[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-radiation-enteritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-radiation-enteritis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Acute Radiation Enteritis",[29,30,31,32],"Acute radiation-induced rectal injury","Rectal cancer","Conventional pelvic radiotherapy","Dexamethasone enema","NOT_YET_RECRUITING","2026-04-21",{"date":36,"type":37},"2026-04-23","ACTUAL",{"date":39,"type":21},"2026-04-24",{"date":41,"type":21},"2028-04-24",{"name":43,"class":44},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"100616170","phase-2-preventive-efficacy-of-bergmann-enema-for-acute-radiation-induced-rectal-injury-in-rectal-cancer-patients-undergoing-short-course-radiotherapy-100616170","NCT07302126","Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy","Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy: a Prospective, Single-arm, Phase II 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 with pathologically confirmed mid-lower rectal cancer;\n4. Undergoing short-course pelvic radiotherapy (total dose of 25-35Gy in 5.0-7.0 fractions over 5 consecutinve days);\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 Bergmann;\n9. Inability to cooperate with the enema;\n10. Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.",{"count":20,"type":21},[24],"Research Objective and Principle: To evaluate the effectiveness of Bergmann enema in preventing acute radiation-induced rectal injury in patients with rectal cancer, thereby providing a basis for treatment options for potential radiation-induced rectal injury patients, aiming for adoption by international guidelines.\n\nPrimary Objective: Incidence of grade 2 or higher radiation-induced rectal injury.\n\nSecondary Objectives: Severity of radiation-induced rectal injury, completion rate of short-course radiotherapy, safety of Bergmann enema, quality of life, pathological complete response (pCR) rate.\n\nStudy Design: Prospective, single-center, single-arm study.\n\nStudy Population and Expected Enrollment: Patients with rectal cancer undergoing short-course radiotherapy, expecting to enroll 40 patients.\n\nTrial Duration: From December 2025 to December 2026.\n\nIntervention: Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.\n\nStatistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 80%, and it is expected that Bergmann enema preventive treatment can reduce it to 50%. The sample size was estimated using a formula designed to calculate single-group rate, 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.",[27],[29,30,58,59],"Short-course radiotherapy","Bergmann enema","2025-12-11",{"date":62,"type":37},"2025-12-24",{"date":60,"type":21},{"date":65,"type":21},"2026-12-11",{"name":43,"class":44},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":45},"100576273","phase-1-efficacy-and-safety-of-adjunctive-use-of-rifaximin-in-preventing-radiotherapy-induced-diarrhea-in-cancer-patients-100576273","NCT06783153","Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients","Inclusion Criteria:\n\n* Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.\n* Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.\n\nExclusion Criteria:\n\n* Patients who have a record of intestinal resection in their medical history.\n* Patients with a medical background of irritable bowel syndrome.\n* Patients with a history of inflammatory bowel disease.\n* Patients who regularly take anti-diarrheal medications before commencing radiotherapy.\n* Patients experiencing diarrhea at the outset of the study.\n* Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications.\n* Pregnant or lactating woman.\n* Patients allergic to rifamycin.",{"count":74,"type":21},80,[76,24],"PHASE1","Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.",[79,27,80,81,82,83,84,85],"Radiotherapy Induced Diarrhea","Prostate Cancer","Cervical Adenocarcinoma","Bladder (Urothelial, Transitional Cell) Cancer","Rectal Adenocarcinoma","Pelvic Radiotherapy","Rifaximin","2025-01-14",{"date":88,"type":37},"2025-01-20",{"date":88,"type":21},{"date":91,"type":21},"2025-12",{"name":93,"class":44},"Mansoura University"]