NutriCa65-PDAC is a clinical study for patients aged 65 years or older with pancreatic ductal adenocarcinoma, a type of pancreatic cancer. Many patients with pancreatic cancer experience weight loss, reduced appetite, loss of muscle mass, dehydration, digestive problems, taste changes, fatigue and reduced quality of life. These problems may affect how patients tolerate cancer treatment and how well they function in daily life. The purpose of this study is to find out whether early, structured and personalised nutritional care provided by trained dietitians can improve health-related quality of life compared with usual nutritional care. The study will also examine whether personalised nutritional care can improve nutritional status, fluid balance, body weight, body composition, muscle strength, physical function, symptoms, psychological well-being, hospital contacts and treatment course. The study has two parts: a feasibility part and a main randomised trial. In the feasibility part, a small number of participants will receive the personalised nutritional care intervention for about one month. This part will test whether the study procedures are practical and acceptable for patients and staff. It will assess recruitment, consent procedures, completion of questionnaires and physical tests, dietitian workflow, nutritional assessments, optional app use, safety reporting and optional biological sample collection. Participants in the feasibility part will not be randomised and will not be included in the primary or secondary efficacy analyses of the main randomised trial. Their clinical data will be analysed descriptively to help optimise the study procedures before or during early implementation of the main trial. The main part of the study is a randomised controlled trial. About 250 participants will be randomly assigned to one of two groups. One group will receive personalised nutritional care from a trained dietitian for 6 months. This may include assessment of nutritional and fluid needs, an individual nutrition plan, dietary counselling, symptom-adapted advice, oral nutritional supplements if needed, advice on fortified foods or snacks, and consideration of tube feeding or intravenous nutrition if clinically needed and agreed with the treating physician. The other group will receive usual nutritional care according to local clinical practice. Clinically needed nutritional care will not be withheld from any participant. Participants will be followed for 12 months. Study assessments are planned at baseline, 3 months, 6 months and 12 months. These assessments may include questionnaires about quality of life, anxiety and depression, coping, loneliness and taste changes; measurements of weight and body composition; assessment of food intake and hydration; and simple physical function tests such as hand grip strength, gait speed and the Timed Up and Go test. Existing routine CT scans may also be used to assess body composition if suitable images are available. No extra 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, but it is not required for participation and is not part of the nutritional treatment itself. Participants may also choose to give separate consent for optional blood and stool samples. These samples may be used for exploratory analyses of biomarkers, immune cells, circulating tumour DNA and gut microbiome. Participants can take part in the main study even if they do not wish to provide biological samples. Biological samples from feasibility participants may also be used for exploratory biomarker and microbiome analyses if separate consent is provided, but they will not be used to assess the clinical efficacy of the randomised nutritional intervention. The main outcome of the study is the change in health-related quality of life from baseline to 3 months, measured using the EORTC QLQ-C30 questionnaire. The study will also assess nutritional, functional, psychosocial, healthcare-use and exploratory biological outcomes.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
250
Personalised nutritional care delivered by a trained dietitian for 6 months, including nutritional and hydration assessment, individual energy/protein/fluid targets, dietary counselling, symptom-directed advice, oral nutritional supplements (ONS) when indicated, optional food fortification/fortified meals or snacks, and escalation to enteral/parenteral nutrition if clinically indicated and agreed with the treating physician.
Department of Oncology
Herlev, Denmark
Department of Surgery, Oncology and Gastroenterology
Padova, Italy
Department of Medicine
Bergen, Norway
Department of Medical Oncology
Bucharest, Romania
Department of Medical Oncology
Madrid, Spain
Change in HRQoL global health status
Change from baseline to Month 3 in HRQoL measured by the EORTC QLQ-C30. The primary analysis will focus on the EORTC QLQ-C30 global health status/QoL scale, unless otherwise specified in the final SAP before database lock.
Time frame: 3 months
HRQoL
HRQoL at months 6 and 12
Time frame: 6 and 12 months
Incidence and prevalence of malnutrition and dehydration
Incidence and prevalence of malnutrition according to GLIM criteria and dehydration according to calculated plasma osmolality
Time frame: 12 months
Change in body weight
Change from baseline in body weight, measured in kilograms
Time frame: Baseline to 3, 6 and 12 months
Mean change from baseline in percentage of daily energy requirement achieved
For each participant, the percentage of daily energy requirement achieved will be calculated as: daily energy intake in kilocalories divided by the protocol-defined individual daily energy requirement in kilocalories, multiplied by 100. The individual daily energy requirement may be estimated or measured according to the protocol and will be used only as the denominator for this calculation. This outcome will be reported as the mean change from baseline in percentage points. Higher values indicate that a greater proportion of the participant's daily energy requirement was achieved.
