Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000706774
Ethics application status
Approved
Date submitted
23/04/2022
Date registered
17/05/2022
Date last updated
23/03/2023
Date data sharing statement initially provided
17/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of perioperative administration of seasonal influenza vaccine and arginine-enriched immunonutrition on perioperative immune status (PaSIVI): A Feasibility and Pilot Study
Scientific title
The impact of perioperative administration of seasonal influenza vaccine and arginine-enriched immunonutrition on perioperative immune status of patients presenting for cancer surgery (PaSIVI): A Feasibility and Pilot Study
Secondary ID [1] 306992 0
None
Universal Trial Number (UTN)
None
Trial acronym
PaSIVI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Surgery 326109 0
Perioperative immunosuppression 326212 0
Condition category
Condition code
Cancer 323427 323427 0 0
Any cancer
Surgery 323596 323596 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised control trial will include participants undergoing abdominopelvic cancer surgery only
Arm 1: Control - no intervention
Arm 2: Influenza vaccine only:
1. Seasonal quadrivalent influenza vaccine, 0.5mL - administered 1 day prior to abdomino-pelvic cancer surgery or on day of surgery, administered by doctor.
Arm 3: Influenza vaccine and arginine immunonutrition:
1. Seasonal quadrivalent influenza vaccine, 0.5mL - administered 1 day prior to abdomino-pelvic cancer surgery or on day of surgery, adminsitered by doctor.
2. Dietary supplementation of oral arginine - 4.5g twice daily (powder to be diluted in 200ml water), prescribed 5 days before and after surgery
Intervention code [1] 323435 0
Treatment: Drugs
Intervention code [2] 323518 0
Treatment: Other
Comparator / control treatment
Participants in the control arm proceed with surgery without preoperative influenza vaccine, nor receive perioperative arginine supplementation
Control group
Active

Outcomes
Primary outcome [1] 331162 0
To characterise the effect of influenza vaccine and immunonutrition on perioperative natural killer cell number
Timepoint [1] 331162 0
Natural kill cell number, in ex-vivo assays from participant blood collected at baseline, pre-induction of anaesthesia, postoperative days 1, 3 and 5.
Primary outcome [2] 331272 0
To characterise the effect of influenza vaccine and immunonutrition on perioperative natural killer cell activity
Timepoint [2] 331272 0
Natural kill cell activity, in ex-vivo assays from participant blood collected at baseline, pre-induction of anaesthesia, postoperative days 1, 3 and 5.
Secondary outcome [1] 409057 0
To measure the rate of recruitment of eligible patients into the study by audit of screening logs for the study.
Timepoint [1] 409057 0
Cumulative data will be assessed at the end of the 24month recruitment period
Secondary outcome [2] 409659 0
Feasibility will be assessed as successful delivery of the randomised treatment arm in 90% participants, to be measured by audit of electronic study records in which study treatment of subjects will be recorded
Timepoint [2] 409659 0
Cumulative data will be assessed at the end of the 24month recruitment period

Eligibility
Key inclusion criteria
Inclusion Criteria:
• Male or female
• Age >18 years.
• Elective surgery
• Major intra-abdominal cancer surgery, including:
o Colorectal
o Sarcoma
o Upper gastrointestinal
o Hepatobiliary
o Genitourinary
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of allergy or anaphylaxis to previous influenza vaccine
• Contraindication to the influenza vaccine
• Patients on immunotherapy: Including: Immune checkpoint inhibitors; T-cell therapy; Monoclonal antibodies; Treatment vaccines and Immune system modulators (modulating therapy e.g., cytokines such as Interferon, interleukin, haematopoietic growth factors such as erythropoietin, IL-11, G-CSF; BCG, thalidomide, lanalidomide, monoclonal antibodies (mabs, mibs), steroids
• History of allergy or anaphylaxis to arginine or arginine supplemented products
• Participants who have already received a dose of the influenzae vaccine for that calendar year
• Palliative surgery for end-stage disease with no curative intent
• Patients with existing metastatic disease
• Emergency surgery
• Extensive comorbid disease, i.e. ASA > 3
• Age <18 years old
• Refusal or inability to provide valid informed consent
• Currently enrolled in another clinical trial unless agreed by the CPI and PI that co-enrolment can occur.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation in a 1:1:1 ratio using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A statistical analysis plan will be completed prior to statistician unblinding and commencement of analysis. Descriptive statistics will consist of number and percentage for categorical variables, and mean and standard deviation (SD) or median and interquartile range (IQR) will be reported for continuous variables (parametric and non-parametric, respectively). The asymptotic [Wald] method based on the normal approximation for the two-sided 95% confidence interval for a single proportion will be used to obtain the confidence interval for the proportion of eligible patients who provided informed consent (primary aim 1) and the proportion of randomized patients for whom the anaesthetic procedure was completed successfully, for each procedure separately (primary aim 2).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2022
Actual
30/09/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
54
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22236 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 37398 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 311304 0
Charities/Societies/Foundations
Name [1] 311304 0
Peter MacCallum Foundation Grant
Country [1] 311304 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Peter MacCallum Cancer Centre
305 Grattan St, Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 312668 0
None
Name [1] 312668 0
Address [1] 312668 0
Country [1] 312668 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310806 0
PETER MACCALLUM CANCER CENTRE HUMAN RESEARCH ETHICS COMMITTEE [EC00235]
Ethics committee address [1] 310806 0
Ethics committee country [1] 310806 0
Australia
Date submitted for ethics approval [1] 310806 0
06/12/2021
Approval date [1] 310806 0
01/04/2022
Ethics approval number [1] 310806 0
HREC/81869/PMCC

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

Contacts
Principal investigator
Name 118938 0
Dr Julia Dubowitz
Address 118938 0
Department of Anaesthesia, Perioperative and Pain Medicine
Peter MacCallum Cancer Centre
305 Grattan St, Parkville, VIC, 3050
Country 118938 0
Australia
Phone 118938 0
+613 8559 7681
Fax 118938 0
Email 118938 0
[email protected]
Contact person for public queries
Name 118939 0
Julia Dubowitz
Address 118939 0
Department of Anaesthesia, Perioperative and Pain Medicine
Peter MacCallum Cancer Centre
305 Grattan St, Parkville, VIC, 3050
Country 118939 0
Australia
Phone 118939 0
+613 8559 7681
Fax 118939 0
Email 118939 0
[email protected]
Contact person for scientific queries
Name 118940 0
Julia Dubowitz
Address 118940 0
Department of Anaesthesia, Perioperative and Pain Medicine
Peter MacCallum Cancer Centre
305 Grattan St, Parkville, VIC, 3050
Country 118940 0
Australia
Phone 118940 0
+613 8559 7681
Fax 118940 0
Email 118940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data from the feasibility trial will not be made publicly available due to the limited power of the study. The PI will reconsider IPD status if a large (main) study is run


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.