Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001217392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/08/2026
Date registered
Help: Date registered
1/10/2026
Date last updated
Help: Date last updated
1/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
1/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
EXERcise during chemoTherapy infusION for people with metastatic Colorectal cancer; a randomised controlled trial (EXERTION-mC)
Scientific title
Effect of EXERcise during chemoTherapy infusION on tumour depth of response for people with metastatic Colorectal cancer; a randomised controlled trial (EXERTION-mC)
Additional trial identifiers [1] 318165 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EXERTION-mC
Related trial records

Health condition
Health condition(s) studied:
Metastatic colorectal cancer 343216 0
Condition category
Condition code
Cancer 339304 339304 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will exercise whilst seated in their treatment chair receiving chemotherapy infusion, using a modified cycle ergometer, supervised by an exercise physiologist (EP). Participants will cycle for 20 minutes continuously at a moderate intensity (40-50% heart rate reserve and a rate of perceived exertion 12-14). Except for the baseline session where no exercise is performed, the exercise intervention will take place in each remaining scheduled chemotherapy infusion until 6 months after the commencement of chemotherapy. It is anticipated that this may be up to 10 visits.

Participants will be monitored for 10 minutes prior to commencing exercise, during the 20 minutes of exercise and for 20 minutes following exercise. Monitoring will include heart rate and oxygen saturation (every 5 minutes), and blood pressure (every 10 minutes). Rating of perceived exertion will also be obtained while cycling.

All participants will receive two x 30minute consultations with an Exercise Physiologist at Baseline (Day 1) and at end of chemotherapy (at 24 weeks), who will provide general exercise advice and information about exercise services available as part of routine care and how to access them. All participants will complete baseline, 12 week and 24 week questionnaires. All participants will wear a research-grade activity monitor for 1 week at baseline, 12 weeks and 24 weeks, and will additionally wear a consumer grade activity monitor for the entire duration of the study. All participants will complete a symptom diary on days 2 and 4 after each chemotherapy infusion for up to 6 months following commencement of chemotherapy.
Intervention code [1] 335051 0
Treatment: Other
Description of the comparator or control
Participants will receive standard chemotherapy treatment without engaging in exercise during infusion.

All participants will receive two x 30 minute consultations with an Exercise Physiologist at Baseline (Day 1) and end of chemotherapy (At 24 weeks), who will provide general exercise advice and information about exercise services available as part of routine care and how to access them. All participants will complete baseline, 12 week and 24 week questionnaires. All participants will wear a research-grade activity monitor for 1 week at baseline, 12 weeks and 24 weeks, and will additionally wear a consumer grade activity monitor for the entire duration of the study. All participants will complete a symptom diary on days 2 and 4 after each chemotherapy infusion for up to 6 months following the commencement of chemotherapy.
Control group
Active

Outcomes
Primary outcome [1] 346599 0
Tumour depth of response (maximal tumour shrinkage)
Timepoint [1] 346599 0
12 weeks following chemotherapy commencement, 24 weeks following chemotherapy commencement (primary timepoint)
Secondary outcome [1] 466601 0
Progression-free survival
Timepoint [1] 466601 0
once at 12 months following chemotherapy commencement
Secondary outcome [2] 466602 0
Hospitalisations
Timepoint [2] 466602 0
12 months following chemotherapy commencement
Secondary outcome [3] 466603 0
Relative dose intensity of chemotherapy
Timepoint [3] 466603 0
24 weeks following chemotherapy commencement
Secondary outcome [4] 466606 0
Cancer-related fatigue
Timepoint [4] 466606 0
baseline, 12 weeks following chemotherapy commencement, 24 weeks following chemotherapy commencement
Secondary outcome [5] 466607 0
Peripheral Neuropathy
Timepoint [5] 466607 0
baseline, 12 weeks following chemotherapy commencement, 24 weeks following chemotherapy commencement
Secondary outcome [6] 466608 0
Health-related quality of life
Timepoint [6] 466608 0
baseline, 12 weeks following chemotherapy commencement, 24 weeks following chemotherapy commencement
Secondary outcome [7] 466609 0
Exercise self-efficacy
Timepoint [7] 466609 0
baseline, 12 weeks following chemotherapy commencement, 24 weeks following chemotherapy commencement
Secondary outcome [8] 466610 0
Patient-reported physical activity
Timepoint [8] 466610 0
baseline, 12 weeks following chemotherapy commencement, 24 weeks following chemotherapy commencement
Secondary outcome [9] 466611 0
Symptom burden
Timepoint [9] 466611 0
on days 2 and 4 following each chemotherapy infusion during the intervention period
Secondary outcome [10] 466618 0
Physical activity
Timepoint [10] 466618 0
For one week following infusion at: baseline, 12 weeks following chemotherapy commencement; and 24 weeks following chemotherapy commencement
Secondary outcome [11] 466619 0
Body composition (fat, muscle mass, fat-free mass). This will be assessed as a composite outcome.
Timepoint [11] 466619 0
baseline, 24 weeks following chemotherapy commencement
Secondary outcome [12] 466620 0
Chemotherapy-related adverse events
Timepoint [12] 466620 0
For each chemotherapy infusion from baseline to 24 weeks following commencement of chemotherapy
Secondary outcome [13] 466621 0
Chemotherapy treatment related adverse events
Timepoint [13] 466621 0
For each chemotherapy infusion from baseline to 24 weeks following commencement of chemotherapy
Secondary outcome [14] 466622 0
Uptake of exercise services
Timepoint [14] 466622 0
baseline, 24 weeks following chemotherapy commencement
Secondary outcome [15] 466623 0
Uptake of dietitian services
Timepoint [15] 466623 0
baseline, 24 weeks following chemotherapy commencement
Secondary outcome [16] 466624 0
Patient experience
Timepoint [16] 466624 0
24 weeks following chemotherapy commencement
Secondary outcome [17] 466625 0
Cost-effectiveness
Timepoint [17] 466625 0
Baseline, 12 months following commencement of chemotherapy
Secondary outcome [18] 466626 0
Adherance to intra-infusion exercise
Timepoint [18] 466626 0
during each scheduled intra-infusion exercise session within the 24-week intervention period
Secondary outcome [19] 466628 0
Exercise intensity
Timepoint [19] 466628 0
Every 5 minutes during intra-infusion exercise within the 24-week intervention period
Secondary outcome [20] 468508 0
Duration of hospitalisations
Timepoint [20] 468508 0
12 months following chemotherapy commencement.

