A multicentre randomized, double-blinded and placebo-controlled clinical trial on the efficacy and safety of once daily propranolol 80 mg retard for the prevention of cutaneous malignant melanoma recurrence - MELABLOCK

AZIENDA SANITARIA DI FIRENZE0 个研究点目标入组 23 人开始时间: 2021年9月9日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•1.18-75 years old with newly diagnosed histologically proven resected melanoma;
•2.Stage: Ib (T1b, T2a), IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0; IIIA (N1a, N1b)
•3.Signed Informed Consent;
•4.Performance Status of 0-1 (ECOG);
•5.Hematopoietic functionality at the entry of the study: leukocytes, platelets, hemoglobin and neutrophils within the normal limits of laboratory references;
•6.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;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•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 a-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;
•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 breast feeding.

发起方

AZIENDA SANITARIA DI FIRENZE