[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-mucositis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-mucositis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,43,56,85,120,160,193,216,236,266,290,318,345,368,394,422,448,470],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054145","phase-3-a-clinical-study-to-compare-bupizenge-with-lidocaine-for-pain-due-to-oral-mucositis-in-patients-with-head-and-neck-cancer-100054145",false,"NCT07672236","A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.","A Randomized, Open-label, Phase III Trial to Assess the Efficacy and Safety of BupiZenge Compared to Lidocaine for Pain Associated With Oral Mucositis in Head and Neck Cancer","BEAM-Pain","Inclusion Criteria:\n\n* Participant must provide signed written informed consent prior to trial participation and must be willing and able to comply with all requirements and restrictions of the trial.\n* Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing.\n* Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.\n* About to start IMRT with curative intent with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative intended dose of at least 60 Gy and a maximum of 72 Gy. Proton therapy given at equivalent biological doses is allowed.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n* Female participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive measure or practice total sexual abstinence from the time of giving informed consent until at least 24 hours after last dose of IMP.\n\nExclusion Criteria:\n\n* Participation in another investigational interventional clinical trial within 3 months prior to first dosing, or for a longer period if required by local regulations, or within 5 half-lives of the investigational agent taken (whichever is longer). An exception is studies where patients are randomized to different radiotherapy settings, e.g. participation in DAHANCA 35 is allowed.\n* Previous radiation therapy to the head and\u002For neck area.\n* Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.\n* Receiving high-dose (\\> 15 mg per day prednisolone), corticosteroids (for any indication).\n* Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.\n* Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).\n* Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy \\[PEG\\] or nasogastric tube) for any reason.\n* Moderate\u002Fsevere liver or kidney disease defined as:\n\n  1. AST\u002FALT \\> 3 × upper limit of normal (ULN) or bilirubin \\> 1.5 × ULN (unless related to Gilbert's syndrome)\n  2. glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Known diagnosis of epilepsy.\n* Known phenylketonuria (PKU).\n* Pregnancy or breastfeeding.\n* Any condition or circumstance-based on the investigator's assessment-that could increase risk to the participant, confound trial results, or interfere with compliance \u002F participation (including inability or unwillingness to follow trial procedures, or any clinically significant physical or psychiatric condition).","ALL","18 Years","80 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief.\n\nBupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth.\n\nThis study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids.\n\nThe main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy.\n\nThe study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth.\n\nThe study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine.\n\nTreatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.",[28,29],"Head & Neck Cancer","Oral Mucositis","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-07-07",{"date":38,"type":22},"2027-01-31",{"name":40,"class":41},"OncoZenge AB","INDUSTRY",11,{"id":44,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":45,"targetDuration":4,"studyType":23,"phases":46,"briefSummary":26,"conditions":47,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":55,"locationsCount":42},"100644515",{"count":21,"type":22},[25],[28,29],"NOT_YET_RECRUITING","2026-06-23",{"date":51,"type":34},"2026-06-26",{"date":53,"type":22},"2026-06-25",{"date":38,"type":22},{"name":40,"class":41},{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100634768","phase-3-traditional-chinese-medicine-for-the-prevention-of-radiotherapy-induced-oral-mucositis-rtom-100634768","NCT07543978","Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)","Modified Dahuang Huanglian Xiexin Mouthwash for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM): A Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 to 70 years (inclusive) at the time of screening.\n2. Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx.\n3. Planned to receive radiotherapy.\n4. No prior history of radiotherapy to the head and neck region.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support):\n\n   Hemoglobin (Hb) ≥90 g\u002FL Absolute neutrophil count (ANC)≥1.5×10⁹\u002FL Platelet count (PLT) ≥80×10⁹\u002FL Total bilirubin (BIL) \\\u003C 1.25×upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5×ULN Serum creatinine (Cr)≤ULN, or calculated creatinine clearance (Cockcroft-Gault formula) \\> 50 mL\u002Fmin\n7. Signed written informed consent prior to any study-related procedures.\n8. Judged by the investigator to be able to comply with the study protocol.\n9. Negative pregnancy test (for women of childbearing potential) at screening.