Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma

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.

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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (5)

• 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