None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Canberra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
25 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Participants will be recreationally active, healthy adults, 25-40 years old.
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
Outcome results
None listed