[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chemotherapy-induced-oral-mucositis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chemotherapy-induced-oral-mucositis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100618119","effect-of-oral-ice-chips-to-prevent-chemotherapy-induced-oral-mucositis-in-patient-with-solid-tumor-treated-with-5-fluorouracil-and-methotrexate-100618119",false,"NCT07327476","Effect of Oral Ice Chips to Prevent Chemotherapy-Induced Oral Mucositis in Patient With Solid Tumor Treated With 5 Fluorouracil and Methotrexate","Effects Of Oral Ice Chips On Prevention of Chemotherapy Induced Oral Mucositis In Patients With Solid Tumors Treated With 5 Fluorouracil and Methotrexate In Tertiary Care Hospital , Lahore: A Randomize Control Trial","Inclusion Criteria\n\n* Adults aged 18-60 years.\n* Patients treated with 5-Fluorouracil and Methotrexate regimens.\n* Patients scheduled for a two-week cycle of chemotherapy.\n* Patients able to tolerate ice and able to communicate effectively.\n\nExclusion Criteria\n\n* Patients with diabetes mellitus, cardiovascular disorders, or any immune- compromised disease.\n* Patients with head and neck surgeries, oral or pharyngeal cancer, or any problems in the oral cavity.\n* Patients currently enrolled in or who have signed consent for any other clinical studies that could interfere with the desired outcomes.","ALL","18 Years","60 Years",{"count":20,"type":21},102,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this randomized controlled clinical trial is to determine whether oral cryotherapy using ice chips can prevent and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients receiving 5-fluorouracil and methotrexate chemotherapy regimens.\n\nThe main questions it aims to answer are:\n\nDoes the application of oral ice chips reduce the severity of oral mucositis compared to routine mouth care alone?\n\nIs there a significant difference in oral mucositis grades between patients receiving oral cryotherapy and those receiving standard mouthwash care?\n\nResearchers will compare the experimental group receiving oral ice chips during chemotherapy plus routine mouthwash care with the control group receiving routine mouthwash care only to evaluate the effectiveness of oral cryotherapy in reducing oral mucositis severity.\n\nParticipants will:\n\nBe randomly assigned to either the experimental group (n = 51) or control group (n = 51)\n\nReceive chemotherapy with 5-fluorouracil or methotrexate\n\nUse routine mouthwash (normal saline\u002Fsodium bicarbonate\u002Fchlorhexidine) at home\n\nReceive oral ice chips during chemotherapy infusion (experimental group only)\n\nBe assessed for oral mucositis severity using the WHO Oral Mucositis Grading Scale before and after the intervention",[27],"Chemotherapy Induced Oral Mucositis",[29,30,31],"Cryotherapy","Solid tumor","oral mucositis","NOT_YET_RECRUITING","2026-06-13",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":21},"2026-07-15",{"date":40,"type":21},"2026-11-30",{"name":42,"class":43},"University of Health Sciences Lahore","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":44},"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":54,"type":21},50,[24],"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.",[58,59,60],"Oral Mucositis","Chemotherapy-induced Oral Mucositis","Head and Neck Neoplasms",[62,63,64,65,66,67,68,69,70],"Ozone Therapy","Cancer Treatment-Induced Oral Mucositis","Supportive Oncology","Non-Pharmacological Treatment","Head and Neck Cancer","Oral Toxicity","Salivary Function","Xerostomia","Randomized Controlled Trial","RECRUITING","2026-03-19",{"date":74,"type":36},"2026-03-24",{"date":76,"type":21},"2026-03-01",{"date":78,"type":21},"2026-12-15",{"name":80,"class":43},"University of Pavia"]