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Efficacy of Propranolol Treatment to Prevent Melanoma Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01988831
Recruitment Status : Suspended (We must delay the study for some financial reasons)
First Posted : November 20, 2013
Last Update Posted : May 10, 2019
Information provided by (Responsible Party):
Le Gal, University Hospital, Geneva

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Experimental: 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.

Drug: Propranolol hydrochloride
This intervention apply to Propranolol group
Other Names:
  • Inderal
  • Avlocardyl
  • Hemipralon LP
  • Propranolol EG
  • PROPRANOLOL Ratiopharm
  • Propranolol Teva

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Overall survival [ Time Frame: 5 years ]
    We investigate the impact of propranolol treatment on the 5 years survival.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01988831

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Hôpital universitaire de Genève
Geneva, GE, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
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Principal Investigator: Frédérique-Anne Le Gal, MD/PhD Hôpital cantonal universitaire de Genève
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Responsible Party: Le Gal, Associate Physician, PD, MD/PhD, University Hospital, Geneva Identifier: NCT01988831    
Other Study ID Numbers: HUG-MEL-BB
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Keywords provided by Le Gal, University Hospital, Geneva:
Malignant melanoma
Additional relevant MeSH terms:
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Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents