Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial
Overview
- Phase
- Phase 2
- Intervention
- Placebo pill
- Conditions
- Stages III Skin Melanoma
- Sponsor
- University Hospital, Geneva
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
- Status
- Suspended
- Last Updated
- 6 years ago
Overview
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.
Investigators
Le Gal
Associate Physician, PD, MD/PhD
University Hospital, Geneva
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
Arms & Interventions
Placebo
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.
Intervention: Placebo pill
Betablocker
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.
Intervention: Propranolol hydrochloride
Outcomes
Primary Outcomes
Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
Time Frame: 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 Outcomes
- Use of serum microRNA profile as a predictor for recurrence(5 years)
- Overall survival(5 years)