[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487212":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":64,"collaborators":34,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":34,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":34,"enrollmentInfo":77,"targetDuration":34,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":34,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"placebo","PLACEBO_COMPARATOR","Group I Placebo group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus placebo tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows:\n\nDay 1 and Day 15: Oxaliplatin 85 mg\u002Fm2 intravenous infusion in 250-500 mL 5% dextrose solution and leucovorin 400 mg\u002Fm2 intravenous infusion in 5% dextrose solution both were given over 120 minutes at the same time in separate bags using a Y-line access, followed by 5-fluorouracil 400 mg\u002Fm2 intravenous bolus given over 2-4 minutes, followed by 5-fluorouracil 2400 mg\u002Fm2 intravenous infusion in 500 mL 5% dextrose solution as a 46-hour infusion.",[13],"Drug: Placebo tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"ketotifen oral tablets","ACTIVE_COMPARATOR","Group II ketotifen group n=32 Patients will receive 12 cycles of modified FOLFOX-6 regiment plus ketotifen tablets 2mg daily throughout the twelve chemotherapy cycles. The chemotherapy cycles will be received every 2 weeks and will be as follows:\n\nDay 1 and Day 15 : Oxaliplatin 85 mg\u002Fm2 intravenous infusion in 250-500 mL 5% dextrose solution and leucovorin 400 mg\u002Fm2 intravenous infusion in 5% dextrose solution both were given over 120 minutes at the same time in separate bags using a Y-line access, followed by 5-fluorouracil 400 mg\u002Fm2 intravenous bolus given over 2-4 minutes, followed by 5-fluorouracil 2400 mg\u002Fm2 intravenous infusion in 500 mL 5% dextrose solution as a 46-hour infusion",[19],"Drug: Ketotifen Oral Tablet",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Placebo tablets","12 cycles of modified FOLFOX-6 regimen (Oxaliplatin, Fluorouracil, calcium leucovorin) with 2 mg placebo tablets",[9],[27],"Oxaliplatin, Fluorouracil, calcium leucovorin",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ketotifen Oral Tablet","ketotifen is a potent anti histaminic drug that may prevent oxaliplatin induced peripheral neuropathy and mucositis and will be administered 2 mg daily along with the 12 cycles of modified Folfox-6 regimen",[15],[33],"ketotifen",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"salma S wahby, Master","CONTACT","00201111103067","salmawahby135@outlook.com",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Tarek M mostafa, Professor of clinical pharmacy","01154594035","tarek.mostafa@pharm.tanta.edu.eg",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Oncology department Tanta university","RECRUITING","Tanta","Other","31511","Egypt","EG",{"type":55,"coordinates":56},"Point",[57,58],31.00192,30.78847,{"lat":58,"lon":57},[61],{"name":62,"role":38,"phone":63,"phoneExt":34,"email":40},"salma S wahby","01111103067",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Salma Samah Sayed Wahby","clinical pharmacist","100487212","phase-3-the-possible-protective-role-of-ketotifen-against-oxaliplatin-induced-peripheral-neuropathy-100487212",false,"NCT05624138","The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy","The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer","Inclusion Criteria:\n\n* Patients with histologically confirmed diagnosis of Stage III colorectal cancer.\n* Patients who will be scheduled to receive modified FOLFOX-6.\n* Patients with no contraindication to chemotherapy.\n* Males and females aged ≥ 18 years old.\n* Adequate baseline hematologic values (absolute neutrophilic 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 (ClCr) ˃ 45 mL\u002Fmin).\n* Patients with adequate liver function (serum bilirubin \\\u003C 1.5 mg\u002Fdl).\n* Patients with performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG) score.\n\nExclusion Criteria:\n\n* Children \\\u003C 18 years old.\n* Prior exposure to neurotoxic chemotherapy (Oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH) for at least 6 months prior the study treatment.\n* Evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes, brain tumor, brain trauma).\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* Patients with glaucoma, cataract, other chronic eye disease, seizure, diabetes, heart diseases, low blood pressure, dizziness, vertigo, ménière's disease and CNS disorders.\n* Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants, other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and phenytoin, etc…).\n* Patients on amifampridine, bupropion and donepezil.\n* Concurrent active cancer originating from a primary site other than colon or rectum.\n* Pregnant and breastfeeding women.","ALL","18 Years",{"count":78,"type":79},64,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","The aim of current study is to evaluate the possible protective role of Ketotifen against oxaliplatin-induced peripheral sensory neuropathy in patient with stage III colorectal cancer.\n\nThis study will be a randomized placebo controlled parallel study.64 patients with colorectal cancer will be randomized to 2 groups:\n\nGroup I (control group; n=32) which will receive 12 cycles of modified FOLFOX-6 regimen plus placebo tablets twice daily.\n\nGroup II (ketotifen group; n=32) which will receive modified FOLFOX-6 regimen in addition to ketotifen 2 mg daily\n\nBlood sample collection and biochemical assessment:\n\n* Serum IL-6 as a marker of inflammation.\n* Serum superoxide dismutase (SOD) as a biomarker of oxidative stress.\n* Serum neurotensin as a biomarker for neuropathy.\n\nAssessment of oxaliplatin induced peripheral sensory neuropathy will be done through:\n\n* The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy at baseline and by the end of every two oxaliplatin cycles.\n* The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy\u002FGynecologic Oncology Group \"FACT\u002FGOG-Ntx-12\" at baseline and by the end of every two oxaliplatin cycles.\n* The assessment of the severity of neuropathic pain through brief pain inventory short form \"BPI-SF\" worst item. Severity of neuropathic pain will be assessed at baseline and by the end of every two oxaliplatin cycles.",[85],"Neuropathy;Peripheral","2025-05-09",{"date":88,"type":89},"2025-05-11","ACTUAL",{"date":91,"type":89},"2022-11-09",{"date":93,"type":79},"2025-06",{"name":5,"class":6},1]