NCT06149546Recruiting
Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 11 Oct 2023
- Start date
- 1 May 2024
- Primary completion date
- Nov 2027
- Lead sponsor
- Cancer Trials Ireland
- Diseases
- Pancreatic cancer
- NCT number
- NCT06149546
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 1 May 2024 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Patients who are unable to consume oral diet and require prolonged enteral and/or parenteral nutritional support.
- Women who are pregnant or breastfeeding due to differing nutritional needs and macronutrient metabolism.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.