Breast CancerPhase 4NCT04434404
Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy
A Phase 4 study testing L-Carnitine 500Mg Oral Tablet in people with Breast Cancer, run by Horus University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- L-Carnitine 500Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2018to 10 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
- aged 20-60 and
- female patients were included.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardioprotection of Silymarin for Patients Received 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- L-Carnitine 500Mg Oral Tablet
- Keywords
- anthracycline-containg chemotherapy, cardiotoxicity, breast cancer patients, slymarin, l-carnitine
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Carnitine 500Mg Oral TabletDrug
Also called Silymarin
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | 33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents Receives: 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 Receives: 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 Receives: Drug: L-Carnitine 500Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy
Measured: from the baseline untill 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start10 Sep 2018
- Primary completion13 Aug 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hosny ahmed elewa, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434404
- Sponsor's protocol ID
- 32551/09/2018
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy
- ClinicalTrials.gov ID
- NCT04434404
- Acronym / sponsor ID
- 32551/09/2018
- Conditions
- Breast Cancer
- Keywords
- anthracycline-containg chemotherapy, cardiotoxicity, breast cancer patients, slymarin, l-carnitine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: L-Carnitine 500Mg Oral Tablet33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents |
| L-carnitine group | Active comparator | Drug: L-Carnitine 500Mg Oral Tablet25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine |
| Silymarin group | Active comparator | Drug: L-Carnitine 500Mg Oral Tablet25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
- aged 20-60 and
- female patients were included.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Carnitine 500Mg Oral TabletAlso: Silymarineighty-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. | Drug | L-carnitine group, Silymarin group, control group |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-Carnitine 500Mg Oral Tablet in people with Breast Cancer, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.