Clinical trial NCT04434404: Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy
Official title: Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: anthracycline-containg chemotherapy
cardiotoxicity
breast cancer patients
slymarin
l-carnitine
Lead sponsor: Horus University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 83
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a parallel randomized (simple randomization; odd number took silymarin and even number took l carnitine) controlled prospective open label one.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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,

Primary outcomes:
measure: The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy
timeFrame: from the baseline untill 3 months
Secondary outcomes:
measure: The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy
timeFrame: from the baseline untill 3 months
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Horus University
state: Tanta City
Study officials:
References: