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

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Dietary Supplement: Control; Dietary Supplement: Intervention

• Registration Number: NCT06149546
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2027-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Ability to give signed informed consent and willing and able to comply with the protocol.
2. Patients aged 18 years and above.
3. 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).
4. Patients have CT scan available and suitable for body composition analysis within 8 weeks prior to randomisation.
5. Patients have adequate upper limb dexterity to allow assessment of hand grip strength.

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Exclusion Criteria

1. Patients who are unable to consume oral diet and require prolonged enteral and/or parenteral nutritional support.
2. Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent.
3. Patients who can/will not consume fish and pork products due to allergy, intolerance, religious beliefs, or dietary preferences.
4. 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.
5. Patients with uncontrolled hypertension (BP >180/110 mm Hg) which prohibits exercise.
6. Patients with muscle wasting disorders, e.g. paraplegia, motor neuron disease, Duchenne muscular dystrophy, multiple sclerosis.
7. Women who are pregnant or breastfeeding due to differing nutritional needs and macronutrient metabolism.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	* 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
Intervention	Intervention	* 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

Primary Outcome Measures

Name	Time	Method
Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
To compare the effectiveness of the intervention compared to the control on treatment response	6 months	Treatment response will be assessed by Radiographic Classification of Borderline Resectable Pancreatic Cancer
Effectiveness of the intervention compared to the control on Overall Survival	6 months	Overall survival rate at 6 months following the first day of chemotherapy and median overall survival time.
Changes in skeletal muscle between control and intervention cohorts.	6 months	To compare the effectiveness of a multi-modal nutrition-led intervention on skeletal muscle (mass in kg) via diagnostic and restaging CT scans
Effectiveness of the intervention compared to the control on weight changes	12 weeks	To compare the effectiveness of a multi-modal nutrition-led intervention on weight changes (kg and %) versus the control.
To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence.	12 weeks	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.
Effectiveness of the intervention compared to the control on body composition indices	6 months	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.
To compare the effectiveness of the intervention compared to the control on treatment delivery	6 months	Treatment delivery will be defined based on unplanned hospital admissions (frequency, duration (days), reason).
Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score)	12 weeks	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
Change in Timed-up and Go (seconds) between control and intervention cohorts.	12 weeks	To compare the effectiveness of a multi-modal nutrition-led intervention on function (change in Timed-up and Go (seconds)) versus the control.
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.	12 weeks	Changes in Interleukin-6 (IL-6) will be measured between control and intervention cohorts.
Changes in lumbar skeletal muscle index between control and intervention cohorts.	6 months	To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar skeletal muscle index (cm²/m²) via diagnostic and restaging CT scans.

Trial Locations

Locations (1)

St Vincent's University Hospital; 🇮🇪 Dublin, Leinster, Ireland