[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-mucositis-in-patients-undergoing-hsct\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-mucositis-in-patients-undergoing-hsct":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100655191","phase-2-study-of-a-copaiba-based-mouthwash-combined-with-low-level-laser-therapy-in-the-prevention-of-oral-mucositis-in-patients-undergoing-hematopoietic-stem-cell-transplantation-100655191",false,"NCT07810530","Study of a Copaiba-Based Mouthwash Combined With Low-Level Laser Therapy in the Prevention of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation","Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy of a Copaiba-Based Mouthwash Combined With Low-Level Laser Therapy in the Prevention of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Patients aged 12 years or older;\n* Patients indicated for autologous HSCT;\n* Patients with intact oral mucosa on the first day of conditioning;\n* Patients able to understand and adhere to the protocol;\n* Patients able to perform the oral hygiene protocol;\n* Patients who, after receiving information and instructions, can provide free and informed consent (ICF) and assent forms.\n\nExclusion Criteria:\n\n* Patients currently receiving drugs for treatment and\u002For prevention of oral mucositis (OM);\n* Patients who had HSCT indicated but whose procedure was canceled for any reason;\n* Patients undergoing a second autologous HSCT;\n* Patients reporting any allergy to copaiba-based compounds.","ALL","12 Years",{"count":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Oral mucositis (OM) one of the most significant acute toxicity of Hematopoietic Stem Cell Transplantation (HSCT). There is already scientific evidence suporting OM the use of: low-level laser therapy (LLLT), cryotherapy (in autologous HSCT when conditioning regimens include high-dose melphalan), and keratinocyte growth factor (in autologous HSCT with high-dose chemotherapy associated with RT). In this sense, an alternative treatment becomes necessary. Based on the preliminary results of the phase I study, a double-blind, randomized phase II study is suggested to evaluate the effectiveness of copaiba-based mouthwash in the prevention of oral mucositis in HSCT was proposed. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x\u002Fday. Each group will have 38 patients and be blind to the group in which they are included. They will be evaluated daily by a dental surgeon about oral mucositis, pain in the oral cavity and oropharynx, and dysphagia and will undergo daily laser therapy sessions, until neutropenic recovery.",[26,27,28,29],"Oral Mucositis","Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy","Oral Mucositis Due to Chemotherapy","Oral Mucositis in Patients Undergoing HSCT",[31,32],"Oral mucositis","Hematopoietic Stem Cell Transplantation","RECRUITING","2026-09-03",{"date":36,"type":37},"2026-09-09","ACTUAL",{"date":39,"type":37},"2026-03-29",{"date":41,"type":20},"2028-02",{"name":43,"class":44},"Instituto Nacional de Cancer, Brazil","OTHER_GOV"]