Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 11:41 PM
Study NCT ID:
NCT05510856
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2022-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000085', 'term': 'Acetates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2022-08-13', 'studyFirstSubmitQcDate': '2022-08-19', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'McGill Pain Questionnaire', 'timeFrame': 'every 2 weeks', 'description': 'questionnaire'}, {'measure': '12-item neurotoxicity questionnaire', 'timeFrame': 'every 4 weeks', 'description': 'questionnaire'}, {'measure': 'EORTC Core Quality of Life questionnaire', 'timeFrame': 'up to 6 months', 'description': 'questionnaire'}, {'measure': 'Common Terminology Criteria for Adverse Events', 'timeFrame': 'every 4 weeks', 'description': 'questionnaire'}], 'secondaryOutcomes': [{'measure': 'Neurofilament light chain (NfL)', 'timeFrame': 'up to 6 months', 'description': 'biological biomarker'}, {'measure': 'Nuclear factor- kappa B (NF- κB)', 'timeFrame': 'up to 6 months', 'description': 'biological biomarker'}, {'measure': 'Neurotensin (NT)', 'timeFrame': 'up to 6 months', 'description': 'biological biomarker'}, {'measure': 'Hemeoxygenase-1', 'timeFrame': 'up to 6 months', 'description': 'biological biomarker'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxaliplatin,peripheral neuropathy'], 'conditions': ['Oncology']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.', 'detailedDescription': 'This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer.\n\nThis study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups:\n\nGroup 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months).\n\nGroup 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months).\n\nGroup 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A) Adults ≥ 18 years old male and female patients. B) Patients with gastrointestinal cancer receiving oxaliplatin chemotherapy\n\nExclusion Criteria:\n\n* A) Preexisting neuropathic or brain disorders. B) Previous use of chemotherapeutic agents including taxanes, platinum, vinca alkaloids, and bortezomib.\n\nC) Concomitant use of drugs reported to have neuroprotective role and analgesics.\n\nD) Patients with diabetes, uncontrolled hypertension, congestive heart failure, drug addiction and patients who were receiving tamoxifen.\n\nE) Patients with abnormal renal function tests (serum creatinine ≤ 30 ml/min) or liver function tests (≥ 3 times the upper normal range).\n\nF) Participants with a documented medical history of neuropathy. G) Concomitant use of other antidepressants, anticonvulsants, high-dose vitamin supplements or drugs known to influence serotonin levels.\n\nH) Pregnancy and lactating women. I) Uncooperative patients and patients who have psychological problems or on antipsychotic medications.'}, 'identificationModule': {'nctId': 'NCT05510856', 'briefTitle': 'Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients', 'orgStudyIdInfo': {'id': 'oxaliplatin induced neuropathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duloxetine', 'description': 'group 1', 'interventionNames': ['Other: Duloxetine']}, {'type': 'EXPERIMENTAL', 'label': 'Gabapentin', 'description': 'group 2', 'interventionNames': ['Other: Gabapentin']}, {'type': 'EXPERIMENTAL', 'label': 'Lacosamide', 'description': 'group 3', 'interventionNames': ['Other: Lacosamide']}], 'interventions': [{'name': 'Duloxetine', 'type': 'OTHER', 'description': 'Duloxetine 30mg / day for 12 cycles (up to 6 months)', 'armGroupLabels': ['Duloxetine']}, {'name': 'Gabapentin', 'type': 'OTHER', 'description': 'Gabapentin 300 mg / day for 12 cycles (up to 6 months)', 'armGroupLabels': ['Gabapentin']}, {'name': 'Lacosamide', 'type': 'OTHER', 'description': 'Lacosamide 50 mg / day for 12 cycles (up to 6 months)', 'armGroupLabels': ['Lacosamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '040', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Oncology Department, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist', 'investigatorFullName': 'Sally Said Mohamed Tantawy', 'investigatorAffiliation': 'Tanta University'}}}}