Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000018718
Ethics application status
Approved
Date submitted
12/11/2021
Date registered
11/01/2022
Date last updated
19/09/2023
Date data sharing statement initially provided
11/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the effects of exercise on the body’s responses to complex abdominal cancer surgery
Scientific title
Mechanistic understanding of how preoperative exercise improves perioperative outcomes: a substudy of the NHMRC-funded PRIORITY trial
Secondary ID [1] 305748 0
ANZCA Regkey 22_039
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a substudy of the PRIORITY trial registered under ACTRN12621000617864.

Health condition
Health condition(s) or problem(s) studied:
Major abdominal cancer surgery 324244 0
Condition category
Condition code
Cancer 321732 321732 0 0
Biliary tree (gall bladder and bile duct)
Cancer 321733 321733 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 321734 321734 0 0
Liver
Cancer 321735 321735 0 0
Oesophageal (gullet)
Cancer 321736 321736 0 0
Ovarian and primary peritoneal
Surgery 321738 321738 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients included in this substudy will be recruited from the PRIORITY trial (Preoperative exercise for patients undergoing major abdominal cancer surgery). PRIORITY is an NHMRC-funded multicentre randomised controlled trial, investigating primarily the effects of a structured preoperative exercise program on in-hospital complications following major abdominal cancer surgery. For complete details regarding the PRIORITY trial, please see registration ACTRN12621000617864.

This substudy will collect plasma biomarkers from a sample of the PRIORITY cohort, intending to recruit 144 patients for the purposes of this study. The first 144 patients recruited to PRIORITY will be invited to participate in this substudy. Biomarkers will be collected at the following timepoints: (i) within the week preceding planned surgery, and (ii) postoperatively on each day for the first 4 days following surgery. We will also screen for delirium before and after surgery and assess cognition at baseline and at 1 year following surgery.
Intervention code [1] 322151 0
Not applicable
Comparator / control treatment
Participants randomised to the control arm of the parent trial, PRIORITY, will receive no exercise intervention or advice. They will receive all other standard elements of preoperative care delivered to patients undergoing major abdominal cancer surgery. The participants randomised to the control arm in the PRIORITY trial will be the control arm for this observational sub-study.
Control group
Active

Outcomes
Primary outcome [1] 329497 0
Postoperative inflammation between intervention and control groups determined by CRP assessed using blood samples collected preoperatively and postoperatively.
Timepoint [1] 329497 0
Baseline (preoperative) and for 4 postoperative days.
Secondary outcome [1] 402903 0
Perioperative myocardial injury assessed by high sensitive troponin T from blood samples
Timepoint [1] 402903 0
Preoperative (baseline) and the first 4 postoperative days
Secondary outcome [2] 402904 0
Perioperative neuronal injury assessed by neurofilament light from blood samples.
Timepoint [2] 402904 0
Preoperative (baseline) and the first postoperative day.
Secondary outcome [3] 403675 0
Ventricular function assessed by natriuretic peptide.
Timepoint [3] 403675 0
Preoperative (baseline) and the first postoperative day.
Secondary outcome [4] 403678 0
Perioperative inflammation assessed by a panel of cytokines
Timepoint [4] 403678 0
Preoperative (baseline) and the first postoperative day
Secondary outcome [5] 403679 0
Delirium assessed by Confusion Assessment Method.
Timepoint [5] 403679 0
Preoperative (baseline) and twice daily for the first 4 postoperative days
Secondary outcome [6] 403680 0
Cognition assessed by Modified Telephone Interview for Cognitive Status
Timepoint [6] 403680 0
Preoperative (baseline) and one year postoperatively

Eligibility
Key inclusion criteria
(i) recruited to the PRIORITY trial.

There are no additional eligibility criteria for this substudy.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) unable to provide informed consent

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Differences in postoperative inflammation as measured by CRP at baseline and for the first 4 days following surgery will be compared between the exercise group and control group using a mixed-effects model. 95 percent confidence intervals will be calculated. For the primary outcome, a p-value of <0.05 will be considered statistically significant

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/02/2022
Actual
1/03/2022
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
33
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21093 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 21094 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 35946 0
2050 - Camperdown
Recruitment postcode(s) [2] 35947 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 310108 0
Charities/Societies/Foundations
Name [1] 310108 0
Australia and New Zealand College of Anaesthetists
Country [1] 310108 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311173 0
Hospital
Name [1] 311173 0
Peter MacCallum Cancer Centre
Address [1] 311173 0
Grattan Street
Melbourne VIC 3000
Country [1] 311173 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309796 0
Research Ethics & Governance Office Royal Prince Alfred Hospital
Ethics committee address [1] 309796 0
Research Ethics & Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 309796 0
Australia
Date submitted for ethics approval [1] 309796 0
30/09/2021
Approval date [1] 309796 0
22/11/2021
Ethics approval number [1] 309796 0
ETH01123

Summary
Brief summary
The purpose of this substudy is to better understand the effects of exercise on a number of the body’s responses to complex cancer surgery, including immune effects and the performance of certain organs, such as the heart and brain.

Who is it for?
You may be eligible for this study if you are an adult who is undergoing complex surgery for treatment of cancers of the gastro-intestinal tract and has already been enrolled in the PRIORITY trial (as described in registration ACTRN12621000617864).

Study details
In addition to taking part in the PRIORITY trial, participants in this sub-study will be asked to provide blood samples before and after their operation. They will also be asked to complete additional questionnaires before and after their operation to assess for any changes to brain function. Participants will then be asked to complete those questionnaires again one year after their surgery.

It is hoped that this study will help researchers to understand the biological reasons why exercise and fitness influences a person’s ability to recover from major surgery, including whether or not they suffer complications following their operation. The ability to answer this question is an important research target because it will advance an understanding of interventions that can be offered to patients to reduce the risks associated with undergoing complex surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115418 0
Dr Neil Pillinger
Address 115418 0
Department of Anaesthetics
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 115418 0
Australia
Phone 115418 0
+61 295158507
Fax 115418 0
Email 115418 0
neil.pillinger@sydney.edu.au
Contact person for public queries
Name 115419 0
Dr Neil Pillinger
Address 115419 0
Department of Anaesthetics
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 115419 0
Australia
Phone 115419 0
+61 295158507
Fax 115419 0
Email 115419 0
neil.pillinger@sydney.edu.au
Contact person for scientific queries
Name 115420 0
Dr Neil Pillinger
Address 115420 0
Department of Anaesthetics
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 115420 0
Australia
Phone 115420 0
+61 295158507
Fax 115420 0
Email 115420 0
neil.pillinger@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual data
When will data be available (start and end dates)?
After trial publication for a period of up to 5 years
Available to whom?
Future researchers engaging in relevant activity at the approval of the study investigators and requiring seperate HREC approval
Available for what types of analyses?
To answer the predetermined research questions approved by the study investigators
How or where can data be obtained?
Individual requests can be made to the PI by email; neil.pillinger@sydney.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14064Study protocol  neil.pillinger@sydney.edu.au



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.