[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stomatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stomatitis":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,80,105,132,162,195,219],{"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":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100556989","phase-2-testing-the-addition-of-the-drug-bmx-001-a-radioprotector-or-a-placebo-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer-100556989",false,"NCT06532279","Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer","A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation","Inclusion Criteria:\n\n* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.\n* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \\>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \\>= 50 Gy must be documented by the enrolling physician.\n* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.\n* P16 and\u002For human papillomavirus (HPV) status (via polymerase chain reaction \\[PCR\\] or in situ hybridization \\[ISH\\]) must be documented for patients with oropharynx cancer.\n* No patients with T0\u002FTx\u002Funknown primary disease.\n* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.\n* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.\n* Age \\>= 18.\n* Zubrod performance status of 0-2.\n* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable).\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN.\n* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa\u002Flevel 4 neck.\n* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.\n* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.\n* No current treatment of adjuvant post-operative (op) chemoradiation.\n* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\\\u003C 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.\n* No prior induction chemotherapy treatment.\n* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.\n* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.\n* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).\n* No valvular heart disease.\n* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.\n* No history or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.\n* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.\n* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \\[EKGs\\] in prior 3 months of a QTc interval \\> 450 milliseconds (ms) for males and \\> 470 ms for females using the specific\u002Fusual choice by clinical center for correction factor.\n* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.\n* No poorly controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160 and\u002For diastolic blood pressure \\[DBP\\] \\> 95) over 2 repeated measures within 30 days prior to registration.\n* No grade \\>= 2 oral mucositis per CTCAE version 5.0.\n* No grade \\>= 2 hypotension per CTCAE v. 5.0.\n* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.\n* No medical necessity for medications listed as prohibited.\n\n  * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer\u002FInternational Society of Oral Oncology (MASCC\u002FISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.\n  * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.","ALL","18 Years",{"count":19,"type":20},98,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage 0 Hypopharyngeal Carcinoma AJCC v8","Stage 0 Nasopharyngeal Carcinoma AJCC v8","Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage I Hypopharyngeal Carcinoma AJCC v8","Stage I Laryngeal Cancer AJCC v8","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stomatitis","RECRUITING","2026-06-22",{"date":70,"type":71},"2026-06-25","ACTUAL",{"date":73,"type":71},"2025-06-23",{"date":75,"type":20},"2027-01-01",{"name":77,"class":78},"NRG Oncology","OTHER",153,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100330402","phase-2-folic-acid-supplement-versus-placebo-for-treating-mucositis-adverse-events-in-metastatic-renal-cell-carcinoma-patients-receiving-targeted-therapy-100330402","NCT03581773","Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy","FASTERCC: Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy. A Randomized, Double-blind Trial From the Danish Renal Cancer Group (DARENCA Study-4)","DARENCA4","Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.\n\nInclusion Criteria:\n\n1. Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.\n2. Signed written informed consent obtained prior to any study specific procedures.\n3. Patient must be willing and able to comply with the protocol.\n4. Age ≥ 18.\n5. Biopsy proven locally advanced or metastatic renal cell carcinoma.\n6. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.\n7. Fertile women of childbearing potential (\\\u003C2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).\n8. Karnofsky Performance status ≥ 60%.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to folic acid.\n2. Use of prednisolone more than 10 mg daily.",true,{"count":90,"type":20},100,[23],"FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)",[94,66],"Mucositis","2026-04-28",{"date":97,"type":71},"2026-05-04",{"date":99,"type":71},"2017-12-20",{"date":101,"type":20},"2029-09-01",{"name":103,"class":78},"Niels Fristrup",2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100631848","mucolock-for-treatment-of-stomatitis-100631848","NCT07506018","MucoLock™ for Treatment of Stomatitis","A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia","Inclusion Criteria:\n\n* Age 18 years and older\n* Individuals with oral dysesthesia (worst VAS sensitivity\u002Fburning score ≥ 7 over the last week)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Inability to comply with study instructions\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\\*\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.