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Trial registered on ANZCTR


Registration number
ACTRN12624000966594
Ethics application status
Approved
Date submitted
15/07/2024
Date registered
8/08/2024
Date last updated
8/08/2024
Date data sharing statement initially provided
8/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the effect of post-exercise blood biomarkers in healthy volunteers on skin cancer cell lines.
Scientific title
Investigating the effect of post-exercise serum biomarkers in healthy volunteers on keratinocyte cancer cell lines
Secondary ID [1] 311983 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma 333598 0
Cutaneous squamous cell carcinoma 333599 0
Condition category
Condition code
Cancer 330283 330283 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to the exercise intervention, participants will undertake two pre-intervention laboratory visits. This initial visit will be for verbal explanation of the study, documentation, and allow for questions to be answered. Then participants will be required to undergo a standardised VO2 max testing on a cycle ergometer in the UCRISE laboratory to measure their individual aerobic capacity. Female participants will also be asked to complete a menstrual health questionnaire (see appendix 2) at each trial. The two pre-intervention visits will occur no more than 1 week apart.
The exercise intervention will involve moderate-intensity aerobic exercise in the form of cycle ergometry. The protocol involves three x 10-minute intervals on a cycle ergometer at 60% VO2 max, with a 2 minute break between each interval. The intervention will commence within 2 weeks of completing the pre-intervention visit.
This will be replicated in the three trials requiring a total of 180 ml of blood (3 x 60 ml per trial), blood will be collected prior to the exercise intervention, immediately after and 24 hours after the exercise intervention by a trained phlebotomist. There will be a total of three trials to be completed, therefore this process will be repeated three times in total with a 4-week break in-between trials.
The blood from each participant/ trial will be processed, with serum collected. A small sample of serum (5-20µl) will be used in ELISA’s and applied to keratinocyte cancer cell lines. The cell lines will be assessed using a proliferation and apoptosis assay.
Intervention code [1] 328446 0
Lifestyle
Comparator / control treatment
The non-exercise control participants will not be participating in the cycle ergometry and instead will be asked to go about their daily activities of life.
Non-exercise control participants will have their blood collected in the same maner as the exercising participants. This will be replicated in the three trials requiring a total of 180 ml of blood (3 x 60 ml per trial), blood will be collected prior to the exercise intervention, immediately after and 24 hours after the exercise intervention by a trained phlebotomist. There will be a total of three trials to be completed, therefore this process will be repeated three times in total with a 4-week break in-between trials.
Control group
Active

Outcomes
Primary outcome [1] 338025 0
Effect of exercised serum on cell viability on keratinocyte cancer cell lines
Timepoint [1] 338025 0
3 repeated trials (to assess for replicability), 4 weeks in between each trial. Assessed at each of the 3 repeated trials conducted at week 1, 4 and 8.
Primary outcome [2] 338899 0
Effect of exercised serum on apoptosis on keratinocyte cancer cell lines
Timepoint [2] 338899 0
3 repeated trials (to assess for replicability), 4 weeks in between each trial. Assessed at each of the 3 repeated trials conducted at week 1, 4 and 8.
Secondary outcome [1] 434169 0
Characterizing changes in immune biomarkers (Interleukin-6, ) after exercise
Timepoint [1] 434169 0
3 repeated trials (to assess for replicability), 4 weeks in between each trial. Assessed at each of the 3 repeated trials conducted at week 1, 4 and 8.
Secondary outcome [2] 437864 0
Characterizing changes in immune markers (Natural Killer Cells, T cells activation and proliferation)
Timepoint [2] 437864 0
3 repeated trials (to assess for replicability), 4 weeks in between each trial. Assessed at each of the 3 repeated trials conducted at week 1, 4 and 8.

Eligibility
Key inclusion criteria
Participants will be recreationally active, healthy adults, 25-40 years old.
Minimum age
25 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants must not have any prior or current history of or being
treated for any chronic illness or cancer, including any type of skin cancer. All participants with current or previous history of chronic
illness or cancer including cancer will be excluded from the study

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation procedure: using a coin flip method
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
28/10/2024
Actual
Date of last data collection
Anticipated
28/01/2025
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 42843 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 316332 0
University
Name [1] 316332 0
University of Canberra
Country [1] 316332 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Country
Australia
Secondary sponsor category [1] 318513 0
None
Name [1] 318513 0
Address [1] 318513 0
Country [1] 318513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315142 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 315142 0
http://www.canberra.edu.au/research/ucresearch/integrityandethics/human-ethics
Ethics committee country [1] 315142 0
Australia
Date submitted for ethics approval [1] 315142 0
14/11/2023
Approval date [1] 315142 0
19/04/2024
Ethics approval number [1] 315142 0
202413589

Summary
Brief summary
This study will investigate the effect of post-exercise serum biomarkers in healthy volunteers on keratinocyte cancer cell lines

Who is it for?
This is a study in healthy volunteers. You may be eligible to join this study if you are aged between 25 and 40 years old and recreationally active and do not have any chronic illnesses or previous history of any type of skin cancer.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups: an exercise group, where the exercise will be a short bout of moderate intensity aerobic exercise (cycle ergometry) or a second group where participants will go about their daily activities (no cycle ergometry). All participants will provide blood prior to their activity, immediately after their activity and 24 hours after the activity. Participants in each group will do this three times every 4 weeks over a 12 -week period.

Participants’ blood samples at each visit will be analysed for cell viability and immune biomarker levels.

This project will provide clarity, through the investigation of underlying mechanistic factors, to a field that currently has conflicting and limiting evidence. This may ultimately benefit individuals with keratinocyte cancer, in a downstream fashion, by potentially identifying a novel effective adjuvant therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133798 0
Ms Heidi Bochenek
Address 133798 0
The University of Canberra 11 Kirinari st, Building 29 level C - UCRISE office Bruce, Australian Capital Territory, 2617 Australia
Country 133798 0
Australia
Phone 133798 0
+61 435071422
Fax 133798 0
Email 133798 0
[email protected]
Contact person for public queries
Name 133799 0
Heidi Bochenek
Address 133799 0
The University of Canberra 11 Kirinari st, Building 29 level C - UCRISE office Bruce, Australian Capital Territory, 2617 Australia
Country 133799 0
Australia
Phone 133799 0
+61 435071422
Fax 133799 0
Email 133799 0
[email protected]
Contact person for scientific queries
Name 133800 0
Heidi Bochenek
Address 133800 0
The University of Canberra 11 Kirinari st, Building 29 level C - UCRISE office Bruce, Australian Capital Territory, 2617 Australia
Country 133800 0
Australia
Phone 133800 0
+61 435071422
Fax 133800 0
Email 133800 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


What supporting documents are/will be available?




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.