Placebo will be taken daily during the study period

Study participants in the treated group will take 80 mgR propranolol once daily .

Melanoma

Propranolol

Placebo

MELABLOCK: A Clinical Trial on the Efficacy and Safety of Propranolol 80 mg in Melanoma Patients

Melablock: A Multicentre Randomized, Double---blinded and Placebo---controlled Clinical Trial on the Efficacy and Safety of Once Daily Propranolol 80 mg Retard for the Prevention of Cutaneous Malignant Melanoma Recurrence

To assess the effect of treatment with propranolol 80 mg retard (R) on overall survival for cutaneous malignant melanoma (CMM) patients in stage II/IIIA (T2, N0 or N1, M0) at five years of follow---up,after at least one year of treatment. Chi-square and Fisher's exact tests will be used to analyze the associations between the categorical variables. Logistic regression adjusting for confounding factors will be also performed. Wilcoxon tests will be used to compare continuous variables. Overall survival and Disease Free Survival curves will be estimated by the Kaplan-Meier method. Log-rank test will be used to compare survival time between groups and Cox proportional hazards models to evaluate the effect of β-blockers treatment and duration of treatment on melanoma recurrence and mortality, considering stratification factors.

To evaluate the effect of treatment on disease free survival (DFS) at five years for CMM patients in stage II/IIIA. Chi-square and Fisher's exact tests will be used to analyze the associations between the categorical variables. Logistic regression adjusting for confounding factors will be also performed. Wilcoxon tests will be used to compare continuous variables. Overall survival and Disease Free Survival curves will be estimated by the Kaplan-Meier method. Log-rank test will be used to compare survival time between groups and Cox proportional hazards models to evaluate the effect of β-blockers treatment and duration of treatment on melanoma recurrence and mortality, considering stratification factors.

To evaluate the effect of treatment on specific mortality for CMM patients in stage II/IIIA. Chi-square and Fisher's exact tests will be used to analyze the associations between the categorical variables. Logistic regression adjusting for confounding factors will be also performed. Wilcoxon tests will be used to compare continuous variables. Overall survival and Disease Free Survival curves will be estimated by the Kaplan-Meier method. Log-rank test will be used to compare survival time between groups and Cox proportional hazards models to evaluate the effect of β-blockers treatment and duration of treatment on melanoma recurrence and mortality, considering stratification factors.

To evaluate the long---term safety of treatment on CMM patients in stage II/IIIA.This study will use the NCI Common Terminology Criteria for Adverse events version 3.0, for toxicity and adverse event reporting. The CTCAE provides descriptive terminology and a grading scale for each adverse event listed. A copy of the CTCAE can be found at http://ctep.cancer.gov. AEs will be assessed according to the CTCAE grade associated with the AE term. AEs that do not have a corresponding CTCAE term will be assessed according to their impact on the participant's ability to perform daily activities

VINCENZO DE GIORGI, MD

Azienda Sanitaria di Firenze

Cancer

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tremor/breast neoplasms

MELABLOCK: A Clinical Trial on the Efficacy and Safety of Propranolol 80 mg in Melanoma Patients

Molecular Signature of Valproic Acid in Breast Cancer With Functional Imaging Assessment - a Pilot

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