Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Phase 2

Recruiting

• Conditions: Doxorubicin Induced Cardiomyopathy
• Interventions: Drug: Atorvastatin 40 Mg Oral Tablet; Other: Placebo

• Registration Number: NCT05792293
• Lead Sponsor: Ain Shams University

Brief Summary

This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity

Detailed Description

The study participants are female patients with breast cancer receiving Anthracycline based chemotherapy.

They will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo.

Full echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-03-19
• Study First Posted: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines

Exclusion Criteria

• Patients with impaired LV systolic function (EF below 50%)
• Patients with severe valvular heart disease
• Patients previously diagnosed with coronary artery disease
• Patients with baseline elevated liver enzymes
• Patients with prior chemotherapy or radiation therapy
• Pregnant females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Atorvastatin 40 Mg Oral Tablet	Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
Control Group	Placebo	Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Primary Outcome Measures

Name	Time	Method
Incidence of cancer therapy related cardiac dysfunction among the two groups	Six months	cancer therapy related cardiac dysfunction defined as drop in ejection fraction more than 10% and to a value below 53% assessed by 3D echocardiography

Secondary Outcome Measures

Name	Time	Method
Changes in left ventricular volumes assessed by 3D echocardiography among the two groups	Six months
Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups	Six months
Changes in left ventricular diastolic function among the two groups	Six months

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt