Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000299808
Ethics application status
Approved
Date submitted
11/03/2012
Date registered
15/03/2012
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Pancreatic Insufficiency Using Creon in Patients with Pancreatic Cancer
Scientific title
Treatment of Pancreatic Insufficiency Using Creon Compared with Placebo, in Patients with Locally Advanced or Metastatic Pancreatic Cancer: Effect on Weight, Quality of Life, Nutrition and Survival
Secondary ID [1] 280105 0
Nil
Universal Trial Number (UTN)
U1111-1129-0160
Trial acronym
PICNIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic carcinoma 286020 0
Condition category
Condition code
Cancer 286207 286207 0 0
Pancreatic
Cancer 286233 286233 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral pancreatic enzyme replacement therapy using a drug called Creon at a dose of 25,000 international units per capsule. This medication will be taken at an initial dose of 2 capsules with meals, and one capsule with snacks each day, continuously whilst on the study. This equates to approximately 9 capsules per day, depending on the number of meals taken. Reassessment of symptoms at one months may lead to a dose escalation up to 3 capsules with meals and/or two capsules with snacks, in the presence of symptoms suggestive of pancreatic exocrine insufficiency, such as bloating, flatulence and diarrhoea. The dose escalation equates to approximately 12-15 capsules per day, depending on the number of meals taken.

The medication will be continued for at least 2 months, and until the participant does not tolerate it, or elects to discontinue study assessments, or the participant dies.
Intervention code [1] 284431 0
Treatment: Drugs
Comparator / control treatment
Placebo: Gelatine capsules filled with pharmaceutical lactose powder. The capsules in both arms will have an identical taste and appearance.
Control group
Placebo

Outcomes
Primary outcome [1] 286684 0
Change in weight. The hypothesis is that enzyme supplementation will stop weight loss or cause body weight to increase. Weight will be measured on the same scales at each clinic visit, every month for the first 3 visits, then 3 monthly.
Timepoint [1] 286684 0
Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.
Secondary outcome [1] 296455 0
Quality of life, using the EORTC QLQ C30 instrument, and the PAN-26 pancreatic module.
Timepoint [1] 296455 0
Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.
Secondary outcome [2] 296456 0
Survival. All patients will be followed until death. This data is captured using hospital electronic records and through regular contact with participants and their families.
Timepoint [2] 296456 0
12 months
Secondary outcome [3] 296457 0
Nutrition, assessed by a dietitian, who will performa standardised assessment using the patient generated subjective global assessment (PGSGA), a validated tool for assessing nutritionin cancer patients. It involves a questionnaire, skin fold measurements and dietary history to form a composite score.
Timepoint [3] 296457 0
Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.

Eligibility
Key inclusion criteria
Metastatic or locally advanced pancreatic cancer
Histologically proven adenocarcinoma; or elevated Ca 19-9 with evidence of a pancreatic mass
ECOG 0-2
Able to participate in the assessement schedule
Being treated with palliative intent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already on pancreatic enzyme replacement for any reason
Presence of steatorrhoea
Expected survival of less than 2 months
Patients who have had resection or radiotherapy with curative intent with no evidence of recurrent disease
Hypersensitivity or intolerance to any of the study medications

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)
Participants will be given a participant information and consent form after they have been identified by an investigator or delegated person. They will undergo screening to ensure eligibility criteria are met, and be randomised. The person who will determine if a subject is eligile will not be aware which arm the will be allocated to.
All study personnel will be blinded to the intervention apart from the pharmacist. The study pharmacist will hold the allocation schedule at a central administration site, and will dispense study medication to be given to participants. The allocation will be concealed to the patient and to all study personnel.
The intervention capsule will be identical to the placebo capsule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list will be generated by a statistician using permuted block randomisation in a 1:1 ratio to assign participants, which will be kept by pharmacy. No personnel other than pharmacy wil have access to the allocation list, unless a participant requires emergency unblinding.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
18/03/2012
Actual
30/05/2012
Date of last participant enrolment
Anticipated
Actual
2/06/2014
Date of last data collection
Anticipated
Actual
7/10/2014
Sample size
Target
60
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6040 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 6041 0
Newcastle Private Hospital - New Lambton Heights
Recruitment postcode(s) [1] 5091 0
2298
Recruitment postcode(s) [2] 5092 0
2305

