Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06459193
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2024-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014292', 'term': 'Trimetazidine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria', 'timeFrame': 'weekly for up to 8 weeks', 'description': 'Number of patients reported neuropathy from paclitaxel. a 1 to 5 graded scale; where grade (1) is the minimum value and grade (5) is the maximum value, a greater grades mean greater symptomatic burden.'}, {'measure': "Patient's Quality of Life", 'timeFrame': 'at baseline, at the end of 4 weeks and at the end of 8 weeks', 'description': 'measures the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire.\n\nA total score ranging from 0 (minimum value) to 44 (maximum value), where lower scores mean greater symptomatic burden.'}], 'secondaryOutcomes': [{'measure': 'Changes in serum levels of biomarker namely nerve growth factor (NGF).', 'timeFrame': 'at baseline and at end of 8 weeks', 'description': 'measuring serum level of nerve growth factor using enzyme-linked immunoassay (ELISA) Kit.'}, {'measure': 'Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy.', 'timeFrame': 'at baseline and weekly up to 8 week', 'description': 'any adverse/ side effect will be evaluated.'}, {'measure': 'Severity of chemotherapy induced-peripheral neuropathy.', 'timeFrame': 'at baseline, at the end of 4 weeks and at the end of 8 weeks', 'description': 'The severity of paclitaxel-induced peripheral neuropathy using VAS visual analogue scale.\n\na 10-cm line that represents a continuum between "no pain" and "worst pain."'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paclitaxel', 'Trimetazidine', 'quality of life', 'nerve growth factor', 'peripheral neuropathy'], 'conditions': ['Peripheral Neuropathy Due to Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '32601973', 'type': 'BACKGROUND', 'citation': 'Khalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29.'}, {'pmid': '37199288', 'type': 'BACKGROUND', 'citation': 'Haroun EA, Mansour NO, Eltantawy A, Shams MEE. Effect of cilostazol on preventing paclitaxel-induced neuropathy in patients with breast cancer: A randomized controlled trial. Pharmacotherapy. 2023 Sep;43(9):872-882. doi: 10.1002/phar.2830. Epub 2023 Jun 12.'}, {'pmid': '36898573', 'type': 'BACKGROUND', 'citation': 'Hammad ASA, Sayed-Ahmed MM, Abdel Hafez SMN, Ibrahim ARN, Khalifa MMA, El-Daly M. Trimetazidine alleviates paclitaxel-induced peripheral neuropathy through modulation of TLR4/p38/NF-kappaB and klotho protein expression. Chem Biol Interact. 2023 May 1;376:110446. doi: 10.1016/j.cbi.2023.110446. Epub 2023 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.', 'detailedDescription': 'Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect of many commonly used chemotherapeutic agents that greatly affect patient quality of life. Paclitaxel (PTX), one of the main neurotoxic classes of anticancer drugs, is used to treat several types of solid tumors, including breast cancer. Development of PTX-induced peripheral neuropathy (PIPN) during cancer treatment requires dose reduction limiting its clinical benefits.\n\nThe only currently recognized prophylactic measure for chemotherapy-induced peripheral neuropathy (CIPN) is monitoring for pre-existing neuropathies and then the early detection of clinical symptoms of neuropathy in subjects undergoing neurotoxic chemotherapy treatment.\n\nPreclinical data has shown that the neuroprotective effect of trimetazidine (TMZ) can attenuate PIPN.\n\nTMZ has preclinical evidence about its preventive capacity against peripheral neuropathy. Which represents a possible prophylactic strategy for attenuating PIPN. TMZ is commercially available in various preparations that are relatively affordable and well-tolerated, making it a valid candidate for clinical evaluation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Breast cancer patients who will receive paclitaxel.\n* Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.\n* Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin \\<1.5 mg/dl), renal function (creatinine \\< 1.5 mg/dl).\n\nExclusion Criteria:\n\n* Patients with signs and symptoms of clinical neuropathy at baseline.\n* Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.\n* Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.\n* Patients with contraindications to trimetazidine including Parkinson's disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders."}, 'identificationModule': {'nctId': 'NCT06459193', 'briefTitle': 'Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '2301006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Trimetazidine Tablet 35 mg once daily for the treatment period', 'interventionNames': ['Drug: Trimetazidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo once daily for the treatment period', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Trimetazidine', 'type': 'DRUG', 'description': 'Trimetazidine 35 mg tab once daily', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61512', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia Oncology Center', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Asmaa N. Iqbal Ahmed, Demonstrator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.'}, {'name': 'Engy A. Wahsh, Asst. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, Giza, Egypt'}, {'name': 'Fatma M. Mady, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharmaceutics department, Faculty of Pharmacy, Minia University, Minia, Egypt.'}, {'name': 'Eman M. Sadek, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.'}, {'name': 'Ahmed Mostafa Abd-Elaziz, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Clinical Oncology, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'name': 'Noha Mahmood Abd-Allah, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Minia University, Minia, Egypt.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator', 'investigatorFullName': 'Asmaa Najm Iqbal Ahmed', 'investigatorAffiliation': 'Minia University'}}}}