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NCT Number: NCT04434404

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

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.

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Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Horus University

Damietta, Tanta City, 34518, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

Other names: Silymarin

Primary outcomes

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

    Time frame: from the baseline untill 3 months

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

Secondary outcomes

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

    Time frame: from the baseline untill 3 months

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

Sponsors and collaborators

Lead sponsor

Horus University

Other

Registry information

Official study title

Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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