Trial | NCT04434404  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    83
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.
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 Started
Sep 10
2018
Primary Completion
Aug 13
2019
Study Completion
Dec 10
2019
Last Update
Jun 16
2020

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 names: Silymarin

control group Placebo Comparator

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

L-carnitine group Active Comparator

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

Silymarin group Active Comparator

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

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,
No Results Posted