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

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

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.

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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

Resource links provided by the National Library of Medicine


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




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



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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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434404


Locations
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Egypt
Horus University
Damietta, Tanta City, Egypt, 34518
Sponsors and Collaborators
Horus University
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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    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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