Breast Cancer
Conditions
Keywords
anthracycline-containg chemotherapy, cardiotoxicity, breast cancer patients, slymarin, l-carnitine
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.
Interventions
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.
Sponsors
Horus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed