ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cancer

inflammation

Condition category

Condition code

Cancer

Any cancer

Inflammatory and Immune System

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

cytokines IL-6 and IL-10 measured in serum from venous blood samples.

Timepoint [1]

Pre- and post- 2-week training period.

Secondary outcome [1]

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]

Pre and post 2-week training period (training effect).

Secondary outcome [2]

Timepoint [2]

Pre and post first exercise session at each intensity (acute effect)

Secondary outcome [3]

Pressure pain thresholds using algometry.

Timepoint [3]

Pre- and post- 2-week training period (training effect).

Secondary outcome [4]

Pressure pain thresholds using algometry.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Prince of Wales Hospital - Randwick

Recruitment postcode(s) [1]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Education

Address [1]

105 Phillip St, Parramatta, NSW, 2150

Country [1]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

High St, Kensington, NSW, 2052.

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Prince of Wales Hospital

Address [1]

320-346 Barker St, Randwick, NSW, 2031.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District Human Research Ethics Committee,

Ethics committee address [1]

Barker Street, Randwick, NSW, 2031.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/10/2015

Approval date [1]

09/02/2016

Ethics approval number [1]

HREC 15/170

Summary

Brief summary

Cancer patients often experience inflammation, which is thought to be associated with cancer development and progression, as well as being linked to side effects experienced during and after treatment. As exercise is known to have an effect on systemic inflammation, the aim of this project is to investigate the effect of exercise intensity on markers of inflammation in patients with cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have been diagnosed with any cancer type, and are 3-12 months post-completion of primary cancer treatment with curative intent.

Study details
Participants who enrol in this study will be randomly allocated by chance (similar to flipping a coin) to begin with 2 weeks of either low- or high-intensity exercise involving stationary cycling. Participants will complete 3, 25 minute (total time required per visit: 1 hour) exercise sessions per week (i.e. 6 sessions in total) supervised by an accredited exercise physiologist. After completing the 2-week program, participants will take a 6-week break before switching over to the other intensity for a further two weeks. Blood samples and tests of muscle pain will be performed before each 2-week exercise period, after the first session of each exercise period, and at the end of each 2-week exercise period.

It is hoped this research will help us to determine the intensity of exercise that best reduces markers of inflammation in cancer patients, with improvements in cancer pain.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Goldstein

Address

Lowy Cancer Research Centre, Wallace Wurth Building, Corner Botany & High Streets, Kensington NSW 2052.

Country

Australia

Phone

+61 2 9065 1813

Fax

d.goldstein@unsw.edu.au

Contact person for public queries

Name

Briana Clifford

Address

School of Health Sciences, Wallace Wurth Building, Corner Botany & High Streets, UNSW, Kensington NSW 2052

Country

Australia

Phone

+61 290651813

Fax

b.clifford@unsw.edu.au

Contact person for scientific queries

Name

Briana Clifford

Address

School of Health Sciences, Wallace Wurth Building, Corner Botany & High Streets, UNSW, Kensington NSW 2052

Country

Australia

Phone

+61 290651813

Fax

b.clifford@unsw.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?

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 (b.clifford@unsw.edu.au).

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

Source	Title	Year of Publication	DOI
Embase	The effect of exercise intensity on the inflammatory profile of cancer survivors: A randomised crossover study.	2023	https://dx.doi.org/10.1111/eci.13984

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically