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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Trials Ireland

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Control
  • Intervention

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators