MELABLOCK: A Clinical Trial on the Efficacy and Safety of Propranolol 80 mg in Melanoma Patients

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The effectiveness of propranolol in infantile hemangiomas, the apparent better response to propranolol in breast cancer and the use of propranolol in a proportion of patients who did not develop melanoma recurrence suggested to use this unselective β---blocker to test the study hypothesis. The investigators propose a randomized double---blind placebo---controlled clinical trial (RTC) to evaluate whether the treatment with propranolol 80 mgR/die reduce the risk of CMM recurrence and mortality. Patients with resected stage II/IIIA CMM will be recruited in various Centers in Italy. Participants will be randomly assigned to propranolol treatment or placebo (1:1 ratio), treated for at least 1 year and followed for 2 years. Recruitment will proceed simultaneously at the different Centers, and will be completed in 2 years. The primary outcome of the entire trial will be, however, estimated by assessing a reduction in overall mortality at five years. The investigators will also evaluate general CMM recurrence and CMM specific mortality.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Sanitaria di Firenze
• Treatments: Propranolol

Criteria

Inclusion Criteria:

1. Stage: Ib (T1b, T2a), IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0; IIIA (N1a, N1b)

2. Signed Informed Consent;

3. Performance Status of 0---1 (ECOG);

4. Hematopoietic functionality at the entry of the study: leukocytes, platelets, hemoglobin and neutrophils within the normal limits of laboratory references;

5. Hepatic and renal functionality at the entry of the study: LDH, bilirubin, AST, ALT, alkalinephosphatase, BUN and serum creatinine within the normal range of each laboratory;

Exclusion Criteria:

1. Primary not cutaneous melanoma;

2. Clinical/radiological evidence or laboratory/pathology report of not completely resectedmelanoma;

3. History of cancer

4. Current use or past use in the last two years of any b---blockers for any other medical condition

5. Current use of verapamil, diltiazem or similar calcium channel blocker

6. Current use of centrally acting antihypertensive drugs as α---methyldopa, clonidine

7. Hypersensitivity to propranolol or to any of the excipients;

8. Acute heart failure or during episodes of heart failure decompensation requiring i.v.

inotropic therapy;

9. Cardiogenic shock;

10. Sinoatrial block ;

11. Second or third degree atrio---ventricular block;

12. Marked bradycardia (less than 60 beats/min) ;

13. Extreme hypotension (systolic blood pressure <100mmHg) ;

14. Severe asthma or severe chronic obstructive pulmonary disease ;

15. Sick sinus syndrome;

16. Severe forms of peripheral arterial occlusive disease and Raynaud's syndrome;

17. Metabolic acidosis

18. Asthma

19. Diabetes

20. Heart failure

21. History of psoriasis

22. Pregnancy or breast feeding or planning on becoming pregnant during the 3 years of treatment (for major details see the Section "Pregnancy in the Study", below);

23. Any medical condition that in the physician's opinion would potentially interfere with the patient ability to adhere to protocol and treatment;

24. Any logistic condition that do not allow follow---up of the disease of the patient.

25. Hypersensitivity to propranolol, child bearing or breastfeeding.

26. Pheocromocytoma 27. Prinzmetal's Angina 28. Fasting -