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Trial registered on ANZCTR


Registration number
ACTRN12624000804583
Ethics application status
Approved
Date submitted
14/06/2024
Date registered
29/06/2024
Date last updated
29/06/2024
Date data sharing statement initially provided
29/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise-induced immune cell mobilisation in advanced melanoma: a comparison of high intensity interval training (HIIT) vs moderate intensity continuous training (MICT)
Scientific title
Exercise-induced immune cell mobilisation in advanced melanoma: a comparison of high intensity interval training (HIIT) vs moderate intensity continuous training (MICT) in adult patients with stage III-IV melanoma
Secondary ID [1] 311314 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 332565 0
Condition category
Condition code
Cancer 329264 329264 0 0
Malignant melanoma
Physical Medicine / Rehabilitation 330845 330845 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327762 0
Lifestyle
Intervention code [2] 328882 0
Treatment: Other
Comparator / control treatment
A single bout of 20-minutes of Moderate Intensity Continuous Training (MICT)
Control group
Active

Outcomes
Primary outcome [1] 337086 0
Magnitude of change in levels (cells/µL) of circulating T-cell subsets (CD8+ and CD4+) following an acute bout of HIIT vs MICT.
Timepoint [1] 337086 0
Immediately pre- and immediately post-exercise.
Secondary outcome [1] 430615 0
Magnitude of change in levels (cells/µL) of circulating Natural Killer (NK) cell subsets following an acute bout of HIIT vs MICT.
Timepoint [1] 430615 0
Immediately pre- and immediately post-exercise.
Secondary outcome [2] 430616 0
Magnitude of change in markers of functional capacity CD69, CX3CR1, perforin and granzyme markers following an acute bout of HIIT vs MICT assessed as a composite secondary outcome
Timepoint [2] 430616 0
Immediately pre- and immediately post-exercise.
Secondary outcome [3] 430617 0
Magnitude of change in concentrations of IL-7 following an acute bout of HIIT vs MICT.
Timepoint [3] 430617 0
Immediately pre- and immediately post-exercise.
Secondary outcome [4] 430618 0
Difference in measures of post-exercise fatigue between a bout of HIIT vs MICT.
Timepoint [4] 430618 0
48-hours following each bout of exercise
Secondary outcome [5] 436643 0
Magnitude of change in concentrations of IL-15 following an acute bout of HIIT vs MICT.
Timepoint [5] 436643 0
Immediately pre- and immediately post-exercise.
Secondary outcome [6] 436647 0
Difference in measures of post-exercise delayed onset muscle soreness between a bout of HIIT vs MICT.
Timepoint [6] 436647 0
48-hours following each bout of exercise
Secondary outcome [7] 436648 0
Difference in measures of post-exercise recovery mood between a bout of HIIT vs MICT.
Timepoint [7] 436648 0
48-hours following each bout of exercise

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316742 0
University
Name [1] 316742 0
The University of Sydney
Country [1] 316742 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318952 0
None
Name [1] 318952 0
Address [1] 318952 0
Country [1] 318952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314466 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 314466 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [1] 314466 0
Australia
Date submitted for ethics approval [1] 314466 0
Approval date [1] 314466 0
29/01/2024
Ethics approval number [1] 314466 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131678 0
A/Prof Kate Edwards
Address 131678 0
D18 Susan Wakil Health Building, Western Avenue, THE UNIVERSITY OF SYDNEY NSW 2006
Country 131678 0
Australia
Phone 131678 0
+61 02 9036 7396
Fax 131678 0
Email 131678 0
kate.edwards@sydney.edu.au
Contact person for public queries
Name 131679 0
Sarah Marvin
Address 131679 0
D18 Susan Wakil Health Building, Western Avenue, THE UNIVERSITY OF SYDNEY NSW 2006
Country 131679 0
Australia
Phone 131679 0
+61 02 9351 9164
Fax 131679 0
Email 131679 0
sarah.marvin@sydney.edu.au
Contact person for scientific queries
Name 131680 0
Sarah Marvin
Address 131680 0
D18 Susan Wakil Health Building, Western Avenue, THE UNIVERSITY OF SYDNEY NSW 2006
Country 131680 0
Australia
Phone 131680 0
+61 02 9351 9164
Fax 131680 0
Email 131680 0
sarah.marvin@sydney.edu.au

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?

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.