\n* Advanced kidney disease\n* Patients receiving antineoplastic therapy \\[e.g., tyrosine kinase inhibitors (TKIs), radiation\\] that could increase the risk of oral dysesthesia\n* Known altered mental status, encephalopathy, or cognition impairment\n* Ataxia\n* Known alcohol use disorder\n* Concomitant opioid therapy\n* Diagnosis of oral cancer currently undergoing therapy\n* Already using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)\\*\n* Any opioid pain medication\\*\n* Treatment with another investigational drug or other intervention within 2 weeks. Patients will be recommended to stop previous medication for 2 weeks before starting the study treatment.\n\n(asterisk) \\*Modifiable criteria, with a timeframe of 2 weeks for a washout period.",{"count":113,"type":20},25,[115],"NA","The purpose of this research is to test how well people can tolerate MucoLock™ as a treatment for mouth pain or burning sensation and how well it works to reduce mouth pain or burning sensation. Study participants will be asked to use MucoLock™ topical solution as a \"swish and spit\" solution (similar to mouthwash) three times per day for 5 minutes each time, for 28 days.",[66,118,119,120,121],"Pain","Burning Mouth","Burning Mouth Syndrome","Oral Dysesthesia","2026-04-16",{"date":124,"type":71},"2026-04-20",{"date":126,"type":71},"2026-04-15",{"date":128,"type":20},"2028-05",{"name":130,"class":78},"Baptist Health South Florida",1,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"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":141,"type":20},156,[143],"PHASE3","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.",[146,66,147,148],"Radiotherapy-Induced Oral Mucositis","Oral Mucositis","Radiotherapy Side Effects",[146,150,66,147,151],"RTOM","Radiation Injury","NOT_YET_RECRUITING","2026-04-14",{"date":155,"type":71},"2026-04-22",{"date":157,"type":20},"2026-04-30",{"date":159,"type":20},"2027-12-31",{"name":161,"class":78},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":131},"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":171,"type":20},22,[23],"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.",[147,66,175,176],"Gastrointestinal Mucositis","Hematopoietic Stem Cell Transplantation",[178,179,180,181,182,183,184,185,186],"Amimestrocel","Mesenchymal Stem Cells","Umbilical Cord","Mucositis Prevention","Total Body Irradiation","Melphalan","Conditioning Regimen","Allogeneic Transplantation","Single-Arm Trial","2026-04-12",{"date":153,"type":71},{"date":190,"type":71},"2026-02-15",{"date":192,"type":20},"2028-01-31",{"name":194,"class":78},"The First Affiliated Hospital of Soochow University",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":218},"100620436","phase-4-an-open-label-single-arm-study-of-prophylaxis-for-datopotamab-deruxtecan-dato-dxd--related-stomatitis-in-eligible-patients-with-metastatic-or-inoperable-locally-recurrent-breast-cancer-or-locally-advanced-or-metastatic-epidermal-growth-factor-receptor-mutated-non-small-cell-lung-cancer-100620436","NCT07357597","An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.","A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)","TROPION-SWISH","Inclusion Criteria:\n\nPatients are eligible to be included in the study only if all the following criteria apply:\n\nDisease Characteristics\n\n1. Patients with any of the following disease characteristics are eligible (specific population subject to FDA Dato-DXd label):\n\n   • Patients with unresectable or metastatic HR+\u002FHER2- (IHC 0, IHC 1+, or IHC 2+\u002FISH-) breast cancer who have received prior ET and chemotherapy for unresectable or metastatic disease.\n\n   OR\n\n   • Adult patients with unresectable or metastatic TNBC who are not candidates for PD-1\u002FPD-L1 inhibitor therapy. Participants will be enrolled upon FDA approval on use of Dato-DXd for this indication.\n\n   OR\n\n   • Patients with locally advanced or metastatic EGFRm NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy.\n\n   Age\n2. Patient must be ≥ 18 years, at the time of signing the informed consent.\n\n   Type of Patient and Disease Characteristics-\n3. Has documentation that Dato-DXd will be prescribed for the labelled indication and has not received any dose of Dato-DXd prior to enrollment.\n4. Is willing to comply with use of prophylactic dexamethasone mouthwash at the start of first infusion and throughout Dato-DXd administration.\n5. ECOG performance status 0 or 1.\n6. Has adequate bone marrow function (hemoglobin ≥ 9 g\u002FdL; red blood cell\u002Fplasma transfusion is not allowed within 1 week prior to screening assessment).\n7. All women of childbearing potential must have a negative serum pregnancy test result at screening.\n\n   Informed Consent\n8. Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and the protocol.\n\nExclusion Criteria:\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Has received Dato-DXd prior to enrollment.\n\n   Medical Conditions\n2. As judged by the investigator, any evidence of cardiac, pulmonary, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the patient to participate in the study.\n3. Has any-grade active and uncontrolled stomatitis or mouth ulcers at baseline (participants with prior medical history of stomatitis or mouth ulcers are eligible).\n4. Use of steroid-containing mouthwash is contraindicated in, including but not limited to:\n\n   * Active oral infections (eg, viral, bacterial, or fungal), where the use of a steroid-containing mouthwash may impair local immune response and delay healing\n   * Known hypersensitivity or allergy to corticosteroids or any excipients contained in the mouthwash formulation\n5. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localized fungal infections of skin or nails are eligible).\n6. Has clinically significant corneal disease.\n7. Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients of Dato-DXd (including, but not limited to, polysorbate 80).\n8. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n9. Is pregnant, or breastfeeding, or planning to become pregnant.\n\n   Other Exclusions\n10. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n11. