Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

NCT ID: NCT05792293

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Doxorubicin Induced Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single blind

Study Groups

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Study Group

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Group Type EXPERIMENTAL

Atorvastatin 40 Mg Oral Tablet

Intervention Type DRUG

40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects

Control Group

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Atorvastatin 40 Mg Oral Tablet

40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Lotfy Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed L Mohamed, Master

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed L Mohamed, Master

Role: CONTACT

+201141141677

Facility Contacts

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Ahmed L Mohamed, Master

Role: primary

+201141141677

Other Identifiers

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FMASUMD45/2021

Identifier Type: -

Identifier Source: org_study_id

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