Status:
RECRUITING
Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06149546
Start Date
May 1 2024
End Date
November 1 2028
Last Update
July 8 2025
Active Locations (1)
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1
St Vincent's University Hospital
Dublin, Leinster, Ireland, D04 T6F4