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

NCT04434404 | Completed Phase 4

• 1 other identifier: 32551/09/2018
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  from the baseline untill 3 months

Secondary Outcomes (1)

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

  from the baseline untill 3 months

Study Arms (3)

control group

PLACEBO COMPARATOR

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

L-carnitine group

ACTIVE COMPARATOR

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

Drug: L-Carnitine 500Mg Oral Tablet

Silymarin group

ACTIVE COMPARATOR

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

Drug: L-Carnitine 500Mg Oral Tablet

Interventions

L-Carnitine 500Mg Oral Tablet DRUG

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.

Also known as: Silymarin

L-carnitine group; Silymarin group; control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: as all our participants were breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
• aged 20-60 and
• female patients were included.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Horus University

Damietta, Tanta City, 34518, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Interventions

Carnitine; Tablets; Silymarin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of pharmacy practice department

Model Details: This study was a parallel randomized (simple randomization; odd number took silymarin and even number took l carnitine) controlled prospective open label one.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: September 10, 2018
• Primary Completion: August 13, 2019
• Study Completion: December 10, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)