ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

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]

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]

Four weeks

Secondary outcome [1]

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]

Four weeks

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Eastern Health

Address [1]

Box Hill Hospital
Nelson Road, Box Hill
Victoria, 3128

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

28/09/2011

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Anna McLiesh

Address

C/o Suite 14, Level 3
1 Arnold Street
Box Hill
Victoria, 3128

Country

Australia

Phone

+61 0408527203

Fax

a.mcliesh@gmail.com

Contact person for scientific queries

Name

Dr. Anna McLiesh

Address

C/o Suite 14, Level 3
1 Arnold Street
Box Hill
Victoria, 3128

Country

Australia

Phone

+61 0408527203

Fax

a.mcliesh@gmail.com

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.

Trial Review

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