Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Ain Shams University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Doxorubicin Induced Cardiomyopathy

Treatments: Other: Placebo; Drug: Atorvastatin 40 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05792293

FMASUMD45/2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Treatment:

Drug: Atorvastatin 40 Mg Oral Tablet

Control Group

Placebo Comparator group

Description:

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Treatment:

Other: Placebo