Pancreatic CancerNutriCa65-PDACNCT07821554
Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma
A study testing Experimental: Personalised nutritional care delivered by a trained dietitian in people with Pancreatic Cancer, run by Inna Chen, MD at 5 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Experimental: Personalised nutritional care delivered by a trained dietitian
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Nov 2026to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Denmark1 site
Department of Oncology
Herlev, 2730
Inna Markovna Chen, MD, +45 38682898, Inna.Chen@regionh.dk
Susann Theile, susann.theile@regionh.dk
Italy1 site
Department of Surgery, Oncology and Gastroenterology
Padova
Giovanni Marchegiani, MD, giovanni.marchegiani@unipd.it
Norway1 site
Department of Medicine
Bergen
Ane Rømmen Rømen do Carmo, MD, ane.rommen.do.carmo@helsebergen.no
Bjørn Tore Tore Gjertsen, MD, Bjorn.Gjertsen@uib.no
Romania1 site
Department of Medical Oncology
Bucharest
Ruxandra Irimia, MD, ruxandra.maria.irimia@gmail.com
Spain1 site
Department of Medical Oncology
Madrid
Angela Lamarca, MD, angela.lamarca@quironsalud.es
Bjørn Tore Tore Gjertsen, MD, Bjorn.Gjertsen@uib.no
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Experimental: Personalised nutritional care delivered by a trained dietitian
- Keywords
- Pancreatic ductal adenocarcinoma, Pancreatic cancer, Older adults, Personalised nutrition, Nutritional care, Dietitian-led intervention, Malnutrition, Cancer cachexia, Weight loss, Sarcopenia, Dehydration, Body composition, Health-related quality of life, EORTC QLQ-C30, Physical function, Oral nutritional supplements, Chemotherapy-induced taste alteration, Gut microbiome, Pragmatic randomised trial, Biomarkers
- Medical subject headings
- Pancreatic Neoplasms, Malnutrition, Weight Loss, Sarcopenia, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Personalised nutritional care delivered by a trained dietitianDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Personalised nutritional care delivered by a trained dietitian for 6 months | Experimental | 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. Dietitian-led assessment and treatment aiming to meet at least 75% of energy and protein requirements and appropriate fluid intake; regular contacts; ONS when indicated; optional food fortification/fortified meals/snacks; symptom-directed advice. Optional mHealth tool may support data capture and communication but is not part of the intervention. Receives: Dietary Supplement: Experimental: Personalised nutritional care delivered by a trained dietitian |
| Control Arm | Active comparator | Usual nutritional care according to local standard practice at the participating site, documented in detail. Scheduled nutritional assessments should be performed by trial staff not delivering the intervention where feasible to minimise spillover. Receives: Dietary Supplement: Experimental: Personalised nutritional care delivered by a trained dietitian |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (22)
HRQoL
HRQoL at months 6 and 12
Measured: 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
Measured: 12 months
Change in body weight
Change from baseline in body weight, measured in kilograms
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline to 12 months
Change in hand grip strength
Change from baseline in hand grip strength measured by dynamometry, reported in kilograms
Measured: 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.
Measured: Baseline, 3, 6 and 12 months
Change in gait speed
Change from baseline in usual gait speed, reported in meters per second.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inna Chen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Hospital Universitario Fundación Jiménez Díaz, Azienda Ospedaliera di Padova, Emergency and Clinical Hospital "Dr. Agrippa Ionescu"
- Responsible party
- Sponsor-investigator, Inna Chen, MD, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821554
- Sponsor's protocol ID
- PA 2616
- Other IDs
- Proposal number: 101288867
- Acronym
- NutriCa65-PDAC
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07821554
- Acronym / sponsor ID
- NutriCa65-PDAC / PA 2616
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic ductal adenocarcinoma, Pancreatic cancer, Older adults, Personalised nutrition, Nutritional care, Dietitian-led intervention, Malnutrition, Cancer cachexia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Inna Chen, MDUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Hospital Universitario Fundación Jiménez Díaz, Azienda Ospedaliera di Padova, Emergency and Clinical Hospital "Dr. Agrippa Ionescu"
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised nutritional care delivered by a trained dietitian for 6 months | Experimental | Dietary Supplement: Experimental: Personalised nutritional care delivered by a trained dietitianPersonalised 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. Dietitian-led assessment and treatment aiming to meet at least 75% of energy and protein requirements and appropriate fluid intake; regular contacts; ONS when indicated; optional food fortification/fortified meals/snacks; symptom-directed advice. Optional mHealth tool may support data capture and communication but is not part of the intervention. |
| Control Arm | Active comparator | Dietary Supplement: Experimental: Personalised nutritional care delivered by a trained dietitianUsual nutritional care according to local standard practice at the participating site, documented in detail. Scheduled nutritional assessments should be performed by trial staff not delivering the intervention where feasible to minimise spillover. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Personalised nutritional care delivered by a trained dietitianPersonalised 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. | Dietary supplement | Control Arm, Personalised nutritional care delivered by a trained dietitian for 6 months |
Primary outcome
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.
22 secondary outcomes
HRQoL
Time frame: 6 and 12 months
Incidence and prevalence of malnutrition and dehydration
Time frame: 12 months
Change in body weight
Time frame: Baseline to 3, 6 and 12 months
Mean change from baseline in percentage of daily energy requirement achieved
Time frame: Baseline, 3 months, 6 months and 12 months
Changes in symptoms
Time frame: 12 months
Healthcare utilisation
Time frame: 12 months
Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale Anxiety subscale
Time frame: Baseline to 3, 6 and 12 months
Change in body mass index
Time frame: Baseline to 3, 6 and 12 months
Change in bioelectrical impedance analysis-derived muscle mass
Time frame: Baseline to 3, 6 and 12 months
Change in CT-derived skeletal muscle index
Time frame: Baseline to 12 months
Change in hand grip strength
Time frame: Baseline to 3, 6 and 12 months
Number of participants with sarcopenia
Time frame: Baseline, 3, 6 and 12 months
Change in gait speed
Time frame: Baseline to 3, 6 and 12 months
Change in Timed Up and Go test time
Time frame: Baseline to 3, 6 and 12 months
Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale Depression subscale
Time frame: Baseline to 3, 6 and 12 months
Change in coping measured by the Sense of Coherence Scale
Time frame: Baseline to 3, 6 and 12 months
Change in loneliness measured by loneliness questionnaire
Time frame: Baseline to 3, 6 and 12 months
Percentage of participants achieving at least 75% of estimated or measured daily energy requirement
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
Time frame: Baseline, 3 months, 6 months and 12 months
Percentage of participants achieving at least 75% of estimated or measured daily protein requirement
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
Time frame: Baseline, 3 months, 6 months and 12 months
Percentage of participants achieving at least 75% of estimated or measured daily fluid requirement
Time frame: Baseline, 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Personalised nutritional care delivered by a trained dietitian in people with Pancreatic Cancer, run by Inna Chen, MD at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Italy, Norway, Romania, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inna Markovna Chen, MD (+45 38682898, inna.chen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HRQoL global health status (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.