Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)

Study Overview
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Brief Summary
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The study will examine if a multi-modal nutritional care package, with or without resistance training delivered with neoadjuvant chemotherapy, is effective at preventing loss of muscle strength during neoadjuvant chemotherapy for pancreatic cancer. There are two arms in this study: Control Arm will receive standard dietetic care and be prescribed standard pancreatic enzyme replacement therapy and oral nutritional supplement drinks with their neoadjuvant chemotherapy. The intervention Arm will have 3 additional dietitian visits and 6 physiotherapist visits that the control group will not.

Detailed Description
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This is a translational, single-site, open-label, randomised, prospective 12-week study. 70 (35 in each arm) patients will be enrolled in the study; The study will examine if a multi-modal nutritional care package, with or without resistance training delivered concurrently to neoadjuvant chemotherapy, is effective at preventing loss of muscle strength during neoadjuvant chemotherapy for pancreatic cancer. There are two arms in this study: The control group will receive standard dietetic care and be prescribed standard pancreatic enzyme replacement therapy and oral nutritional supplement drinks concurrently with their neoadjuvant chemotherapy. The intervention group in comparison to the control group will have 3 additional dietitian visits and 6 physiotherapist visits that the control group will not.

Official Title
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Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Dietary Supplement: Control
* Dietary Supplement: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give signed informed consent and willing and able to comply with the protocol. Patients aged 18 years and above. Patients with newly diagnosed, pathologically confirmed pancreatic ductal adenocarcinoma who will undergo neoadjuvant chemotherapy following formal MDT assessment at St Vincent's University Hospital, specifically FOLFIRINOX or Gemcitabine with Nab-Paclitaxel (and/or any additional therapy regimen approved by NCCP). Patients have CT scan available and suitable for body composition analysis within 8 weeks prior to randomisation. Patients have adequate upper limb dexterity to allow assessment of hand grip strength. Exclusion Criteria: Patients who are unable to consume oral diet and require prolonged enteral and/or parenteral nutritional support. Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent. Patients who can/will not consume fish and pork products due to allergy, intolerance, religious beliefs, or dietary preferences. Patients with known blood clotting disorders, e.g antiphospholipid syndrome, factor V Leiden syndrome, haemophilia /any liver disease which has progressed to liver cirrhosis where prolonged fish oil supplementation is unsafe. Patients with uncontrolled hypertension (BP >180/110 mm Hg) which prohibits exercise. Patients with muscle wasting disorders, e.g. paraplegia, motor neuron disease, Duchenne muscular dystrophy, multiple sclerosis. Women who are pregnant or breastfeeding due to differing nutritional needs and macronutrient metabolism.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>High protein, high energy diet Fish oil supplement (ProSure®) Pancreatic Enzymes (Creon®) A daily individualised step target (10% above your own baseline) Four scheduled appointments with a dietitian | Dietary Supplement: Control<br>* High protein, high energy diet Fish oil supplement (ProSure®) Pancreatic Enzymes (Creon®) A daily individualised step target (10% above your own baseline) Four scheduled appointments with a dietitian<br>|
| Experimental: Intervention<br>High protein, high energy diet Fish oil supplement (ProSure®) Pancreatic Enzymes (Creon®) A daily individualised step target (10% above your own baseline) Seven scheduled appointments with a dietitian Six scheduled appointments with a physiotherapist | Dietary Supplement: Intervention<br>* High protein, high energy diet Fish oil supplement (ProSure®) Pancreatic Enzymes (Creon®) A daily individualised step target (10% above your own baseline) Seven scheduled appointments with a dietitian Six scheduled appointments with a physiotherapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy | To compare the effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (Percentage change in handgrip strength as determined by handgrip dynamometry) during chemotherapy with an intensive multi-modal nutrition and physiotherapist delivered intervention (1:1 randomisation). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the intervention compared to the control on weight changes | To compare the effectiveness of a multi-modal nutrition-led intervention on weight changes (kg and %) versus the control. | 12 weeks | 
