Efficacy of Propranolol Treatment to Prevent Melanoma Progression

NCT ID: NCT01988831

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2022-03-31

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.

Conditions

Stages III Skin Melanoma; Stages II Skin Melanoma; Stage IB Skin Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo pill

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Propranolol hydrochloride

Intervention Type: DRUG

This intervention apply to Propranolol group

Interventions

Propranolol hydrochloride

This intervention apply to Propranolol group

Intervention Type: DRUG

Placebo pill

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

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Le Gal

Associate Physician, PD, MD/PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frédérique-Anne Le Gal, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital cantonal universitaire de Genève

Locations

Hôpital universitaire de Genève

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 21518948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21933972 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24182700 (View on PubMed)

Other Identifiers

HUG-MEL-BB

Identifier Type: -

Identifier Source: org_study_id