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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.
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Scientific title
Investigating the effect of post-exercise serum biomarkers in healthy volunteers on keratinocyte cancer cell lines
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Secondary ID [1]
311983
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma
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Cutaneous squamous cell carcinoma
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Condition category
Condition code
Cancer
330283
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0
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328446
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Effect of exercised serum on cell viability on keratinocyte cancer cell lines
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Assessment method [1]
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Cell proliferation assay
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Timepoint [1]
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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.
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Primary outcome [2]
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Effect of exercised serum on apoptosis on keratinocyte cancer cell lines
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Assessment method [2]
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Apopercentage assay
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Timepoint [2]
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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.
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Secondary outcome [1]
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Characterizing changes in immune biomarkers (Interleukin-6, ) after exercise
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Assessment method [1]
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Enzyme-linked immunosorbent assays (ELISA kits)
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Timepoint [1]
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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.
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Secondary outcome [2]
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Characterizing changes in immune markers (Natural Killer Cells, T cells activation and proliferation)
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Assessment method [2]
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IL-15 Enzyme-linked immunosorbent assays (ELISA kits)
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Timepoint [2]
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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.
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Eligibility
Key inclusion criteria
Participants will be recreationally active, healthy adults, 25-40 years old.
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Minimum age
25
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation procedure: using a coin flip method
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/08/2024
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Actual
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Date of last participant enrolment
Anticipated
28/10/2024
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Actual
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Date of last data collection
Anticipated
28/01/2025
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Actual
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Sample size
Target
6
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT
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Recruitment postcode(s) [1]
42843
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2617 - Bruce
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Canberra
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Canberra
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
318513
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Canberra Human Research Ethics Committee
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Ethics committee address [1]
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http://www.canberra.edu.au/research/ucresearch/integrityandethics/human-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/11/2023
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Approval date [1]
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19/04/2024
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Ethics approval number [1]
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202413589
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Heidi Bochenek
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Address
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The University of Canberra 11 Kirinari st, Building 29 level C - UCRISE office Bruce, Australian Capital Territory, 2617 Australia
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Country
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Australia
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Phone
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+61 435071422
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Heidi Bochenek
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Address
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The University of Canberra 11 Kirinari st, Building 29 level C - UCRISE office Bruce, Australian Capital Territory, 2617 Australia
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Country
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Australia
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Phone
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+61 435071422
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Heidi Bochenek
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Address
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The University of Canberra 11 Kirinari st, Building 29 level C - UCRISE office Bruce, Australian Capital Territory, 2617 Australia
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Country
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Australia
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Phone
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+61 435071422
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23991
Informed consent form
Informed consent form
387685-(Uploaded-15-07-2024-11-32-30)-Participant-Information-Form HB 23022024 (1).docx
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Other
Screening Questionnaire
387685-(Uploaded-15-07-2024-11-32-45)-Appendix 1 Screening questionnaire HB 13112023.pdf
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Other
Menstrual cycle questionnaire
387685-(Uploaded-15-07-2024-11-32-57)-Appendix 2 Menstrual cycle questionnaire HB 13112023.pdf
23994
Other
Recruitment poster
387685-(Uploaded-15-07-2024-11-33-37)-Appendix 3 Recruitment HB 13112023.pdf
24022
Ethical approval
Ethical approval by University of Canberra HREC (a...
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More Details
]
387685-(Uploaded-24-07-2024-11-27-12)-Bochenek in vitro ethics approval.pdf
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.
Download to PDF