[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649620":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ALA Group","EXPERIMENTAL","ALA Group: patients will receive Alpha lipoic acid 600mg oral tablet twice daily for 6 months",[13],"Drug: alpha lipoic acid 600 mg twice daily",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Control group will receive identical placebo oral tablet twice daily for 6 months",[19],"Other: Placebo Tablet",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","alpha lipoic acid 600 mg twice daily","Thiotex Forte® 600 mg film coated tablets.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Tablet","Placebo tablets \u002Ftwice daily for 6 months",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ghada Ramadan Youssef","CONTACT","+20 01097001838","ghada.ms2425015@pharma.asu.edu.eg",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Nasser Institute for Research and Treatment.","RECRUITING","Cairo","Egypt","EG",{"type":45,"coordinates":46},"Point",[47,48],31.24967,30.06263,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":52,"phoneExt":26,"email":36},"+2001097001838",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ghada Ramadan","Teaching Assistant","100649620","phase-2-protective-role-of-alpha-lipoic-acid-in-chemotherapy-induced-mucositis-100649620",false,"NCT07736495","Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis","Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Newly diagnosed chemotherapy naive CRC patients\n3. Planned to receive FOLFOX-6 protocol as adjuvant, neoadjuvant or palliative therapy.\n4. Adequate liver function (liver transaminases level \\\u003C 3 times upper normal limits and total bilirubin \\\u003C 1.5 times upper normal limits).\n5. Adequate kidney function (estimated glomerular filtration rate \\>60 ml\u002Fmin).\n6. Adequate bone marrow function (WBCs count \\> 3000 cells\u002Fmm3, ANC count \\>1500 cells\u002Fmm3 and platelets count \\> 100,000 cells\u002Fmm3).\n\nExclusion Criteria:\n\n1. Presence of other primary cancers.\n2. Treatment with ALA for any other indication.\n3. Allergy to ALA.\n4. Pregnant or lactating women.\n5. Patients with previous mucositis for any reason.\n6. Patients who cannot tolerate oral intake.\n7. Patients receiving other dietary antioxidant supplements.","ALL","18 Years",{"count":67,"type":68},50,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE2","PHASE3","Colorectal cancer (CRC) represents one of the most common cancers worldwide and 5-Fluorouracil (5-FU) is still the mainstay of treatment. However, 5-FU is often implicated in inducing oral mucositis (OM), a painful inflammatory condition that may hinder oral intake, negatively impact quality of life and disrupt adherence with cancer treatment.\n\nOxidative stress and inflammation play a vital role in OM pathogenesis. Alpha-lipoic acid (ALA) is a powerful antioxidant and anti-inflammatory agent that has demonstrated protective effects towards chemotherapy-induced mucosal damage in preclinical studies.\n\nTherefore, ALA may be a promising strategy to minimize or avoid 5-FU-induced oral mucositis in patients with colorectal cancer, which deserves additional clinical investigation.",[75],"Colorectal Cancer",[77,78,79,80,81,82],"Alpha lipoic acid","Colorectal cancer","Oral Mucositis","5-Fluorouracil","Oxidative stress","Inflammation","2026-07-29",{"date":85,"type":86},"2026-07-30","ACTUAL",{"date":88,"type":86},"2026-07-27",{"date":90,"type":68},"2026-12-29",{"name":5,"class":6},1]