Clinical trial · Interventional
Efficacy of Propranolol Treatment to Prevent Melanoma Progression
Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We must delay the study for some financial reasons
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IB Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stages III Skin Melanoma | — | UNRESOLVED | — |
| Stages II Skin Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo pill | Drug | — | UNRESOLVED |
| Propranolol hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- 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.
- interventionNames
- Drug: Placebo pill
- type
- EXPERIMENTAL
- label
- Betablocker
- description
- 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.
- interventionNames
- Drug: Propranolol hydrochloride
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDDe 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. PMID 21518948
- BACKGROUNDLemeshow 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. PMID 21933972
- BACKGROUNDDe 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. PMID 24182700