[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-ampamp-neck-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-ampamp-neck-squamous-cell-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100606849","proactive-risk-based-optimization--notifications-for-treatment--outcomes-in-head--neck-cancer-100606849",false,"NCT07180901","Proactive Risk-based Optimization & Notifications for Treatment & Outcomes in Head & Neck Cancer","Proactive Risk-based Optimization & Notifications for Treatment & Outcomes (PRONTO) in Head & Neck Cancer: A Strategy to Reduce Delays From Surgery to Post-Operative Adjuvant Therapy in Head and Neck Cancer","PRONTO-HN","Inclusion Criteria:\n\n* All adult patients (age 18 or older).\n* Pathologically confirmed oral cavity or laryngeal squamous cell carcinoma.\n* Diagnosed from July 2024 to September 2026.\n* With planned primary intention surgical resection.\n* With or without adjuvant therapy.\n* Treated at the Centre Hospitalier de l'Université de Montréal.\n\nExclusion Criteria:\n\n* Patients who do not end up receiving surgery.\n* S-PORT \\> 180 days","ALL","18 Years",{"count":20,"type":21},85,"ESTIMATED","INTERVENTIONAL",[24],"NA","Delays between surgery and the initiation of post-operative radiotherapy (S-PORT) in head and neck cancer (HNC) patients are prevalent and associated with worse oncologic outcomes. This pilot study evaluates whether a proactive, automated care coordination system (PRONTO-HN) can improve adherence to recommended S-PORT intervals of ≤42 days at the Centre hospitalier de l'Université de Montréal (CHUM).\n\nThe study is a single-center, quasi-experimental, interrupted time-series design with two phases. Group A (control) includes patients treated before the intervention (using a prospectively maintained database from August 2024 to August 2025). Group B (intervention) includes patients treated with the new coordination system from September 2025 to September 2026.\n\nThe intervention includes automated alerts, multidisciplinary task coordination, and risk stratification based on a predictive model developed and published by our team. This model uses only pre-operative data to estimate the likelihood that a patient will require adjuvant therapy after surgery, stratifying patients into high- and low-risk categories. High-risk patients receive intensified coordination protocols, including early oncology and dental consultations and shorter target times for pathology results.\n\nPrimary objective: Reduce the proportion of patients with S-PORT \\> 42 days. Secondary\u002Ftertiary objectives: Reduce mean S-PORT time. Evaluate impacts on overall, locoregional, and disease-free survival in a 2- and 3-year follow up study.\n\nPatients are identified at the time the operating room request is submitted. Demographic, clinical, and oncologic data are collected and stored securely in REDCap. As the intervention is administrative in nature and does not modify patient care, consent is waived.\n\nStatistical analysis will evaluate the intervention's effect and identify predictors of delays. A sample of 38 patients per group provides adequate power to detect a drop in S-PORT \\> 42 days from 80% to 50%.",[27,28,29],"Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer","Head &Amp;Amp; Neck Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma",[31,32,33],"Surgery to post-operative radiation therapy interval","Treatment delays","Oral cavity cancer","RECRUITING","2025-09-11",{"date":37,"type":38},"2025-09-18","ACTUAL",{"date":40,"type":38},"2025-08-21",{"date":42,"type":21},"2029-10-21",{"name":44,"class":45},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100606824","phase-1-the-force-trial-pilot-fish-oil-enriched-nutrition-for-radiotherapy-in-cancer-of-the-head-and-neck-100606824","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)",{"count":56,"type":21},15,[58,59],"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.",[28],[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"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",{"date":37,"type":38},{"date":81,"type":21},"2026-01-01",{"date":83,"type":21},"2027-12-31",{"name":85,"class":45},"Anna Arthur, PhD"]