Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-29 @ 3:44 PM
Study NCT ID:
NCT04434404
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D012838', 'term': 'Silymarin'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D044947', 'term': 'Flavonolignans'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was a parallel randomized (simple randomization; odd number took silymarin and even number took l carnitine) controlled prospective open label one.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-15', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'addition of l-carnitine to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy'}], 'secondaryOutcomes': [{'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', 'description': 'addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anthracycline-containg chemotherapy', 'cardiotoxicity', 'breast cancer patients', 'slymarin', 'l-carnitine'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'as all our participants were breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),\n* aged 20-60 and\n* female patients were included.\n\nExclusion Criteria:\n\n* patients with a history of heart failure, arrhythmia, history of cardiac catheterizations or, history of angina, uncontrolled hypertension and uncontrolled diabetes,\n* patients with impaired liver function tests,\n* previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens,\n* previous history of chest wall irradiation.\n* Brain metastasis,\n* pregnant patients and\n* patients who refused informed consent,'}, 'identificationModule': {'nctId': 'NCT04434404', 'briefTitle': 'Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Horus University'}, 'officialTitle': 'Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy', 'orgStudyIdInfo': {'id': '32551/09/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': '33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents', 'interventionNames': ['Drug: L-Carnitine 500Mg Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-carnitine group', 'description': '25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine', 'interventionNames': ['Drug: L-Carnitine 500Mg Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Silymarin group', 'description': '25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg', 'interventionNames': ['Drug: L-Carnitine 500Mg Oral Tablet']}], 'interventions': [{'name': 'L-Carnitine 500Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Silymarin'], 'description': '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\n\nwithout 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.', 'armGroupLabels': ['L-carnitine group', 'Silymarin group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34518', 'city': 'Damietta', 'state': 'Tanta City', 'country': 'Egypt', 'facility': 'Horus University', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of pharmacy practice department', 'investigatorFullName': 'hosny ahmed elewa', 'investigatorAffiliation': 'Horus University'}}}}