Stage IB Skin Melanoma, Stages III Skin Melanoma, Stages II Skin Melanoma
Conditions
Keywords
Malignant melanoma, betablocker, propranolol, interventional, prospective, adjuvant, recurrence
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.
Interventions
DRUGPropranolol hydrochloride
This intervention apply to Propranolol group
DRUGPlacebo pill
We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Outcome results
None listed