries
Name 7383 0
Dr. Anna McLiesh
Address 7383 0
C/o Suite 14, Level 3
1 Arnold Street
Box Hill
Victoria, 3128
Country 7383 0
Australia
Phone 7383 0
+61 0408527203
Fax 7383 0
Email 7383 0
[email protected]

No information has been provided regarding IPD availability


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.