[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiation-proctitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiation-proctitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,66,110,142,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100639569","soft-tissue-radiation-injury-patient-reported-evaluation-in-a-single-centre-cohort-study-stripe-100639569",false,"NCT07611864","Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)","karolinskaUH","Inclusion Criteria:\n\n* Adult patients (\\>18 years old)\n* Late radiation tissue injury\n* Treated with HBOT\n\nExclusion Criteria:\n\n* Requested not to be included in the study (Retrospective cohort)\n* Not signed informed consent (Prospective cohort)","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","12 Months","OBSERVATIONAL","Radiotherapy cures many cancers but can cause late radiation-induced tissue injury (LRTI), leading to long-term symptoms from the bladder and bowel and reduced health-related quality of life (HRQoL). Hyperbaric oxygen therapy (HBOT) is an established treatment that reduces chronic inflammation and promotes tissue repair. Randomized studies have demonstrated improvements in symptoms and quality of life, but only a small proportion of affected patients receive HBOT.\n\nThis study aims to longitudinally describe a cohort of patients with LRTI treated with HBOT at Karolinska University Hospital and to analyze associations between treatment, timing, and patient characteristics. The goal is to improve understanding of which patients benefit most from HBOT and when treatment should be initiated.",[25,26,27],"Cystitis, Radio Induced","Soft Tissue Radionecrosis (STRN)","Radiation Proctitis","RECRUITING","2026-06-01",{"date":31,"type":32},"2026-06-03","ACTUAL",{"date":34,"type":32},"2026-05-05",{"date":36,"type":20},"2040-12-31",{"name":38,"class":39},"Karolinska University Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100622054","association-between-clinical-subtypes-and-prognosis-in-radiation-rectal-injury-100622054","NCT07378631","Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury","Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury: A Prospective, Observational Study","Inclusion Criteria:\n\n1. 18-80 years;\n2. Diagnosed with radiation rectal injury.\n\nExclusion Criteria:\n\n1. Ongoing cancer therapy;\n2. Tumor recurrence or metastasis.","80 Years",{"count":50,"type":20},150,"This is a prospective, observational study aimed at exploring the associations between the clinical subtypes of radiation rectal injury and prognosis. The study is planed to commence in November 2025 and prospectively observe 150 patients. During the study period, researchers will not intervene in clinical treatment decisions but will only collect patient clinical information, intestinal endoscopy\u002Fimaging\u002Fpathological data, test results, and follow-up data. The study results will fill the evidence gap in this field, advance the diagnosis and treatment of radiation-induced rectal injury, and provide scientific support for improving the prognosis of similar patients.",[53,27],"Radiotherapy",[55,56],"radiotherapy","radiation proctitis","2026-01-22",{"date":59,"type":32},"2026-01-30",{"date":61,"type":32},"2025-12-04",{"date":63,"type":20},"2026-12-31",{"name":65,"class":39},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":74,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":89,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100612907","gut-microbiome-in-gynecological-cancer-patients-with-pelvic-toxicity-controls-versus-ozone-treatment-microzoginetox-100612907","NCT07259681","Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)","Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.","MicrOGineTox","Inclusion Criteria for all patients (Cases and Controls):\n\n1. Adult women (\\>=18 years).\n2. Diagnosed with gynecological tumors (any location and stage).\n3. Previously treated with radiotherapy and\u002For chemotherapy.\n4. Must accept and sign the specific informed consent for this study.\n\n   Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):\n5. Must present chronic TPIRQT with \\>= 3 months of duration after habitual symptomatic treatment.\n6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.\n\nExclusion Criteria for all patients (Cases and Controls):\n\n1. Not meeting all inclusion criteria.\n2. Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.\n3. Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.