[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583397":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Fundacion Clinica Valle del Lili","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TV5M01 Oral Gel for Radiation-Induced Mucositis","EXPERIMENTAL","This arm will receive TV5M01 oral gel (5% green tea extract with 0.1% morphine) as an oral rinse. Participants will use 10 mL of the preparation three times daily at 8-hour intervals (±2 hours) from the diagnosis of grade 1 or higher mucositis throughout radiation therapy or until mucositis resolves. The medication should be administered at consistent times daily without fasting requirements. Doses vomited while in clinic may be replaced; however, participants should not take replacement doses for self-administered doses vomited at home. Missed doses should be skipped rather than doubled at the next scheduled time.",[13],"Combination Product: Green Tea Extract with Morphine",{"label":15,"type":16,"description":17,"interventionNames":18},"Triple Mixture Oral Rinse for Radiation-Induced Mucositis","ACTIVE_COMPARATOR","This arm will receive a Triple Mixture oral rinse (combination of 0.19% w\u002Fw Lidocaine, 0.29% w\u002Fw Nystatin, and 5.50% w\u002Fv Hydroxides). Participants will use 10 mL of the preparation three times daily at 8-hour intervals (±2 hours) from the diagnosis of grade 1 or higher mucositis until mucositis resolves. The medication should be administered at consistent times daily without fasting requirements. Doses vomited while in clinic may be replaced; however, participants should not take replacement doses for self-administered doses vomited at home. Missed doses should be skipped rather than doubled at the next scheduled time.",[19],"Combination Product: Active Comparator: Triple Mixture Oral Rinse for Radiation-Induced Mucositis",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Green Tea Extract with Morphine","TV5M01 is a novel oral rinse combining 5% green tea extract with 0.1% morphine in a gel formulation specifically designed for the treatment of radiation-induced oral mucositis. This unique combination leverages the antioxidant and anti-inflammatory properties of green tea polyphenols (particularly EGCG) with the analgesic effects of morphine delivered directly to the oral mucosa. Unlike other interventions, this formulation is administered as a 10 mL rinse three times daily with subsequent ingestion, targeting both local tissue healing and pain relief through a dual-action mechanism.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Active Comparator: Triple Mixture Oral Rinse for Radiation-Induced Mucositis","This arm will receive a Triple Mixture oral rinse (combination of 0.19% w\u002Fw Lidocaine, 0.29% w\u002Fw Nystatin, and 5.50% w\u002Fv Hydroxides). Participants will use 10 mL of the preparation three times daily at 8-hour intervals (±2 hours) from the diagnosis of grade 1 or higher mucositis until mucositis resolves. The medication should be administered at consistent times daily without fasting requirements. Doses vomited while in clinic may be replaced; however, participants should not take replacement doses for self-administered doses vomited at home. Missed doses should be skipped rather than doubled at the next scheduled time",[15],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Fundación Valle del Lili","Cali","Valle del Cauca Department","760031","Colombia","CO",{"type":40,"coordinates":41},"Point",[42,43],-76.5199,3.43054,{"lat":43,"lon":42},[46,52,56,59,61,63],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Liliana Vallecilla, MD","CONTACT","+6023319090","4022","liliana.vallecilla@fvl.org.co",{"name":53,"role":48,"phone":49,"phoneExt":54,"email":55},"Angela Zambrano, MD","7906","angela.zambrano@fvl.org.co",{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Angela R Zambrano, MD","PRINCIPAL_INVESTIGATOR",{"name":47,"role":60,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":62,"role":60,"phone":26,"phoneExt":26,"email":26},"Mario M Barbosa, MD, MSc",{"name":64,"role":60,"phone":26,"phoneExt":26,"email":26},"Lina M Galvis, MD",{"type":58,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Angela Zambrano","Principal Investigator","100583397","phase-1-safety-and-efficacy-trial-of-tv5m01-for-radiation-induced-mucositis-in-head-and-neck-cancer-patients-100583397",false,"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.","ALL","18 Years","60 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","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.",[88,89],"Squamous Cell Carcinoma of the Head and Neck","Oral Mucositis",[91,92],"Oral mucositis","Squamous cell carcinoma","NOT_YET_RECRUITING","2025-03-26",{"date":96,"type":97},"2025-04-01","ACTUAL",{"date":99,"type":81},"2025-12-28",{"date":101,"type":81},"2026-12-31",{"name":5,"class":6},1]