Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-17 @ 3:14 PM
Study NCT ID:
NCT06703593
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in echocardiographic findings', 'timeFrame': 'Approximately few days ( less than a week ) before Cycle 1 "baseline" and after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.', 'description': 'Elevation or maintenance of Ejection fraction percentage (EF %)'}, {'measure': 'Changes in serum levels of pro brain natriuretic peptide (pro-BNP) and cardiac troponins', 'timeFrame': 'Just before Cycle 1 "baseline" and 1 hour after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.', 'description': 'Decline in serum concentration of pro brain natriuretic peptide (pro-BNP) measured in picograms per milliliter (pg/mL) and cardiac troponins measured in picograms per milliliter (pg/mL).'}], 'secondaryOutcomes': [{'measure': 'Changes in the oxidative stress marker malondialdehyde (MDA)', 'timeFrame': 'ust before Cycle 1 "baseline" and 1 hour after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.', 'description': 'Decline in serum concentration of malondialdehyde (MDA) measured in micro mole / Litre'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alpha lipoic acid, Anthracyclines induced Cardiotoxicity'], 'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'According to the European Society of Cardiology 2022, the primary prevention of cancer therapyrelated cardiovascular toxicity during anthracycline chemotherapy include renin-angiotensin- aldosterone system blockers, beta-blockers, and mineralocorticoid receptor antagonists that have shown a significant benefit in preventing left ventricular ejection fraction (LVEF) reduction, but with no statistical differences in the incidence on the various other clinical outcomes as overt congestive heart failure (CHF). Also, other strategies have been investigated including; adjusting the infusion time and dose intensity of anthracyclines. Dexrazoxane and liposomal anthracyclines are currently approved in patients with high and very high chemotherapy-related cardiovascular disease (CTRCD) risk or who have already received high cumulative anthracyclines doses (Lyon, 2022). The incidence is about 4% when the dose of doxorubicin is 500-550 mg/m2, 18% when the dose is 551-600 mg/m2 and 36% when the dose exceeds 600 mg/m2 (Lefrak, 1973). Alpha-lipoic acid (ALA) was reported to have a cardioprotective role against doxorubicin-induced cardiotoxicity through attenuation of oxidative stress via scavenging reactive oxygen species (ROS), regenerating endogenous antioxidants including glutathione, vitamin E, and C, its metal chelation activity and its ability to repair oxidative damage. (Werida et al, 2022)', 'detailedDescription': 'ALA effectively inhibits nuclear factor-kappa B with subsequent decreasing pro- inflammatory cytokines production (TNF-α, IL-6) and increasing the release of anti- inflammatory cytokines such as interleukin-10 (FahimehHaghighatdoostabMitraHariri, 2019).\n\nRelying on the antioxidant and anti-inflammatory effect of Alpha lipoic acid confirmed by a variety of studies in vitro and in vivo, ALA is selected to be studied in Egyptian breast cancer patients who will be treated with doxorubicin including regimens.\n\nAim of the study:\n\nThe aim of the current study is to evaluate the efficacy and tolerability of ALA administration and its impact on the occurrence of doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer by evaluation of the following:\n\n1. Evaluation of the occurrence of chemotherapy induced cardiotoxicity by;\n\n 1. Changes in echocardiographic findings and serum levels of pro brain natriuretic peptide (pro-BNP) and cardiac troponins.\n 2. Severity of DIC will be evaluated by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 For Heart Failure.\n 3. Estimation of oxidative stress burden by measurement of MDA.\n2. Evaluation of ALA safety by:\n\nALA safety will be monitored and assessed through patient face to face interviews (at the end of each cycle) and phone calls weekly about the occurrence of any of the following side effects: (Ex; insomnia, fatigue, diarrhea, and skin rash).\n\nPatients will be followed up by monitoring of the side effect reporting card (intervention arm)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': '1. Women aged more than 18 years\n2. Breast cancer diagnosis\n3. Entering first cycle of chemotherapy containing ATC\n4. Subject must be willing and able to sign an informed consent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged more than 18 years\n2. Breast cancer diagnosis\n3. Entering first cycle of chemotherapy containing ATC\n4. Subject must be willing and able to sign an informed consent\n\nExclusion Criteria:\n\n1. History of renal (serum creatinine greater than 2.0 mg/ml) or hepatic insufficiency (bilirubin\\> 3.0 mg/dl or serum albumin \\< 3.5 g/dl or prothrombin time \\< 60% in the absence of orally administered anticoagulant therapy or ultrasound signs of chronic liver damage\n2. History of heart failure\n3. Baseline LVEF \\< 50% determined by transthoracic echocardiogram\n4. Current participation in any other clinical investigation\n5. History of severe adverse reaction to Alpha lipoic acid\n6. Concomitant use of Trastuzumab (HER2 positive patients)\n7. Previous intake of alpha lipoic acid in the previous 3 months\n8. Women with prior exposure to anthracyclines and neurotoxic agents (Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, isonicotinic acid hydrazide "INH,", etc.) in the last 6 months.\n9. Presence of clinical evidence for severe cardiac illness (i.e., angina pectoris and arrhythmias)\n10. Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation)'}, 'identificationModule': {'nctId': 'NCT06703593', 'briefTitle': 'Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Evaluation of the Impact of Alpha Lipoic Acid Administration on the Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'CL-2311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alpha Lipoic acid intervention arm', 'description': 'Alpha Lipoic acid 1200 mg daily for 6 months', 'interventionNames': ['Drug: Alpha lipoic acid']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention arm', 'description': 'not taking Alpha Lipoic acid'}], 'interventions': [{'name': 'Alpha lipoic acid', 'type': 'DRUG', 'otherNames': ['Neuropatex', 'lipoic acid'], 'description': 'ALA effectively inhibits nuclear factor-kappa B with subsequent decreasing proinflammatory cytokines production (TNF-α, IL-6) and increasing the release of anti- inflammatory cytokines such as interleukin-10 (Haghighatdoost and Hariri, 2019). Relying on the antioxidant and anti-inflammatory effect of Alpha lipoic acid confirmed by a variety of studies in vitro and in vivo, ALA is selected to be studied in Egyptian breast cancer patients who will be treated with doxorubicin including regimens.', 'armGroupLabels': ['Alpha Lipoic acid intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11837', 'city': 'Cairo', 'state': 'El-Sherouk City', 'country': 'Egypt', 'facility': 'The British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator and Teaching assistant at the Clinical Pharmacy Practice Department', 'investigatorFullName': 'Alaa jamal', 'investigatorAffiliation': 'British University In Egypt'}}}}