[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631708":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":47,"responsibleParty":58,"collaborators":27,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":27,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":27,"enrollmentInfo":70,"targetDuration":27,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":27,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard group","PLACEBO_COMPARATOR","Patients will receive modified FOLFOX-6 regimen or XELOX regimen The chemotherapy cycles will be received every 14 days for modified FOLFOX-6 regimen or every 21 days for XELOX regimen for 6 months and will be as follows :modified FOLFOX regimen , oxaliplatin 85 mg\u002Fm2 intravenous infusion in 500 mL 5% dextrose solution(on days 1 and 15) and leucovorin 400 mg\u002Fm2 intravenous infusion in 250 mL 5% dextrose solution both were given over 2 hours at the same time in separate bags using a Y-line access , followed by 5-fluorouracil 400 mg\u002Fm2 intravenous bolus given over 5 minutes, followed by 5-fluorouracil 2400 mg\u002Fm2 intravenous infusion in 500 mL 5% dextrose solution as a 46-hour infusion. XELOX regimen , oxaliplatin 130 mg\u002Fm2 intravenous infusion in 500 mL 5% dextrose over 2 hours and capecitabine 850 mg\u002Fm2 or 1000 mg\u002Fm2 per dose twice daily (total dose 1700 or 2000 per day )from evening of day 1 to morning of day15 plus starch placebo orally",[13],"Drug: Starch Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group","ACTIVE_COMPARATOR","patients with colorectal cancer will receive modified FOLFOX-6 regimen or XELOX regimen throughout the chemotherapy cycles plus memantine oral tablet 5 mg PO once daily initially; increased by increments of 5 mg\u002Fday each week; maintenance target dosage 20 mg\u002Fday and rosuvastatin tablet 20 mg orally daily.",[19,20],"Drug: Memantine","Drug: Rosuvastatin 20 Mg Oral Tablet",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Starch Placebo","starch placebo oral tablet will be given to patients plus the modified FOLFOX chemotherapy regimen or XELOX chemotherapy regimen",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Memantine","memantine 5 mg PO once daily initially; increased by increments of 5 mg\u002Fday each week; maintenance target dosage 20 mg\u002Fday",[15],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Rosuvastatin 20 Mg Oral Tablet","rosuvastatin 20 mg orally daily.",[15],[37],{"name":38,"affiliation":5,"role":39},"Eman Ayman Elsayed Abdallah a Abdallah, Pharm D","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":44},"CONTACT","022+01285941144","aymanemy155@gmail.com",{"name":46,"role":42,"phone":27,"phoneExt":27,"email":27},"Eman Ibrahim Abd Elkhader El berry i Lecturer of Clinical Pharmacy, MD",[48],{"facility":49,"status":27,"city":49,"state":27,"zip":27,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":27},"Tanta","Egypt","EG",{"type":53,"coordinates":54},"Point",[55,56],31.00192,30.78847,{"lat":56,"lon":55},{"type":39,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Eman Ayman Elsayed Abdallah","principle investigator","100631708","phase-2-neuroprotection-of-memantine-and-rosuvastatin-100631708",false,"NCT07504198","Neuroprotection of Memantine and Rosuvastatin","Neuroprotective Effect of Memantine and Rosuvastatin Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer","Inclusion criteria\n\n* Age above 18 years old for both gender .\n* Adequate baseline hematologic values (absolute neutrophil count ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL and hemoglobin level ≥ 10 g\u002Fdl).\n* Patients with adequate renal function (serum creatinine \\\u003C 1.5 mg\u002Fdl or creatinine clearance ˃ 45 mL\u002Fmin).\n* Patients with adequate liver function (serum bilirubin \\\u003C 1.5 mg\u002Fdl).\n* Patients with performance status \\\u003C2 according to Eastern Cooperative Oncology Group (ECOG) score.\n* Patients who will be scheduled to receive modified FOLFOX-6 or XELOX regimen.\n* Patients with histologically confirmed diagnosis of stage III or stage IV colorectal cancer.\n\nExclusion criteria:\n\n* Children \\\u003C 18 years old.\n* Prior exposure to neurotoxic chemotherapy (oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH).\n* Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C.\n* History of known allergy to oxaliplatin or other platinum agents.\n* Patients with other inflammatory or stressful conditions.\n* Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants, other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and phenytoin).\n* Patients on amantadine , acetazolamide, dextromethorphan, aluminum hydroxide magnesium hydroxide and febuxostat .\n* Concurrent active cancer originating from a primary site other than colon or rectum.\n* Pregnant and breastfeeding women.\n* Sever renal insufficiency (creatinine clearance \\\u003C 25 ml\u002F minute) .","ALL","18 Years",{"count":71,"type":72},46,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE2","PHASE3","Memantine is used to slow the neurotoxicity of Alzheimer disease. Rosuvastatin used as a lipid-lowering agent . Increased bioavailability of endothelial-derived nitric oxide improves endothelium function , increases cerebral blood flow which may all contribute to the neuroprotective effects of rosuvastatin .\n\nThe goal of this clinical trial is to prevent oxaliplatin induced peripheral neuropathy in patients with colorectal cancer.The aim of this current study is to assess the neuroprotective effect of memantine and rosuvastatin against oxaliplatin induced peripheral neuropathy.",[79],"Peripheral Nerve Disease","NOT_YET_RECRUITING","2026-03-25",{"date":83,"type":84},"2026-03-31","ACTUAL",{"date":86,"type":72},"2026-03",{"date":88,"type":72},"2027-05",{"name":5,"class":6},1]