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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: L-Carnitine 500Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was a parallel randomized (simple randomization; odd number took silymarin and even number took l carnitine) controlled prospective open label one.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents | Drug: L-Carnitine 500Mg Oral Tablet<br>* 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.<br>* Other names: Silymarin;|
| Active Comparator: L-carnitine group<br>25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine | Drug: L-Carnitine 500Mg Oral Tablet<br>* 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.<br>* Other names: Silymarin;|
| Active Comparator: Silymarin group<br>25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg | Drug: L-Carnitine 500Mg Oral Tablet<br>* 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.<br>* Other names: Silymarin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthracycline-containg chemotherapy, cardiotoxicity, breast cancer patients, slymarin, l-carnitine