[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629574":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":53,"responsibleParty":77,"collaborators":12,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":12,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":106,"whyStopped":12,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"control","NO_INTERVENTION","25 patients will receive only the standard of care as the chemotherapy regimen consists of ; cisplatin+gemcitabine.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Vit C","ACTIVE_COMPARATOR","25 patients will receive Vitamin C 500 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ).",[18],"Drug: Vitamin C",{"label":20,"type":15,"description":21,"interventionNames":22},"CoQ10","25 patients will receive Coenzyme q10 30 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ).",[23],"Drug: Coenzyme Q 10",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Vitamin C","Vitamin C 500 mg administered orally",[14],[31],"Ascorbic acid",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Coenzyme Q 10","30 mg administered orally",[20],[20],[38],{"name":39,"affiliation":40,"role":41},"Nagwa A Sabri, PHD","Professor of Clinical Pharmacy-Faculty of Pharmacy-Ain Shams University","PRINCIPAL_INVESTIGATOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Ghada S Elseidy, Master","CONTACT","01124006769","02","ghada.ms2324013@pharma.asu.edu.eg",{"name":50,"role":45,"phone":51,"phoneExt":47,"email":52},"Rana S Fouad, PHD","01208164247","ranasayed@pharma.asu.edu.eg",[54],{"facility":55,"status":12,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Nasser Institute for Research and Treatment","Cairo","Shoubra","11617","Egypt","EG",{"type":62,"coordinates":63},"Point",[64,65],31.24967,30.06263,{"lat":65,"lon":64},[68,72,75],{"name":69,"role":45,"phone":70,"phoneExt":47,"email":71},"Rasha M AbdelMotagalee, Senior","01067366826","elsayedonco@hotmail.com",{"name":73,"role":45,"phone":74,"phoneExt":47,"email":12},"Mohammed H","01002406744",{"name":76,"role":41,"phone":12,"phoneExt":12,"email":12},"Rasha M AbdelMotagalee, Consultant",{"type":41,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"ghada saeid","Principal Investigator","100629574","phase-2-renoprotective-role-of-vitamin-c-and-coenzyme-q10-in-nephrotoxicity-100629574",false,"NCT07476443","Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity","The Potential Renoprotective Effect of Vitamin c and Coenzyme q10 Against Cisplatin Induced Nephrotoxicity in Cancer Patients","VitC-CoQ10","Inclusion Criteria:\n\n* Chemotherapy-naïve patients diagnosed with different types of cancer.\n* Age :adult patients (aged 18-65 years)\n* Candidates eligible for induction chemotherapy (cisplatin+gemcitabine). Baseline (eGFR) ≥60 ml\u002Fmin\u002F1.73 m².\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2.\n* Hematologic parameters (WBC count ≥ 3,000\u002Fmm³ -- Platelet count ≥ 75,000\u002Fmm³-- Hb level ≥ 8.0 g\u002FdL)\n* Alanine aminotransferase (ALT) ≤3×(ULN).\n\nExclusion Criteria:\n\n* Prior chemotherapy.\n* Uncontrolled Diabetes mellitus, active infection, heart failure, liver impairment, gastritis or G-6-P) deficiency.\n* History of nephrotoxic drugs use over the past 3 months prior to recruitment (e.g., aminoglycosides, amphotericin B, or vancomycin).\n* Known allergy to any of the study drugs.","ALL","18 Years","65 Years",{"count":92,"type":93},75,"ESTIMATED","INTERVENTIONAL",[96,97],"PHASE2","PHASE3","Cisplatin is a widely used chemotherapy drug for many solid tumors (e.g., lung, bladder, ovarian, head and neck cancers). Despite its efficacy, its clinical use is limited by severe side effects, mainly nephrotoxicity, which occurs in \\~30% of patients after treatment. Once inside cells, cisplatin undergoes activation, leading to DNA and mitochondrial damage, oxidative stress, inflammation, apoptosis, and eventual acute kidney injury (AKI) or chronic kidney disease (CKD). Vitamin C (ascorbic acid) is a water-soluble antioxidant with broad protective roles, including free radical scavenging, DNA and protein protection, and glutathione restoration. Coenzyme Q10 (CoQ10) is a lipid-soluble antioxidant involved in mitochondrial energy production and regeneration of other antioxidants (vitamins C \\& E). Both antioxidants are generally safe at studied doses, with only mild gastrointestinal side effects reported. Therefore, evaluating their role in preventing cisplatin-induced nephrotoxicity in cancer patients is clinically valuable.\n\nAim of the study :\n\nThis study aims to evaluate the protective effects of (Vitamin C and Coenzyme q10) against cisplatin-induced nephrotoxicity in chemotherapy-naïve cancer patients.",[100],"Nephrotoxicity",[102,27,20,103,104,105],"Cisplatin","cancer","nephrotoxicity","KIM-1","NOT_YET_RECRUITING","2026-03-12",{"date":109,"type":110},"2026-03-17","ACTUAL",{"date":112,"type":93},"2026-04-20",{"date":114,"type":93},"2027-08-20",{"name":5,"class":6},1]