[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468433":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"AHS Cancer Control Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal Nutrition Therapy","EXPERIMENTAL","To assess a multimodal nutrition therapy (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient).\n\nResource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition.\n\nBOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and\u002For radiotherapy.",[13],"Other: Resource® Support Plus",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Resource® Support Plus","Nestlé Resource Support Plus® is a high energy- and protein-density Medical Food enriched with omega 3 polyunsaturated fatty acids. This is a nutritionally complete formula, in an easy to swallow, palatable, concentrated low volume, available in 2 flavours optimized for cancer patients undergoing chemotherapy and\u002For radiation in taste tests. It provides in a 125 mL serving: 250 kcal, 11.5 g protein and 0.95g of omega-3 fatty acid (eicosapentaenoic acid, EPA).",[9],[25],{"name":26,"affiliation":27,"role":28},"Vickie Baracos","Cross Cancer Institute, Alberta Health Services","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","780-432-8232","Vickie.Baracos@albertahealthservices.ca",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Cross Cancer Institute","RECRUITING","Edmonton","Alberta","T6G 1Z2","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-113.46871,53.55014,{"lat":47,"lon":46},[50],{"name":26,"role":31,"phone":51,"phoneExt":18,"email":33},"7804328232",{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100468433","phase-2-nutritional-supplementation-in-head-and-neck-cancers-100468433",false,"NCT05379712","Nutritional Supplementation in Head and Neck Cancers","A Randomized Open Label Trial of Multimodal Oral Nutritional Supplementation Versus Standard Care, to Prevent \u002F Attenuate Malnutrition in Patients with Cancers of the Head and Neck Receiving (chemo)-radiotherapy Treatment.","Inclusion Criteria:\n\n1. Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.\n2. Male or female\n3. ≥18 years of age\n4. Histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy\n5. Capable of volitional oral nutritional intake at baseline.\n6. A diagnostic CT image taken with a maximum of 30 days before initiation of radical intent radiotherapy. If the CT scan history in the patient's clinical record does not include a study within this window, a baseline non-contrast enhanced CT abdomen will be conducted.\n7. An Eastern Cooperative Oncology Group Performance Status of ≤ 2\n\nExclusion Criteria:\n\n1. Fed by nasogastric tube, gastrostomy or total parenteral nutrition\n2. Cancer of the nasopharynx, thyroid or salivary gland\n3. Life expectancy \\\u003C6 months.\n4. A known hypersensitivity \u002F allergy to the investigational product or to any ingredient in their formulations (e.g. Milk\u002FLactose, Fish).\n5. Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.\n6. Patients with untreated brain metastases (patients with previously resected and\u002For radiated brain metastases without neurologic symptoms are permitted).\n7. Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).\n8. In the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)","ALL","18 Years",{"count":64,"type":65},81,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.",[71,72,73],"Malnourishment","Nutritional Deficiency","Undernutrition",[75,76],"Nutritional Support","Oral Nutritional Supplements","2025-03-25",{"date":79,"type":80},"2025-03-28","ACTUAL",{"date":82,"type":80},"2024-10-25",{"date":84,"type":65},"2026-10",{"name":5,"class":6},1]