Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001558718
Ethics application status
Approved
Date submitted
22/11/2022
Date registered
16/12/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
16/12/2022
Date results provided
16/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of exercise intensity on inflammation in cancer survivors
Scientific title
The effect of exercise intensity on inflammation in cancer survivors
Secondary ID [1] 308470 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 328278 0
inflammation 328279 0
Condition category
Condition code
Cancer 325319 325319 0 0
Any cancer
Inflammatory and Immune System 325320 325320 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised crossover design where participants are randomised to either high intensity (60-70% Heart rate reserve) or low intensity (30-40% heart rate reserve) aerobic exercise (stationary cycling) for 2-weeks (6 exercise sessions; 3 per week for 2 weeks, 30 mins total duration per session; 5 min warmup, 20 mins at prescribed intensity, 5 mins cooldown). After the completion of the two-week intervention, the participants undergo a 6-week washout period followed by the opposite exercise intensity intervention. The exercise sessions delivered one-on-one and are supervised by an accredited exercise physiologist who is a member of the research team. The exercise sessions take place in a specialized exercise laboratory in the Wallace Wurth Building, Department of Exercise Physiology at UNSW. HR monitors are used to monitor continuous heart rate to determine compliance with the exercise prescription. Attendance at exercise sessions is recorded to measure adherence to the intervention.
Intervention code [1] 324910 0
Rehabilitation
Intervention code [2] 325060 0
Treatment: Other
Intervention code [3] 325061 0
Lifestyle
Comparator / control treatment
Low intensity (30-40% heart rate reserve) stationary cycling will serve as the comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 333181 0
cytokines IL-6 and IL-10 measured in serum from venous blood samples.
Timepoint [1] 333181 0
Pre- and post- 2-week training period.
Secondary outcome [1] 416078 0
Cytokines and chemokines: Interleukin-7, Interleukin-8, Interleukin-1 alpha D. Interleukin 1 receptor antagonist, C-C motif chemokine ligand (CCL) 2, C-C motif chemokine ligand (CCL) 3 (Macrophage Inflammatory Protein 1 alpha), C-C motif chemokine ligand (CCL) 4 (Macrophage inflammatory protein 1 beta), C-C motif chemokine ligand (CCL) 5 (RANTES), C-C motif chemokine (CCL) 11 (Eotaxin), CXC motif chemokine ligand (CXCL) 10 (IP10), CXC motif chemokine ligand (CXCL)12 (Stromal cell derived factor 1 alpha). This will be measured in serum isolated from venous blood samples. These cytokines will be assessed as a composite outcome in a network analysis. Where appropriate, individual outcomes may be assessed.
Timepoint [1] 416078 0
Pre and post 2-week training period (training effect).
Secondary outcome [2] 416093 0
Cytokines and chemokines: Interleukin-7, Interleukin-8, Interleukin-1 alpha D. Interleukin 1 receptor antagonist, C-C motif chemokine ligand (CCL) 2, C-C motif chemokine ligand (CCL) 3 (Macrophage Inflammatory Protein 1 alpha), C-C motif chemokine ligand (CCL) 4 (Macrophage inflammatory protein 1 beta), C-C motif chemokine ligand (CCL) 5 (RANTES), C-C motif chemokine (CCL) 11 (Eotaxin), CXC motif chemokine ligand (CXCL) 10 (IP10), CXC motif chemokine ligand (CXCL)12 (Stromal cell derived factor 1 alpha). This will be measured in serum isolated from venous blood samples. These cytokines will be assessed as a composite outcome in a network analysis. Where appropriate, individual outcomes may be assessed.
Timepoint [2] 416093 0
Pre and post first exercise session at each intensity (acute effect)
Secondary outcome [3] 416094 0
Pressure pain thresholds using algometry.
Timepoint [3] 416094 0
Pre- and post- 2-week training period (training effect).
Secondary outcome [4] 416095 0
Pressure pain thresholds using algometry.
Timepoint [4] 416095 0
Pre- and post- first exercise session at each intensity (acute effect).

Eligibility
Key inclusion criteria
People 3-12 months post completion of primary cancer treatment with curative intent. Any cancer type.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently undergoing active cancer treatment.
- Currently taking any regular anti-inflammatory medication.
- Currently taking any regular analgesic medication.
- Pregnant or breastfeeding women.
- Anyone on an experimental drug trial.
- Anyone who could not freely give informed consent.

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)
No allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random group allocation sequence was generated using online random number generator (random.org).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM statistical package for social sciences (SPSS, version 22) will be used to run a restricted maximum likelihood- based linear mixed model to estimate the effect of exercise intensity on outcomes after a single exercise session and after 2-week of training. The order of intensity (low intensity first vs. high intensity first) and the exercise training bout (the first training period vs. the second training period irrespective of intensity) will be modelled as additional fixed effects in the model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
1/11/2018
Date of last data collection
Anticipated
Actual
30/01/2019
Sample size
Target
25
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23631 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 39051 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 312713 0
Government body
Name [1] 312713 0
Australian Government Department of Education
Country [1] 312713 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St, Kensington, NSW, 2052.
Country
Australia
Secondary sponsor category [1] 314332 0
Hospital
Name [1] 314332 0
Prince of Wales Hospital
Address [1] 314332 0
320-346 Barker St, Randwick, NSW, 2031.
Country [1] 314332 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312013 0
South Eastern Sydney Local Health District Human Research Ethics Committee,
Ethics committee address [1] 312013 0
Ethics committee country [1] 312013 0
Australia
Date submitted for ethics approval [1] 312013 0
23/10/2015
Approval date [1] 312013 0
09/02/2016
Ethics approval number [1] 312013 0
HREC 15/170

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

Contacts
Principal investigator
Name 123174 0
Prof David Goldstein
Address 123174 0
Lowy Cancer Research Centre, Wallace Wurth Building, Corner Botany & High Streets, Kensington NSW 2052.
Country 123174 0
Australia
Phone 123174 0
+61 2 9065 1813
Fax 123174 0
Email 123174 0
[email protected]
Contact person for public queries
Name 123175 0
Briana Clifford
Address 123175 0
School of Health Sciences, Wallace Wurth Building, Corner Botany & High Streets, UNSW, Kensington NSW 2052
Country 123175 0
Australia
Phone 123175 0
+61 290651813
Fax 123175 0
Email 123175 0
[email protected]
Contact person for scientific queries
Name 123176 0
Briana Clifford
Address 123176 0
School of Health Sciences, Wallace Wurth Building, Corner Botany & High Streets, UNSW, Kensington NSW 2052
Country 123176 0
Australia
Phone 123176 0
+61 290651813
Fax 123176 0
Email 123176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data related to the main outcomes of this study may be shared upon request.
When will data be available (start and end dates)?
Data is available immediately following publication up until 7 years after study completion (November 2025) as required by ethics.
Available to whom?
Researchers who provide a methodologically sounds proposal. Access to data will be assessed on a case by case basis by the primary sponsor (UNSW employee associated with the study).
Available for what types of analyses?
Only to achieve the aims in the data acquisition proposal.
How or where can data be obtained?
Data will can be obtained from the primary investigator via email ([email protected]).


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
EmbaseThe effect of exercise intensity on the inflammatory profile of cancer survivors: A randomised crossover study.2023https://dx.doi.org/10.1111/eci.13984
N.B. These documents automatically identified may not have been verified by the study sponsor.