Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05338723

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Cardiotoxicity Breast Cancer	Drug: Rosuvastatin 20mg	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients

Actual Study Start Date :

Sep 15, 2020

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control-group This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy.
Active Comparator: rosuvastatin-group This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).	Drug: Rosuvastatin 20mg 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).

Arm

Intervention/Treatment

No Intervention: control-group

This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy.

Active Comparator: rosuvastatin-group

This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).

Drug: Rosuvastatin 20mg

20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months).

Outcome Measures

Primary Outcome Measures

arrhythmia detected by electrocardiography (ECG) [6 months]
Patients will undergo electrocardiography (ECG) prior to the initiation of chemotherapy , after 3 months and after 6 months to detect any arrhythmia.
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography [6 months]
Patients will undergo transthoracic echocardiography 24 hours prior to the initiation of chemotherapy, after 3 months and after 6 months to detect change in LVEF

Secondary Outcome Measures

change of serum level of High sensitivity troponin I (hs-TnI). [6 months]
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI).
change of serum level of Myeloperoxidase (MPO). [6 months]
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO).
change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT). [6 months]
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6).
change of serum level of Liver function test (ALT). [6 months]
Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 25-75 years old.
Gender: female
Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%.
Patients with normal renal and hematological functions.
Alanine amino transferase (ALT ≤ 3 times ULN).

Exclusion Criteria:

Pregnant or lactating females.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2
Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)<50%.
Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy.
Alanine amino transferase (ALT > 3 times ULN).
Patients already taking statins or other lipid lowering therapy.
Patients with a known hypersensitivity to any of the used drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Department of Clinical Oncology, Tanta University Hospital	Tanta		Egypt

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: khlood m. kettana, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khlood Mohamed Kettana, demonstrator at clinical pharmacy department,faculty of pharmacy, Tanta University

ClinicalTrials.gov Identifier:

NCT05338723

Other Study ID Numbers:

rosuva2020

First Posted:

Apr 21, 2022

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Breast Neoplasms

Cardiotoxicity

Rosuvastatin Calcium

Study Results

No Results Posted as of Apr 21, 2022