Efficacy of Propranolol Treatment to Prevent Melanoma Progression
|ClinicalTrials.gov Identifier: NCT01988831|
Recruitment Status : Suspended (We must delay the study for some financial reasons)
First Posted : November 20, 2013
Last Update Posted : May 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stages III Skin Melanoma Stages II Skin Melanoma Stage IB Skin Melanoma||Drug: Propranolol hydrochloride Drug: Placebo pill||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||March 2022|
Placebo Comparator: 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.
Drug: Placebo pill
We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.
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
- 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.
- Use of serum microRNA profile as a predictor for recurrence [ Time Frame: 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 [ Time Frame: 5 years ]We investigate the impact of propranolol treatment on the 5 years survival.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988831
|Hôpital universitaire de Genève|
|Geneva, GE, Switzerland, 1211|
|Principal Investigator:||Frédérique-Anne Le Gal, MD/PhD||Hôpital cantonal universitaire de Genève|