Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 6:36 AM
Study NCT ID:
NCT06135493
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2023-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], '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': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2023-11-11', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of paclitaxel-induced peripheral neuropathy', 'timeFrame': '12 weeks', 'description': 'Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)'}], 'secondaryOutcomes': [{'measure': 'Patient QOL', 'timeFrame': '12 weeks', 'description': 'Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)'}, {'measure': 'Pain Severity', 'timeFrame': '12 Weeks', 'description': 'Pain intensity will be assessed through Visaul Analogue Scale Scale 0-10'}, {'measure': 'Serum biomarker', 'timeFrame': '12 weeks', 'description': 'Level of Nerve growth factor (NGF) in Serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paclitaxel', 'Breast Cancer', 'Peripheral Neuropathy'], 'conditions': ['Peripheral Neuropathy Due to Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect.\n\nThe purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Losartan.\n* Not Known Hypertensive patients\n* Not Known Diabetic patients\n* Treatment with Losartan/ARBs/ACE-I prior to the study.\n* Previous neuropathy\n* Renal impairment (Serum creatinine \\> 2 mg/dl)\n* Significant liver disease: liver enzymes 2 folds the upper normal limit\n* Metastatic breast cancer\n* Pregnancy or lactation\n* Taking other medication for neuropathic pain\n* Significant Hypotension'}, 'identificationModule': {'nctId': 'NCT06135493', 'briefTitle': 'Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.', 'orgStudyIdInfo': {'id': 'REC-FPFUE-30/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg', 'interventionNames': ['Drug: Losartan']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'description': 'Using losartan to prevent paclitaxel-induced peripheral neuropathy', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Invistigator', 'investigatorFullName': 'Alaa Mahmoud Ahmed Shawqy Mahmoud', 'investigatorAffiliation': 'Future University in Egypt'}}}}