Eligibility
Key inclusion criteria
Voluntarily signed the informed consent form;
Ability to speak and understand English or supported by health service interpreters;
Diagnosed with metastatic colorectal cancer;
Has measurable metastatic lesions on CT or MRI based on RECIST v1.1 criteria;
Having prescribed at least 6 months of chemotherapy with at least 5 months remaining;
Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
Willingness and ability to comply with all study procedures;
Infusion duration >= 60 minutes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Presence of any condition that is contraindicated to exercise;
Presence of orthopaedic problems, comorbid condition or pain that would limit lower body exercise;
Currently taking beta-blocker medication;
Currently undergoing immunotherapy

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)
Randomisation will be the responsibility of the study statistician and will be disclosed using the REDCap Randomisation Module.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur sequentially through computer-generated random numbers. Participants will be stratified by treatment regimen, targeted therapy and study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In the absence of clinical outcomes data, sample size estimation has been conservatively set at d=0.45. Relevant pre-clinical data indicates that pharmacologically increasing blood flow alongside chemotherapy significantly reduces tumour volumes, with a large effect size (d=1.2). Recognising the difference between sustained pharmacological blood flow enhancement and the 20-minute increase induced by intra-infusion exercise, a more conservative estimate is warranted.

Exercise training studies of colon/breast cancer patients during chemotherapy, using tumour cell lysis as a proxy for potential clinical outcomes and hospitalisations, have reported effect sizes of d=0.61-0.69.

Based on the above, we have adopted a conservative estimate of d=0.45. For power=0.8 and Type I error rate=0.05, the sample required to detect d=0.45 is 79 per group. Allowing for 20% drop-out, we will recruit 197 patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2026
Actual
Date of last participant enrolment
Anticipated
1/07/2029
Actual
Date of last data collection
Anticipated
30/06/2030
Actual
Sample size
Target
197
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 30045 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 30046 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 46438 0
2050 - Camperdown
Recruitment postcode(s) [2] 46439 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 322728 0
Charities/Societies/Foundations
Name [1] 322728 0
Wereld Kanker Onderzoek Fonds (World Cancer Research Fund)
Country [1] 322728 0
Netherlands
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 325650 0
None
Name [1] 325650 0
Address [1] 325650 0
Country [1] 325650 0
Other collaborator category [1] 284064 0
Hospital
Name [1] 284064 0
Chris O'Brien Lifehouse
Address [1] 284064 0
Country [1] 284064 0
Australia
Other collaborator category [2] 284065 0
Hospital
Name [2] 284065 0
Concord Repatriation General Hospital
Address [2] 284065 0
Country [2] 284065 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321171 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 321171 0
Ethics committee country [1] 321171 0
Australia
Date submitted for ethics approval [1] 321171 0
25/05/2026
Approval date [1] 321171 0
21/08/2026
Ethics approval number [1] 321171 0

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

Contacts
Principal investigator
Name 152898 0
Prof Kate Edwards
Address 152898 0
University of Sydney, Level 7 Susan Wakil Health Building, Camperdown NSW 2006
Country 152898 0
Australia
Phone 152898 0
+61 2 9036 7396
Fax 152898 0
Email 152898 0
[email protected]
Contact person for public queries
Name 152899 0
Catherine Seet-Lee
Address 152899 0
University of Sydney, Level 7 Susan Wakil Health Building, Camperdown NSW 2006
Country 152899 0
Australia
Phone 152899 0
+61 2 9351 1000
Fax 152899 0
Email 152899 0
[email protected]
Contact person for scientific queries
Name 152900 0
Catherine Seet-Lee
Address 152900 0
University of Sydney, Level 7 Susan Wakil Health Building, Camperdown NSW 2006
Country 152900 0
Australia
Phone 152900 0
+61 2 9351 1000
Fax 152900 0
Email 152900 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.