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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

L-Carnitine 500Mg Oral Tablet

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring anthracycline-containg chemotherapy, cardiotoxicity, breast cancer patients, slymarin, l-carnitine

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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,

Sites / Locations

Horus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group

L-carnitine group

Silymarin group

Arm Description

33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents

25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine

25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04434404

First Posted

June 11, 2020

Last Updated

June 15, 2020

Sponsor

Horus University

1. Study Identification

Unique Protocol Identification Number

NCT04434404

Brief Title

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

Official Title

Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

September 10, 2018 (Actual)

Primary Completion Date

August 13, 2019 (Actual)

Study Completion Date

December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Horus University

4. Oversight

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.

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

Participant

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents

Arm Title

L-carnitine group

Arm Type

Active Comparator

Arm Description

25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine

Arm Title

Silymarin group

Arm Type

Active Comparator

Arm Description

25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg

Intervention Type

Drug

Intervention Name(s)

L-Carnitine 500Mg Oral Tablet

Other Intervention Name(s)

Silymarin

Intervention Description

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.

Primary Outcome Measure Information:

Title

The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy

Description

addition of l-carnitine to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy

Time Frame

from the baseline untill 3 months

Secondary Outcome Measure Information:

Title

The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy

Description

addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy

Time Frame

from the baseline untill 3 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

as all our participants were breast cancer patients

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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,

Facility Information:

Facility Name

Horus University

City

Damietta

State/Province

Tanta City

ZIP/Postal Code

34518

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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