| To compare the effectiveness of the intervention compared to the control on treatment delivery | Treatment delivery will be defined based on the occurrence of dose limiting toxicity (NCI CTCAE grading V5). | 6 months | 
| To compare the effectiveness of the intervention compared to the control on treatment delivery | Treatment delivery will be defined based on the need for dose reduction due to weight loss. | 6 months | 
| To compare the effectiveness of the intervention compared to the control on treatment delivery | Treatment delivery will be defined based on unplanned hospital admissions (frequency, duration (days), reason). | 6 months | 
| To compare the effectiveness of the intervention compared to the control on treatment response | Treatment response will be assessed by Resectability Status per National Cancer Control Network (NCCN) | 6 months | 
| To compare the effectiveness of the intervention compared to the control on treatment response | Treatment response will be assessed by Radiographic Classification of Borderline Resectable Pancreatic Cancer | 6 months | 
| To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence. | Patient acceptance/adherence is defined as attendance at dietetic and physiotherapy appointments, dose of ONS and PERT delivered vs prescribed, step target achievement, exercise program adherence and progress. | 12 weeks | 
| Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score) | To compare the effectiveness of a multi-modal nutrition-led intervention on patient health-related quality of life (change in European Organisation for Research and Treatment of Cancer - Core Quality of Life questionnaire (EORTC QLQ-C30) function or symptom score) versus the control. The core EORTC QLQ C30 questionnaire has five functioning subscale scores and nine symptoms subscale scores. Minimum value = 0; Max value = 100 Function Scales: Higher numbers mean better function Symptom Scale: Higher numbers mean more symptoms | 12 weeks | 
| Change in Timed-up and Go (seconds) between control and intervention cohorts. | To compare the effectiveness of a multi-modal nutrition-led intervention on function (change in Timed-up and Go (seconds)) versus the control. | 12 weeks | 
| Changes in inflammatory markers and cytokine levels between control and intervention cohorts. | Changes in C-reactive Protein (CRP) will be measured between control and intervention cohorts. | 12 weeks | 
| Changes in inflammatory markers and cytokine levels between control and intervention cohorts. | Changes in Tumour Necrosis Factor-alpha (TNF-α) will be measured between control and intervention cohorts. | 12 weeks | 
| Changes in inflammatory markers and cytokine levels between control and intervention cohorts. | Changes in Interleukin-6 (IL-6) will be measured between control and intervention cohorts. | 12 weeks | 
| Changes in lumbar skeletal muscle index between control and intervention cohorts. | To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar skeletal muscle index (cm²/m²) via diagnostic and restaging CT scans. | 6 months | 
| Changes in skeletal muscle between control and intervention cohorts. | To compare the effectiveness of a multi-modal nutrition-led intervention on skeletal muscle (area in cm²) via diagnostic and restaging CT scans | 6 months | 
| Changes in skeletal muscle between control and intervention cohorts. | To compare the effectiveness of a multi-modal nutrition-led intervention on skeletal muscle (mass in kg) via diagnostic and restaging CT scans | 6 months | 
| Effectiveness of the intervention compared to the control on body composition indices | To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar adipose tissue (area in cm²) via diagnostic and restaging CT scans. | 6 months | 
| Effectiveness of the intervention compared to the control on body composition indices | To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar adipose tissue (mass in kg) via diagnostic and restaging CT scans. | 6 months | 
| Effectiveness of the intervention compared to the control on body composition indices | To compare the effectiveness of a multi-modal nutrition-led intervention on body composition indices: assessment of muscle attenuation (Hounsfield Units (HU)) via diagnostic and restaging CT scans. | 6 months | 
| Effectiveness of the intervention compared to the control on Overall Survival | Overall survival rate at 6 months following the first day of chemotherapy and median overall survival time. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Multi-modal Nutritional