[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635134":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL",null,[13],"Drug: Experimental Group (dexamethasone enema)",{"label":15,"type":16,"description":11,"interventionNames":17},"Control Group","ACTIVE_COMPARATOR",[18],"Drug: Control group (dexamethasone enema)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Experimental Group (dexamethasone enema)","Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Control group (dexamethasone enema)","Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Xiaosheng He","CONTACT","+862085655905","hexsheng@mail.sysu.edu.cn",[36],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Sixth Affiliated Hospital, Sun Yat-sen University","Guangzhou","Guangdong","510655","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.25,23.11667,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100635134","phase-2-improvement-effect-of-dexamethasone-enema-for-acute-radiation-induced-rectal-injury-100635134",false,"NCT07548736","Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury","Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Aged 18 to 75 years, regardless of gender;\n2. Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;\n3. Patients pathologically diagnosed with rectal cancer;\n4. Undergoing conventional pelvic radiotherapy (total dose of 40-50.4Gy in 25-28 fractions);\n5. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months;\n6. Assessment by the attending physician and researcher indicates that vital organ function can tolerate the treatment risks.\n\nExclusion Criteria:\n\n1. Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;\n2. Patients who have received pelvic radiotherapy;\n3. Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;\n4. Pregnant or breastfeeding women;\n5. Patients expected to undergo major surgery during the study period;\n6. Participation in other clinical trials within 4 weeks prior to enrollment;\n7. A history of alcohol abuse, drug use, or substance abuse within the past year;\n8. Severe allergic constitution, or allergy to dexamethasone;\n9. Inability to cooperate with the enema;\n10. Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.","ALL","18 Years","75 Years",{"count":64,"type":65},40,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","Research Objective and Principle: Through a randomized controlled study, evaluate the effectiveness of dexamethasone in improving radiation-induced rectal injury in rectal cancer patients undergoing pelvic radiotherapy, thereby providing evidence for treatment options in patients at risk of radiation-induced rectal injury and aiming for adoption in international guidelines.\n\nPrimary Objective: Improvement rate of radiation-induced rectal injury. Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of pelvic radiotherapy, safety of dexamethasone enema, quality of life, pathological complete response (pCR) rate.\n\nStudy Design: Prospective, single-center, randomized controlled study. Study Population and Expected Enrollment: Patients with rectal cancer undergoing conventional pelvic radiotherapy, expecting to enroll 40 patients.\n\nTrial Duration: From February 2026 to February 2028.\n\nIntervention:\n\nExperimental Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.\n\nControl Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion.\n\nStatistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 86%, and it is expected that the experimental group can reduce it to 40%. The sample size was estimated using a formula designed to compare 2 proportions, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.",[71],"Acute Radiation Enteritis",[73,74,75,76],"Acute radiation-induced rectal injury","Rectal cancer","Conventional pelvic radiotherapy","Dexamethasone enema","NOT_YET_RECRUITING","2026-04-21",{"date":80,"type":81},"2026-04-23","ACTUAL",{"date":83,"type":65},"2026-04-24",{"date":85,"type":65},"2028-04-24",{"name":5,"class":6},1]