Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000265370
Ethics application status
Approved
Date submitted
20/01/2017
Date registered
21/02/2017
Date last updated
12/04/2019
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of pre-operative exercise on cardiovascular fitness in patients undergoing surgery for major upper gastro-intestinal cancer.
Scientific title
A randomised controlled trial comparing high intensity exercise to standard pre-operative preparation to improve cardiovascular fitness in major upper gastro-intestinal cancer patients
Secondary ID [1] 290777 0
JHHGIS09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer involving the upper gastrointestinal tract, including oesophagus, stomach, duodenum, pancreas, liver and bile duct. 301375 0
Condition category
Condition code
Surgery 301128 301128 0 0
Other surgery
Anaesthesiology 301129 301129 0 0
Anaesthetics
Cancer 301539 301539 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a hospital gym for a structured and supervised high intensity interval exercise program over three sessions per week for 4 weeks pre-operatively. Each participant will have a prescibed exercise program by a physiotherapist.

Each supervised session will comprise of at least 30 minutes of aerobic exercise in the form of a walking program, and a cycling program on an electromagnetically braked cycle ergometer. The walking program will be prescribed at a walking speed equal to 80% of the average speed achieved during the 6MWT. The cycling program will be prescribed at = 60% of peak power achieved during the CPET. Progression of the intensity and duration of the program’s aerobic components, both supervised and unsupervised, will be titrated to a dyspnoea score of 4-6 (Borg scale) or a rating of perceived exertion (RPE) of 14-16 depending on the symptom of exercise limitation
Intervention code [1] 296852 0
Treatment: Other
Comparator / control treatment
Current standard of care. Patients are adivsed by the treating surgeon to exercise and improve their fitness but are not provided with a supervised/ structured program.
Control group
Active

Outcomes
Primary outcome [1] 300740 0
Change in mean anaerobic threshold as determined by;
- Proportion of participants achieving an increase of at least 1.8mL/kg/min as determined by serial cardiopulmonary exercise testing prior and following participation in exercise program.

CPET testing will be performed on a calibrated electronically-braked cycle ergometer. The rate at which power will increase each minute will be individualised, with the aim of achieving a test duration of between 8 and 12 minutes. Breath-by-breath expired gas analysis will be undertaken using a Medisoft Exp'air metabolic cart. Peak exercise capacity will be defined as the rate of oxygen consumption averaged over the final 20 second epoch of the CPET. Lactate threshold will be determined using the ‘combined method
Timepoint [1] 300740 0
time point of initial CPET is following the first clinic visit to book surgery and the final CPET is in the week prior to surgery
Secondary outcome [1] 330762 0
Major surgical complication as defined by Clavien-Dindo IIIb or greater
Timepoint [1] 330762 0
90 days postoperatively
Secondary outcome [2] 330763 0
Change in serum C1q prior to and following exercise program
Timepoint [2] 330763 0
initial test following clinic visit where surgery is booked
final test in the week prior to surgery
Secondary outcome [3] 330764 0
Sarcopaenia as determined by CT Scan at time of diagnosis and 3 months following surgery
Timepoint [3] 330764 0
Initial scan around the time of initial clinic visit and subsequent CT scan 3 months following surgery
Secondary outcome [4] 330765 0
Physiotherapist supervised 6 minute walk test result
Timepoint [4] 330765 0
measured during initial and final exercise session
Secondary outcome [5] 330766 0
Mortality
Timepoint [5] 330766 0
90 days post-operatively
Secondary outcome [6] 330767 0
Days spent in ICU (mean)
Timepoint [6] 330767 0
Days spent in ICU post-operatively prior to discharge.
Secondary outcome [7] 330768 0
Length of stay (mean)
Timepoint [7] 330768 0
length of stay post-operatively
Secondary outcome [8] 330769 0
Post-operative pulmonary complication as defined by the Melbourne Group Scale
Timepoint [8] 330769 0
30 days post-operatively

Eligibility
Key inclusion criteria
All patients undergoing major upper gastrointestinal (GI) cancer surgery at John Hunter and Newcastle Private Hospitals
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unresectable/ metastatic disease at any point within the study
- Known Class III/IV heart failure or moderate to severe pulmonary hypertension
- Poorly controlled cardiac arrhythmia/ excluded by an anaesthetist or a cardiologist
- Uncontrolled hypertension >180/100
- Angina
- Claudication
- Vascular Aneurysm
- Severe COPD with FEV1<50% predicted
- For safety reasons, we cannot enrol people who don’t speak basic English in a
maximal intensity exercise program as we cannot provide a safe environment
without a trained, NSW Health registered translator for every exercise session.

