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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
This research project is aimed at people who have known cancer of the pancreas, who may have symptoms or signs of pancreatic exocrine insufficiency (PEI).
Pancreatic exocrine insufficiency (PEI) occurs when diseases of the pancreas prevent it from functioning properly. In the healthy state the pancreas releases substances in into the intestinal system to breakdown ingested fats. In patients with cancer of the pancreas this process can be impaired due to blockage of the pancreatic duct or due to poor function of the pancreas. This means that some patients with pancreatic cancer cannot breakdown fats and so they cannot absorb fats from their food. This results in:

- Weight loss
- or inability to gain weight
- Non-absorption of essential vitamins found in fats (for example vitamin A, D, E and K)
- Unpleasant fatty diarrhoea which is frequent, foul smelling and difficult to flush

Pancreatic enzyme replacement therapy (or PERT) is a medication that these patients can take which replaces the most important of the body’s natural pancreatic enzymes and therefore allows better breakdown and absorption of fats. This helps patients with pancreatic cancer to maintain a healthy weight, and have reduction in the unpleasant side effects of frequent diarrhoea. This is important for this patient group as it reduces time spent in hospital towards the end of their life due to complications arising from low weight and malnutrition and improves their quality of life. Good nutrition is also important if patients are going to be able to tolerate other treatment, for instance chemotherapy.

This research project will involve patients with known cancer of the pancreas. They will be randomly allocated into two groups. Each group will be given a supply of tablets, to be taken at home for a period of 4 weeks. Neither group will know what medication the tablets contain. Group A will receive PERT tablets, and group B will receive a placebo tablet (meaning a completely harmless tablet with no medication in it). The patients will be required to keep a bowel chart whilst taking the medication. Patients will be able to contact a dietician for support if they require it throughout the 4 week period.
Both at the start and at the end of the 4 week study period, patients will be weighed, and they will also have their stool tested. The stool testing requires two samples only (i.e. One at the start and one at the end of the study period), and can be done at a time which is convenient for the patient. Patients will also complete a questionnaire relating to their quality of life, both before and after the 4-week medication period.
PERT medication is already used to help alleviate some of the unpleasant symptoms associated with pancreatic cancer, however not all doctors prescribe it routinely. The results of this study may support or refute its use in patients with pancreatic cancer, and will therefore give doctors good evidence for prescribing or not prescribing PERT to help their patients with this condition.
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


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No Supporting Document Provided



Results publications and other study-related documents

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