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Trial registered on ANZCTR
Registration number
ACTRN12624001101572
Ethics application status
Approved
Date submitted
28/08/2024
Date registered
12/09/2024
Date last updated
12/09/2024
Date data sharing statement initially provided
12/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The effects of exercise in patients with melanoma undergoing adjuvant immunotherapy with immune checkpoint inhibitor therapy – the EXHIBIT Study
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Scientific title
The safety and feasibility of exercise in patients with melanoma undergoing adjuvant immunotherapy with immune checkpoint inhibitor therapy – the EXHIBIT Study
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Secondary ID [1]
312266
0
None.
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Universal Trial Number (UTN)
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Trial acronym
EXHIBIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous melanoma
334203
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Condition category
Condition code
Cancer
330866
330866
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0
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Malignant melanoma
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Physical Medicine / Rehabilitation
331552
331552
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The EXHIBIT trial is a prospective two-armed randomised controlled trial with an exercise group and a control group.
Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) and follow a step-down approach.
• Phase 1 (0-3 months): two supervised multimodal (aerobic and resistance) exercise sessions and one unsupervised aerobic exercise session per week.
• Phase 2 (4-6 months): one supervised multimodal exercise session and two unsupervised exercise sessions per week, consisting of one aerobic and one multimodal exercise session.
• Phase 3 (7-12 months, or until scheduled ICI treatment completion): patients will be encouraged to continue exercising and will be provided with a home-based exercise program, including two multimodal and one aerobic exercise session per week. Patients will also receive a monthly check-in call to discuss their exercise (including modifications and any potential exercise-related adverse events).
Supervised exercise sessions will be conducted in small groups by qualified exercise professionals. These sessions will be conducted at community- or hospital-based gyms, however if face-to-face sessions are unachievable, home-based exercise sessions (supervised live remotely via Zoom) may be made available. Participants will be provided with a home-based exercise program for the unsupervised exercise sessions. The supervised sessions will be at a moderate-vigorous intensity and the unsupervised sessions will be at a moderate intensity, assessed with the Borg RPE Scale. Exercise sessions will be scheduled on days where participants are not receiving ICI treatment, and will be encouraged to have sessions separated by at least a day. The specific exercises that will be prescribed will be tailored to each individual by the exercise professional (based on their condition and fitness level at baseline) with ongoing monitoring and will be modified based on their response. Examples of aerobic exercises that may be included are stationary cycling and using an aerobic step. Examples of resistance exercises that may be included are squats and a chest press.
Exercise attendance and adherence will be monitored using an exercise training log that will be completed by the exercise professional for supervised exercise sessions and by the participant for unsupervised exercise sessions.
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Intervention code [1]
328899
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Treatment: Other
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Comparator / control treatment
Participants randomised to the control group will receive usual medical care (not receive a prescribed exercise program) and general exercise advice as per the current exercise oncology guidelines.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility of patient recruitment.
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Assessment method [1]
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The number of patients who agree to participate in the study out of the total number of eligible patients. This will be collected with an audit of recruitment records.
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Timepoint [1]
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Upon conclusion of the study.
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Primary outcome [2]
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Feasibility of the attendance to exercise sessions.
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Assessment method [2]
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The percentage of sessions attended out of the total offered during the intervention. Attendance to the supervised sessions will be recorded by the exercise professional, and attendance to the unsupervised sessions will be recorded by the patient in an exercise log to be provided to researchers.
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Timepoint [2]
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At 12 weeks (primary endpoint), 24 weeks and 12 months after intervention commencement.
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Primary outcome [3]
339220
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Safety of the exercise intervention
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Assessment method [3]
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Incidence and severity of exercise-related adverse events and severe immune-related adverse events measured by review of exercise session registers, clinician-reported adverse event logs, and medical record review.
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Timepoint [3]
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At 12 weeks (primary endpoint), 24 weeks, and 12 months after intervention commencement.
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Secondary outcome [1]
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Symptoms/Side Effects (Patient-Reported)
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Assessment method [1]
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Patient-Reported Outcome Common Terminology of Adverse Events (PRO-CTCAE)
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Timepoint [1]
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Weekly for the first 12 weeks after intervention commencement and every 4 weeks thereafter.
