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NCT Number: NCT07821554

Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma

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.

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Key information

Conditions

Pancreatic Cancer Atrophy Body Weight Body Weight Changes Dehydration Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Malnutrition Metabolic Diseases Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Water-Electrolyte Imbalance Weight Loss

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Herlev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is 65 years or older at the time of signing informed consent.
  • Histologically or cytologically confirmed borderline resectable, locally advanced or metastatic pancreatic ductal adenocarcinoma.
  • Participant is managed at a participating oncology, surgical or gastroenterology site and is planned to start, or has recently started, an eligible PDAC treatment within 14 days.
  • ECOG performance status 0-2.
  • Signed informed consent before any study-specific procedure.

Exclusion criteria

  • Expected life expectancy of less than 3 months, in the judgement of the investigator.
  • Unable to provide informed consent and no legally authorised representative procedure is applicable under local regulations.
  • Participation in another interventional nutrition trial or structured nutritional programme that would interfere with the NutriCa65 intervention or outcome assessments.
  • Known allergy, intolerance or contraindication to all available oral nutritional supplements or intervention products, where no suitable alternative can be provided.
  • Clinical condition making participation in trial procedures unsafe or excessively burdensome, as judged by the investigator.
  • Any other condition that, in the investigator's opinion, would compromise participant safety, rights or data integrity.

Treatment and study plan

Experimental: Personalised nutritional care delivered by a trained dietitian

Dietary Supplement

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.

Primary outcomes

  1. Change in HRQoL global health status

    Time frame: 3 months

    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.

Secondary outcomes

  1. HRQoL

    Time frame: 6 and 12 months

    HRQoL at months 6 and 12

  2. Incidence and prevalence of malnutrition and dehydration

    Time frame: 12 months

    Incidence and prevalence of malnutrition according to GLIM criteria and dehydration according to calculated plasma osmolality

  3. Change in body weight

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in body weight, measured in kilograms

  4. Mean change from baseline in percentage of daily energy requirement achieved

    Time frame: Baseline, 3 months, 6 months and 12 months

    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.

  5. Changes in symptoms

    Time frame: 12 months

    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

  6. Healthcare utilisation

    Time frame: 12 months

    Healthcare utilisation, including unplanned hospital admissions, emergency department visits, ICU admissions, length of stay, treatment interruptions and time receiving active anti-cancer treatment.

  7. Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale Anxiety subscale

    Time frame: Baseline to 3, 6 and 12 months

    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.

  8. Change in body mass index

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in body mass index, calculated from body weight and height and reported as kg/m²

  9. Change in bioelectrical impedance analysis-derived muscle mass

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in muscle mass estimated by bioelectrical impedance analysis, reported in kilograms

  10. Change in CT-derived skeletal muscle index

    Time frame: Baseline to 12 months

    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.

  11. Change in hand grip strength

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in hand grip strength measured by dynamometry, reported in kilograms

  12. Number of participants with sarcopenia

    Time frame: Baseline, 3, 6 and 12 months

    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.

  13. Change in gait speed

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in usual gait speed, reported in meters per second.

  14. Change in Timed Up and Go test time

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in time required to complete the Timed Up and Go test, reported in seconds.

  15. Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale Depression subscale

    Time frame: Baseline to 3, 6 and 12 months

    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.

  16. Change in coping measured by the Sense of Coherence Scale

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in coping assessed using the Sense of Coherence Scale. Higher scores indicate a stronger sense of coherence.

  17. Change in loneliness measured by loneliness questionnaire

    Time frame: Baseline to 3, 6 and 12 months

    Change from baseline in loneliness assessed using the [insert exact loneliness questionnaire name]. Higher scores indicate greater loneliness.

  18. Percentage of participants achieving at least 75% of estimated or measured daily energy requirement

    Time frame: Baseline, 3 months, 6 months and 12 months

    The percentage of participants with daily energy intake corresponding to at least 75% of their estimated or measured daily energy requirement will be reported.

  19. Mean change from baseline in daily protein intake as percentage of estimated or measured protein requirement

    Time frame: Baseline, 3 months, 6 months and 12 months

    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.

  20. Percentage of participants achieving at least 75% of estimated or measured daily protein requirement

    Time frame: Baseline, 3 months, 6 months and 12 months

    The percentage of participants with daily protein intake corresponding to at least 75% of their estimated or measured daily protein requirement will be reported.

  21. Mean change from baseline in daily fluid intake as percentage of estimated or measured fluid requirement

    Time frame: Baseline, 3 months, 6 months and 12 months

    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.

  22. Percentage of participants achieving at least 75% of estimated or measured daily fluid requirement

    Time frame: Baseline, 3 months, 6 months and 12 months

    The percentage of participants with daily fluid intake corresponding to at least 75% of their estimated or measured daily fluid requirement will be reported.

