[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517354":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":36,"overallStatus":43,"whyStopped":36,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stratum A (Symptomatic)","EXPERIMENTAL","Response rates at 1 month with a combination of steroids and CHL in this study is expected to be 65% as compared to the standard 50% response with the use of dexamethasone alone. For the study with an α of 0.1 and power of 80%,50 pts will be needed to achieve the desired output. In the first stage, 22 patients will be needed for assessment and continued to stage 2 if \\>10 responses are seen.The stage 2 of the study will be considered successful if \\>29 responses are achieved using the pre-specified response assessment criteria.Considering an attrition rate of 10% from lack of follow-up and another 10% for disease progression, an estimated 60 patients will be accrued in stratum A with the purpose of achieving 50 patients with endpoints available for analysis.",[13],"Drug: Chlorophyllin",{"label":15,"type":10,"description":16,"interventionNames":17},"Stratum B (Asymptomatic)","This stratum includes pts without neurological worsening during imaging diagnosis of RN (asymptomatic RN).Approx 30% of patients continue to be neurologically\u002F radiologically stable or regression of imaging findings without need for further interventions (including corticosteroids).In the proposed study with the use of CHL, 45% patients are assumed to remain clinically and neurologically stable. With an α of 0.1 and power of 80%, 48 patients will be needed to achieve the desired outcome. In the first stage, 23 patients will be needed for assessment and continue to stage 2 if \\>6 responses are seen.\n\nThe phase 2 study will be considered successful if \\>18 responses are achieved using the pre-specified response assessment criteria. Further considering an attrition rate of 10% from lack of follow-up and another 10% for disease progression, an estimated 58 patients will be accrued in stratum B with the purpose of achieving 48 patients with endpoints available for analysis.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Chlorophyllin","Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food coloring agent.",[9,15],[9,25],"Stratum A (Asymptomatic)",[27],{"name":28,"affiliation":29,"role":30},"Archya Dasgupta, MD","Tata Memorial Hospital","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Archya Dasgupta, MD, DNB","CONTACT","02224177000",null,"archya1010@gmail.com",{"name":39,"role":34,"phone":36,"phoneExt":36,"email":40},"Tejpal Gupta, MD, DNB","drtejpalgupta@gmail.com",[42],{"facility":29,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Mumbai","Maharashtra","400012","India","IN",{"type":50,"coordinates":51},"Point",[52,53],72.88261,19.07283,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":36,"phoneExt":36,"email":36},"Dr Archya Dasgupta, MD",{"type":30,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Dr Archya Dasgupta","Assistant Professor, Radiation Oncology",[62],{"name":63,"class":6},"Bhabha Atomic Research Centre","100517354","phase-2-a-study-of-chlorophyllin-for-the-management-of-brain-radio-necrosis-in-patients-with-diffuse-glioma-100517354",false,"NCT06016452","A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma","A Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma","CHROME","Inclusion Criteria:\n\n* Histological diagnosis of diffuse glioma.\n* Radionecrosis on imaging with new neurological symptoms\u002F worsening of prior deficits (Stratum A) or\n* without new symptoms (Stratum B).\n* Karnofsky Performance Scale (KPS) ≥ 50.\n\nExclusion Criteria:\n\n* No tissue diagnosis.\n* KPS\\\u003C 50.\n* Disease progression\n* Contraindications to corticosteroids.\n* Altered mental status with deficits in understanding or inability to consent to the study.\n* Brainstem glioma\n* Indeterminate for radionecrosis vs disease progression\n* Prior treatment with bevacizumab (either for disease progression or radionecrosis)","ALL","18 Years","70 Years",{"count":76,"type":77},118,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN).\n\nAt the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients.\n\nThis is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis.\n\nChlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent.\n\nThis is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years.\n\nThe study is funded by Bhabha Atomic Research Centre (BARC).",[83,84,85,86],"Diffuse Glioma","Radionecrosis of Brain","High Grade Glioma","Glioblastoma Multiforme","2025-04-08",{"date":89,"type":90},"2025-04-11","ACTUAL",{"date":92,"type":90},"2023-11-13",{"date":94,"type":77},"2025-11",{"name":5,"class":6},1]