\n10. Willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Pre-existing oral mucositis prior to the start of radiotherapy.\n2. Prior radiotherapy to the head and neck region.\n3. Major surgery within 3 weeks prior to enrollment.\n4. Uncontrolled cardiac conditions or symptoms, including but not limited to:\n\n   New York Heart Association (NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment Clinically significant supraventricular or ventricular arrhythmia requiring intervention\n5. Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.\n6. Active infection requiring systemic therapy.\n7. Known history of substance abuse, alcohol abuse, or drug addiction.\n8. Pregnancy or breastfeeding.\n9. Any other condition that, in the investigator's judgment, may interfere with the participant's ability to complete the study or compromise the collection of study data, including but not limited to serious concurrent illness (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or unfavorable family or social circumstances.","70 Years",{"count":65,"type":22},156,[25],"This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).\n\nParticipants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.",[69,70,29,71],"Radiotherapy-Induced Oral Mucositis","Stomatitis","Radiotherapy Side Effects",[69,73,70,29,74],"RTOM","Radiation Injury","2026-04-14",{"date":77,"type":34},"2026-04-22",{"date":79,"type":22},"2026-04-30",{"date":81,"type":22},"2027-12-31",{"name":83,"class":84},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100623722","phase-2-amimestrocel-injection-for-preventing-severe-oral-mucositis-in-hsct-patients-100623722","NCT07400328","Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients","A Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and\u002For Melphalan","Inclusion Criteria:\n\n1. Aged 18 to 65 years.\n2. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplantation.\n3. The conditioning regimen must contain total body irradiation (TBI) and\u002For melphalan.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function defined as:Left ventricular ejection fraction (LVEF) ≥ 50%.Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin.\n6. Voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n1. History of allergy to mesenchymal stem cells or any component of the Amimestrocel injection preparation.\n2. Presence of active, uncontrolled bacterial, fungal, or viral infection.\n3. History of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell skin cancer.\n4. Pregnant or lactating women, or those planning pregnancy during the study period.\n5. Previous receipt of any cell therapy product.\n6. Severe psychiatric disorder or cognitive impairment that would limit the ability to provide informed consent or comply with study procedures.\n7. Any condition that, in the investigator's judgment, makes the subject unsuitable for study participation.","65 Years",{"count":94,"type":22},22,[96],"PHASE2","This study aims to see if a single intravenous infusion of a cell therapy called Amimestrocel injection can help prevent severe mouth sores (oral mucositis) in patients receiving a stem cell transplant.\n\nPatients getting a stem cell transplant often receive strong chemotherapy (with radiation and\u002For a drug called melphalan) that can cause painful mouth and gut sores, making eating difficult and increasing infection risk. Amimestrocel injection is made from human umbilical cord cells that may help reduce inflammation and promote healing.\n\nAbout 22 adult patients scheduled for this type of transplant at one hospital in China will receive the infusion 1-2 days before their stem cell transplant. Researchers will closely check for mouth sores, pain, and side effects for the first 28 days, and continue safety monitoring for 100 days.\n\nThe main goal is to see if the treatment lowers the rate of severe (Grade 3-4) mouth sores. The study will also track pain levels, need for pain medication, diarrhea, time for blood counts to recover, and overall safety.",[29,70,99,100],"Gastrointestinal Mucositis","Hematopoietic Stem Cell Transplantation",[102,103,104,105,106,107,108,109,110],"Amimestrocel","Mesenchymal Stem Cells","Umbilical Cord","Mucositis Prevention","Total Body Irradiation","Melphalan","Conditioning Regimen","Allogeneic Transplantation","Single-Arm Trial","2026-04-12",{"date":75,"type":34},{"date":114,"type":34},"2026-02-15",{"date":116,"type":22},"2028-01-31",{"name":118,"class":84},"The First Affiliated Hospital of Soochow University",1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":132,"conditions":133,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":119},"100488116","effect-of-a-novel-topical-composition-on-the-incidence-of-severe-oral-mucositis-in-head--neck-cancer-radiated-patients-and-quality-of-life-assessed-by-proms-100488116","NCT05635929","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. A Two Phases Study, Part of STOP OM PROJECT. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial.","STOPOMP","Inclusion Criteria:\n\nAcute Phase\n\n* Patients diagnosed with Head \\& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nChronic Phase\n\n* Patients who have completed radiotherapy treatment at least 6 months before study enrollement.\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nExclusion Criteria:\n\nAcute Phase\n\n* Patients who are unable to properly use the products.