Other outcomes

  1. Overall survival

    Time frame: 12 months

    Overall survival and cancer-specific survival, adjusted for baseline clinical characteristics, disease stage, performance status and anti-cancer treatment

  2. Mean change from baseline in C-reactive protein concentration

    Time frame: Baseline, 3 months, 6 months and 12 months

    C-reactive protein concentration will be measured in blood and reported in mg/L among participants with available samples or routine clinical laboratory data.

  3. Liquid biopsy and cfDNA profiling

    Time frame: 36 months

    Liquid biopsy and cfDNA profiling, including targeted next-generation sequencing and/or genome-wide methylation profiling, where funded and consented.

  4. Change from baseline in gut microbiome alpha diversity measured by Shannon diversity index

    Time frame: Baseline, 3 months, 6 months and 12 months

    Gut microbiome alpha diversity will be assessed in stool samples using 16S rRNA gene sequencing or shotgun metagenomic sequencing, depending on the final analytical platform. Alpha diversity will be reported using the Shannon diversity index. Higher values indicate greater within-sample microbial diversity.

  5. Mean mHealth application usability score measured by the System Usability Scale

    Time frame: 1 month and 3 months

    Usability of the optional mHealth application will be assessed among app users using the System Usability Scale. Scores range from 0 to 100, with higher scores indicating better perceived usability.

  6. Mean total healthcare cost per participant

    Time frame: Baseline to 12 months

    Total healthcare costs per participant will be estimated from healthcare utilisation data, including hospital contacts, admissions, emergency department visits, intensive care unit admissions, outpatient contacts, nutritional support and cancer treatment-related healthcare use, and reported in euros.

  7. Mean change from baseline in growth differentiation factor 15 concentration

    Time frame: Baseline, 3 months, 6 months and 12 months

    Growth differentiation factor 15 concentration will be measured in blood and reported in pg/mL among participants who provide optional biological sample consent and have available samples.

  8. Mean change from baseline in interleukin-6 concentration

    Time frame: Baseline, 3 months, 6 months and 12 months

    Interleukin-6 concentration will be measured in blood and reported in pg/mL among participants who provide optional biological sample consent and have available samples.

  9. Change from baseline in gut microbiome beta diversity measured by Bray-Curtis dissimilarity

    Time frame: Baseline, 3 months, 6 months and 12 months

    Gut microbiome beta diversity will be assessed in stool samples using 16S rRNA gene sequencing or shotgun metagenomic sequencing, depending on the final analytical platform. Bray-Curtis dissimilarity will be used to compare microbial community composition between baseline and follow-up samples.

  10. Percentage of app users retained at 30 days based on mHealth application log data

    Time frame: 30 days after first app use

    Thirty-day app retention will be defined as the percentage of participants who use the mHealth application at least once during the 30-day period after first app use.

  11. Number of mHealth application sessions per app user

    Time frame: Baseline to 6 months

    Engagement with the optional mHealth application will be assessed using application log data and reported as the number of app sessions per app user.

  12. Number of chatbot interactions per app user

    Time frame: Baseline to 6 months

    Use of the chatbot function will be assessed using application log data and reported as the number of chatbot interactions per app user.

  13. Participant-reported benefit of the mHealth application measured by a study-specific questionnaire

    Time frame: 1 month, 3 months and 6 months

    Participant-reported benefit of the optional mHealth application will be assessed among app users using a study-specific questionnaire. Higher scores indicate greater perceived benefit.

  14. Incremental cost-effectiveness ratio for personalised nutritional care compared with usual nutritional care

    Time frame: Baseline to 12 months

    The incremental cost-effectiveness ratio will be calculated as the difference in mean costs between study groups divided by the difference in mean change in EORTC QLQ-C30 global health status/quality-of-life score.

  15. Budget impact of implementing personalised nutritional care

    Time frame: Baseline to 12 months

    Budget impact will be estimated as the difference in total expected costs between implementation of personalised nutritional care and usual nutritional care over 12 months, reported in euros.

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Sponsors and collaborators

Lead sponsor

Inna Chen, MD

Other

Collaborators

  • Azienda Ospedaliera di Padova
  • Emergency and Clinical Hospital "Dr. Agrippa Ionescu"
  • Haukeland University Hospital
  • Hospital Universitario Fundación Jiménez Díaz

Registry information

Official study title

A Multicentre, Parallel-group, Open-label, Two-arm Randomised Trial of Personalised Nutritional Care Compared With Usual Nutritional Care in Patients Aged 65 Years or Older With Pancreatic Ductal Adenocarcinoma

Acronym: NutriCa65-PDAC

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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