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Secondary outcome [2]
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Cancer-Related Fatigue (Patient-Reported)
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Assessment method [2]
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European Organization for Research and Treatment of Cancers Quality of Life Questionnaire-Fatigue Module (EORTC QLQ-FA12)
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Timepoint [2]
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At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
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Secondary outcome [3]
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Quality of Life (Patient-Reported)
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Assessment method [3]
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Functional Assessment of Cancer Therapy – Melanoma (FACT-M)
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Timepoint [3]
439104
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At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
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Secondary outcome [4]
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Anxiety (Patient-Reported)
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Assessment method [4]
439105
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Hospital Anxiety and Depression Scale (HADS)
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Timepoint [4]
439105
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At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
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Secondary outcome [5]
439107
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Work Role Functioning ( (Patient-Reported)
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Assessment method [5]
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Work Role Functioning Questionnaire (WRFQ)
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Timepoint [5]
439107
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At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
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Secondary outcome [6]
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Body Composition
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Assessment method [6]
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Dual-energy x-ray absorptiometry (DEXA)
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Timepoint [6]
439108
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At baseline, 12 weeks and 24 weeks after intervention commencement.
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Secondary outcome [7]
439109
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Upper Limb Muscular Strength
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Assessment method [7]
439109
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Chest press- hypothetical 1 repetition maximum (h1RM)
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Timepoint [7]
439109
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At baseline, 12 weeks and 24 weeks after intervention commencement.
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Secondary outcome [8]
439110
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Lower Limb Muscular Strength
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Assessment method [8]
439110
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Leg press- h1RM
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Timepoint [8]
439110
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At baseline, 12 weeks and 24 weeks after intervention commencement.
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Secondary outcome [9]
439111
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Grip Strength
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Assessment method [9]
439111
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Handgrip Dynamometer
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Timepoint [9]
439111
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At baseline, 12 weeks and 24 weeks after intervention commencement.
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Secondary outcome [10]
439112
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Exercise Capacity
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Assessment method [10]
439112
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Steep Ramp Test
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Timepoint [10]
439112
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At baseline, 12 weeks and 24 weeks after intervention commencement.
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Secondary outcome [11]
439113
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Physical Function
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Assessment method [11]
439113
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30-second sit to stand
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Timepoint [11]
439113
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At baseline, 12 weeks and 24 weeks after intervention commencement.
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Secondary outcome [12]
439114
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Immunotherapy Adherence/Completion Rates
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Assessment method [12]
439114
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Medical records
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Timepoint [12]
439114
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At 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [13]
439116
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Hospital Admissions
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Assessment method [13]
439116
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Medical Records
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Timepoint [13]
439116
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At 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [14]
439117
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Disease Progression
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Assessment method [14]
439117
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Medical records
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Timepoint [14]
439117
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At 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [15]
439118
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Any grade immune-related adverse events
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Assessment method [15]
439118
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Medical records
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Timepoint [15]
439118
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At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [16]
439122
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Sleep (Patient-Reported)
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Assessment method [16]
439122
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Pittsburgh Sleep Quality Index (PSQI)
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Timepoint [16]
439122
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At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [17]
439123
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Sleep (Objectively Assessed)
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Assessment method [17]
439123
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Fitbit Activity Tracker
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Timepoint [17]
439123
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At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [18]
439127
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Physical Activity (Patient-Reported)
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Assessment method [18]
439127
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Godin-Leisure Time Exercise Questionnaire
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Timepoint [18]
439127
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At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [19]
439128
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Physical Activity (Objectively Assessed)
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Assessment method [19]
439128
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Fitbit Activity Tracker
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Timepoint [19]
439128
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At baseline, 12 weeks, 24 weeks and 12 months.
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Secondary outcome [20]
439129
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Blood Biomarkers (Routine)
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Assessment method [20]
439129
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Medical records
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Timepoint [20]
439129
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At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
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Secondary outcome [21]
439130
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Blood Biomarkers (Study Specific)
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Assessment method [21]
439130
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Blood samples
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Timepoint [21]
439130
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At baseline and 12 weeks after intervention commencement, blood will be drawn pre-, immediately post-, and 1hr post-exercise capacity test.
At 24 weeks after intervention commencement one blood draw at rest will be performed.
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Secondary outcome [22]
439379
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Feasibility of patient retention - this is an additional primary outcome
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Assessment method [22]
439379
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The number of patients who did not withdraw from the intervention out of the total that commenced the study.
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Timepoint [22]
439379
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At 12-weeks (primary endpoint), 24-weeks and 12 months after intervention commencement.
