Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-23
First Post:
2023-01-25
Brief Title:
Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines
Sponsor:
Giulio Stefanini
Organization:
Humanitas Hospital Italy
Study Overview
Official Title:
Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines CONTROL Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTROL
Brief Summary:
As the cancer-related prognosis improves thanks to recent advances in cancer-targeted therapies the prognostic burden of chemotherapy-related complications - including cardiotoxicity - is increasingly recognised So far the evidence supporting pharmacological preventive strategies in cardio-oncology has been inconsistent and conflicting and there is a clear need for well-designed trials with novel interventions In this study by using cardiac magnetic resonance the investigators want to assess if a commonly used beta-blocker with a unique pharmacological profile ie nebivolol can prevent cardiac dysfunction in patients with breast cancer or diffuse large B-cell lymphoma undergoing chemotherapy with anthracyclines
Detailed Description:
During the last decades major efforts have been made in the field of cancer therapy to improve prognosis and quality of life of patients treated with any sort of chemotherapy Cardiotoxicity represents one of the most relevant adverse effects of chemotherapy primarily in patients treated with anthracyclines The potential protective role of cardiovascular medications in the prevention of cardiotoxicity associated with anthracyclines chemotherapy is still a matter of debate since evidence in this field are scarce and largely inconclusive Indeed prior studies were often limited by a non-blinded design or an echocardiography-based assessment of left ventricular ejection fraction with a relevant inter and intra-operator variability The primary objective of the trial is to evaluate the cardioprotective effects of the betablocker nebivolol in an individually randomized parallel placebo-controlled double-blinded patient treating physician investigator outcomes assessor statistician superiority trial in patients with a solid tumor ie breast cancer or a hematologic malignancy ie diffuse large B cell lymphoma who have a normal cardiac function as assessed by echocardiography and will receive anthracyclines as part of their first-line chemotherapy program Indeed recent evidence suggests that anthracycline cardiotoxicity seems mainly due to an anthracycline-induced dysregulation of mitochondrial activity and metabolism in cardiomyocytes Nebivolol has a distinctive profile among beta-blockers with the unique power of increasing the nitric oxide bioavailability Nebivolol-induced nitric oxide release has shown favourable effects in terms of antioxidant activity cardiac neo-angiogenesis mitochondrial and endothelial protection On this basis the individually randomized parallel placebo-controlled double-blinded patient treating physician investigator outcomes assessor statistician superiority CONTROL trial will assess the cardioprotective effects of a commonly used betablocker nebivolol in patients with baseline normal left ventricular systolic function receiving anthracycline chemotherapy as first-line chemotherapy for breast cancer or diffuse large B-cell lymphoma The assessment of left ventricular ejection fraction and related endpoints will be performed with cardiac magnetic resonance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None