Actively Recruiting
Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
Led by Cancer Trials Ireland · Updated on 2025-07-08
70
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to give signed informed consent and willing and able to comply with the protocol.
- Patients aged 18 years and above.
- Newly diagnosed, pathologically confirmed pancreatic ductal adenocarcinoma.
- Scheduled to undergo neoadjuvant chemotherapy with FOLFIRINOX, Gemcitabine with Nab-Paclitaxel, or NCCP-approved regimens.
- CT scan available within 8 weeks prior to randomisation suitable for body composition analysis.
- Adequate upper limb dexterity for hand grip strength assessment.
You will not qualify if you...
- Unable to consume oral diet and require prolonged enteral or parenteral nutritional support.
- History of significant non-compliance to medical treatments or inability to provide reliable informed consent.
- Allergy, intolerance, religious beliefs, or dietary preferences preventing consumption of fish and pork products.
- Known blood clotting disorders or liver disease with cirrhosis making fish oil supplementation unsafe.
- Uncontrolled hypertension (blood pressure above 180/110 mm Hg) prohibiting exercise.
- Muscle wasting disorders such as paraplegia, motor neuron disease, Duchenne muscular dystrophy, or multiple sclerosis.
- Women who are pregnant or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
St Vincent's University Hospital
Dublin, Leinster, Ireland, D04 T6F4
Actively Recruiting
Research Team
C
Cancer Trials Ireland
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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