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Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Primary Purpose

Stages III Skin Melanoma, Stages II Skin Melanoma, Stage IB Skin Melanoma

Status

Suspended

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Propranolol hydrochloride

Placebo pill

About this trial

This is an interventional treatment trial for Stages III Skin Melanoma focused on measuring Malignant melanoma, betablocker, propranolol, interventional, prospective, adjuvant, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital universitaire de Genève

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Betablocker

Arm Description

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: '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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Overall survival

We investigate the impact of propranolol treatment on the 5 years survival.

Full Information

NCT ID

NCT01988831

First Posted

November 13, 2013

Last Updated

May 9, 2019

Sponsor

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT01988831

Brief Title

Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Official Title

Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Suspended

Why Stopped

We must delay the study for some financial reasons

Study Start Date

June 2016 (undefined)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Geneva

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stages III Skin Melanoma, Stages II Skin Melanoma, Stage IB Skin Melanoma

Keywords

Malignant melanoma, betablocker, propranolol, interventional, prospective, adjuvant, recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Betablocker

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Propranolol hydrochloride

Other Intervention Name(s)

Inderal, Avlocardyl, Hemipralon LP, Propranolol EG, PROPRANOLOL Ratiopharm, Propranolol Teva

Intervention Description

This intervention apply to Propranolol group

Intervention Type

Drug

Intervention Name(s)

Placebo pill

Intervention Description

We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.

Primary Outcome Measure Information:

Title

Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence

Description

Time Frame

five years

Secondary Outcome Measure Information:

Title

Use of serum microRNA profile as a predictor for recurrence

Description

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

Title

Overall survival

Description

We investigate the impact of propranolol treatment on the 5 years survival.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédérique-Anne Le Gal, MD/PhD

Organizational Affiliation

Hôpital cantonal universitaire de Genève

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital universitaire de Genève

City

Geneva

State/Province

ZIP/Postal Code

1211

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

21518948

Citation

De Giorgi V, Grazzini M, Gandini S, Benemei S, Lotti T, Marchionni N, Geppetti P. Treatment with beta-blockers and reduced disease progression in patients with thick melanoma. Arch Intern Med. 2011 Apr 25;171(8):779-81. doi: 10.1001/archinternmed.2011.131.

Results Reference

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PubMed Identifier

21933972

Citation

Lemeshow S, Sorensen HT, Phillips G, Yang EV, Antonsen S, Riis AH, Lesinski GB, Jackson R, Glaser R. beta-Blockers and survival among Danish patients with malignant melanoma: a population-based cohort study. Cancer Epidemiol Biomarkers Prev. 2011 Oct;20(10):2273-9. doi: 10.1158/1055-9965.EPI-11-0249. Epub 2011 Sep 20.

Results Reference

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PubMed Identifier

24182700

Citation

De Giorgi V, Gandini S, Grazzini M, Benemei S, Marchionni N, Geppetti P. Effect of beta-blockers and other antihypertensive drugs on the risk of melanoma recurrence and death. Mayo Clin Proc. 2013 Nov;88(11):1196-203. doi: 10.1016/j.mayocp.2013.09.001.

Results Reference

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Efficacy of Propranolol Treatment to Prevent Melanoma Progression

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