\n* Patients who do not consent to participate in the study.\n* Patients who were being treated for another type of cancer.\n\nChronic Phase\n\n* Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.\n* Patients who do not consent to participate in the study.",{"count":129,"type":22},63,[131],"NA","The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \\& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \\& Neck cancer radiated patients.",[29,134,135,136,137,138,139,140,141],"Quality of Life","Mucositis","Pain","Speech","Saliva","Radiation Toxicity","Chemotherapeutic Toxicity","Head and Neck Cancer",[29,143,144,136,145,146,147,148,149,141,150],"Cancer Therapy Toxic Effect","Cancer Support","Ulcers","Treatment Interruptions","Oral Mucosa","Radiotherapy","Chemotherapy","Severe Oral Mucositis","2026-04-10",{"date":153,"type":34},"2026-04-15",{"date":155,"type":34},"2022-10-11",{"date":157,"type":22},"2027-03",{"name":159,"class":41},"Mucosa Innovations, S.L.",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":119},"100630735","ozone-therapy-with-biomimetic-oral-care-for-cancer-related-oral-mucositis-100630735","NCT07491536","Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis","Combined Gas Ozone Therapy and Biomimetic Oral Care in the Management of Radio- and Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Clinical Trial","OZOMUC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of radio- and\u002For chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale\n* Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers\n* Clinically stable general health condition (ASA physical status I-III)\n* Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Oral mucositis grade 4 according to the WHO Oral Toxicity Scale\n* Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis)\n* Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease)\n* Ongoing head and neck radiotherapy with cumulative dose \\>70 Gy or completion within 7 days prior to enrollment\n* Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents\n* Systemic or topical therapies known to interfere with salivary function or mucosal healing (e.g., anticholinergics, tricyclic antidepressants, diuretics)\n* Known allergy or hypersensitivity to components of the oral care products or materials used during ozone therapy\n* Severe or uncontrolled systemic diseases (including hepatic, renal, respiratory, or cardiac insufficiency)\n* Severe immunosuppression or neutropenia (neutrophils \\\u003C1,000\u002Fmm³)\n* Pregnancy or breastfeeding\n* Alcohol or substance abuse, or any condition that may compromise adherence to the protocol\n* Inability to attend scheduled follow-up visits through Day 30",{"count":169,"type":22},50,[131],"Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment.\n\nThis randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone.\n\nEligible participants will be randomly assigned to one of two parallel groups. The control group will receive gas ozone therapy administered in an outpatient setting according to a standardized protocol. The experimental group will receive the same ozone therapy combined with a defined home oral care regimen. Each participant will be followed for 30 days.\n\nThe primary outcome is the change in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale. Secondary outcomes include oral pain intensity, salivary flow rates, perceived dry mouth, taste alterations, swallowing function, oral pH, overall oral health-related quality of life, and treatment tolerability.\n\nThe findings of this study are expected to clarify the role of ozone-based supportive care strategies in the management of cancer therapy-related oral mucositis and to contribute to the development of standardized non-pharmacological treatment protocols.",[29,173,174],"Chemotherapy-induced Oral Mucositis","Head and Neck Neoplasms",[176,177,178,179,141,180,181,182,183],"Ozone Therapy","Cancer Treatment-Induced Oral Mucositis","Supportive Oncology","Non-Pharmacological Treatment","Oral Toxicity","Salivary Function","Xerostomia","Randomized Controlled Trial","2026-03-19",{"date":186,"type":34},"2026-03-24",{"date":188,"type":22},"2026-03-01",{"date":190,"type":22},"2026-12-15",{"name":192,"class":84},"University of Pavia",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":119},"100626516","efficacy-of-high-level-laser-therapy-in-managing-oral-mucositis-among-pediatric-patients-undergoing-hematopoietic-stem-cell-transplantation-100626516","NCT07436650","Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation","Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Children under the age of 18 years undergoing bone marrow transplantation during the phase of oral mucositis.\n* Oral mucositis starting from grade II on the WHO scale for OM.\n* Willingness to undergo treatment for four consecutive days and to return for evaluation 7 and 11 days after enrolment.\n\nExclusion Criteria:\n\n* Previous treatment with photobiomodulation for oral mucositis.\n* Limited mouth opening less than 2 cm.\n* Presence of dysplastic oral lesions.\n* Radiotherapy in the head and neck area.