\n4. Unwillingness or inability to provide written informed consent for study participation.","FEMALE",{"count":76,"type":20},38,"4 Months","Patients treated for gynecological tumors with radiotherapy (RT) and\u002For chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.",[80,81,82,83,27,84,85,86,87,88],"Pelvic Toxicity","Radiation Toxicity","Chemotherapy Toxicity","Gynecological Tumors","Radiation Cystitis","Vaginal Mucositis","Vulvar Mucositis","Quality of Life","Dysbiosis",[90,91,92,93,53,94,95,96,97,98,88],"Gut microbiota","Ozone","Ozone therapy","Gynecological tumors","Chemotherapy","Side effects","Actinic proctitis","Actinic cystitis","Quality of life","NOT_YET_RECRUITING","2025-12-16",{"date":102,"type":32},"2025-12-22",{"date":104,"type":20},"2026-01-15",{"date":106,"type":20},"2028-03-31",{"name":108,"class":39},"Bernardino Clavo, MD, PhD",2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":40},"100612010","phase-2-a-phase-ii-single-arm-study-of-high-bioavailability-curcumin-as-neoadjuvant-chemoradiotherapy-in-mid-to-low-rectal-cancer-integrated-clinical-and-translational-analysis-of-tumor-tissue-100612010","NCT07248020","A Phase II Single-Arm Study of High-Bioavailability Curcumin as Neoadjuvant Chemoradiotherapy in Mid-to-Low Rectal Cancer: Integrated Clinical and Translational Analysis of Tumor Tissue","BCMRECRAD","Inclusion Criteria:\n\n(A) Males and females more than 20 years of age (B) Signed informed consent (C) Patients with a pathologically proven rectal adenocarcinoma located less than 10 cm to the anus.\n\n(D) Clinical staging (AJCC 8th ed.): T2-4 N0 M0 or T any N1-2 M0 (E) Distal metastasis has been excluded by imaging study: by chest-to-pelvic computed tomography or Positron Emission Tomography (F) Preoperative pelvic staging by pelvic Magnetic Resonance Imaging (preferred) or trans-rectal ultrasound (G) Patients with WHO\u002FECOG performance scale 0 or 1\n\nExclusion Criteria:\n\n(A) Refuse to sign the informed consent (B) Distal metastasis revealed by the imaging study (C) Patients does not receive radiotherapy (D) Unable to receive further curative resection (E) Patients receive tumor resection before the neoadjuvant treatment (F) Patients have history of more than 5 Gy of pelvic radiation (G) Patients in pregnancy or lactation status (H) Patients have allergic history to curcumin, 5-fluouracil or oxaliplatin (I) Patients of childbearing potential can not cooperate with appropriate contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) (J) Patients with any concurrent malignancy; patients with history of malignancy should be cancer-free for more than 5 years (K) Patients with New York Heart Association (NYHA) class III or IV heart failure, unstable angina pectoris, unstable cardiac arrhythmia or tachycardia (heart rate \\> 100 beats\u002Fminute) (L) Patients have concurrent uncontrolled medical conditions, such as illness ongoing or requiring IV antibiotics, severe chronic renal failure (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) or severe active hepatitis(AST\u002FALT\\>3x upper normal limit)、Total Bilirubin\\>2 mg\u002Fdl (M) Patients with previous or current drug abuse (N) Patients underwent major surgery within 28 days of study enrollment (except diverting colostomy) (O) Patients have Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis (P) Patients have known dipyrimidine dehydrogenase deficiency (DPD) (Q) Patients with congenital iron metabolic or hematopoietic diseases (R) Patients with synchronous colon cancer (S) The Patients with hematologic abnormalities (INR \\> 1.5, white blood cell (WBC) count \\\u003C 3,000\u002FμL, absolute neutrophil count (ANC) \\\u003C 1,500\u002FμL, platelet count \\\u003C 100,000\u002FμL, hemoglobin \\\u003C 9.0 g\u002FdL not caused by tumor treatment) or known hematologic diseases (aplastic anemia, myelodysplastic syndrome (MDS), leukemia, malignant lymphoma, multiple myeloma, hereditary hematologic diseases such as thalassemia, sickle cell anemia, etc.).\n\n(T) The patient has diabetes mellitus (U) The patient is taking the immunosuppressants Cyclosporine, Tacrolimus, Sirolimus, and Everolimus and antigoagulants (warfarin、NOACs、aspirin) (V) Patients with The medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements","20 Years",{"count":119,"type":20},72,"INTERVENTIONAL",[122],"PHASE2","This clinical study investigates the anti-inflammatory and anti-cancer properties of a high-bioavailability formulation of curcumin (BCM-95) in patients with mid-to-low rectal cancer receiving neoadjuvant chemoradiotherapy (nCRT). Curcumin, a polyphenolic compound derived from Curcuma longa, has demonstrated potent anti-inflammatory and anti-neoplastic activities through the modulation of multiple molecular signaling pathways. It has been recognized by the U.S. Food and Drug Administration (FDA) as \"Generally Recognized as Safe\" (GRAS; GRN No. 686), with an excellent safety profile when administered orally. Reported adverse effects are rare and primarily related to interference with bile secretion or iron metabolism.\n\nDespite its biological potential, conventional curcumin exhibits extremely low oral bioavailability due to its lipophilic nature, rapid metabolism, and systemic elimination. Clinical studies have reported that even at an oral dose of 12 grams per day, the maximum plasma concentration reaches only about 0.051 mg\u002FmL, with up to 75% of the administered dose excreted in feces. To overcome this limitation, the current trial utilizes a curcumin formulation with enhanced absorption (BCM-95), which combines curcumin with essential oils of turmeric to improve systemic bioavailability.