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

July 4, 2025 updated by: Cancer Trials Ireland
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
    • Leinster
      • Dublin, Leinster, Ireland, D04 T6F4
        • Recruiting
        • St Vincent's University Hospital
        • Contact:
          • Ray McDermott, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: 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
Experimental: 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
Dietary supplement: 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

What is the study measuring?

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
Time Frame: 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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the intervention compared to the control on weight changes
Time Frame: 12 weeks
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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.
Time Frame: 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.
12 weeks
Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score)
Time Frame: 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
12 weeks
Change in Timed-up and Go (seconds) between control and intervention cohorts.
Time Frame: 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.
12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Time Frame: 12 weeks
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.
Time Frame: 12 weeks
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.
Time Frame: 12 weeks
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.
Time Frame: 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.
6 months
Changes in skeletal muscle between control and intervention cohorts.
Time Frame: 6 months
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.
Time Frame: 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
6 months
Effectiveness of the intervention compared to the control on body composition indices
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 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.
6 months
Effectiveness of the intervention compared to the control on Overall Survival
Time Frame: 6 months
Overall survival rate at 6 months following the first day of chemotherapy and median overall survival time.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Investigators

  • Principal Investigator: Oonagh Griffin, Dr, SVUH/University College Dublin
  • Principal Investigator: Ray McDermott, Prof, St Vincent's University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRIAL-IE 20-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pseudo-anonymised data will be shared with research partner University College of Dublin for performance of the study.

IPD Sharing Time Frame

Study duration

IPD Sharing Access Criteria

IPD data will be shared for all patients who provide informed consent to participation in the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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