NCT06149546 Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
| NCT ID | NCT06149546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Trials Ireland |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-05-01 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Oonagh Griffin, Dr
PRINCIPAL INVESTIGATOR
SVUH/University College Dublin
Frequently Asked Questions
Who can join the NCT06149546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06149546 currently recruiting?
Yes, NCT06149546 is actively recruiting participants. Contact the research team at info@cancertrials.ie for enrollment information.
Where is the NCT06149546 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT06149546 clinical trial?
NCT06149546 is sponsored by Cancer Trials Ireland. The principal investigator is Oonagh Griffin, Dr at SVUH/University College Dublin. The trial plans to enroll 70 participants.
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