ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

Pancreatic

Cancer

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]

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]

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]

Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.

Secondary outcome [1]

Quality of life, using the EORTC QLQ C30 instrument, and the PAN-26 pancreatic module.

Timepoint [1]

Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.

Secondary outcome [2]

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]

12 months

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Calvary Mater Newcastle - Waratah

Recruitment hospital [2]

Newcastle Private Hospital - New Lambton Heights

Recruitment postcode(s) [1]

2298

Recruitment postcode(s) [2]

2305

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Calvary Mater Newcastle

Address [1]

Locked Bag No 7
Hunter Regional Mail Centre
NSW 2310

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag No 1
New Lambton
NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2011

Approval date [1]

27/07/2011

Ethics approval number [1]

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

Dr Nicholas Zdenkowski

Address

Department of Medical Oncology
Calvary Mater Newcastle
Locked Bag No 7
HRMC
NSW 2310

Country

Australia

Phone

+61249211156

Fax

nicholas.zdenkowski@calvarymater.org.au

Contact person for public queries

Name

Louise Plowman

Address

Calvary Mater Newcastle
2 Edith St
Waratah
NSW 2298

Country

Australia

Phone

+61 2 49211154

Fax

+61 2 49680384

megan.livingston@calvarymater.org.au

Contact person for scientific queries

Name

Nicholas Zdenkowski

Address

Calvary Mater Newcastle
2 Edith St
Waratah
NSW 2298

Country

Australia

Phone

+61 2 65801807

Fax

+61 2 49680384

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

No additional documents have been identified.

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