Personalised Nutritional Care in Older Patients With Pancreatic Ductal Adenocarcinoma (NutriCa65-PDAC)
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.
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Inna Markovna Chen, MD
- 電話番号：+45 38682898
- メール：Inna.Chen@regionh.dk
研究連絡先のバックアップ
- 名前：Susann Theile
- 電話番号：+45 38689598
- メール：susann.theile@regionh.dk
研究場所
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Padova、イタリア
- Department of Surgery, Oncology and Gastroenterology
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コンタクト：
- Giovanni Marchegiani, MD
- メール：giovanni.marchegiani@unipd.it
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Madrid、スペイン
- Department of Medical Oncology
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コンタクト：
- Bjørn Tore Tore Gjertsen, MD
- メール：Bjorn.Gjertsen@uib.no
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コンタクト：
- Angela Lamarca, MD
- メール：angela.lamarca@quironsalud.es
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Herlev、デンマーク、2730
- Department of Oncology
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コンタクト：
- Inna Markovna Chen, MD
- 電話番号：+45 38682898
- メール：Inna.Chen@regionh.dk
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副調査官：
- Mette Nissen, MD
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コンタクト：
- Susann Theile
- メール：susann.theile@regionh.dk
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副調査官：
- Gilava Borhani-Khomani, MD
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主任研究者：
- Inna Markovna Chen, MD
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副調査官：
- Troels Dreier Christensen, MD
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副調査官：
- Julia Sidenius Johansen, PhD
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Bergen、ノルウェー
- Department of Medicine
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コンタクト：
- Ane Rømmen Rømen do Carmo, MD
- メール：ane.rommen.do.carmo@helsebergen.no
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コンタクト：
- Bjørn Tore Tore Gjertsen, MD
- メール：Bjorn.Gjertsen@uib.no
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Bucharest、ルーマニア
- Department of Medical Oncology
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コンタクト：
- Ruxandra Irimia, MD
- メール：ruxandra.maria.irimia@gmail.com
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Personalised nutritional care delivered by a trained dietitian for 6 months
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.
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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.
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アクティブコンパレータ：Control Arm
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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in HRQoL global health status
時間枠：3 months
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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.
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3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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HRQoL
時間枠：6 and 12 months
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HRQoL at months 6 and 12
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6 and 12 months
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Incidence and prevalence of malnutrition and dehydration
時間枠：12 months
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Incidence and prevalence of malnutrition according to GLIM criteria and dehydration according to calculated plasma osmolality
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12 months
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Change in body weight
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in body weight, measured in kilograms
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Baseline to 3, 6 and 12 months
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Mean change from baseline in percentage of daily energy requirement achieved
時間枠：Baseline, 3 months, 6 months and 12 months
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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.
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Baseline, 3 months, 6 months and 12 months
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Changes in symptoms
時間枠：12 months
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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
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12 months
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Healthcare utilisation
時間枠：12 months
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Healthcare utilisation, including unplanned hospital admissions, emergency department visits, ICU admissions, length of stay, treatment interruptions and time receiving active anti-cancer treatment.
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12 months
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Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale Anxiety subscale
時間枠：Baseline to 3, 6 and 12 months
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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.
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Baseline to 3, 6 and 12 months
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Change in body mass index
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in body mass index, calculated from body weight and height and reported as kg/m²
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Baseline to 3, 6 and 12 months
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Change in bioelectrical impedance analysis-derived muscle mass
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in muscle mass estimated by bioelectrical impedance analysis, reported in kilograms
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Baseline to 3, 6 and 12 months
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Change in CT-derived skeletal muscle index
時間枠：Baseline to 12 months
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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.
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Baseline to 12 months
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Change in hand grip strength
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in hand grip strength measured by dynamometry, reported in kilograms
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Baseline to 3, 6 and 12 months
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Number of participants with sarcopenia
時間枠：Baseline, 3, 6 and 12 months
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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.
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Baseline, 3, 6 and 12 months
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Change in gait speed
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in usual gait speed, reported in meters per second.
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Baseline to 3, 6 and 12 months
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Change in Timed Up and Go test time
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in time required to complete the Timed Up and Go test, reported in seconds.
