Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000801314
Ethics application status
Approved
Date submitted
25/05/2017
Date registered
31/05/2017
Date last updated
31/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating Pancreatic Enzyme Replacement Therapy (PERT) supplements in pancreatic cancer treatment
Scientific title
An evaluation of pancreatic enzyme supplementation in treating pancreatic cancer symptoms in the palliative setting
Secondary ID [1] 291993 0
nil
Universal Trial Number (UTN)
U1111-1196-7366
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 303346 0
Malabsorption 303348 0
Condition category
Condition code
Cancer 302774 302774 0 0
Pancreatic
Oral and Gastrointestinal 302871 302871 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. This is an observational trial of best practice. This is not an interventional trial. Malabsorption symptoms - each patient will be assessed by the dietician, or clinical nurse specialist or palliative physician for malabsorption and offered treatment with enzyme replacement therapy (PERT). If the patient consents to taking PERT, symptoms will be recorded at the initial assessment and at 7 and 21 days after taking PERT or until the following endpoints - the patient is unable to swallow tablets, is discharged from the service or dies. Any side effects of PERT (e.g. constipation) will be also noted.
2. Nutritional assessment - the dietician will perform a nutritional assessment and recommend dietary changes based on the patient’s identified needs. If the patient agrees to commence PERT, the dietician will provide an education pamphlet on the action of PERT for the patient and carer. The dietician will also liaise with the Hospice Medical Specialist regarding appropriate dosages of PERT to be prescribed according to the patient’s meal requirements. The effectiveness of PERT on malabsorption symptoms will be reviewed weekly and dosages increased through GP liaison.
3. This study will also measure quality of life in this patient group using the EORTC QLQ C30 and PAN26 instruments. The PAN26 instrument has been tested internationally and comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes). Measurement of quality of life will be recorded at the initial visit and then at 7 and 21 days after taking PERT or until the following endpoints - the patient is unable to swallow tablets, is discharged from the service or dies.
Intervention code [1] 298115 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302165 0
Quality of life using 2 validated tools- EORTC Q-30 and PAN 26. The data analysis was performed according to the manuals of each tool.
Timepoint [1] 302165 0
Initial visit, then 7 days and 21 days
Secondary outcome [1] 335432 0
There was no secondary outcome.
Timepoint [1] 335432 0
There was no secondary outcome timepoint.

Eligibility
Key inclusion criteria
Patients with advanced pancreatic cancer referred to Nurse Maude's Palliative Care (NMPC) service will be eligible for the study until 50 patients in total have been recruited. The intervention will be given to patients who have had pancreatic surgery and those who have not, as exocrine pancreatic insufficiency (EPI) can be caused by tumour-related pancreatic duct obstruction (Fieker et al, 2009).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those patients who have cognitive impairment or are unable to complete the quality of life questionnaire for any reason, including language difficulties, will be excluded..
Patients who have been prescribed PERT already.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The EORTC QLQ-C30 and QLQ-PAN26 results were analysed in accordance with the EORTC manual . Missing data was assigned the mean value of the answered items of each domain if more than 50% of the items were completed. There were no clear patterns evident for the missing data except that many did not complete the sex domain questions and therefore these have not been summarised. Mean changes for each domain between the baseline and two follow-up periods were analysed using paired t-tests. All analyses were undertaken using SPSS v22.0 (SPSS Inc., Armonk, NY, USA). A two tailed p-value <0.05 was taken to indicate statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/05/2013
Date of last participant enrolment
Anticipated
Actual
27/03/2015
Date of last data collection
Anticipated
Actual
16/04/2015
Sample size
Target
50
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 8910 0
New Zealand
State/province [1] 8910 0

Funding & Sponsors
Funding source category [1] 296503 0
Charities/Societies/Foundations
Name [1] 296503 0
Canterbury Medical research Foundation
Country [1] 296503 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Nurse Maude Association
Address
15 Mansfield Ave, Merivale, Christchurch, NZ 8011
Country
New Zealand
Secondary sponsor category [1] 295465 0
None
Name [1] 295465 0
Address [1] 295465 0
Country [1] 295465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297728 0
Nurse Maude Ethics Advisory Committee
Ethics committee address [1] 297728 0
Ethics committee country [1] 297728 0
New Zealand
Date submitted for ethics approval [1] 297728 0
01/04/2013
Approval date [1] 297728 0
03/05/2013
Ethics approval number [1] 297728 0

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

Contacts
Principal investigator
Name 74954 0
Dr Amanda Landers
Address 74954 0
Nurse Maude Association, 15 Mansfield Ave, Merivale, Christchurch 8164
Country 74954 0
New Zealand
Phone 74954 0
+64 3 375 4274
Fax 74954 0
Email 74954 0
[email protected]
Contact person for public queries
Name 74955 0
Amanda Landers
Address 74955 0
Nurse Maude Association, 15 Mansfield Ave, Merivale, Christchurch 8164
Country 74955 0
New Zealand
Phone 74955 0
+64 3 375 4274
Fax 74955 0
Email 74955 0
[email protected]
Contact person for scientific queries
Name 74956 0
Amanda Landers
Address 74956 0
Nurse Maude, 15 Mansfield Ave, Merivale, Christchurch 8164
Country 74956 0
New Zealand
Phone 74956 0
+64 3 375 4274
Fax 74956 0
Email 74956 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.