\n* Vulnerable groups of patients or decision-impaired individuals as prisoners, handicapped and mentally retarded individuals",{"count":201,"type":22},14,[131],"The goal of this clinical trial is to learn if high-level laser therapy can manage oral mucositis in pediatric patients undergoing hematopoietic bone marrow transplantation. The main question it aims to answer is :\n\nIs high-level laser therapy effective as a treatment for oral mucositis in pediatric hemopoietic stem cell transplant patients? Researchers will compare patients receiving basic oral care to see the effect on the WHO oral mucositis scale.\n\nParticipants will be subjected to high level laser on lesion sites .",[29],[29,206,207],"High Level Laser Therapy","Hematopoietic Stem cell Transplant","2026-03-17",{"date":184,"type":34},{"date":211,"type":34},"2025-06-15",{"date":213,"type":22},"2030-12",{"name":215,"class":84},"Ain Shams University",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":119},"100504850","prevention-of-oral-mucositis-in-head-and-neck-cancer-100504850","NCT05853692","Prevention of Oral Mucositis in Head and Neck Cancer.","Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.","OMHNC-1","Inclusion Criteria:\n\n* Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose\n* Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection\n* Patients able self-apply the product.\n\nExclusion Criteria:\n\n* Patients with documented contraindication to any of the components of \"Gel X\" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors\n* Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment\n* Patients participating to other clinical studies",{"count":225,"type":22},130,[131],"Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.\n\nGel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.\n\nThe aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.",[29],{"date":184,"type":34},{"date":231,"type":34},"2022-10-10",{"date":233,"type":22},"2028-06-10",{"name":235,"class":84},"Catholic University of the Sacred Heart",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":244,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":119},"100622773","a-study-to-describe-the-effect-of-photobiomodulation-low-level-laser-therapy-in-reducing-the-severity-and-incidence-of-oral-mucositis-oral-ulceration-in-oral-cancer-patients-undergoing-radiation-treatment-100622773","NCT07387978","A Study to Describe the Effect of Photobiomodulation (Low Level Laser Therapy) in Reducing the Severity and Incidence of Oral Mucositis (Oral Ulceration) in Oral Cancer Patients Undergoing Radiation Treatment","A Pilot Study to Describe the Effect of Photobiomodulation in Reducing the Severity and Incidence of Oral Mucositis in Oral Cancer Patients Undergoing Radiation Treatment","PBM","Inclusion Criteria:\n\n* Patient has provided written informed consent using the PBM PICF\n* Age ≥ 18 years of age at Screening\n* Histological diagnosis of HNC of the oral cavity with no evidence of macroscopic or microscopic residual disease post-surgery (R0 or R1 resection) with histopathological confirmation and no gross residual lymphadenopathy in the planned PBM treatment area\n* Planned treatment with RT or chemoradiotherapy to a dose of ≥ 50 Gy Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1)\n* Intact oral mucosa (no visible ulceration, dehiscence, or active infection)\n\nExclusion Criteria:\n\n* Gross macroscopic and\u002For microscopic residual disease post-surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area\n* Prior RT to the head and neck including the oral or oropharyngeal mucosa\n* Prior cytotoxic chemotherapy in the last 3 months\n* Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)\n* Concurrent administration of cetuximab\n* Known to be pregnant or planning to become pregnant within the trial period\n* Diagnosis of epilepsy",true,{"count":246,"type":22},30,[131],"The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +\u002F- chemotherapy.\n\nParticipants will receive PBM treatment five times a week throughout the course of their radiotherapy.\n\nThe main question it aims to answer is whether photobiomodulation reduces the incidence and severity of oral mucositis.",[29],[251,252,253,254,255,256],"photobiomodulation","low level laser therapy","head and neck cancer","oral cancer","radiotherapy","oral mucositis","2026-01-27",{"date":259,"type":34},"2026-02-04",{"date":261,"type":34},"2025-11-26",{"date":263,"type":22},"2028-11",{"name":265,"class":84},"Peter MacCallum Cancer Centre, Australia",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":272,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":119},"100540362","floss-project-facilitated-lessons-on-oral-and-systemic-health-in-survivors-100540362","NCT06315855","F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)","Inclusion Criteria:\n\n* male and female cancer survivors who are either ≥ 6 months after competing primary therapy for cancer treatment (N=100)\n* between 25-75 years of age\n* all race\u002Fethnic groups\n* own a smart phone.