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 are allocated a research number on entry to the study.

Allocation into treatment or control group is randomised independently of study investigators by Hunter Medical Research Institute.

Allocation involves contacting the holder of the allocation schedule who is off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Simple stratification according to procedure type has already been performed (I.e. oesophagectomy vs other Upper GI/ HPB resections)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
The change in CPET from baseline to follow-up between intervention and control groups will be performed using final CPET as the dependent variable, and group and baseline CPET as
the independent variables in a linear regression model. A similar model will be used to
analyse the secondary outcome of C1q

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2017
Actual
3/04/2017
Date of last participant enrolment
Anticipated
1/10/2018
Actual
22/03/2018
Date of last data collection
Anticipated
1/02/2019
Actual
29/06/2018
Sample size
Target
100
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7286 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 7287 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [3] 10326 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 15058 0
2305 - New Lambton
Recruitment postcode(s) [2] 15059 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 21994 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 295332 0
Other Collaborative groups
Name [1] 295332 0
Hunter Cancer Research Alliance
Country [1] 295332 0
Australia
Funding source category [2] 295333 0
Charities/Societies/Foundations
Name [2] 295333 0
John Hunter Charitable Trust
Country [2] 295333 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Local Health District
Address
Locked Bag 1
New Lambton NSW 2305
Country
Australia
Secondary sponsor category [1] 294159 0
None
Name [1] 294159 0
Address [1] 294159 0
Country [1] 294159 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296670 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296670 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 296670 0
Australia
Date submitted for ethics approval [1] 296670 0
29/11/2016
Approval date [1] 296670 0
08/03/2017
Ethics approval number [1] 296670 0

Summary
Brief summary
The study aims to compare high intensity exercise to standard pre-operative preparation to improve cardiovascular fitness in major upper gastrointestinal cancer patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo major upper gastrointestinal cancer surgery at John Hunter Hospital or Newcastle Private Hospital.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive standard pre-operative care, which consists of advice to improve fitness but no supervised or structured program. Participants in the other group will undertake prescribed, structured and supervised high intensity interval exercise over three sessions per week whilst on the wait list for major cancer surgery (approximately 30 days). This exercise will be primarily on a stationary bicycle with some walking sessions and tests for grip strength and walking distance within 6 minutes.

All participants will undergo cardiovascular exercise testing upon enrolment and the week prior to surgery in order to assess any changes in fitness. A blood test will also be taken at the start and completion of the program, and a CT Scan used at the point of diagnosis and then 3 months following completion of the study. Participants will be followed for 90 days post-operatively in order to review any surgical complications, length of time in hospital, and other clinical outcomes. If the pre-operative fitness intervention is successful in this cancer population, and improved fitness relates to better outcomes, then borderline operative candidates may be able to undergo a similar program with a view to extending the option of curative surgery to a larger patient population.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1593 1593 0 0
/AnzctrAttachments/372047-1702154.01 Ongoing Approval Multi-site LeadHREC.pdf (Ethics approval)

Contacts
Principal investigator
Name 71246 0
Dr David Burnett
Address 71246 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre 2310

Lookout Rd, New Lambton NSW 2305
Country 71246 0
Australia
Phone 71246 0
+612 49855153
Fax 71246 0
Email 71246 0
[email protected]
Contact person for public queries
Name 71247 0
Rosemary Carroll
Address 71247 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre, NSW 2305
Country 71247 0
Australia
Phone 71247 0
+612 4985 5153
Fax 71247 0
Email 71247 0
[email protected]
Contact person for scientific queries
Name 71248 0
Vanessa Wills
Address 71248 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre, NSW 2310
Country 71248 0
Australia
Phone 71248 0
+612 49214269
Fax 71248 0
Email 71248 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
Study closed early no data to share


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.