\n\nThe primary objective of this single-arm, phase II trial is to evaluate whether oral curcumin supplementation can mitigate radiation-induced gastrointestinal toxicity-particularly radiation enteritis-during neoadjuvant chemoradiotherapy for rectal cancer. The secondary objectives include assessing its effect on treatment response, such as the pathological complete response (pCR) rate, tumor regression grade, and patient-reported outcomes related to bowel function and quality of life.\n\nIn addition, a translational research component is embedded within this study. Serial tumor tissue and blood samples will be collected at predefined time points to explore the molecular and immunological mechanisms underlying curcumin's therapeutic effects. Analyses will include assessments of inflammatory cytokines, oxidative stress markers, and tumor microenvironmental changes using molecular and histopathologic methods.\n\nOverall, this study aims to provide both clinical and mechanistic evidence supporting the potential of high-bioavailability curcumin as a safe, adjunctive therapeutic strategy to improve treatment tolerance and oncologic outcomes in rectal cancer patients undergoing chemoradiotherapy.",[125,126,127,27,128],"Rectal Cancer","Locally Advanced Rectal Cancer","Radiation-Induced Enteritis","Chemoradiotherapy-Related Toxicity",[130,131,132],"Curcumin","Rectal cancer","Chemoradiotherapy","2025-11-18",{"date":135,"type":32},"2025-11-25",{"date":137,"type":20},"2026-01-01",{"date":139,"type":20},"2028-12-31",{"name":141,"class":39},"Chang Gung Memorial Hospital",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":120,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":40},"100575725","phase-2-dietary-supplements-to-treat-radiation-induced-rectal-injury-100575725","NCT06776016","Dietary Supplements to Treat Radiation-Induced Rectal Injury","A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury","Inclusion Criteria:\n\n* Age 18-75 years\n* At least 3 months since the completion of pelvic radiotherapy\n* No evidence of tumor recurrence or metastasis\n* Rectal bleeding with grade 1-2 by LENT-SOMA scales\n\nExclusion Criteria:\n\n* Acute or chronic infectious diseases\n* Serious systemic diseases\n* Known allergies to any components of the study medication\n* Colonoscopy indicating rectal ulceration (\\>1cm2), fistula, stricture, or necrosis\n* Late complications related to pelvic radiation injury\n* Other hemorrhagic or coagulation disorders\n* Previous rectal resection\n* Bowel obstruction or perforation that require surgery\n* Cognitive or psychological disorder","75 Years",{"count":151,"type":20},33,[122],"This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. Efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the study.",[53,27],[55,56,156,157,158],"tributyrin","rectal bleeding","butyrate","2025-05-10",{"date":161,"type":32},"2025-05-13",{"date":163,"type":32},"2025-01-15",{"date":165,"type":20},"2025-12-31",{"name":65,"class":39},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":174,"targetDuration":4,"studyType":120,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100587224","phase-1-evaluate-the-distribution-and-dynamic-behavior-of-nuclide-labeled-th-sc01-cells-in-vivo-in-patients-with-radiation-proctitis-100587224","NCT06925607","Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis","A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis","Inclusion Criteria:\n\n1. Signed informed consent\n2. Good physical condition (WHO performance status score 0-1).\n3. Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors\n4. Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.\n5. The LENT-SOMA score was ≥1 during the screening period.\n6. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.\n\nExclusion Criteria:\n\n1. Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.\n2. Patients with allergic constitution or severe systemic autoimmune diseases.\n3. Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.\n4. Pregnant or lactating women.\n5. Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.\n6. Patients with a LENT-SOMA score of 4 during the screening period.\n7. Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.\n8. Patients with uncontrolled tumors, tumor recurrence or metastasis.\n9. Subjects received any investigational drug within 3 months prior to the screening.\n10. Subjects received stem cell treatment.\n11. Participants considered inappropriate to participate in this clinical trial",{"count":5,"type":20},[176],"PHASE1","A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis",[27],"2025-04-07",{"date":181,"type":32},"2025-04-13",{"date":183,"type":20},"2025-04",{"date":185,"type":20},"2026-12",{"name":187,"class":188},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY"]