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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: L-Carnitine 500Mg Oral Tablet

• Registration Number: NCT04434404
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-09-10
• Primary Completion: 2019-08-13
• Study Completion: 2019-12-10
• Status Verified: 2020-06
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-15
• Last Update Submitted: 2020-06-15
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-carnitine group	L-Carnitine 500Mg Oral Tablet	25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine
control group	L-Carnitine 500Mg Oral Tablet	33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents
Silymarin group	L-Carnitine 500Mg Oral Tablet	25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg

Primary Outcome Measures

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

Name	Time	Method
The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy	from the baseline untill 3 months	addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy

Trial Locations

Locations (1)

Horus University; 🇪🇬 Damietta, Tanta City, Egypt