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

NCT06149546 | Recruiting

• 1 other identifier: CTRIAL-IE 20-26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Multi-modal Nutritional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Effectiveness of the intervention compared to the control on weight changes

  12 weeks

• To compare the effectiveness of the intervention compared to the control on treatment delivery

  6 months

• To compare the effectiveness of the intervention compared to the control on treatment delivery

  6 months

• To compare the effectiveness of the intervention compared to the control on treatment delivery

  6 months

• To compare the effectiveness of the intervention compared to the control on treatment response

  6 months

Study Arms (2)

Control

EXPERIMENTAL

* 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

Intervention

EXPERIMENTAL

* 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

Interventions

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

Control

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (1)

St Vincent's University Hospital

Dublin, Leinster, D04 T6F4, Ireland

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Oonagh Griffin, Dr

  SVUH/University College Dublin

  PRINCIPAL INVESTIGATOR

• Ray McDermott, Prof

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Trials Ireland

CONTACT

+35316677211; info@cancertrials.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 29, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Study duration
• Access Criteria: IPD data will be shared for all patients who provide informed consent to participation in the study

Locations

IE (1)