Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT07137793
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in ejection fraction', 'timeFrame': '3 MONTHS'}], 'secondaryOutcomes': [{'measure': 'changes in serum levels of the measured biological markers', 'timeFrame': '3 MONTHS'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pentoxyfillne', 'breast cancer', 'cardioprotective', 'Doxorubicin Induced Cardiotoxicity'], 'conditions': ['Doxorubicin Induced Cardiotoxicity', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31972363', 'type': 'BACKGROUND', 'citation': 'Matboli M, Habib EK, Hussein Mohamed R, Mahran NA, Seleem HS, Nosseir N, Hasanin AH. Pentoxifylline alleviated cardiac injury via modulating the cardiac expression of lncRNA-00654-miR-133a-SOX5 mRNA in the rat model of ischemia-reperfusion. Biomed Pharmacother. 2020 Apr;124:109842. doi: 10.1016/j.biopha.2020.109842. Epub 2020 Jan 20.'}, {'pmid': '7678547', 'type': 'BACKGROUND', 'citation': 'Dezube BJ, Sherman ML, Fridovich-Keil JL, Allen-Ryan J, Pardee AB. Down-regulation of tumor necrosis factor expression by pentoxifylline in cancer patients: a pilot study. Cancer Immunol Immunother. 1993;36(1):57-60. doi: 10.1007/BF01789132.'}, {'pmid': '17196208', 'type': 'BACKGROUND', 'citation': 'Fernandes JL, de Oliveira RTD, Mamoni RL, Coelho OR, Nicolau JC, Blotta MHSL, Serrano CV Jr. Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory activity in patients with coronary artery disease--a randomized placebo-controlled study. Atherosclerosis. 2008 Jan;196(1):434-442. doi: 10.1016/j.atherosclerosis.2006.11.032. Epub 2006 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the cardioprotective effect of pentoxifylline against doxorubicin-induced cardiotoxicity in breast cancer patients. The main questions it aims to answer are:\n\n1. What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not?\n2. What are the changes in serum levels of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), and TNF-α (secondary outcomes) in breast cancer patients receiving pentoxifylline compared to those who do not? Researcher will compare breast cancer patients receiving standard chemotherapy alone (Group one: Positive control group; n=23) to breast cancer patients receiving standard chemotherapy plus pentoxifylline (Group two: pentoxifylline group; n=23) to see if pentoxifylline mitigates the cardiac side effects associated with doxorubicin treatment.\n\nParticipants will:\n\nBe randomized to receive either a chemotherapeutic regimen alone or with pentoxifylline.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females with breast cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old.\n* Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).\n* Patients intended to receive at least 4 cycles of doxorubicin or more.\n* Patients with performance status \\<2 according to Eastern Cooperative Oncology Group (ECOG) score.\n* Echocardiographic LVEF ≥55%.\n* Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).\n* Patients with adequate liver function and adequate renal function.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Age \\<18 years old and \\>65 years old.\n* Women with history of breast cancer.\n* Formerly treated with DOX.\n* Patients with a known hypersensitivity to any of the used drugs.\n* Treatment with blood thinners for 6 months prior to the screening.\n* Treatment with NSAIDS like ketorolac,ibuprofen.\n* Patients taking any other cardioprotective medications.\n* Pregnancy and breast feeding.\n* Alcohol abuse.\n* Creatine Clearance \\< 50 mL/min.\n* History of heart failure or LVEF \\<50%.\n* Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.'}, 'identificationModule': {'nctId': 'NCT07137793', 'acronym': 'PTX / BC', 'briefTitle': 'Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'TP/RE/5/25M-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Positive control group receiving standard chemotherapy for breast cancer .'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentoxifylline 400mg plus chemotherapy', 'interventionNames': ['Drug: Pentoxifylline 400mg plus chemotherapy']}], 'interventions': [{'name': 'Pentoxifylline 400mg plus chemotherapy', 'type': 'DRUG', 'description': 'patient will receive standard chemotherapy for breast cancer plus pentoxifylline 400 mg orally 3 times per day with meals.', 'armGroupLabels': ['Pentoxifylline 400mg plus chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damanhūr', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Damnhour Oncology Center', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'centralContacts': [{'name': 'sondos mahmoud elfeky, bachelor degree in pharmacy', 'role': 'CONTACT', 'email': 'sonddoselfiqy@gmail.com', 'phone': '01148031701', 'phoneExt': '+02'}, {'name': 'Sahar kamal Hegazy professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Sahar kamal Hegazy professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}, {'name': 'Eman Ibrahim Elberri Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'bachelor', 'investigatorFullName': 'Sondos Mahmoud Elfeky', 'investigatorAffiliation': 'Tanta University'}}}}