Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT04737967
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2021-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}, {'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-30', 'studyFirstSubmitDate': '2021-01-30', 'studyFirstSubmitQcDate': '2021-01-30', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in average daily pain intensity', 'timeFrame': '6 weeks', 'description': 'Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF). Absolute change in the average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) from baseline to the end of 6 weeks measured by item # 5 of Brief Pain Inventory Score (BPI-SF). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain).'}, {'measure': 'Electrophysiological studies', 'timeFrame': '6 weeks', 'description': 'nerve conduction velocity at the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology Pain', 'Chemotherapy-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University.\n\nAll procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine.\n\nThe first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016).\n\nThe second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients, 18 years of age or older, with a cancer treated with Paclitaxel\n2. Patients must have a life expectancy of at least 24 weeks.\n3. Patients must sign an informed consent.\n4. Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.\n5. Patient matching high risk on the CIPN risk stratification scoring system\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases.\n2. Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.\n3. Patients may receive no other concurrent complementary medicines during this study.\n4. Patients with neuropathy induced diabetes.\n5. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections.'}, 'identificationModule': {'nctId': 'NCT04737967', 'briefTitle': 'The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mendel AI'}, 'officialTitle': 'The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'CIPN101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venlafaxine Treated Arm', 'interventionNames': ['Drug: Venlafaxine']}, {'type': 'EXPERIMENTAL', 'label': 'Memantine Treated Arm', 'interventionNames': ['Drug: Memantine']}], 'interventions': [{'name': 'Venlafaxine', 'type': 'DRUG', 'description': 'Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)', 'armGroupLabels': ['Venlafaxine Treated Arm']}, {'name': 'Memantine', 'type': 'DRUG', 'description': 'Patients will receive memantine (10 mg) once daily (Morel et al., 2016)', 'armGroupLabels': ['Memantine Treated Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Gehad Sayed Ahmed, MD', 'role': 'CONTACT', 'email': 'Gehad.S.Fadl@kasralainy.edu.eg', 'phone': '+201222352664'}], 'facility': 'Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Gehad Sayed Ahmed, MD', 'role': 'CONTACT', 'email': 'Gehad.S.Fadl@kasralainy.edu.eg', 'phone': '+201222352664'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mendel AI', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'G Fadl', 'investigatorAffiliation': 'Cairo University'}}}}