A Phase 2 interventional study of Propranolol hydrochloride and Placebo pill in Stages III Skin Melanoma, Stages II Skin Melanoma and Stage IB Skin Melanoma, sponsored by University Hospital, Geneva. Suspended at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-10.
Sponsored by University Hospital, Geneva · Phase 2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 450 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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.
Drug: Placebo pill
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.
Drug: Propranolol hydrochloride
This intervention apply to Propranolol group
Also known as: Inderal, Avlocardyl, Hemipralon LP, Propranolol EG, PROPRANOLOL Ratiopharm, Propranolol Teva
We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.
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.
Time frame: five years
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.
Time frame: 5 years
Overall survival
We investigate the impact of propranolol treatment on the 5 years survival.
Time frame: 5 years
This study is suspended, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva