Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

April 4, 2023 updated by: Ahmed Lotfy Mohamed, Ain Shams University
This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cancer therapy related cardiac dysfunction among the two groups
Time Frame: 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
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups
Time Frame: Six months
Six months
Changes in left ventricular volumes assessed by 3D echocardiography among the two groups
Time Frame: Six months
Six months
Changes in left ventricular diastolic function among the two groups
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

March 19, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASUMD45/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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