Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma

NCT07821554 | Not Yet Recruiting

• 2 other identifiers: PA 2616Proposal number: 101288867
• Study Type: interventional
• Target: 250
• Locations: 5 countries
• Sites: 5

Brief 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 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.

Conditions

Pancreatic Cancer

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; Circulating tumour DNA

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (22)

• HRQoL

  6 and 12 months

• Incidence and prevalence of malnutrition and dehydration

  12 months

• Change in body weight

  Baseline to 3, 6 and 12 months

• Mean change from baseline in percentage of daily energy requirement achieved

  Baseline, 3 months, 6 months and 12 months

• Changes in symptoms

  12 months

Other Outcomes (15)

• Overall survival

  12 months

• Mean change from baseline in C-reactive protein concentration

  Baseline, 3 months, 6 months and 12 months

• Liquid biopsy and cfDNA profiling

  36 months

Study Arms (2)

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.

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.

Dietary Supplement: Experimental: Personalised nutritional care delivered by a trained dietitian

Interventions

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.

Control Arm; Personalised nutritional care delivered by a trained dietitian for 6 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inna Chen, MD: lead
• Haukeland University Hospital: collaborator
• Hospital Universitario Fundación Jiménez Díaz: collaborator
• Azienda Ospedaliera di Padova: collaborator
• Emergency and Clinical Hospital "Dr. Agrippa Ionescu": collaborator

Study Sites (5)

Department of Oncology

Herlev, 2730, Denmark

Location

Department of Surgery, Oncology and Gastroenterology

Padova, Italy

Location

Department of Medicine

Bergen, Norway

Location

Department of Medical Oncology

Bucharest, Romania

Location

Department of Medical Oncology

Madrid, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Malnutrition; Weight Loss; Sarcopenia; Dehydration

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Inna Markovna Chen, MD

CONTACT

+45 38682898; inna.chen@regionh.dk

Susann Theile

CONTACT

+45 38689598; susann.theile@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead of the Pancreatic Cancer Centre

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DK (1); RO (1); ES (1); NO (1)