Clinical trial NCT01988831: Efficacy of Propranolol Treatment to Prevent Melanoma Progression
Official title: Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Stages III Skin Melanoma
Stages II Skin Melanoma
Stage IB Skin Melanoma
Keywords: Malignant melanoma
betablocker
propranolol
interventional
prospective
adjuvant
recurrence
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
timeFrame: five years
Secondary outcomes:
measure: Use of serum microRNA profile as a predictor for recurrence
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpital universitaire de Genève
state: GE
Study officials:
affiliation: Hôpital cantonal universitaire de Genève
name: Frédérique-Anne Le Gal, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Giorgi V, Grazzini M, Gandini S, Benemei S, Lotti T, Marchionni N, Geppetti P. Treatment with beta-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.
citation: Lemeshow S, Sorensen HT, Phillips G, Yang EV, Antonsen S, Riis AH, Lesinski GB, Jackson R, Glaser R. beta-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.
citation: De Giorgi V, Gandini S, Grazzini M, Benemei S, Marchionni N, Geppetti P. Effect of beta-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.