\n\nExclusion Criteria:\n\n* all head and neck\u002Foral cancer survivors\n* less then 25 years and older than 75 years of age\n* recurrence\u002Fsecond cancers or undergoing treatment\n* unable to provide informed consent.","25 Years","75 Years",{"count":275,"type":22},100,[131],"The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors.",[29,279,280],"Periodontal Diseases","Cancer","2026-01-20",{"date":283,"type":34},"2026-01-22",{"date":285,"type":34},"2024-08-20",{"date":287,"type":22},"2027-08-25",{"name":289,"class":84},"Georgetown University",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":298,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":307,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":4},"100621578","photobiomodulation-in-the-prevention-and-management-of-oral-mucositis-in-children-100621578","NCT07372443","Photobiomodulation in the Prevention and Management of Oral Mucositis in Children","Usefulness of Photobio-modulation in the Prevention and Management of Oral Mucositis in Pediatric Patients Undergoing Antineoplastic Treatment: Randomized Clinical Trial","PBMOM-PEDMX","Inclusion Criteria:\n\nPrevention Arm - Inclusion Criteria\n\n* Age 4 to 17 years\n* Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck.\n* Within days 1-3 of the start of any chemotherapy cycle; for leukemia patients, in consolidation phase as defined by protocol.\n* No signs of oral mucositis at enrollment.\n* Availability and willingness to attend scheduled photobiomodulation (PBM) application sessions.\n* Parent\u002Flegal guardian signed informed consent and child assent when applicable (≥ 8 years).\n* No documented primary immunodeficiency.\n* No severe concomitant systemic infection or medical condition that, in the investigator's judgment, contraindicates participation.\n* No PBM treatment within 14 days prior to enrollment.\n* No history of adverse reactions to light therapies or known photosensitivity.\n* No history of seizure disorder or diagnosis of epilepsy.\n\nTreatment Arm - Inclusion Criteria\n\n* Age 4 to 17 years\n* Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck.\n* Currently receiving chemotherapy (any cycle of the regimen).\n* Presence of oral mucositis of any grade during chemotherapy, identified within the first 3 days from onset of the mucositis episode.\n* Parent\u002Flegal guardian signed informed consent and child assent when applicable (≥ 8 years).\n* No documented primary immunodeficiency.\n* No severe concomitant systemic infection or medical condition that, in the investigator's judgment, contraindicates participation.\n* No photobiomodulation (PBM) treatment within 14 days prior to enrollment.\n* No history of adverse reactions to light therapies or known photosensitivity.\n* No history of seizure disorder or diagnosis of epilepsy.\n\nExclusion Criteria:\n\n* Documented primary immunodeficiency.\n* Severe concomitant systemic infection or unstable medical condition.\n* PBM treatment within 14 days prior to enrollment.\n* Known photosensitivity or prior adverse reaction to light therapy.\n* History of seizures or epilepsy.\n* Any condition that, in the investigator's opinion, would interfere with study participation or safety.\n\nParticipant Withdrawal Criteria\n\n* Attendance to fewer than 80% of scheduled treatment sessions.\n* Any adverse event or persistent discomfort attributed to PBM that leads the participant or guardian to decline further intervention.\n* Withdrawal of consent by parent\u002Fguardian or assent withdrawal by participant when applicable.\n* Development of a new medical condition that, per investigator judgment, contraindicates continuation.","4 Years","17 Years",{"count":301,"type":22},49,[131],"Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and treatment of antineoplastic therapy-induced OM in children aged 4-17 with leukemia, lymphoma, or head and neck tumors. A total of 49 participants will be enrolled. The study has two components: (1) Treatment - parallel comparison of PBM versus bioadhesive gel for established OM; (2) Prevention - crossover design in which patients receive both interventions across successive chemotherapy cycles. PBM will be delivered with a 660 nm device, 40 mW, 10 J\u002Fcm². The primary outcome is OM grade by the WHO scale assessed on days 7, 11, 14, and 21. Expected results include reduced OM incidence, severity, duration, and pain with favorable safety and tolerability, supporting standardized PBM protocols in pediatric oncology in Mexico.",[29,305,306],"Chemotherapy Effect","Pediatric Cancer",[308],"Photobiomodulation","2026-01-19",{"date":311,"type":34},"2026-01-28",{"date":313,"type":22},"2026-01",{"date":315,"type":22},"2027-08",{"name":317,"class":84},"Universidad de Guanajuato",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":325,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":119},"100473201","phase-2-coconut-oil-to-prevent-mouth-sores-in-pediatric-patients-receiving-high-dose-chemotherapy-100473201","NCT05441813","Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy","A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens","Inclusion Criteria:\n\nSubject must meet all the following applicable inclusion criteria to participate in this study:\n\n1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.\n2. Age greater than or equal to 7 years to 26 years at the time of consent\n3. Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT\n4. ECOG Performance Status of less than or equal to 2 or Lansky\u002FKarnofsky Performance Status of greater than or equal to 50 within 7 days prior to date of enrollment.\n5. No evidence of mouth lesions at time of enrollment\n6. Ability of the subject and parent\u002Fcaregiver to understand and comply with study procedures for the entire length of the study\n7. Able and willing to swish\u002Fspit the oral formulation\n\nExclusion Criteria:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n1. Allergy to tree nuts\n2. Planned discharge home prior to engraftment\n3. Using coconut oil mouth rinses within 30 days prior to enrollment\n4. Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission\n5. Patient has undergone HSCT within the last 90 days prior to admission","7 Years","26 Years",{"count":328,"type":22},60,[96],"The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral mucositis between the 2 groups will be evaluated. Some of the standard of care rinses that can be used to prevent mucositis are normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations.",[29],[333,334,335],"Prevention","Virgin Coconut Oil","Mouth Rinse","2026-01-06",{"date":338,"type":34},"2026-01-07",{"date":340,"type":34},"2023-02-15",{"date":342,"type":22},"2036-07",{"name":344,"class":84},"Wake Forest University Health Sciences",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":244,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":4},"100615812","effect-of-cold-application-and-artificial-saliva-in-the-prevention-of-chemotherapy-induced-oral-mucositis-100615812","NCT07297472","Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis","Effect of Cold Application and Artificial Saliva in the Prevention of Chemotherapy-Induced Oral Mucositis in Patients With Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients who undergo chemotherapy.\n* Patients who do not have oral mucositis.\n* Patients who are aged 18 years and older.\n* Patients who are male or female.\n* Patients who agree to be included in the study sample.\n\nExclusion Criteria:\n\n* Patients who was refused to participate in the study.\n* Patients who was not undergoing chemotherapy.\n* Patients how was undergoing chemo-radiotherapy.\n* Patients who selected for pilot study.\n\n  * Patients diagnosed with oral mucositis.",{"count":328,"type":22},[131],"the Objectives of this clinical trial is :\n\n1. To determine the effect of Cold Application for preventing of chemotherapy-Induced oral mucositis in cancer patients.\n2. To examine the effect of artificial saliva for preventing of chemotherapy-Induced oral mucositis in cancer patients.\n3. To compare between the effect of artificial saliva and cold application for preventing of chemotherapy-Induced oral mucositis in cancer patients.\n4. To find out the differences between the effect of artificial saliva and cold application based on patient demographics and clinical data.",[29],[357,358],"Cold application","Artificial saliva","2025-12-19",{"date":361,"type":34},"2025-12-26",{"date":363,"type":22},"2026-01-01",{"date":365,"type":22},"2026-06-01",{"name":367,"class":84},"Karbala University",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":383,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":119},"100465033","intraoral-photobiomodulation-therapy-to-prevent-oral-mucositis-in-patients-undergoing-hematopoietic-cell-transplantation-100465033","NCT05335434","Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation","A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis.\n* Age ≥18 years.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT.\n* Participants who have a history of radiation therapy to the head and neck.\n* Participants who have a history of photosensitivity or underlying disease with known photosensitivity.\n* Participants who are planned to receive palifermin for OM prevention.",{"count":376,"type":22},20,[131],"This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device.\n\nThe name of the study device involved in this study is:\n\n\\- THOR LX2.3 with LED Lollipop",[380,381,29,382],"Myeloablative Allogeneic Hematopoietic Cell Transplantation","Intraoral Photobiomodulation Therapy","Mucosal Ulcer",[384,381,29,382],"Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT)","2025-12-08",{"date":387,"type":34},"2025-12-15",{"date":389,"type":34},"2022-06-10",{"date":391,"type":22},"2026-07-19",{"name":393,"class":84},"Dana-Farber Cancer Institute",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":119},"100583397","phase-1-safety-and-efficacy-trial-of-tv5m01-for-radiation-induced-mucositis-in-head-and-neck-cancer-patients-100583397","NCT06875791","Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.","A Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Patients Undergoing Treatment for Head and Neck Cancer","TEMOR","Inclusion Criteria:\n\nAge ≥ 18 years and \\\u003C 60 years\n\nDiagnosis of HNSCC of the oral cavity, larynx, oro- and hypopharynx, diagnostic stage III-IV according to the AJCC 8th edition, scheduled to start radiotherapy\n\nAbility to swallow solids and liquids before starting radiotherapy treatment\n\nAdequate contraception for both sexes:\n\nFor women: negative pregnancy test for women of childbearing age; must be surgically sterile, postmenopausal (defined as absence of menstrual cycle for at least 12 consecutive months), or comply with an acceptable contraceptive regimen during and 3 months after the treatment period\n\nFor men: must be surgically sterile or comply with a contraceptive regimen during and for 3 months after the treatment period\n\nPerformance status (ECOG) of 0-1, measured within 72 hours prior to treatment initiation\n\nExpected life expectancy ≥ 6 months\n\nAdequate renal function \\[creatinine ≤ 1.5 times the upper limit of normal (ULN) or Glomerular Filtration Rate ≥ 50 ml\u002Fmin\\]\n\nAdequate liver function \\[total bilirubin ≤ 1.5 x ULN; AST or