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n12. Previous enrollment in the present study.",{"count":90,"type":20},[205],"PHASE4","This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer.",[66],"2026-01-21",{"date":210,"type":71},"2026-01-22",{"date":212,"type":20},"2026-02-27",{"date":214,"type":20},"2027-10-09",{"name":216,"class":217},"AstraZeneca","INDUSTRY",20,{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":104},"100521595","phase-3-low-power-laser-therapy-as-prevention-of-oral-mucositis-and-oropharyngeal-pain-in-patients-undergoing-allogenetic-hsct-100521595","NCT06071637","Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT","Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n* Patients with indication for allogeneic HSCT;\n* Patients over 18 years old;\n* Patients with intact oral mucosa on the first day of conditioning (D-7);\n* Patients able to cooperate with treatment;\n* Patients capable of performing the oral hygiene protocol;\n* Patients who agreed to participate in the study through the informed consent form (TCLE) in accordance with Resolution 466\u002F12 of the National Health Council.\n\nExclusion Criteria:\n\n* Patients who are receiving medication for the treatment and\u002For prevention of mucositis;\n* Patients who were not previously evaluated and released by INCA's Dentistry section team","100 Years",{"count":228,"type":20},84,[143],"Objective: To compare the effects of two low-power laser therapy protocols (application of a wavelength in the mouth, red region and another in the neck infrared region X simultaneous dual application of two wavelengths, red and infrared region in the mouth and neck) in the prevention of oral mucositis and oropharyngeal pain, dysphagia, TPN and opioid use in patients undergoing HSCT allogenic.\n\nMaterials and methods: This is a phase III, double-blind, randomized study that will use LBP to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and Group B). Patients will be included enrolled at the Bone Marrow Transplant Center - Cancer Hospital I - INCA, with indication of allogeneic HSCT, over 18 years old, able to cooperate with the treatment and perform the oral hygiene protocol, who present oral mucosa complete on the first day of conditioning (D-7) and who agree to participate in the study through the term of free and clarified informed consent. The randomization will be carried out in permuted blocks using the REDCap® program by a member of the non-blind team. In group A, extraoral applications will be carried out with the issuance of radiation in the infrared region of the electromagnetic spectrum (808nm) and intraorally in the red region of the electromagnetic spectrum (660nm). In group B, the extra applications and intraoral will be performed with simultaneous double radiation emission in the regions red and infrared of the electromagnetic spectrum (660nm\u002F808nm). for both groups will use the device from DMC (São Carlos, São Paulo, Brazil), with a indium gallium aluminum phosphide (InGaAlP) and aluminum gallium arsiade diode (AlGaAs), with a power of 100mW and a beam area of 0.09842 cm². The LBP will be performed by a dental surgeon, on weekdays, starting on D-7 and end on the day of the \"marrow take\" (patient presents 500 neutrophils for three days consecutive). The region treated in extraoral applications will be the carotid triangle bilateral, bounded by the superior belly of the omohyoid, posterior belly of the digastric and by the anterior border of the sternocleidomastoid muscle; and intraorally, the mucous membranes right and left cheeks, lower and upper lips, upper and lower labial mucous membranes, right and left lateral borders of the tongue, lingual belly, buccal floor and soft palate. Patients will be evaluated daily (weekdays per week) for oral mucositis, pain in the oral cavity and oropharynx, dysphagia, use of total parenteral nutrition and opioids. Patients and dentists responsible for evaluating patients will be blinded to the study, that is, they will not know about the treatment that the patient will receive. The data from interest will be collected from the physical records and electronic systems of the institution, through standardized forms and will be included in REDCap®. Statistical analyzes will be carried out using the latest available version of the R software for Windows. It will be A descriptive analysis of the data found in the clinical, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the chi-square test of Pearson. Statistical analyzes will be performed using the latest available version of the R software for Windows. A descriptive analysis of the data found will be carried out in clinical examination, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the Pearson's chi-square test. Mucositis-free survival analyzes (any degree) and dysphagia (any degree) will be performed by the Kaplan-Meier method and the curves compared by log-rank test. The time interval between the start of conditioning and date of first grade ≥1 mucositis or dysphagia to date of the \"marrow take\" (500 neutrophils in the peripheral blood for three consecutive days). Participants without mucositis or dysphagia will be censored on the date of marrow collection. Tests of hypothesis with p-value \\< 0.05. The sample calculation predicted 82 patients, who will be evaluated by intention of treatment, counting with 10% loss to reach 37 patients in group A and 37 in group B. The estimate of the presence of oral mucositis grades 2, 3 and 4 in group A is 36.8% and in group B 10%. The estimate of the presence of dysphagia grades 3 and 4 (or pain in oropharynx grades 2 and 3) in group A is 80% and in group B 40%. the statistical test The two-tailed Z test with pooled variance was used, with a type 1 error of 0.05 and the error type 2 of 0.20. This research project was approved by the Research Ethics Committee responsible (CAAE 67172223.9.0000.5274, opinion No. 5.947.434) and will be conducted in a according to Resolution 466\u002F12 of the National Health Council and the Good News Guide Clinical Practices.",[176,232,66],"Low-Level Light Therapy",[176,232,66],"2023-10-02",{"date":236,"type":71},"2023-10-06",{"date":238,"type":71},"2023-08-01",{"date":240,"type":20},"2027-02-28",{"name":242,"class":243},"Instituto Nacional de Cancer, Brazil","OTHER_GOV"]