Stages III Skin Melanoma | Efficacy of Propranolol Treatment to Prevent Melanoma Progression
Stages III Skin Melanoma research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Stages III Skin Melanoma
Stages II Skin Melanoma
Stage IB Skin Melanoma
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Propranolol hydrochlorideThis intervention apply to Propranolol group
Drug:Placebo pillWe use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo113 patients will be enrolled in the placebo group with respect to randomization. Placebo group will be prescribed placebo pills in the same packaging as propranolol treated group. The frequency and duration of the treatment is the same as propranolol arm. The placebo group will have the same cardiology consultation as propranolol treated group to ensure the respect of blindness.
Betablockerdrug: 'Propranolol hydrochloride' 338 patients will be enrolled in the "Propranolol" Group and treated with propranolol. The dosage will be determined by the cardiologist as the maximum tolerated dose to a maximum of 160mg/day. One long acting pill a day until an evidence of disease progression or the end of the study.
Start Date: June 2016
Completed Date: March 2022
Phase: Phase 2
Primary Outcome: Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
Secondary Outcome: Use of serum microRNA profile as a predictor for recurrence
Study sponsors, principal investigator, and references
Principal Investigator: Frédérique-Anne Le Gal, MD/PhD
Lead Sponsor: University Hospital, Geneva
De Giorgi V, Grazzini M, Gandini S, Benemei S, Lotti T, Marchionni N, Geppetti P. Treatment with β-blockers and reduced disease progression in patients with thick melanoma. Arch Intern Med. 2011 Apr 25;171(8):779-81. doi: 10.1001/archinternmed.2011.131.