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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
Scientific title
The safety and feasibility of exercise in patients with melanoma undergoing adjuvant immunotherapy with immune checkpoint inhibitor therapy – the EXHIBIT Study
Secondary ID [1] 312266 0
None.
Universal Trial Number (UTN)
Trial acronym
EXHIBIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous melanoma 334203 0
Condition category
Condition code
Cancer 330866 330866 0 0
Malignant melanoma
Physical Medicine / Rehabilitation 331552 331552 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328899 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 339216 0
Feasibility of patient recruitment.
Timepoint [1] 339216 0
Upon conclusion of the study.
Primary outcome [2] 339219 0
Feasibility of the attendance to exercise sessions.
Timepoint [2] 339219 0
At 12 weeks (primary endpoint), 24 weeks and 12 months after intervention commencement.
Primary outcome [3] 339220 0
Safety of the exercise intervention
Timepoint [3] 339220 0
At 12 weeks (primary endpoint), 24 weeks, and 12 months after intervention commencement.
Secondary outcome [1] 439101 0
Symptoms/Side Effects (Patient-Reported)
Timepoint [1] 439101 0
Weekly for the first 12 weeks after intervention commencement and every 4 weeks thereafter.
Secondary outcome [2] 439102 0
Cancer-Related Fatigue (Patient-Reported)
Timepoint [2] 439102 0
At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
Secondary outcome [3] 439104 0
Quality of Life (Patient-Reported)
Timepoint [3] 439104 0
At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
Secondary outcome [4] 439105 0
Anxiety (Patient-Reported)
Timepoint [4] 439105 0
At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
Secondary outcome [5] 439107 0
Work Role Functioning ( (Patient-Reported)
Timepoint [5] 439107 0
At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
Secondary outcome [6] 439108 0
Body Composition
Timepoint [6] 439108 0
At baseline, 12 weeks and 24 weeks after intervention commencement.
Secondary outcome [7] 439109 0
Upper Limb Muscular Strength
Timepoint [7] 439109 0
At baseline, 12 weeks and 24 weeks after intervention commencement.
Secondary outcome [8] 439110 0
Lower Limb Muscular Strength
Timepoint [8] 439110 0
At baseline, 12 weeks and 24 weeks after intervention commencement.
Secondary outcome [9] 439111 0
Grip Strength
Timepoint [9] 439111 0
At baseline, 12 weeks and 24 weeks after intervention commencement.
Secondary outcome [10] 439112 0
Exercise Capacity
Timepoint [10] 439112 0
At baseline, 12 weeks and 24 weeks after intervention commencement.
Secondary outcome [11] 439113 0
Physical Function
Timepoint [11] 439113 0
At baseline, 12 weeks and 24 weeks after intervention commencement.
Secondary outcome [12] 439114 0
Immunotherapy Adherence/Completion Rates
Timepoint [12] 439114 0
At 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [13] 439116 0
Hospital Admissions
Timepoint [13] 439116 0
At 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [14] 439117 0
Disease Progression
Timepoint [14] 439117 0
At 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [15] 439118 0
Any grade immune-related adverse events
Timepoint [15] 439118 0
At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [16] 439122 0
Sleep (Patient-Reported)
Timepoint [16] 439122 0
At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [17] 439123 0
Sleep (Objectively Assessed)
Timepoint [17] 439123 0
At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [18] 439127 0
Physical Activity (Patient-Reported)
Timepoint [18] 439127 0
At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [19] 439128 0
Physical Activity (Objectively Assessed)
Timepoint [19] 439128 0
At baseline, 12 weeks, 24 weeks and 12 months.
Secondary outcome [20] 439129 0
Blood Biomarkers (Routine)
Timepoint [20] 439129 0
At baseline, 12 weeks, 24 weeks and 12 months after intervention commencement.
Secondary outcome [21] 439130 0
Blood Biomarkers (Study Specific)
Timepoint [21] 439130 0
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.
Secondary outcome [22] 439379 0
Feasibility of patient retention - this is an additional primary outcome
Timepoint [22] 439379 0
At 12-weeks (primary endpoint), 24-weeks and 12 months after intervention commencement.
Secondary outcome [23] 439380 0
Depression (Patient-Reported)
Timepoint [23] 439380 0
At baseline, 12 weeks, 24 weeks, and 12 months after intervention commencement.
Secondary outcome [24] 439606 0
Feasibility of adherence to the exercise program- this is an additional primary outcome.
Timepoint [24] 439606 0
At 12-weeks (primary), 24-weeks and 12-months after intervention commencement.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central computerised randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked computer-generated sequence in a 1:1 ratio
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
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
19/09/2024
Actual
Date of last participant enrolment
Anticipated
2/06/2026
Actual
Date of last data collection
Anticipated
2/09/2028
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27023 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 27024 0
The Alfred - Melbourne
Recruitment hospital [3] 27025 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 43094 0
3000 - Melbourne
Recruitment postcode(s) [2] 43095 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 316651 0
Charities/Societies/Foundations
Name [1] 316651 0
Cabrini Foundation
Country [1] 316651 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 319548 0
None
Name [1] 319548 0
Address [1] 319548 0
Country [1] 319548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315430 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315430 0
Ethics committee country [1] 315430 0
Australia
Date submitted for ethics approval [1] 315430 0
03/07/2024
Approval date [1] 315430 0
03/09/2024
Ethics approval number [1] 315430 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134674 0
Dr Dr Eva Zopf
Address 134674 0
Australian Catholic University, Mary MacKillop Institute for Health Research, Level 5, 215 Spring Street, Melbourne, 3000, Victoria
Country 134674 0
Australia
Phone 134674 0
+613 9230 8105
Fax 134674 0
Email 134674 0
[email protected]
Contact person for public queries
Name 134675 0
Dr Eva Zopf
Address 134675 0
Australian Catholic University, Mary MacKillop Institute for Health Research, Level 5, 215 Spring Street, Melbourne, 3000, Victoria
Country 134675 0
Australia
Phone 134675 0
+613 9230 8105
Fax 134675 0
Email 134675 0
[email protected]
Contact person for scientific queries
Name 134676 0
Dr Eva Zopf
Address 134676 0
Australian Catholic University, Mary MacKillop Institute for Health Research, Level 5, 215 Spring Street, Melbourne, 3000, Victoria
Country 134676 0
Australia
Phone 134676 0
+613 9230 8105
Fax 134676 0
Email 134676 0
[email protected]

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.