MELABLOCK: A Clinical Trial on the Efficacy and Safety of Propranolol 80 mg in Melanoma Patients
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
The effectiveness of propranolol in infantile hemangiomas, the apparent better response to
propranolol in breast cancer and the use of propranolol in a proportion of patients who did
not develop melanoma recurrence suggested to use this unselective β---blocker to test the
study hypothesis. The investigators propose a randomized double---blind placebo---controlled
clinical trial (RTC) to evaluate whether the treatment with propranolol 80 mgR/die reduce the
risk of CMM recurrence and mortality. Patients with resected stage II/IIIA CMM will be
recruited in various Centers in Italy. Participants will be randomly assigned to propranolol
treatment or placebo (1:1 ratio), treated for at least 1 year and followed for 2 years.
Recruitment will proceed simultaneously at the different Centers, and will be completed in 2
years. The primary outcome of the entire trial will be, however, estimated by assessing a
reduction in overall mortality at five years. The investigators will also evaluate general
CMM recurrence and CMM specific mortality.