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

• ClinicalTrials.gov Identifier: NCT04434404
• Recruitment Status: Completed
• First Posted: June 16, 2020
• Last Update Posted: June 16, 2020
• Sponsor: Horus University
• Information provided by (Responsible Party): hosny ahmed elewa, Horus University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: L-Carnitine 500Mg Oral Tablet	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant)
• Primary Purpose: Prevention
• Official Title: Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy
• Actual Study Start Date: September 10, 2018
• Actual Primary Completion Date: August 13, 2019
• Actual Study Completion Date: December 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: control group; 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; 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.; Other Name: Silymarin
Active Comparator: L-carnitine group; 25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine	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.; Other Name: Silymarin
Active Comparator: Silymarin group; 25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg	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.; Other Name: Silymarin

Outcome Measures

Primary Outcome Measures :

1. The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy [ Time Frame: from the baseline untill 3 months ]
   addition of l-carnitine to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy

Secondary Outcome Measures :

1. The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy [ Time Frame: from the baseline untill 3 months ]
   addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: as all our participants were breast cancer patients
• Accepts Healthy Volunteers: No

Criteria

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,

Contacts and Locations

Locations

Egypt

Horus University

Damietta, Tanta City, Egypt, 34518

Sponsors and Collaborators

Horus University

More Information

• Responsible Party: hosny ahmed elewa, head of pharmacy practice department, Horus University
• ClinicalTrials.gov Identifier: NCT04434404
• Other Study ID Numbers: 32551/09/2018
• First Posted: June 16, 2020
• Last Update Posted: June 16, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by hosny ahmed elewa, Horus University:

anthracycline-containg chemotherapy; cardiotoxicity; breast cancer patients; slymarin; l-carnitine

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Silymarin; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs