[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-radiation-dermatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-radiation-dermatitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,54,85,111,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100635482","effectiveness-of-09-normal-saline-soaking-in-managing-acute-radiation-dermatitis-100635482",false,"NCT07553260","Effectiveness of 0.9% Normal Saline Soaking in Managing Acute Radiation Dermatitis","The Effectiveness of Saline Soaks in Managing Acute Radiation Dermatitis","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Patients receiving definitive radiotherapy for sarcomas or head and neck cancer (primary or postoperative treatment)\n* Planned radiation dose between 60-70 Gy according to disease-specific protocols\n* No prior history of malignancy other than sarcomas\n* Ability and willingness to comply with study procedures (\\>90% expected adherence)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients receiving palliative radiotherapy\n* Known pre-existing skin disorders affecting radiation area (e.g., systemic lupus erythematosus, scleroderma)\n* ECOG performance status ≥2\n* Previous radiotherapy to the same treatment field\n* Any condition that, in the investigator's judgment, may interfere with participation or wound healing assessment","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to learn if normal saline soaks can reduce the severity of acute radiation dermatitis in patients with sarcomas or head and neck cancer receiving radiotherapy. It will also learn if saline soaks can improve wound healing and reduce treatment interruptions caused by skin toxicity. The main questions it aims to answer are:\n\n1. Does the application of normal saline soaks reduce the severity of acute radiation dermatitis according to CTCAE Version 5.0?\n2. Does the use of normal saline soaks improve wound healing time and reduce the frequency and duration of radiotherapy interruptions? Researchers will compare standard care plus saline soaks (intervention group) to standard care alone (control group) to see if saline soaks reduce skin reaction severity and improve clinical outcomes.\n\nParticipants will:\n\n1. Be randomly assigned to receive either standard care alone or standard care with daily saline soaks\n2. Apply saline-soaked gauze to the affected radiation area for 5-10 minutes once daily (intervention group only)\n3. Attend weekly clinic visits for skin assessment during radiotherapy\n4. Be assessed for skin reaction severity, wound healing, and treatment interruptions at baseline, after 4 weeks, and 2 weeks after completing treatment",[26,27,28],"Acute Radiation Dermatitis","Head and Neck Cancer (H&N)","Sarcomas",[30,31,32,33,34,35,36,37,38,39,40],"Dermatitis, Radiation-Induced","Skin Diseases, Radiation-Induced","Radiotherapy","Head and Neck Neoplasms","Sarcoma","Sodium Chloride","Wound Healing","Skin Care","Moist Desquamation","Supportive Care","Treatment Outcome","NOT_YET_RECRUITING","2026-04-20",{"date":44,"type":45},"2026-04-27","ACTUAL",{"date":47,"type":20},"2026-05",{"date":49,"type":20},"2027-06",{"name":51,"class":52},"King Hussein Cancer Center","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":53},"100580479","mepilex-lite-dressings-for-the-treatment-of-acute-radiation-dermatitis-of-anal-canal-skin-100580479","NCT06837831","Mepilex Lite Dressings for the Treatment of Acute Radiation Dermatitis of Anal Canal Skin","Clinical Efficacy of Mepilex Lite Dressings Combined With Indomethacin Suppositories in the Treatment of Acute Radiation Dermatitis Caused by Rectal Cancer Radiotherapy: a Randomized Controlled Trial","Inclusion criteria\n\n1. Confirmed rectal cancer by histopathological diagnosis;\n2. Individuals with clear indications for radiotherapy;\n3. Individuals who receive radiation therapy for the first time and develop grade 2 or higher acute radiation dermatitis after receiving radiation therapy;\n4. Age ≥ 18 years old;\n5. Those who voluntarily participate in this study and sign the informed consent form.\n\nExclusion criteria\n\n1. Individuals with allergic constitution and allergies to the drugs and materials used in this study;\n2. Those who withdraw or interrupt radiotherapy midway;\n3. Individuals with mental illness, emotional instability, or inability to express their own feelings;\n4. Individuals with various comorbidities such as serious cardiovascular and cerebrovascular diseases, digestive system diseases, hematological diseases, and infectious diseases;\n5. Physical condition score (Eastern Cooperative Oncology Group, ECOG) \\>3 points;\n6. Individuals suffering from anal fissures and other diseases that cause skin damage to the anal canal;\n7. Individuals with an artificial anus.",{"count":62,"type":20},274,[23],"Background: According to GLOBOCAN 2022 statistics, colorectal cancer has become the third most common cancer disease worldwide, and also the second leading cause of death. The incidence rate of rectal cancer is particularly prominent. Radiotherapy is one of the important methods for comprehensive treatment of rectal cancer, but the radiation damage caused by radiotherapy cannot be ignored. During radiotherapy for rectal cancer, the skin of the anal canal will be damaged by radiation, resulting in acute radiation dermatitis, which is characterized by redness, pain, and ulcers. The main symptom of patients is anal pain. As the radiation dose accumulates, the skin damage to the anal canal becomes increasingly severe, and the patient's anal pain becomes more severe, which seriously affects the patient's quality of life. Mepilex Lite Dressings can absorb the exudate, keep it moist, promote the healing of radioactive dermatitis, and relieve pain. However, when inserting into the anal canal, the patient reported significant pain that was difficult to tolerate. Therefore, indomethacin suppositories were administered rectally before inserting the dressing, which has been proven to have a reliable analgesic effect by research. In summary, the main objective of this study is to determine the effectiveness of Mepilex Lite Dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis of anal canal skin in patients with rectal cancer undergoing radiotherapy.