Back to resultsRole of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
Primary Purpose
Doxorubicin Induced Cardiomyopathy
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin 40 Mg Oral Tablet
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Doxorubicin Induced Cardiomyopathy focused on measuring Anthracyclines, Doxorubuicn, Cardiotoxicity
Eligibility Criteria
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
Sites / Locations
- Ain Shams University hospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study Group
Control Group
Arm Description
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
Outcomes
Primary Outcome Measures
Incidence of cancer therapy related cardiac dysfunction among the two groups
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
Changes in left ventricular volumes assessed by 3D echocardiography among the two groups
Changes in left ventricular diastolic function among the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05792293
Brief Title
Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
Official Title
Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Doxorubicin Induced Cardiomyopathy
Keywords
Anthracyclines, Doxorubuicn, Cardiotoxicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blind
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40 Mg Oral Tablet
Intervention Description
40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of cancer therapy related cardiac dysfunction among the two groups
Description
cancer therapy related cardiac dysfunction defined as drop in ejection fraction more than 10% and to a value below 53% assessed by 3D echocardiography
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups
Time Frame
Six months
Title
Changes in left ventricular volumes assessed by 3D echocardiography among the two groups
Time Frame
Six months
Title
Changes in left ventricular diastolic function among the two groups
Time Frame
Six months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients diagnosed with breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed L Mohamed, Master
Phone
+201141141677
Email
Doc.ahmedlotfy91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed L Mohamed, Master
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed L Mohamed, Master
Phone
+201141141677
Email
Doc.ahmedlotfy91@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
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