ALT ≤ 3 x ULN or ≤ 5 x ULN if due to tumor liver involvement\\]\n\nProvision of signed and dated informed consent before initiating any study-related procedure\n\nMeeting the diagnostic criteria for grade 1 or higher mucositis according to WHO classification\n\nMeeting the criteria for starting radiotherapy\n\nWilling and able to participate in the trial and comply with all trial requirements\n\nExclusion Criteria:\n\nPatients not eligible for radiotherapy\n\nStomatological disease such as ulcers, edema, exudation in the oropharyngeal mucosa before radiotherapy\n\nWomen who are pregnant or breastfeeding\n\nPatients allergic or sensitive to any of the compounds in the gel or study medications\n\nPresence of lesions that completely occlude the upper digestive tract\n\nPatients with a history of disorders, specifically those with psychotic psychiatric disorders such as schizophrenia, schizoaffective disorder, and delusional disorder, and substance\u002Falcohol abuse\n\nPatients participating or who have participated in another clinical trial in the last 30 days\n\nAnother uncontrollable, severe, hemodynamically unstable concurrent medical condition requiring urgent attention or threatening the patient's life\n\nReceiving chemotherapy regimens with delayed toxicity within the last 4 weeks (six weeks for nitrosourea or mitomycin C) or continuous or weekly chemotherapy regimen with limited potential for delayed toxicity within the last two weeks\n\nAny evidence of oral infection or disease in the oral cavity other than HNSCC\n\nAny important medical disease or incidental abnormal laboratory finding that could increase the participant's risk in the study (based on the investigator's judgment)\n\nConcomitant therapy with drugs that inhibit or enhance opioid action\n\nHypersensitivity to opioids, respiratory depression, obstructive airway disease, acute liver disease, seizure disorder, increased intracranial pressure, paralytic ileus, patients with known sensitivity to morphine, pheochromocytoma, acute asthma exacerbations, history of cardiac arrhythmia, heart failure.","60 Years",{"count":404,"type":22},40,[406,96],"PHASE1","This study is a Phase 2, double-blind, randomized controlled trial evaluating the safety and efficacy of TV5M01 (a 5% green tea and 0.1% morphine gel) compared to triple mixture (0.19% lidocaine, 0.29% nystatin, and 5.50% hydroxides) for treating radiation-induced oral mucositis in patients with head and neck squamous cell carcinoma.\n\nThe trial will enroll 40 patients (20 per group) with stage III-IV head and neck cancer receiving radiotherapy who develop grade 1 or higher mucositis. Participants will apply the assigned mouthwash three times daily from mucositis diagnosis until resolution.\n\nPrimary outcomes include safety (incidence of infections and adverse events) and efficacy (duration of grade 3-4 mucositis, days with severe pain). Secondary outcomes include quality of life and analgesic use. Randomization will use minimization methodology to balance important prognostic factors.\n\nThe study design incorporates two interim analyses after 10 and 19 participants, with clear safety monitoring and stopping rules. If successful, this trial could provide an evidence-based treatment option for radiotherapy-induced mucositis, potentially improving treatment completion rates and quality of life for head and neck cancer patients.",[409,29],"Squamous Cell Carcinoma of the Head and Neck",[411,412],"Oral mucositis","Squamous cell carcinoma","2025-03-26",{"date":415,"type":34},"2025-04-01",{"date":417,"type":22},"2025-12-28",{"date":419,"type":22},"2026-12-31",{"name":421,"class":84},"Fundacion Clinica Valle del Lili",{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":17,"minAge":429,"maxAge":18,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":119},"100556461","effect-of-sodium-bicarbonate-saline-and-black-mulberry-syrup-on-degree-of-oral-mucositis-in-children-receiving-chemotherapy-100556461","NCT06525402","Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy","The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* The willingness of the family and the child to participate in the study\n* Parent and child have separately informed written consent form\n* Be between 6-18 years old\n* Receiving chemotherapy and being hospitalized for chemotherapy treatment\n* Being fed orally\n\nExclusion Criteria:\n\n* Oral mucositis in the first intraoral evaluation\n* Having diabetes\n* Receiving radiotherapy\n* Having a surgical procedure in the mouth and jaw area\n* Receiving steroid therapy during chemotherapy treatment\n* Using a method other than the methods used in the study to protect the oral mucous membrane throughout the study","6 Years",{"count":431,"type":22},54,[131],"This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.",[29,305],[436,437,438,29,149,439],"Sodium Bicarbonate","Saline","Black Mulberry Syrup","Children","2025-03-23",{"date":413,"type":34},{"date":443,"type":34},"2025-01-30",{"date":445,"type":22},"2025-12-31",{"name":447,"class":84},"Burdur Mehmet Akif Ersoy University",{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":469},"100451637","efficacy-of-orosol-in-the-treatment-of-chemo--and-radiation-induced-mucositis-100451637","NCT05161091","Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.","Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Randomized, Double-blind, Placebo-controlled Trial.","OROSOL","Inclusion Criteria:\n\n* Adult patient, male or female, either\n\n  * treated with chemotherapy for hematological cancer (leukemia, lymphoma) and suffering from grade 2 to 4 mucositis (according to WHO \u002F NCI-CTCAE), or\n  * treated with radiotherapy or radio-chemotherapy (cisplatin or cetuximab) for head and neck cancer and suffering from grade 2 to 4 mucositis (according to WHO \u002F NCI-CTCAE),\n* Agreeing not to take any treatment for mucositis other than the treatment proposed in this study, apart from the classic symptomatic treatment for mucositis recommended by WHO.