Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy

Breast Cancer Clinical Trial

Official title:

Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434404
• Other study ID #: 32551/09/2018
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: June 2020
• Source: Horus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the study aim to protect patients received anthracyclines containing chemotherapy from cardiotoxcity induced by anthracyclines derivatives. by using L-carnitine and Silymarin for protection the heart from anthracyclines toxicities, and in addition its a comparitive study between L-carnitine and Silymarin.

Description:

Aim: Anthracycline induced cardiotoxicity is the most common constrains of its use in treatment of various types of cancer. This study aimed to investigate benefits from adding L-carnitine and Silymarin compared to anthracycline chemotherapy alone in patients with cancer.

Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University, Egypt, then prospectively randomized to receive their anthracycline containing therapeutic regimen, control group (n=33) or anthracycline plus L-carnitine, L-carnitine group (n=25), or anthracycline plus Silymarin, Silymarin group (n= 25). Blood samples were collected at begging and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA and paired t test. P <0.05 was statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 10, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),

• aged 20-60 and

• female patients were included.

Exclusion Criteria:

• patients with a history of heart failure, arrhythmia, history of cardiac catheterizations or, history of angina, uncontrolled hypertension and uncontrolled diabetes,

• patients with impaired liver function tests,

• previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens,

• previous history of chest wall irradiation.

• Brain metastasis,

• pregnant patients and

• patients who refused informed consent,

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• L-Carnitine 500Mg Oral Tablet
eighty-three eligible patients were recruited 33, 25, and 25 patients in the control group, L-carnitine group, and, Silymarin group respectively, completed the study without cardioprotective agents in a dose of 50 mg/m2. L-carnitine group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine 3 gm L-carnitine® capsules obtained from (MEPACO) was taken PO one day before chemotherapeutic cycle and 1gm /day during the following 21 days. Silymarin group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin as cardioprotective agent.140 mg (Legalon ® 140 mg capsule obtained from (MEDA). Silymarin was taken PO once daily after meals during the chemotherapeutic cycle. The treatment period was 6 months.

Locations

Country	Name	City	State
Egypt	Horus University	Damietta	Tanta City

Sponsors (1)

Lead Sponsor	Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy	addition of l-carnitine to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy	from the baseline untill 3 months
Secondary	The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy	addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy	from the baseline untill 3 months