clinical trial to assess efficacy and safety of once daily 80 mg propranolol therapy to overall survival for cutaneous melanoma

Phase 1

• Conditions: melanoma; MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-003970-18-IT
• Lead Sponsor: AZIENDA SANITARIA DI FIRENZE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified