Impact of nutritional support during chemotherapy for pancreatic cancer

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

This study is testing whether extra nutritional support and exercise can help people with pancreatic cancer keep their strength during chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Trials Ireland (Research network)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Dublin, Leinster)
• Trial ID: NCT06149546 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a multi-modal nutritional care package, with or without resistance training, in preventing muscle strength loss during neoadjuvant chemotherapy for pancreatic cancer. It involves a randomized, open-label design with two groups: one receiving standard dietetic care and the other receiving additional dietitian and physiotherapist support. A total of 70 patients will be enrolled, and the study will last for 12 weeks, focusing on the impact of enhanced nutritional intervention on patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and above with newly diagnosed, pathologically confirmed pancreatic ductal adenocarcinoma who are set to undergo neoadjuvant chemotherapy.

Not a fit: Patients requiring prolonged enteral or parenteral nutritional support or those with significant non-compliance history may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could help maintain muscle strength in patients undergoing chemotherapy for pancreatic cancer, potentially improving their overall treatment outcomes.

How similar studies have performed: While similar nutritional interventions have shown promise in other cancer treatments, this specific approach in pancreatic cancer is relatively novel.

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.

Where this trial is running

Dublin, Leinster

• St Vincent's University Hospital — Dublin, Leinster, Ireland (Recruiting)

Study contacts

• Principal investigator: Oonagh Griffin, Dr — SVUH/University College Dublin
• Study coordinator: Cancer Trials Ireland

Conditions Pancreatic Cancer; Multi-modal Nutritional