\n\nMethod: The research plan will be a prospective randomized controlled trial. Participants were randomly divided into an experimental group (n=137) and a control group (n=137) using a simple randomization method. The control group received indomethacin suppositories and routine nursing measures, while the experimental group received the same treatment as the control group and received insertion of Meipile Lite Dressing into the anal canal. The primary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 14th day after intervention, and the secondary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 7th and 21st days after intervention. At the same time, a questionnaire survey was conducted using the Digital Pain Assessment Scale, Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, and Skin Disease Patient Quality of Life Scale at baseline and on the 7th, 14th, and 21st days after intervention.",[66,67,26,68],"Rectal Cancer, Radiotherapy","Anal Pain","Anal Canal",[70,71,72,73,74,68],"Rectal cancer","mepilex lite dressings","indomethacin suppository","anal pain","Acute radiation dermatitis","RECRUITING","2026-04-06",{"date":78,"type":45},"2026-04-13",{"date":80,"type":45},"2026-02-01",{"date":82,"type":20},"2027-07-31",{"name":84,"class":52},"Qianfoshan Hospital",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":92,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":109,"locationsCount":53},"100622177","efficacy-and-safety-of-qibei-jiedu-formula-for-preventing-and-managing-acute-radiation-dermatitis-in-breast-cancer-patients-100622177","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",{"count":94,"type":20},60,[23],"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.",[26,98,99],"Traditional Chinese Medicine (TCM)","Breast Cancer",[74,101,99,102],"Integrated Traditional Chinese and Western Medicine","Traditional Chinese Medicine","2026-01-27",{"date":105,"type":45},"2026-02-02",{"date":103,"type":20},{"date":108,"type":20},"2026-12-31",{"name":110,"class":52},"LI FENG",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":92,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":53},"100445386","bacterial-cellulose-monolaurin-hydrogel-for-acute-radiation-dermatitis-100445386","NCT05079763","Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis","Bacterial Cellulose-monolaurin Hydrogel for Preventing Therapy-induced High-grade Acute Dermatitis Among Filipinos With Breast Adenocarcinoma: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Female sex at birth\n* Age at least 18 years at the time of invitation\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1\n* With histopathologic diagnosis of breast carcinoma\n* Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions\n* Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* With concurrent or previous history of any malignancy\n* With history of mediastinal or thoracic irradiation\n* With current bilateral synchronous breast carcinoma\n* With diagnosis of metastases from any form of breast cancer\n* With any skin lesion in the planned radiation field deemed deramtologically and\u002For radiotherapeutically relevant\n* With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)\n* With known history of hypersensitivities and\u002For reactions against any component of either experimental or comparator interventions\n* Inability to personally provide informed consent or to personally comply with skin care instructions","80 Years",{"count":120,"type":20},54,[23],"Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potentially leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.",[26],[125,126,127,128],"ARD","postmastectomy","breast cancer","breast adenocarcinoma","2026-01-08",{"date":131,"type":45},"2026-01-12",{"date":133,"type":45},"2021-09-01",{"date":135,"type":20},"2028-12-31",{"name":137,"class":52},"University of the Philippines",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":118,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":53},"100316042","strataxrt-vs-standard-clinical-practice-for-the-prevention-of-acute-dermatitis-in-head-and-neck-cancers-patients-100316042","NCT03394417","StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients","StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers","Inclusion Criteria:\n\n* patients who are 21 years of age or older\n* histological diagnosis of head and neck carcinoma available\n* patients who are to be treated with concurrent chemoradiation\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3\n* no known allergy to StrataXRT or silicone\n* able to give written informed consent, or have written consent given on their behalf\n\nExclusion Criteria:\n\n* patients who cannot apply the skin product or have it administered to them\n* patients with comorbidities and\u002For on medications that may alter the response of the skin e.g. connective tissue disorder\n* patients with existing rashes or wounds in the radiation field at baseline\n* patients receiving concurrent cetuximab during radiotherapy\n* previous radiotherapy to the head and neck region\n* female patients who are pregnant or breast feeding\n* unable to give written informed consent , or are unable to have written consent given on their behalf","21 Years",{"count":147,"type":20},100,[23],"This is a phase IV, prospective, double-blind, randomized controlled trial with 2 study arms. The study population will be patients receiving chemoradiation for head and neck carcinomas, the majority of whom will be outpatients unless they require inpatient supportive care during treatment.\n\nThere will be a 12 to 14-week longitudinal follow-up with 9 assessments conducted during this follow-up.\n\nThe estimated duration of recruitment will be 6-8 years.\n\nIntervention group If a patient is allocated to the intervention group following randomization, the patient will be treated with StrataXRT.\n\nControl group If a patient is allocated to the control group following randomization, the patient will be treated with standard clinical practice which consists of aqueous cream.",[151,26],"Head and Neck Cancers","2024-12-08",{"date":154,"type":45},"2024-12-12",{"date":156,"type":45},"2018-11-08",{"date":49,"type":20},{"name":159,"class":52},"National University Hospital, Singapore"]