Funding & Sponsors
Funding source category [1] 284867 0
Hospital
Name [1] 284867 0
Calvary Mater Newcastle
Country [1] 284867 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Locked Bag No 7
Hunter Regional Mail Centre
NSW 2310
Country
Australia
Secondary sponsor category [1] 283745 0
None
Name [1] 283745 0
Address [1] 283745 0
Country [1] 283745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286849 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 286849 0
Locked Bag No 1
New Lambton
NSW 2305
Ethics committee country [1] 286849 0
Australia
Date submitted for ethics approval [1] 286849 0
30/06/2011
Approval date [1] 286849 0
27/07/2011
Ethics approval number [1] 286849 0
11/07/20/3.01

Summary
Brief summary
This study is a randomised controlled trial for patients with metastatic or locally advanced pancreatic cancer, comparing a drug named Creon - which acts as a pancreatic enzyme supplementation - to placebo, in order to determine its influence on change in weight. We will also look at the drug's effect on quality of life, nutrition and survival, with our expectation being that Creon will decrease the rate of weight loss, improve quality of life, nutrition and length of life. This study is being performed due to previous research showing a benefit to pancreatic enzyme supplements in patients with pancreatic cancer with a bile duct stent in place to relieve a blockage caused by the cancer. It is known that pancreatic cancer causes weight loss, and thought that poor absorption of nutrients may contribute to that weight loss. This study aims to assess whether aiding the aborption of nutrients leads to better nutrition, weight stabilisation, improved quality of life and improved survival.

Trial details

In this study you will be randomly assigned to either the active medication (the Creon drug made of pancreatic enzyme), or to an identical, but non-active placebo capsule. In either group, you will take 2 capsules of Creon/placebo with meals, and one capsule with snacks every day. After one month and depending on how you have tolerated the drug, the dosage may be increased to 3 capsules with meals and/or two capsules with snacks, depending on whether you are feeling bloated, flatulent and/or have diarrhoea. Overall, you will continue the treatment for at least 2 months.

During the study will be assessed by study personnel including the doctor, nurse and dietitian. The assessments are weight measurement, questionnaires about nutrition, symptoms and quality of life. These visits will be monthly for 2 months, then every three months while you and other participants remain on the study.

Who is it for?

You may be eligible for this study if you have metastatic or locally advanced pancreatic cancer and aged 18 and over. Full details of whether or not you can participate can be found in the Inclusion Criteria section of this record.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33889 0
Dr Nicholas Zdenkowski
Address 33889 0
Department of Medical Oncology
Calvary Mater Newcastle
Locked Bag No 7
HRMC
NSW 2310
Country 33889 0
Australia
Phone 33889 0
+61249211156
Fax 33889 0
Email 33889 0
nicholas.zdenkowski@calvarymater.org.au
Contact person for public queries
Name 17136 0
Ms Louise Plowman
Address 17136 0
Calvary Mater Newcastle
2 Edith St
Waratah
NSW 2298
Country 17136 0
Australia
Phone 17136 0
+61 2 49211154
Fax 17136 0
+61 2 49680384
Email 17136 0
megan.livingston@calvarymater.org.au
Contact person for scientific queries
Name 8064 0
Dr Nicholas Zdenkowski
Address 8064 0
Calvary Mater Newcastle
2 Edith St
Waratah
NSW 2298
Country 8064 0
Australia
Phone 8064 0
+61 2 65801807
Fax 8064 0
+61 2 49680384
Email 8064 0
nicholas.zdenkowski@calvarymater.org.au

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
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