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Baseline to 3, 6 and 12 months
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Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale Depression subscale
時間枠：Baseline to 3, 6 and 12 months
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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.
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Baseline to 3, 6 and 12 months
|
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Change in coping measured by the Sense of Coherence Scale
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in coping assessed using the Sense of Coherence Scale.
Higher scores indicate a stronger sense of coherence.
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Baseline to 3, 6 and 12 months
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Change in loneliness measured by loneliness questionnaire
時間枠：Baseline to 3, 6 and 12 months
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Change from baseline in loneliness assessed using the [insert exact loneliness questionnaire name].
Higher scores indicate greater loneliness.
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Baseline to 3, 6 and 12 months
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Percentage of participants achieving at least 75% of estimated or measured daily energy requirement
時間枠：Baseline, 3 months, 6 months and 12 months
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The percentage of participants with daily energy intake corresponding to at least 75% of their estimated or measured daily energy requirement will be reported.
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Baseline, 3 months, 6 months and 12 months
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Mean change from baseline in daily protein intake as percentage of estimated or measured protein requirement
時間枠：Baseline, 3 months, 6 months and 12 months
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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.
|
Baseline, 3 months, 6 months and 12 months
|
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Percentage of participants achieving at least 75% of estimated or measured daily protein requirement
時間枠：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.
|
Baseline, 3 months, 6 months and 12 months
|
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Mean change from baseline in daily fluid intake as percentage of estimated or measured fluid requirement
時間枠：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.
|
Baseline, 3 months, 6 months and 12 months
|
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Percentage of participants achieving at least 75% of estimated or measured daily fluid requirement
時間枠：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.
|
Baseline, 3 months, 6 months and 12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall survival
時間枠：12 months
|
Overall survival and cancer-specific survival, adjusted for baseline clinical characteristics, disease stage, performance status and anti-cancer treatment
|
12 months
|
|
Mean change from baseline in C-reactive protein concentration
時間枠：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.
|
Baseline, 3 months, 6 months and 12 months
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Liquid biopsy and cfDNA profiling
時間枠：36 months
|
Liquid biopsy and cfDNA profiling, including targeted next-generation sequencing and/or genome-wide methylation profiling, where funded and consented.
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36 months
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Change from baseline in gut microbiome alpha diversity measured by Shannon diversity index
時間枠：Baseline, 3 months, 6 months and 12 months
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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.
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Baseline, 3 months, 6 months and 12 months
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Mean mHealth application usability score measured by the System Usability Scale
時間枠：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.
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1 month and 3 months
|
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Mean total healthcare cost per participant
時間枠：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.
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Baseline to 12 months
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Mean change from baseline in growth differentiation factor 15 concentration
時間枠：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.
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Baseline, 3 months, 6 months and 12 months
|
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Mean change from baseline in interleukin-6 concentration
時間枠：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.
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Baseline, 3 months, 6 months and 12 months
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Change from baseline in gut microbiome beta diversity measured by Bray-Curtis dissimilarity
時間枠：Baseline, 3 months, 6 months and 12 months
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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.
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Baseline, 3 months, 6 months and 12 months
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Percentage of app users retained at 30 days based on mHealth application log data
時間枠：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.
|
30 days after first app use
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Number of mHealth application sessions per app user
時間枠：Baseline to 6 months
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Engagement with the optional mHealth application will be assessed using application log data and reported as the number of app sessions per app user.
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Baseline to 6 months
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Number of chatbot interactions per app user
時間枠：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.
|
Baseline to 6 months
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|
Participant-reported benefit of the mHealth application measured by a study-specific questionnaire
時間枠：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.
|
1 month, 3 months and 6 months
|
|
Incremental cost-effectiveness ratio for personalised nutritional care compared with usual nutritional care
時間枠：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.
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Baseline to 12 months
|
|
Budget impact of implementing personalised nutritional care
時間枠：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.
|
Baseline to 12 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PA 2616
- Proposal number: 101288867 (その他の助成金/資金番号：HORIZON-MISS-2025-02-CANCER-05)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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