[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622177":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":53,"collaborators":57,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Standard basic treatment + Qibei Jiedu Formula",[13],"Drug: Standard Basic Treatment Combined with Qibei Jiedu Formula",{"label":15,"type":10,"description":16,"interventionNames":17},"Control Group","Standard basic treatment + Qibei Jiedu Formula simulator (containing 5% of the original formula dosage)",[18],"Drug: Standard Basic Treatment Combined with Qibei Jiedu Formula simulator",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Standard Basic Treatment Combined with Qibei Jiedu Formula","Participants will commence administration of either the Qibei Jiedu Formula on the first day of radiotherapy. The daily regimen consists of one decocted dose, divided into two sealed bags (specification: 100 mL per bag). One bag is to be taken orally twice daily (morning and evening) for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Basic Treatment Combined with Qibei Jiedu Formula simulator","Participants will begin taking either the simulator (containing 5% of the original formula dosage) on the first day of radiotherapy. The daily dose consists of one formula unit, decocted and divided into two bags of medicinal liquid (specification: 100 mL per bag). Participants are to take one bag per dose, twice daily (morning and evening), for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Li Feng, Doctor","CONTACT","+86-87788030","fengli663@126.com",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":38},"Yirui Yan","yyj010906@163.com",[40],{"facility":41,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":25},"National Cancer Center\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","Beijing","Beijing Municipality","100021","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","LI FENG","Director and Chief Physician, Department of Traditional Chinese Medicine",[58],{"name":5,"class":6},"100622177","efficacy-and-safety-of-qibei-jiedu-formula-for-preventing-and-managing-acute-radiation-dermatitis-in-breast-cancer-patients-100622177",false,"NCT07380230","Efficacy and Safety of Qibei Jiedu Formula for Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients","Efficacy and Safety of Qibei Jiedu Formula Versus Placebo in Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients: A Prospective, Double-blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with pathologically confirmed unilateral stage I-III non-inflammatory breast cancer, having undergone breast-conserving surgery or modified radical mastectomy, and having received or planned to receive standard adjuvant therapy according to current clinical guidelines.\n* Scheduled to receive postoperative adjuvant radiotherapy using a hypofractionated regimen (40-50 Gy\u002F15 fractions) as recommended by the NCCN Breast Cancer Guidelines and the CSCO Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition).\n* Meeting the TCM diagnostic criteria for the syndrome of Qi-Yin Deficiency with Blood Stasis and Toxin Accumulation.\n* Karnofsky Performance Status (KPS) score ≥70.\n* Age ≥18 years, female.\n* Voluntarily participating in the study and providing written informed consent.\n\nExclusion Criteria:\n\n* Presence of grade 4 radiation dermatitis requiring urgent intervention at enrollment or during the study.\n* Prior radiotherapy to the breast or chest within the past 3 months.\n* Any skin condition that may interfere with the assessment of radiation dermatitis, such as active infection, atopic dermatitis, psoriasis, vitiligo, active collagen vascular disease (e.g., scleroderma, lupus erythematosus), or other known autoimmune disorders significantly altering skin appearance or physiological response.\n* Pre-existing grade ≥2 hepatic\u002Frenal dysfunction or hematological toxicity (according to CTCAE v5.0 criteria) before treatment.\n* Concurrent participation in other clinical trials or concurrent use of other Chinese herbal preparations.\n* Unstable mental status or inability to cooperate with the study procedures.\n* Pregnant or lactating patients.\n* Known allergy to any component of the herbal formula used in this study.","FEMALE","18 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"NA","1. To evaluate the preventive and therapeutic effects of Qibei Jiedu Formula on acute radiation dermatitis in breast cancer patients, including the incidence of grade 2 or higher radiation dermatitis, wound healing time, and symptom relief.\n2. To observe the safety profile of Qibei Jiedu Formula.\n3. To investigate the potential role of Qibei Jiedu Formula in improving patients' quality of life.\n4. To explore the potential mechanism of action of Qibei Jiedu Formula in preventing and treating acute radiation dermatitis in breast cancer patients through exploratory indicators such as inflammatory cytokines and skin microbiota.\n5. This study is a small-scale exploratory clinical trial. It aims to collect preliminary efficacy and safety data from 60 participants to assess the \"add-on effect\" of Qibei Jiedu Formula on top of \"standard basic care\". The results are intended for estimating effect sizes and generating hypotheses to inform future large-scale studies, not for drawing definitive conclusions.",[76,77,78],"Acute Radiation Dermatitis","Traditional Chinese Medicine (TCM)","Breast Cancer",[80,81,78,82],"Acute radiation dermatitis","Integrated Traditional Chinese and Western Medicine","Traditional Chinese Medicine","NOT_YET_RECRUITING","2026-01-27",{"date":86,"type":87},"2026-02-02","ACTUAL",{"date":84,"type":70},{"date":90,"type":70},"2026-12-31",{"name":55,"class":6},1]