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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Change in HRQoL global health status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Signed informed consent before any study-specific procedure.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Experimental: Personalised nutritional care delivered by a trained dietitian (Dietary Supplement)
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.
干预措施: Experimental: Personalised nutritional care delivered by a trained dietitian (Dietary Supplement)
结局指标
主要结局
Change in HRQoL global health status
时间窗: 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.
次要结局
- 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)
- Healthcare utilisation(12 months)
- Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale Anxiety subscale(Baseline to 3, 6 and 12 months)
- Change in body mass index(Baseline to 3, 6 and 12 months)
- Change in bioelectrical impedance analysis-derived muscle mass(Baseline to 3, 6 and 12 months)
- Change in CT-derived skeletal muscle index(Baseline to 12 months)
- Change in hand grip strength(Baseline to 3, 6 and 12 months)
- Number of participants with sarcopenia(Baseline, 3, 6 and 12 months)
- Change in gait speed(Baseline to 3, 6 and 12 months)
- Change in Timed Up and Go test time(Baseline to 3, 6 and 12 months)
- Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale Depression subscale(Baseline to 3, 6 and 12 months)
- Change in coping measured by the Sense of Coherence Scale(Baseline to 3, 6 and 12 months)
- Change in loneliness measured by loneliness questionnaire(Baseline to 3, 6 and 12 months)
- Percentage of participants achieving at least 75% of estimated or measured daily energy requirement(Baseline, 3 months, 6 months and 12 months)
- Mean change from baseline in daily protein intake as percentage of estimated or measured protein requirement(Baseline, 3 months, 6 months and 12 months)
- Percentage of participants achieving at least 75% of estimated or measured daily protein requirement(Baseline, 3 months, 6 months and 12 months)
- Mean change from baseline in daily fluid intake as percentage of estimated or measured fluid requirement(Baseline, 3 months, 6 months and 12 months)
- Percentage of participants achieving at least 75% of estimated or measured daily fluid requirement(Baseline, 3 months, 6 months and 12 months)
研究者
Inna Chen, MD
Lead of the Pancreatic Cancer Centre
Herlev Hospital