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Trial registered on ANZCTR


Registration number
ACTRN12615000308594
Ethics application status
Approved
Date submitted
4/12/2014
Date registered
1/04/2015
Date last updated
22/05/2019
Date data sharing statement initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Preoperative Immunonutrition in Patients Undergoing Pelvic Exenteration Surgery for Cancer
Scientific title
Patients with cancer undergoing pelvic exenterations will receive either immunonutrition supplements or the equivalent in protein and energy of other nutrition supplements to determine any difference between post operative complications.
Secondary ID [1] 285789 0
Nil known
Universal Trial Number (UTN)
U1111-1164-9005
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 293679 0
Condition category
Condition code
Diet and Nutrition 293977 293977 0 0
Other diet and nutrition disorders
Cancer 297570 297570 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will consume 1 immunonutrition supplement (178mL) 3 times day day for 5 days prior to their surgery.

For one immunonutrition supplement (178mL)

Key Active Ingredients:
Arginine - 4.2g
Omega-3 Fatty Acids
- ALA 1.1g
- EPA 672mg
- DHA 432mg
Nucleotides - 430mg

Energy and Protein:
Energy - 200 calories
Protein - 18g

All patients will fill out a compliance record form, which is a tick sheet outlining whether or not they have consumed each supplement. If they have not consumed a supplement they will be asked to explain why.
Intervention code [1] 290752 0
Prevention
Comparator / control treatment
Control group will consume 3 nutrition supplements each day for five days. Together, they will be approximately equivalent in protein and energy as the immunonutrition supplements. They will drink 3 Resource Protein (200mL each) each day and repeat this for five days. Please see attachment for active ingredients, dose and protein and energy content (viewed on the ANZCTR registry only).

Key active ingredients ARE Protein and Energy for Resource Protein

For one Resource Protein (200mL)

Energy - 250 calories
Protein - 18.8g

All patients will fill out a compliance record form, which is a tick sheet outlining whether or not they have consumed each supplement. If they have not consumed a supplement they will be asked to explain why.
Control group
Active

Outcomes
Primary outcome [1] 293754 0
Length of Stay
Timepoint [1] 293754 0
Time of discharge from hospital
Secondary outcome [1] 311758 0
Number of complications post operation is the primary outcome For example, Respiratory complications - temperature >37.5 degrees Wound infection - any redness in the area requiring antibiotics Infective diarrhoea - clostridium difficile positive stool culture Septicaemia - positive blood culture treated with antibiotics Anastomotic leak - Any dehiscence with clinical or radiological evidence
Timepoint [1] 311758 0
3 months post discharge from hospital
Secondary outcome [2] 312034 0
Immune markers and how outcome is assessed - CRP - serum immunoassay, serum albumin - Dye Binding Method, using Cobas and ESR - Westergren Reference Method, Starrsed Analyse
Timepoint [2] 312034 0
Pre-operation x 2 (pre-operative clinic and the pre-admission clinic), day 3 post operation, day 7 post operation, day 14 post operation and day 21 post operation.

Eligibility
Key inclusion criteria
People who are undergoing pelvic exenteration surgery for cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-People who are under 18
-People who are unable to consent due to language barriers or cognitive function
- People who are unable to consume nutrition supplements 5 days prior to their operation or
- People who are undergoing a pelvic exenteration that is NOT for curative measures

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each patient will be randomly allocated to the intervention or control group in the preadmission clinic. A piece of paper with either intervention group or control group written on it will be placed in a sealed, opaque envelope and the pelvic exenteration nurse will select at random an envelope for each patient. She will then open the envelope for each patient and allocate them to the appropriate group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A subgroup analysis will be performed investigating compliance of supplement drinks and other outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2015
Actual
6/08/2015
Date of last participant enrolment
Anticipated
31/01/2018
Actual
18/01/2018
Date of last data collection
Anticipated
30/04/2018
Actual
18/04/2018
Sample size
Target
100
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3234 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 9014 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 290352 0
Self funded/Unfunded
Name [1] 290352 0
Nil
Country [1] 290352 0
Primary sponsor type
Individual
Name
Sophie Lane
Address
Nutrition and Dietetics Department
Royal Prince Alfred Hospital
Building 12, Missendon Road
Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 289075 0
None
Name [1] 289075 0
Address [1] 289075 0
Country [1] 289075 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292054 0
SLHD Ethics Review Committee
Ethics committee address [1] 292054 0
Ethics committee country [1] 292054 0
Australia
Date submitted for ethics approval [1] 292054 0
25/11/2014
Approval date [1] 292054 0
21/07/2015
Ethics approval number [1] 292054 0
EC00113

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 264 264 0 0
/AnzctrAttachments/367553-Resource 2.0.docx
Attachments [2] 265 265 0 0
/AnzctrAttachments/367553-Resource Protein.docx
Attachments [3] 1555 1555 0 0
/AnzctrAttachments/367553-Customer letter- 12274992 Impact Advanced Recovery 15x6floz AO (1).pdf (Other)

Contacts
Principal investigator
Name 53270 0
Ms Sophie Hogan
Address 53270 0
Nutrition and Dietetics Department, Royal Prince Alfred Hospital
Missendon Road,
Camperdown, NSW, 2050
Country 53270 0
Australia
Phone 53270 0
+61 2 95158053
Fax 53270 0
Email 53270 0
sophie.hogan@health.nsw.gov.au
Contact person for public queries
Name 53271 0
Sophie Hogan
Address 53271 0
Nutrition and Dietetics Department, Royal Prince Alfred Hospital
Missendon Road,
Camperdown, NSW, 2050
Country 53271 0
Australia
Phone 53271 0
+61 2 95158053
Fax 53271 0
Email 53271 0
sophie.hogan@health.nsw.gov.au
Contact person for scientific queries
Name 53272 0
Sophie Hogan
Address 53272 0
Nutrition and Dietetics Department, Royal Prince Alfred Hospital
Missendon Road,
Camperdown, NSW, 2050
Country 53272 0
Australia
Phone 53272 0
+61 2 95158053
Fax 53272 0
Email 53272 0
sophie.hogan@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For ethical reasons IPD will not be available


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
SourceTitleYear of PublicationDOI
EmbaseExploring reasons behind patient compliance with nutrition supplements before pelvic exenteration surgery.2019https://dx.doi.org/10.1007/s00520-018-4445-1
EmbaseThe Impact of Preoperative Immunonutrition and Standard Polymeric Supplements on Patient Outcomes After Pelvic Exenteration Surgery, Taking Compliance Into Consideration: A Randomized Controlled Trial.2020https://dx.doi.org/10.1002/jpen.1709
N.B. These documents automatically identified may not have been verified by the study sponsor.