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

Horus University

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: L-Carnitine 500Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04434404

32551/09/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No 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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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

Treatment:

Drug: L-Carnitine 500Mg Oral Tablet

L-carnitine group

Active Comparator group

Description:

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

Treatment:

Drug: L-Carnitine 500Mg Oral Tablet

Silymarin group

Active Comparator group

Description:

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

Treatment:

Drug: L-Carnitine 500Mg Oral Tablet