Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Phase 2SuspendedNCT01988831

University Hospital, Geneva450 enrolled

Overview

Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

450

Conditions

Stages III Skin Melanoma Stages II Skin Melanoma Stage IB Skin Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient over 18 y.o * Breslow index \> 1mm or any Breslow index with ulcerated primary lesion * Melanoma stage AJCC Ib, IIa, IIb, IIc, IIIa, IIIb or IIIc * Able to undergo outpatient treatment Exclusion Criteria: * No contra indication for betablockers as defined by the compendium * No clinical evidence of coagulopathy * No unstable angina pectoris * No AV-block II or III without pacemaker * No severe congestive heart failure * No untreated phaeochromocytoma * No severe bradycardia * No severe hypotension * No severe impairment of peripheral arterial circulation * No uncontrolled cardiac arrhythmia * No severe asthma or COPD * No uncontrolled diabetes mellitus * No Angioneurotic edema * No severe Aortic valve stenosis * No severe hypertrophic cardiomyopathy * No severe renal dysfunction * No patients on beta blockers by inclusion * No known adverse reaction to betablockers * No pregnant or lactating patients can be included * No melanoma stage AJCC IV by inclusion * No patients requiring a specific oncological treatment

Outcomes

Primary Outcomes

Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence

The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease. We will measure the efficacy of a propranolol treatment on the risk of progression of the disease.

Time frame: five years

Secondary Outcomes

Use of serum microRNA profile as a predictor for recurrence

We will investigate the microRNA profile in the serum of patients of both groups during the whole study to identify biomarkers specific for recurrence.

Time frame: 5 years

Overall survival

We investigate the impact of propranolol treatment on the 5 years survival.