None listed
Conditions
Brief summary
This research will primarily aim to quantify the mobilisation of T-cell subsets (CD8+ and CD4+) in response to a bout of HIIT vs MICT exercise. These cells have been specifically chosen as the PD-1 and CTLA-4 receptors are expressed on these cells respectively. The PD-1 and CTLA-4 pathways are targets of first line immunotherapies for advanced melanoma such as Nivolumab, Pembrolizumab and Ipilimumab. Who is it for? You may be eligible for this study if you are a male or female age 18 or older with stage III-IV melanoma, receiving any immunotherapy. Study details Participants will cycle on a cycle ergometer. Physiological measures (heart rate, oxygen saturation, and blood pressure) will be taken during the pre-exercise resting period, warm-up, exercise task, cool-down, and recovery periods. Rate of perceived exertion (RPE) will also be recorded throughout exercise. It is hoped that findings from this study will establish the optimal exercise intensity parameters for the translation of exercise as an adjunct to immunotherapy.
Interventions
Participants will cycle on a cycle ergometer. Physiological measures (heart rate, oxygen saturation, and blood pressure) will be taken during the pre-exercise resting period, warm-up, exercise task, cool-down, and recovery periods. Rate of perceived exertion (RPE) will also be recorded throughout exercise. Both protocols will involve a 5-minute warm and cool down at a light intensity (workload equivalent to <40% VO2max). Participants will be instructed to avoid anti-inflammatory medications (>4-
Participants will cycle on a cycle ergometer. Physiological measures (heart rate, oxygen saturation, and blood pressure) will be taken during the pre-exercise resting period, warm-up, exercise task, cool-down, and recovery periods. Rate of perceived exertion (RPE) will also be recorded throughout exercise. Both protocols will involve a 5-minute warm and cool down at a light intensity (workload equivalent to <40% VO2max). Participants will be instructed to avoid anti-inflammatory medications (>4-days if possible), abstain from alcohol and moderate to strenuous exercise (24-hours), avoid caffeine (>12-hours), arrive fasted (2-hours), and consume a standardised snack prior to visits 2 and 3. Participants will be asked to keep their diet consistent and not make any significant changes between exercise sessions. There will be a minimum wash-out period of 48-hours between sessions. Arm 1: High Intensity Interval Training (HIIT) Participants will complete a once-off 16 to 20-minute HIIT exercise session utilising a 1:1 work to recovery ratio. One-on-one supervision will be provided by an Accredited Exercise Physiologist. Participants will complete 8 to 10x 1-minute intervals of high intensity cycling (workload equivalent to min. 85% VO2max or 16-18 RPE using the Borg scale) with 1-minute active recovery at a light intensity (workload equivalent to less than 40% VO2max or 8-10 RPE) between intervals. Adherence will be monitored using both workload and RPE. Arm 2: Moderate Intensity Continuous Training (MICT): Participants will complete a once-off 20-minute MICT exercise session. One-on-one supervision will be provided by an Accredited Exercise Physiologist. Participants will cycle continuously for 20-minutes at a workload equivalent to 40 to 60% VO2max (12-14 RPE). Adherence will be monitored using both workload and RPE.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage III-IV melanoma, receiving any immunotherapy, aged minimum 18-years, approval by treating oncologist, willing and able to give informed consent and comply with study requirements.
Exclusion criteria
ECOG <3 or Karnofsky <60, acute systemic infection, presence of any condition that is contraindicated to exercise, presence of any orthopaedic problems or significant pain that would limit lower body exercise, currently taking beta-blocker medication
Outcome results
None listed