\n* Able to give informed consent to participate in research.\n* Beneficiary of a Social Security scheme.\n\nExclusion Criteria:\n\n* A woman who is pregnant, breastfeeding, or may be.\n* Major subject under guardianship, curators, deprived of liberty, or under the safeguard of justice.\n* Medical and \u002F or surgical history deemed by the investigator to be incompatible with the study because it would invalidate any reliable assessment.\n* General state of health considered pejorative (Karnofsky index \\\u003C60).\n* Type 1 or type 2 diabetic subject (presence of honey in Orosol®).\n* Subject on an anticoagulant (AVK or AOD) (interaction of the cranberry contained in Orosol® with anticoagulants (in particular warfarin) with instability of the International Normalized Ratio; the AODs can potentially present the same type of interaction).\n* History of administration of the treatment (or equivalent) in the study.\n* Anticipated difficulties in reading \u002F understanding the protocol and its questionnaires.\n* Subjects in the exclusion period from another clinical trial\n* Refusal of participation.",{"count":431,"type":22},[131],"Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants.\n\nIt is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa; An ulcer appears which will increase in size due to subsequent bacterial, fungal and \u002F or viral growth, while the leakage of toxins through damaged capillaries causes irritation and a burning sensation. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing.\n\nDepending on the severity of the ulceration, infection and feeding possibilities, mucositis is scored between grade 0 (absent) and grade 4 (maximum) (according to the WHO (World Health Organization) classification or the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), the latter degree most often requiring a modification of the anticancer treatment which may have an impact on the prognosis of the disease.\n\nAlthough, theoretically, mucositis is easy to treat because it only requires simple cleaning of the ulcers and stimulation of the growth of the underlying healthy cells to make up for the loss of substance, there are currently only limited symptomatic treatments available.",[29],"2024-08-09",{"date":462,"type":34},"2024-08-12",{"date":464,"type":34},"2022-11-22",{"date":466,"type":22},"2026-12",{"name":468,"class":84},"University Hospital, Clermont-Ferrand",2,{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":119},"100550726","prospect-prior-2-chemo-prior-dental-intervention-before-chemo-to-reduce-chemotherapy-complications-100550726","NCT06450821","PROSpECT-PRIOR-2-CHEMO: PRIOR Dental Intervention Before Chemo to Reduce Chemotherapy Complications","PROSpECT-PRIOR-2-CHEMO: A Feasibility RCT of Novel Dental Intervention PRIOR[Proactive Intensive Oral Review & Treatment] in Patients Scheduled for Chemotherapy for Myeloma-ASCT & Hematological Cancers to Mitigate Chemotherapy Complications","Inclusion Criteria (mod-high\u002Frisk trial participants):\n\n* Adults (≥ 18years) with scheduled Chemotherapy. Specifically, patients who meet the following diagnosis and treatment window requirements:\n\n  * Myeloma- Autologous Stem Cell Transplantation (ASCT) before high-dose myeloablative CT.\n  * Haematological cancers suitable for Allografts Stem Cell Transplant (SCT) before CT\n* Moderate \u002F High Oral Health Risk Assessment - any one of the following:\n\n  * Clinical evidence of caries (2+ teeth)\n  * Clinical evidence on soft and hard tissue examination of infection, sinus, swelling or tenderness\n  * BPE code 3-4 in any remaining sextant\n  * BPE code 1-2 with \\>30% BOP\n* The patient is fully informed, has received PIS (patient information sheet) and considered during a 'cooling-off' period, is competent to consent, and is able to comply with minimum attendance requirements\n\nExclusion Criteria:\n\n* Have a history of head and neck radiotherapy\n* Have been treated with Denusomab, Bevacizumab, Sunitinib or Aflibercept within 9 months of the MDT date.\n* Insufficient teeth \\[defined as \\\u003C2\\]\n* Are incapable of providing informed written consent\n* Are unable to comply with minimum attendance requirements",{"count":328,"type":22},[131],"The aim of this feasibility trial is to determine if it is safe and feasible to treat oral health diseases in people with haematological cancers before they start their chemotherapy to reduce complications and disruption to planned chemotherapy dose or schedule.",[481,482,483,29,484],"Oncology","Periodontitis","Myeloma","Febrile Neutropenia","2024-06-04",{"date":487,"type":34},"2024-06-10",{"date":489,"type":22},"2024-07",{"date":491,"type":22},"2026-10",{"name":493,"class":84},"University of Leeds"]