Trial of propranolol to assess the spread of melanoma

Phase 1

Recruiting

• Conditions: Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12620000156987
• Lead Sponsor: niversity of Queensland Diamantina Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-13
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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.

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 or (5) asthmatic.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is a composite primary outcome. <br>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. <br>Outcome will be assessed on the sentinel node by gene expresion analysis (RT-PCR) and by immunofluorescence.<br>[3 weeks post commencement of trial drug/placebo]

Secondary Outcome Measures

Name	Time	Method
This is a composite secondary outcome:<br>The number and proportion of staining of VCAM and IL33 in CD31+ endothelial cells in immunostaining and microscopy of lymph node sections.<br>This will be assessed by laboratory analysis.[3 weeks post commencement of trial drug/placebo];This is a composite secondary outcome:<br>Surface of CD31+ blood vessels in immunostaining and microscopy of lymph node sections.<br>This will be assessed by laboratory analysis.[3 weeks post commencement of trial drug/placebo];This is a composite secondary outcome:<br>Surface of lymphatic vessels in immunostaining and microscopy of lymph node sections.<br>This will be assessed by laboratory analysis.[3 weeks post commencement of trial drug/placebo]