Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Stage IB Skin Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01988831
• Other study ID #: HUG-MEL-BB
• Status: Suspended
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: March 2022

Study information

• Verified date: May 2019
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 450
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Skin Neoplasms
• Stage IB Skin Melanoma
• Stages II Skin Melanoma
• Stages III Skin Melanoma

Intervention

Drug:
• Propranolol hydrochloride
This intervention apply to Propranolol group
• Placebo pill
We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.

Locations

Country	Name	City	State
Switzerland	Hôpital universitaire de Genève	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

De Giorgi V, Gandini S, Grazzini M, Benemei S, Marchionni N, Geppetti P. Effect of ß-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. — View Citation

De Giorgi V, Grazzini M, Gandini S, Benemei S, Lotti T, Marchionni N, Geppetti P. Treatment with ß-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. — View Citation

Lemeshow S, Sørensen HT, Phillips G, Yang EV, Antonsen S, Riis AH, Lesinski GB, Jackson R, Glaser R. ß-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence	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.	five years
Secondary	Use of serum microRNA profile as a predictor for recurrence	We will investigate the microRNA profile in the serum of patients of both groups during the whole study to identify biomarkers specific for recurrence.	5 years
Secondary	Overall survival	We investigate the impact of propranolol treatment on the 5 years survival.	5 years