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Trial registered on ANZCTR


Registration number
ACTRN12620000156987
Ethics application status
Approved
Date submitted
24/12/2019
Date registered
13/02/2020
Date last updated
13/02/2020
Date data sharing statement initially provided
13/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of R-Propranolol to assess the spread of melanoma.
Scientific title
The effect of R (+)-enantiomer propranolol on the metastatic niche in melanoma: A randomized controlled trial.
Secondary ID [1] 300153 0
Nil known
Universal Trial Number (UTN)
U1111-1247-8062
Trial acronym
The MELPROP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 315690 0
Condition category
Condition code
Cancer 313975 313975 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consenting patients will be awaiting a sentinel node biopsy.
They will be randomized 1:1 to receive a daily oral dose of either (1) 80mg of R-Propranolol (the R (+)-enantiomer of the drug Propranolol) or (2) a placebo.
The duration of administration will be from the day of consent until the day of the sentinel node biopsy. This time period is expected to be 2-3 weeks.
The drug and the placebo will be in capsule form. The dose will be 40mg twice a day.
Participants will be asked to return their capsule bottles in order to monitor adherence.
Intervention code [1] 316424 0
Treatment: Other
Intervention code [2] 316846 0
Treatment: Drugs
Comparator / control treatment
Half of the consented patients will be given a daily oral placebo capsule (Microcrystalline Cellulose).
Control group
Placebo

Outcomes
Primary outcome [1] 322387 0
This is a composite primary outcome.
The outcome measure will be signs of activation of genes induced by Sox18/RBPJ activity: IL33 and VCAM reflecting Sox18 re-expression and RBPJ activity.
Outcome will be assessed on the sentinel node by gene expresion analysis (RT-PCR) and by immunofluorescence.
Timepoint [1] 322387 0
3 weeks post commencement of trial drug/placebo
Secondary outcome [1] 379629 0
This is a composite secondary outcome:
The number and proportion of staining of VCAM and IL33 in CD31+ endothelial cells in immunostaining and microscopy of lymph node sections.
This will be assessed by laboratory analysis.
Timepoint [1] 379629 0
3 weeks post commencement of trial drug/placebo
Secondary outcome [2] 379639 0
This is a composite secondary outcome:
Surface of CD31+ blood vessels in immunostaining and microscopy of lymph node sections.
This will be assessed by laboratory analysis.
Timepoint [2] 379639 0
3 weeks post commencement of trial drug/placebo
Secondary outcome [3] 379640 0
This is a composite secondary outcome:
Surface of lymphatic vessels in immunostaining and microscopy of lymph node sections.
This will be assessed by laboratory analysis.
Timepoint [3] 379640 0
3 weeks post commencement of trial drug/placebo

Eligibility
Key inclusion criteria
Patients newly diagnosed with a primary cutaneous melanoma that is ulcerated and/or thicker than 1mm (stage T1b – T4b, N0, M0 melanoma (2018 AJCC classification) and who elect to undergo a sentinel node biopsy procedure.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they (1) have clinical or imaging signs of regional or distant disease at diagnosis or (2) are currently prescribed any beta-blockers such as Propranolol or (3) have a contra-indication to beta-blockers or (4) are pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Given our pre-clinical findings, we expect a 50% decrease in expression of Sox18 target genes. Groups of 12 patients (3 per stratum, 2 males 1 female) ensure 80% power to detect a significant difference at p=0.05 level.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15553 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28924 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304591 0
Government body
Name [1] 304591 0
NHMRC
Address [1] 304591 0
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 304591 0
Australia
Primary sponsor type
University
Name
University of Queensland Diamantina Institute
Address
Level 6
Translational Research Institute (TRI)
37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 304882 0
None
Name [1] 304882 0
Address [1] 304882 0
Country [1] 304882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305014 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 305014 0
Centres for Health Research
Level 7
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 305014 0
Australia
Date submitted for ethics approval [1] 305014 0
13/02/2019
Approval date [1] 305014 0
30/04/2019
Ethics approval number [1] 305014 0
HREC/2019/QMS/51317

Summary
Brief summary
The purpose of this study is to determine whether a drug (R-Propranolol) is both safe and effective in preventing the spread of melanoma.

Who is it for?

You may be eligible for this study if you are an adult newly diagnosed with an invasive melanoma (Stage T1b-T4b, N0, M0) and are awaiting a sentinel node biopsy.

Study Details

All participants will take either a R-Propranolol capsule or a placebo capsule twice a day for 2-3 weeks before the sentinel node biopsy. Participants will not know the difference between the capsules. There are no other commitments for the participants. The biopsy will be checked for cancer, as usual, and a small amount will be used by the researchers for further analysis.

It is hoped that the research will help determine whether R-Propranolol can be effective in preventing the spread of invasive melanoma.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98970 0
Prof Kiarash Khosrotehrani
Address 98970 0
University of Queensland Diamantina Institute
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country 98970 0
Australia
Phone 98970 0
+61734437088
Fax 98970 0
+61734436966
Email 98970 0
k.khosrotehrani@uq.edu.au
Contact person for public queries
Name 98971 0
Prof Kiarash Khosrotehrani
Address 98971 0
University of Queensland Diamantina Institute
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country 98971 0
Australia
Phone 98971 0
+61734437088
Fax 98971 0
+61734436966
Email 98971 0
k.khosrotehrani@uq.edu.au
Contact person for scientific queries
Name 98972 0
Prof Kiarash Khosrotehrani
Address 98972 0
University of Queensland Diamantina Institute
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country 98972 0
Australia
Phone 98972 0
+61734437088
Fax 98972 0
+61734436966
Email 98972 0
k.khosrotehrani@uq.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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6266 0
Study protocol
Citation [1] 6266 0
Link [1] 6266 0
Email [1] 6266 0
Other [1] 6266 0
Type [2] 6267 0
Informed consent form
Citation [2] 6267 0
Link [2] 6267 0
Email [2] 6267 0
Other [2] 6267 0
Type [3] 6268 0
Ethical approval
Citation [3] 6268 0
Link [3] 6268 0
Email [3] 6268 0
Other [3] 6268 0
Summary results
No Results