Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma

NutriCa65-PDAC is a multicentre, pragmatic, open-label clinical study evaluating personalised nutritional care in patients aged 65 years or older with pancreatic ductal adenocarcinoma. The study is designed to determine whether early, structured nutritional care delivered by trained dietitians can improve health-related quality of life and other clinically relevant nutritional, functional and healthcare-use outcomes compared with usual nutritional care. Pancreatic ductal adenocarcinoma is commonly associated with reduced food intake, weight loss, dehydration, sarcopenia, cachexia, pancreatic exocrine insufficiency, treatment-related symptoms and impaired physical function. These problems may affect quality of life, treatment tolerance, hospital contacts and overall clinical course. The intervention in this study is intended to be integrated into routine oncology pathways and adapted to the participant's symptoms, treatment phase, nutritional needs, functional status and preferences. The study includes an initial feasibility part followed by a main randomised controlled trial. In the feasibility part, approximately 15 participants will receive the personalised nutritional care intervention for about one month. This feasibility part is non-randomised and is intended to assess whether the planned study procedures are acceptable and practical for participants, caregivers and study staff. It will evaluate recruitment and consent procedures, completion of nutritional and functional assessments, questionnaire burden, dietitian workflow, documentation, optional app use, safety reporting and optional biological sample collection. Feasibility participants will not be included in the primary or secondary efficacy analyses of the main randomised trial. Their clinical data will be analysed descriptively to support optimisation of study procedures. If separate consent is provided, biological samples from feasibility participants may be used for exploratory biomarker and microbiome analyses. The main part of the study is a two-arm randomised controlled trial. Participants will be randomly assigned in a 1:1 ratio to personalised nutritional care or usual nutritional care. The intervention period is 6 months, and participants will be followed for a total of 12 months. Participants assigned to personalised nutritional care will receive dietitian-led assessment, counselling and follow-up. The intervention may include assessment of nutritional status and hydration, individual energy, protein and fluid targets, dietary counselling, symptom-adapted advice, oral nutritional supplements when indicated, food fortification or fortified meals/snacks where appropriate, and consideration of enteral or parenteral nutrition if clinically indicated and agreed with the treating physician. Dietitian contact is planned at least weekly during the active intervention period, with more frequent contact if clinically needed or if intake remains below individual requirements. Participants assigned to usual nutritional care will receive nutritional care according to local standard clinical practice. Clinically indicated nutritional care will not be withheld in either study group. Any nutritional support provided as part of usual care or rescue care will be documented. Study assessments are planned at baseline, 3 months, 6 months and 12 months. Assessments may include nutritional screening and GLIM-based malnutrition assessment, body weight, body mass index, circumferences, bioelectrical impedance analysis, dietary intake assessment, estimated or measured energy requirements, hydration assessment using routine clinical laboratory data where possible, and physical function assessments including hand grip strength, gait speed and the Timed Up and Go test when clinically safe. Patient-reported outcomes include health-related quality of life, anxiety and depression, coping, loneliness and chemotherapy-induced taste alterations. The EORTC QLQ-C30 global health status/quality-of-life scale is used for the primary health-related quality-of-life assessment. Additional questionnaires will be used where validated translations and required permissions or licences are available and where participant burden is acceptable. Routine clinical CT scans may be used for CT-derived body composition analysis if suitable images are available. These analyses may include assessment of muscle and adipose tissue compartments using dedicated software. No additional CT scans will be performed for this purpose. Use of a mobile health application is optional. The app may support registration of food intake, weight or communication with the study team and may contribute to structured data capture. The app is not required for participation, is not part of the therapeutic nutritional intervention and may be declined or discontinued without withdrawal from the study. Participants may provide separate consent for optional biological sampling. Blood samples may be used for exploratory analyses of inflammatory, nutritional, cachexia-related, immune and cancer-related biomarkers, including immune-cell subset analyses, circulating tumour DNA or other liquid biopsy analyses where feasible. Stool samples may be collected for gut microbiome analyses using a standardised home collection kit. Participation in the biological sampling part is voluntary and is not required for participation in the main clinical study. The main outcome is change from baseline to 3 months in health-related quality of life measured by the EORTC QLQ-C30 global health status/quality-of-life score. Secondary and exploratory analyses will evaluate nutritional status, hydration, body composition, physical function, psychosocial outcomes, healthcare utilisation, treatment course, survival and exploratory biological outcomes. Feasibility outcomes will be analysed descriptively and separately from the main randomised efficacy analyses.