Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05792293

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Doxorubicin Induced Cardiomyopathy	Drug: Atorvastatin 40 Mg Oral Tablet Other: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Single blind

Primary Purpose:

Prevention

Official Title:

Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Group Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy	Drug: Atorvastatin 40 Mg Oral Tablet 40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects
Placebo Comparator: Control Group Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy	Other: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Study Group

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Drug: Atorvastatin 40 Mg Oral Tablet

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

Placebo Comparator: Control Group

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Ahmed L Mohamed, Master, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Lotfy Mohamed, Principal Investigator, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05792293

Other Study ID Numbers:

FMASUMD45/2021

First Posted:

Mar 31, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Lotfy Mohamed, Principal Investigator, Ain Shams University

Anthracyclines

Doxorubuicn

Cardiotoxicity

Additional relevant MeSH terms:

Cardiomyopathies

Cardiotoxicity

Atorvastatin

Study Results

No Results Posted as of Apr 6, 2023