Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Condition(s) targeted: Stages III Skin Melanoma; Stages II Skin Melanoma; Stage IB Skin Melanoma

Intervention: Propranolol hydrochloride (Drug); Placebo pill (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: University Hospital, Geneva

Official(s) and/or principal investigator(s):
Frédérique-Anne Le Gal, MD/PhD, Principal Investigator, Affiliation: Hôpital cantonal universitaire de Genève

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.

Official title: Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

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

Overall survival

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Hôpital universitaire de Genève, Geneva, GE 1211, Switzerland; Not yet recruiting
Frédérique-Anne Le Gal, MD/PhD, Phone: 22.372.96.90, Ext: +41, Email: frederique-anne.legal@hcuge.ch

Related publications:

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.

Lemeshow S, Sørensen HT, Phillips G, Yang EV, Antonsen S, Riis AH, Lesinski GB, Jackson R, Glaser R. β-Blockers and survival among Danish patients with malignant melanoma: a population-based cohort study. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2273-9. doi: 10.1158/1055-9965.EPI-11-0249. Epub 2011 Sep 20.

De Giorgi V, Gandini S, Grazzini M, Benemei S, Marchionni N, Geppetti P. Effect of β-blockers and other antihypertensive drugs on the risk of melanoma recurrence and death. Mayo Clin Proc. 2013 Nov;88(11):1196-203. doi: 10.1016/j.mayocp.2013.09.001.

Starting date: June 2015
Last updated: December 4, 2014