[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620429":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":30,"collaborators":25,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":25,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":25},{"fullName":5,"class":6},"King Faisal Specialist Hospital & Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dr","ACTIVE_COMPARATOR","Participants in Arm A will receive standard treatment during TomoTherapy (STDoC) plus a fragrance-free, glycerol-based emollient applied to skin starting day 1 of treatment. If participants develop Grade ≥2 radiation dermatitis, an absorbent polyurethane foam dressing (PolyMem-equivalent) will be applied to the affected area. This arm serves as the active comparator for evaluating the efficacy of the experimental intervention (Mepitel).",[13],"Other: Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from day","EXPERIMENTAL","A silicone-based semi-permeable barrier film applied to the skin from day 1 of TomoTherapy. Evaluated as the experimental intervention to prevent or reduce radiation-induced skin toxicity.",[19],"Device: Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.","A foam dressing applied to areas of Grade ≥2 radiation dermatitis for skin protection during TomoTherapy. Part of Arm A.",[9],null,{"type":27,"name":28,"description":17,"armGroupLabels":29,"otherNames":25},"DEVICE","Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)",[15],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Zaheeda Mulla","Supervisor","100620429","reducing-skin-side-effects-in-patients-receiving-radiation-on-tomotherapy-100620429",false,"NCT07357506","Reducing Skin Side Effects in Patients Receiving Radiation on Tomotherapy","Mitigating Cutaneous Toxicity in Patients Undergoing TomoTherapy; A Randomized Controlled Trial of Skin-Protective Strategies","MCTPUT","Inclusion Criteria:\n\n* Patients aged 18 to 80 with newly diagnosed head and neck (H\\&N) carcinoma (confirmed by pathology)\n* Must be receiving radiotherapy using Tomotherapy\n\nExclusion Criteria:\n\n* Prior H\\&N radiotherapy\n* pre-existing skin disease\n* allergy to study products.","ALL","18 Years","80 Years",{"count":46,"type":47},104,"ESTIMATED","INTERVENTIONAL",[50],"NA","* Radiation dermatitis is a common side effect in head and neck cancer (HNC) patients receiving radiotherapy, especially with advanced techniques like TomoTherapy. The use of 6 MegaVoltage (MV) Flattening Filter-Free (FFF) beams and shorter Source to Skin Distance (SSD) in TomoTherapy may increase skin dose, leading to higher rates of skin reactions such as redness, irritation, and pain. These reactions can affect patient comfort, increase the risk of infection, and even interrupt treatment.\n* Although radiation dermatitis is frequent, there is no widely accepted standard for preventing or managing it. Supportive care programs, like the Dermatitis Control Program (DeCoP), and other supportive care programs using silicone-based semi-permeable barrier film have shown that simple measures-such as good skin hygiene and keeping the skin moist, can help reduce skin damage during treatment.\n* This study will evaluate the effectiveness of fragrance-free emollient (glycerol-based) + absorbent polyurethane foam dressing versus silicone-based semi-permeable barrier film dressing in preventing or reducing skin toxicity in HNC patients receiving TomoTherapy. These products are easy to apply, affordable, and widely available, making them practical options for routine care.",[53],"Head and Neck Cancer",[53,55,56],"Radiotherapy","Dermatitis","NOT_YET_RECRUITING","2026-01-21",{"date":60,"type":61},"2026-01-22","ACTUAL",{"date":63,"type":47},"2026-02",{"date":65,"type":47},"2028-01",{"name":5,"class":6}]