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Secondary outcome [23]
439380
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Depression (Patient-Reported)
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Assessment method [23]
439380
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Hospital Anxiety and Depression Scale (HADS)
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Timepoint [23]
439380
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At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
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Secondary outcome [24]
439606
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Feasibility of adherence to the exercise program- this is an additional primary outcome.
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Assessment method [24]
439606
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The number of sessions the target intensity and duration were met out of the total number of exercise sessions attended. Intensity will be measured using the Borg Scale measure of rate of perceived exertion (RPE). Duration will be measured as the minutes of exercise.
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Timepoint [24]
439606
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At 12-weeks (primary), 24-weeks and 12-months after intervention commencement.
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Eligibility
Key inclusion criteria
Diagnosis of cutaneous melanoma
Scheduled to receive adjuvant immune checkpoint inhibitor immunotherapy treatment
Greater than or equal to 18 years of age
ECOG performance status less than or equal to 2
Ability and willingness to travel for the study visits and adhere to the exercise intervention
Written informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Stage IV/metastatic disease
Received neoadjuvant immunotherapy
Received greater than 1 immunotherapy infusion
Receiving treatment for another cancer (excluding non-melanoma skin cancer)
Currently performing equal to or more than 150 mins of moderate to vigorous intensity intentional physical activity per week
Serious active infection; severe neurologic or cardiac impairment according to ACSM criteria
Any contraindications for exercise as determined by the treating clinician
Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician
Pregnant
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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)
Central computerised randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked computer-generated sequence in a 1:1 ratio
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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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
19/09/2024
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Actual
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Date of last participant enrolment
Anticipated
2/06/2026
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Actual
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Date of last data collection
Anticipated
2/09/2028
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27023
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
27024
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The Alfred - Melbourne
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Recruitment hospital [3]
27025
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Cabrini Hospital - Malvern - Malvern
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Recruitment postcode(s) [1]
43094
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3000 - Melbourne
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Recruitment postcode(s) [2]
43095
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3144 - Malvern
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Funding & Sponsors
Funding source category [1]
316651
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Charities/Societies/Foundations
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Name [1]
316651
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Cabrini Foundation
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Address [1]
316651
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Country [1]
316651
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Australia
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Primary sponsor type
University
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Name
Australian Catholic University
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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]
319548
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Address [1]
319548
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Country [1]
319548
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315430
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
315430
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
315430
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Australia
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Date submitted for ethics approval [1]
315430
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03/07/2024
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Approval date [1]
315430
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03/09/2024
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Ethics approval number [1]
315430
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Summary
Brief summary
The purpose of this study is to assess the feasibility and safety of an exercise program concurrent with immune checkpoint inhibitor (ICI) immunotherapy for people diagnosed with melanoma. Who is it for? You may be eligible for this study if you are a patient aged 18 years or over with a diagnosis of cutaneous melanoma and are scheduled to receive adjuvant immune checkpoint inhibitor immunotherapy treatment. Study details Participants will be randomly allocated to either an exercise intervention, or standard medical care. Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) involving both supervised and unsupervised exercise sessions. Participants randomised to the control group will receive usual medical care and general exercise advice as per the current exercise oncology guidelines. Participants will be asked to complete a variety of questionnaires, undergo fitness testing, and provide blood samples. It is hoped that findings from this study will inform researchers of the effects of exercise concurrent to ICI immunotherapy, following surgery, for patients with melanoma.
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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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Dr Dr Eva Zopf
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Address
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Australian Catholic University, Mary MacKillop Institute for Health Research, Level 5, 215 Spring Street, Melbourne, 3000, Victoria
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Country
134674
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Australia
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Phone
134674
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+613 9230 8105
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Fax
134674
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Email
134674
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[email protected]
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Contact person for public queries
Name
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Dr Eva Zopf
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Address
134675
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Australian Catholic University, Mary MacKillop Institute for Health Research, Level 5, 215 Spring Street, Melbourne, 3000, Victoria
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Country
134675
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Australia
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Phone
134675
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+613 9230 8105
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Fax
134675
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Email
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[email protected]
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Contact person for scientific queries
Name
134676
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Dr Eva Zopf
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Address
134676
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Australian Catholic University, Mary MacKillop Institute for Health Research, Level 5, 215 Spring Street, Melbourne, 3000, Victoria
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Country
134676
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Australia
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Phone
134676
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+613 9230 8105
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Fax
134676
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Email
134676
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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
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