Trial record 8 of 481 for:    Open Studies | "Melanoma"

Efficacy of Propranolol Treatment to Prevent Melanoma Progression

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Le Gal, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01988831
First received: November 13, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Stages III Skin Melanoma
Stages II Skin Melanoma
Stage IB Skin Melanoma
Drug: Propranolol hydrochloride
Drug: Placebo pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

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: 450
Study Start Date: March 2014
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988831

Locations
Switzerland
Hôpital universitaire de Genève Not yet recruiting
Geneva, GE, Switzerland, 1211
Contact: Frédérique-Anne Le Gal, MD/PhD    22.372.96.90 ext +41    frederique-anne.legal@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Frédérique-Anne Le Gal, MD/PhD Hôpital cantonal universitaire de Genève
  More Information

Publications:
Responsible Party: Le Gal, Associate Physician, PD, MD/PhD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01988831     History of Changes
Other Study ID Numbers: HUG-MEL-BB
Study First Received: November 13, 2013
Last Updated: November 19, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Malignant melanoma
betablocker
propranolol
interventional
prospective
adjuvant
recurrence

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adrenergic beta-Antagonists
Propranolol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 31, 2014