[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606824":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":21,"responsibleParty":37,"collaborators":40,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":21,"enrollmentInfo":54,"targetDuration":21,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":80,"whyStopped":21,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":21},{"fullName":5,"class":6},"University of Kansas Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supplemental drink","EXPERIMENTAL","This is a single-arm design; comparisons are pre- vs. post-intervention or against feasibility thres",[13,14],"Behavioral: Nutrition counseling","Drug: Fresubin Supportan",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BEHAVIORAL","Nutrition counseling","Weekly standardized nutrition counseling will be provided by a study RDN to promote adherence and address barriers to adherence, acceptability, and adverse events. The RDN will also document any changes to the CRT regimen and hospitalizations.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Fresubin Supportan","Two bottles per day of Fresubin Supportan, a fish oil-enriched high calorie, high protein oral nutrition supplement.",[9],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Anna Arthur, PhD","CONTACT","913-945-7079","aarthur4@kumc.edu",{"name":34,"role":30,"phone":35,"phoneExt":21,"email":36},"Gregory Gan, PhD, MD","913-588-3431","ggan@kumc.edu",{"type":38,"investigatorFullName":29,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Associate Professor",[41],{"name":42,"class":43},"Fresenius Kabi","INDUSTRY","100606824","phase-1-the-force-trial-pilot-fish-oil-enriched-nutrition-for-radiotherapy-in-cancer-of-the-head-and-neck-100606824",false,"NCT07180576","The FORCE Trial Pilot: Fish Oil-enriched Nutrition for Radiotherapy in Cancer of the hEad and Neck","The FORCE Trial Pilot","FORCE","Inclusion Criteria:\n\n* Newly diagnosed with Stage I - IV oral cavity, hypopharyngeal, oropharyngeal, or laryngeal cancer\n* Age 18+\n* Planned for definitive radiotherapy with or without surgery and chemotherapy\n\nExclusion Criteria:\n\n* Metastatic disease\n* Prior head\u002Fneck RT\n* Presence of malnutrition at diagnosis per ASPEN criteria\n* Prior cancer within 3 years (except non-melanoma skin cancer and cervical carcinoma in situ)\n* Inability to consent\n* Severe psychiatric illness\n* Medical conditions impairing participation\u002Fadherence\n* Non-adults, pregnant women, prisoners, and other legally protected vulnerable groups\n* Dairy, soy, and\u002For fish allergy\n* Non-English speaking\n* Documented history of atrial fibrillation or other significant arrhythmias\n* Receiving therapeutic anticoagulation (e.g., warfarin, direct oral anticoagulants) and\u002For clotting disorders (e.g., hemophilia, thrombocytopenia)","ALL","18 Years",{"count":55,"type":56},15,"ESTIMATED","INTERVENTIONAL",[59,60],"PHASE1","PHASE2","en-label, proof-of-concept study designed to evaluate the feasibility, safety, and acceptability of a prophylactic fish oil-enriched nutritional supplement (Fresubin Supportan) in patients with head and neck cancer (HNC) undergoing curative-intent chemoradiotherapy (CRT) at the University of Kansas Medical Center. The study involves daily supplementation starting two weeks prior to CRT and continuing throughout CRT, alongside weekly nutrition counseling.",[63],"Head &Amp;Amp; Neck Squamous Cell Carcinoma",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"nutrition","head and neck cancer","nutrition supplement","nutrition trial","fish oil","cancer patient","sarcopenia","nutrition impact symptoms","body composition","cancer","oncology","fatty acid","cancer survivor","oral nutrition supplement","supportive care","NOT_YET_RECRUITING","2025-09-11",{"date":83,"type":84},"2025-09-18","ACTUAL",{"date":86,"type":56},"2026-01-01",{"date":88,"type":56},"2027-12-31",{"name":29,"class":6}]