[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647386":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":24,"locations":34,"responsibleParty":56,"collaborators":23,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":23,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":37,"whyStopped":23,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Sodium Copper Chlorophyllin","EXPERIMENTAL","Participants will receive oral sodium copper chlorophyllin (CHL) 750 mg once daily (tablet or oral suspension) beginning 48 hours before initiation of myeloablative total body irradiation (TBI) conditioning (Day -9) and continuing until Day +28 after allogeneic hematopoietic stem cell transplantation (HSCT). All participants will receive standard TBI-based conditioning and HSCT as part of routine clinical care. The study will evaluate the efficacy and safety of CHL in reducing the incidence and severity of oral mucositis.",[13],"Drug: Sodium Copper Chlorophyllin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sodium Copper Chlorophyllin","Sodium copper chlorophyllin (CHL) will be administered orally at a dose of 750 mg once daily (tablet or oral suspension) on an empty stomach, starting 48 hours before initiation of myeloablative total body irradiation (TBI) conditioning and continued until Day +28 after allogeneic hematopoietic stem cell transplantation (HSCT). The study drug is administered as an adjunct to standard TBI-based conditioning to evaluate its efficacy in reducing the incidence and severity of oral mucositis.",[9],[21,22],"CHL","Chlorophyllin",null,[25,30],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Sumeet Mirgh, MBBS MD DM Clinical Hematology","CONTACT","+91 9769918905","drsumeetmirgh@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":23,"email":33},"Dr. Anant Gokarn, MBBS MD DM Medical Oncology","+91 8097295540","anantgokarn@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Advanced Centre for Treatment, Research and Education in Cancer","RECRUITING","Navi Mumbai","Maharashtra","410210","India","IN",{"type":44,"coordinates":45},"Point",[46,47],73.01582,19.03681,{"lat":47,"lon":46},[50,54],{"name":51,"role":27,"phone":52,"phoneExt":53,"email":29},"Sumeet Mirgh, MBBS MD DM clinical hematology","+91 8130140245","8679\u002F8696",{"name":55,"role":27,"phone":23,"phoneExt":23,"email":33},"Anant Gokarn, MBBS DM MD Medical Oncology",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Dr Sumeet Mirgh","Professor","100647386","phase-2-chlorophyllin-for-reducing-oral-mucositis-in-total-body-irradiation-prior-to-transplant-100647386",false,"NCT07709195","Chlorophyllin for Reducing Oral Mucositis in Total Body Irradiation Prior to Transplant","Chlorophyllin as an Adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation","ChROMME-TBI","Inclusion Criteria\n\n* Patients ≥12 and ≤65 years of age\n* First allogeneic stem cell transplant\n* Total body irradiation dose (fractionated) ≥8 Gy\n\nExclusion Criteria\n\n* Known hypersensitivity or contraindications to sodium chlorophyllin (CHL)","ALL","12 Years","65 Years",{"count":72,"type":73},17,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The goal of this phase II, single-arm interventional clinical trial is to evaluate whether oral sodium copper chlorophyllin (CHL) can reduce the frequency and severity of oral mucositis in patients aged 12-65 years undergoing myeloablative total body irradiation (TBI) as part of conditioning before their first allogeneic Hematopoietic Stem Cell Transplantation (HSCT).\n\nThe main questions it aims to answer are:\n\nDoes oral chlorophyllin reduce the incidence of Grade III and IV oral mucositis by day +28 after HSCT? Does oral chlorophyllin reduce the duration of severe oral mucositis and the need for total parenteral nutrition (TPN), opioid analgesics, and other treatment-related toxicities, while maintaining acceptable safety?\n\nParticipants will:\n\nReceive oral sodium copper chlorophyllin 750 mg once daily (tablet or oral suspension) starting 48 hours before TBI conditioning and continuing until day +28 after HSCT.\n\nUndergo standard myeloablative TBI-based conditioning and allogeneic Hematopoietic Stem Cell Transplantation (HSCT) as part of routine clinical care.\n\nHave regular clinical assessments for oral mucositis, treatment-related toxicities, engraftment, and graft-versus-host disease (GVHD).\n\nProvide blood and saliva samples at predefined time points for cytokine and pharmacokinetic analyses.",[79,80,81,82],"Oral Mucositis","Total Body Irradiation","Hematological Malignancies","Hematopoietic Stem Cell Transplantation (HSCT)",[22,79,84,85,86,87,80],"Allogeneic HSCT","Phase II Trial","Supportive Care","Acute Leukemia","2026-07-23",{"date":90,"type":91},"2026-07-27","ACTUAL",{"date":93,"type":91},"2024-10-30",{"date":95,"type":73},"2027-03-05",{"name":5,"class":6},1]