[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660041":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":31,"interventions":43,"overallOfficials":18,"centralContacts":52,"locations":18,"responsibleParty":58,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":18,"overallStatus":79,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":18},{"fullName":5,"class":6},"Nutricia Research","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Skeletal Muscle Index","The primary outcome parameter is the difference between test and control group in the mean change from baseline to the end of neoadjuvant chemotherapy in skeletal muscle mass, expressed as skeletal muscle index (SMI) \\[cm2\u002Fm2\\] as measured with a CT scan on the third lumbar vertebra (L3) level as skeletal muscle area (SMA) \\[cm2\\] corrected for height \\[m\\].","From enrollment to the end of intervention at 12 weeks, max product intake up to 28 weeks",[14],{"measure":15,"description":16,"timeFrame":17},"Cumulative Relative Dose Intensity","The key secondary outcome parameter is the difference between test and control group in the mean Cumulative Relative Dose Intensity (cRDI) of FOLFIRINOX or mFOLFIRINOX assessed at the end of neoadjuvant chemotherapy \\[%\\].","From enrollment to the end of intervention at 12 weeks, max study product intake up to 28 weeks",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":24,"maskingDescription":25,"whoMasked":26},"QUADRUPLE","Double blind",[27,28,29,30],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Test product","EXPERIMENTAL","The test product is a food for special medical purposes (FSMP), it is a novel cancer-specific high energy high protein medical nutrition solution.",[37],"Dietary Supplement: A novel cancer-specific high energy high protein medical nutrition solution",{"label":39,"type":34,"description":40,"interventionNames":41},"Control Product","The control product is a commercially available isocaloric isonitrogenous medical nutritional solution.",[42],"Dietary Supplement: A commercially available isocaloric isonitrogenous medical nutritional solution.",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":18},"DIETARY_SUPPLEMENT","A novel cancer-specific high energy high protein medical nutrition solution","Dietary Supplement",[33],{"type":45,"name":50,"description":47,"armGroupLabels":51,"otherNames":18},"A commercially available isocaloric isonitrogenous medical nutritional solution.",[39],[53],{"name":54,"role":55,"phone":56,"phoneExt":18,"email":57},"Danone Global Research & Innovation Center B.V Danone Global Research & Innovation Center B.V","CONTACT","+31 30 2095 000","register.clinicalresearchnutricia@danone.com",{"type":59,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100660041","a-study-looking-at-whether-a-nutritional-composition-can-help-people-with-pancreatic-cancer-stay-stronger-and-better-tolerate-chemotherapy-100660041",false,"NCT07870421","A Study Looking at Whether a Nutritional Composition Can Help People With Pancreatic Cancer Stay Stronger and Better Tolerate Chemotherapy","A Randomized Controlled Study on the Impact of a Specialized Oral Nutritional Supplement on Muscle Mass and Chemotherapy Tolerance in Pancreatic Cancer Patients","HEXCARE-PDAC","Inclusion Criteria:\n\n1. Patients with pancreatic ductal adenocarcinoma (PDAC) who are scheduled to be treated with (modified) FOLFIRINOX\\* chemotherapy (\\* or NALIRIFOX if that becomes the standard of care during the study per recognized (inter)national guidelines) as first therapy after initial diagnosis of PDAC\n2. ECOG performance score 0 or 1\n3. Age 18 years or above\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with metastatic PDAC (i.e. confirmed distant metastases or otherwise confirmed by local practice)\n2. Patients who received prior treatment for PDAC\n3. Life expectancy \\\u003C 3 months\n4. Clinically significant dysphagia, gastrointestinal obstruction or any other condition preventing adequate oral intake to reasonably comply with the protocol recommendation of taking 2 servings of study product per day in the opinion of the Investigator\n5. Presence of an ileostomy or ileal pouch. Participants with an ileostomy at or near the terminal ileum may be enrolled if, in the opinion of the Investigator, the ileostomy does not affect the absorption of nutrients other than sodium, potassium, and water\n6. Severe renal dysfunction (estimated Glomerular Filtration Rate (eGFR) \\\u003C29 mL\u002Fmin\u002F1.73m2 or albumin: creatinine (ACR)\\>30) or other clinically significant renal dysfunction in the opinion of the Investigator\n7. Hepatic encephalopathy regardless of etiology, reflecting clinically significant hepatic dysfunction that may interfere with metabolic stability, cognition, or safe participation in the study in the opinion of the Investigator\n8. Pancreatic insufficiency uncontrolled by enzyme therapy or uncontrolled metabolic conditions such as diabetes mellitus or phenylketonuria, that may compromise the patient's safe participation in the study, in the opinion of the Investigator\n9. Severe hypercalcemia, i.e. total calcium level corrected for albumin \\>14.0mg\u002FdL (\\>3.5mmol\u002FL)\n10. Known allergy or intolerance to any of the ingredients of the study products\n11. Known pregnancy or lactation\n12. Current alcohol or drug abuse in the opinion of the Investigator\n13. Participant not capable of understanding or not willing to adhere to the study procedures and\u002For other protocol requirements in the opinion of the Investigator\n14. Participation in any other studies involving investigational or marketed products within 14 days prior to screening and\u002For during the intervention period","ALL","18 Years",{"count":71,"type":72},216,"ESTIMATED","INTERVENTIONAL",[75],"NA","The HEXCARE-PDAC study is a Phase III, randomized, double-blind, controlled, multicenter trial evaluating the effectiveness of a cancer-specific oral nutritional supplement in preserving skeletal muscle mass and improving chemotherapy tolerance in adults with non-metastatic pancreatic ductal adenocarcinoma (PDAC) receiving neoadjuvant FOLFIRINOX-based chemotherapy. The study aims to determine whether targeted nutritional intervention can mitigate cancer-associated muscle loss and improve treatment delivery and clinical outcomes in patients with PDAC",[78],"Pancreatic Ductal Adenocarcinoma (PDAC)","NOT_YET_RECRUITING","2026-10-06",{"date":82,"type":83},"2026-10-13","ACTUAL",{"date":85,"type":72},"2026-11-01",{"date":87,"type":72},"2030-03-01",{"name":5,"class":6}]