Time frame: Baseline, 3 months, 6 months and 12 months
Changes in symptoms
Nutrition-impact symptoms, including nausea, vomiting, diarrhoea, early satiety, anorexia, fatigue, pain, dysgeusia and symptoms related to pancreatic exocrine insufficiency, with chemotherapy-induced taste alterations assessed using CiTAS where relevant
Time frame: 12 months
Healthcare utilisation
Healthcare utilisation, including unplanned hospital admissions, emergency department visits, ICU admissions, length of stay, treatment interruptions and time receiving active anti-cancer treatment.
Time frame: 12 months
Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale Anxiety subscale
Change from baseline in anxiety symptoms assessed using the Hospital Anxiety and Depression Scale Anxiety subscale. The subscale score ranges from 0 to 21, with higher scores indicating more anxiety symptoms.
Time frame: Baseline to 3, 6 and 12 months
Change in body mass index
Change from baseline in body mass index, calculated from body weight and height and reported as kg/m²
Time frame: Baseline to 3, 6 and 12 months
Change in bioelectrical impedance analysis-derived muscle mass
Change from baseline in muscle mass estimated by bioelectrical impedance analysis, reported in kilograms
Time frame: Baseline to 3, 6 and 12 months
Change in CT-derived skeletal muscle index
Change from baseline in skeletal muscle index derived from routine clinical CT scans where suitable images are available, reported as cm²/m². No study-specific CT scans will be performed for this outcome.
Time frame: Baseline to 12 months
Change in hand grip strength
Change from baseline in hand grip strength measured by dynamometry, reported in kilograms
Time frame: Baseline to 3, 6 and 12 months
Number of participants with sarcopenia
Sarcopenia will be defined according to prespecified study criteria based on muscle strength and muscle mass. The outcome will be reported as the number of participants meeting the criteria for sarcopenia.
Time frame: Baseline, 3, 6 and 12 months
Change in gait speed
Change from baseline in usual gait speed, reported in meters per second.
Time frame: Baseline to 3, 6 and 12 months
Change in Timed Up and Go test time
Change from baseline in time required to complete the Timed Up and Go test, reported in seconds.
Time frame: Baseline to 3, 6 and 12 months
Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale Depression subscale
Change from baseline in depressive symptoms assessed using the Hospital Anxiety and Depression Scale Depression subscale. The subscale score ranges from 0 to 21, with higher scores indicating more depressive symptoms.
Time frame: Baseline to 3, 6 and 12 months
Change in coping measured by the Sense of Coherence Scale
Change from baseline in coping assessed using the Sense of Coherence Scale. Higher scores indicate a stronger sense of coherence.
Time frame: Baseline to 3, 6 and 12 months
Change in loneliness measured by loneliness questionnaire
Change from baseline in loneliness assessed using the \[insert exact loneliness questionnaire name\]. Higher scores indicate greater loneliness.
Time frame: Baseline to 3, 6 and 12 months
Percentage of participants achieving at least 75% of estimated or measured daily energy requirement
The percentage of participants with daily energy intake corresponding to at least 75% of their estimated or measured daily energy requirement will be reported.
Time frame: Baseline, 3 months, 6 months and 12 months
Mean change from baseline in daily protein intake as percentage of estimated or measured protein requirement
Daily protein intake will be assessed from dietary intake data and expressed as a percentage of the participant's estimated or measured daily protein requirement. Higher values indicate a greater proportion of protein requirements achieved.
Time frame: Baseline, 3 months, 6 months and 12 months
Percentage of participants achieving at least 75% of estimated or measured daily protein requirement
The percentage of participants with daily protein intake corresponding to at least 75% of their estimated or measured daily protein requirement will be reported.
Time frame: Baseline, 3 months, 6 months and 12 months
Mean change from baseline in daily fluid intake as percentage of estimated or measured fluid requirement
Daily fluid intake will be assessed from dietary intake data and expressed as a percentage of the participant's estimated or measured daily fluid requirement. Higher values indicate a greater proportion of fluid requirements achieved.
Time frame: Baseline, 3 months, 6 months and 12 months
Percentage of participants achieving at least 75% of estimated or measured daily fluid requirement
The percentage of participants with daily fluid intake corresponding to at least 75% of their estimated or measured daily fluid requirement will be reported.
Time frame: Baseline, 3 months, 6 months and 12 months
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