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NCT Number: NCT06149546

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's University Hospital

Dublin, Leinster, D04 T6F4, Ireland

Location status: Recruiting

Location contact

Ray McDermott, Prof

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Dietary Supplement
  • 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

Dietary Supplement
  • 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 outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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. 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

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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. 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.

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Trials Ireland

CONTACT

[email protected]

+35316677211

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Acronym: FEED

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 29, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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