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

What Was Tested

This registered phase 4 trial tested L-Carnitine.

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.

It had three arms (groups): control group (placebo comparator), L-carnitine group (active comparator) and Silymarin group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Aim: Anthracycline induced cardiotoxicity is the most common constrains of its use in treatment of various types of cancer.

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.

Who Took Part

Enrollment: 83 actual participants took part.

It was open to women only aged from 20 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),. Aged 20-60 and. Female patients were included.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: 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,.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether L-Carnitine was given.

Those kept unaware of assignments: participant.

It started in 2018-09-10 with completion listed for 2019-08-13.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: 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).

It also tracked 1 secondary outcome, for example The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of L-Carnitine in 83 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.