[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618119":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":45,"responsibleParty":68,"collaborators":35,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":35,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":35,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":35,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Health Sciences Lahore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm","ACTIVE_COMPARATOR","Participants in control arm will use standard care as mouth wash only",[13],"Behavioral: Standard Oral Care (Mouthwash)",{"label":15,"type":16,"description":17,"interventionNames":18},"cryotherapy arm","EXPERIMENTAL","Participant in experimental arm will use ice chips during chemotherapy infusion and standard care as mouth wash also.",[19],"Behavioral: Oral Cryotherapy (Ice Chips)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Oral Cryotherapy (Ice Chips)","For participants in the experimental group will undergone cryotherapy in the form of oral ice chips. Oral ice chips will be applied in oral cavity of patients by the researcher as followings: 5 minutes before chemotherapy session, participants will begin sucking on ice chips. During chemotherapy, ice chips will be continuously sucked for 5 minutes, followed by a 5-minutes break, after that this process repeated for another 5minutes total time of application of ice is 30 minutes.",[15],[27],"Oral cryotherapy",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard Oral Care (Mouthwash)","Participants will receive standard oral care using mouthwash (saline\u002Fbicarbonate\u002Fchlorhexidine) three times daily after chemotherapy at home.",[9],[33,34],"Standard Oral Care","Mouthwash",null,[37,42],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Aqsa Noor, MS Nursing","CONTACT","03044548726","aqsanoor448@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":35,"email":35},"Sadam Nazir, MBA","03004981203",[46],{"facility":47,"status":35,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Health Sciences","Lahore","Punjab Province","54000","Pakistan","PK",{"type":54,"coordinates":55},"Point",[56,57],74.35071,31.558,{"lat":57,"lon":56},[60,65],{"name":61,"role":39,"phone":62,"phoneExt":63,"email":64},"Post Graduate Department, MS Nursing","04299231077","04299231075","info@uhs.edu.pk",{"name":66,"role":67,"phone":35,"phoneExt":35,"email":35},"Aqsa Noor, MS nursing","PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Aqsa Noor","MS Nursing Student","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":82,"type":83},102,"ESTIMATED","INTERVENTIONAL",[86],"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",[89],"Chemotherapy Induced Oral Mucositis",[91,92,93],"Cryotherapy","Solid tumor","oral mucositis","NOT_YET_RECRUITING","2026-06-13",{"date":97,"type":98},"2026-06-16","ACTUAL",{"date":100,"type":83},"2026-07-15",{"date":102,"type":83},"2026-11-30",{"name":5,"class":6},1]