None listed
Conditions
Brief summary
The purpose of this study is to determine whether a drug (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 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 Propranolol can be effective in preventing the spread of invasive melanoma.
Interventions
Consenting patients will be awaiting a sentinel node biopsy.
They will be randomized 1:1 to receive a daily oral dose of either (1) 40mg twice daily of 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 a
Consenting patients will be awaiting a sentinel node biopsy. They will be randomized 1:1 to receive a daily oral dose of either (1) 40mg twice daily of 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.
Sponsors
University of Queensland Diamantina Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed