Efficacy of Propranolol Treatment to Prevent Melanoma Progression

University Hospitals (UH)

Status and phase: Suspended; Phase 2

Conditions: Stage IB Skin Melanoma; Stages III Skin Melanoma; Stages II Skin Melanoma

Treatments: Drug: Placebo pill; Drug: Propranolol hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01988831

HUG-MEL-BB

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo pill

Betablocker

Experimental group

Description:

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.

Treatment:

Drug: Propranolol hydrochloride