Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Phase 2

Suspended

• Conditions: Stages III Skin Melanoma; Stages II Skin Melanoma; Stage IB Skin Melanoma
• Interventions: Drug: Propranolol hydrochloride; Drug: Placebo pill

• Registration Number: NCT01988831
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Study Start: 2016-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10
• Primary Completion: 2022-01
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Betablocker	Propranolol hydrochloride	drug: '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.
Placebo	Placebo pill	113 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.

Primary Outcome Measures

Name	Time	Method
Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence	five years	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.

Secondary Outcome Measures

Name	Time	Method
Use of serum microRNA profile as a predictor for recurrence	5 years	We will investigate the microRNA profile in the serum of patients of both groups during the whole study to identify biomarkers specific for recurrence.
Overall survival	5 years	We investigate the impact of propranolol treatment on the 5 years survival.

Trial Locations

Locations (1)

Hôpital universitaire de Genève; 🇨🇭 Geneva, GE, Switzerland