Efficacy of Propranolol Treatment to Prevent Melanoma Progression
This study has suspended participant recruitment.
(We must delay the study for some financial reasons)
Information provided by (Responsible Party):
Le Gal, University Hospital, Geneva
First received: November 13, 2013
Last updated: February 2, 2016
Last verified: February 2016
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.
Stages III Skin Melanoma
Stages II Skin Melanoma
Stage IB Skin Melanoma
Drug: Propranolol hydrochloride
Drug: Placebo pill
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
||Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial
Primary Outcome Measures:
- Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence [ Time Frame: five years ] [ Designated as safety issue: Yes ]
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 Outcome Measures:
- Use of serum microRNA profile as a predictor for recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
We investigate the impact of propranolol treatment on the 5 years survival.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2022 (Final data collection date for primary outcome measure)
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
- Hemipralon LP
- Propranolol EG
- PROPRANOLOL Ratiopharm
- Propranolol Teva
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01988831
|Hôpital universitaire de Genève
|Geneva, GE, Switzerland, 1211 |
University Hospital, Geneva
||Frédérique-Anne Le Gal, MD/PhD
||Hôpital cantonal universitaire de Genève
||Le Gal, Associate Physician, PD, MD/PhD, University Hospital, Geneva
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 13, 2013
||February 2, 2016
Keywords provided by University Hospital, Geneva:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 11, 2016
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs