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

Launched by CANCER TRIALS IRELAND · Nov 20, 2023

Keywords

ClinConnect Summary

The FEED Trial is a clinical study looking at how a special nutritional program can help patients with pancreatic cancer who are receiving chemotherapy. The main goal is to see if this program, which includes extra visits with dietitians and physiotherapists, can prevent the loss of muscle strength that often happens during treatment. Participants in the study will be divided into two groups: one group will receive standard nutritional care, while the other group will get additional support with their diet and exercise.

To join the study, patients need to be at least 18 years old and have a confirmed diagnosis of pancreatic cancer. They should be able to give consent and have a CT scan available to help assess their body composition. However, those who cannot eat normally, have certain medical conditions, or are pregnant or breastfeeding will not be eligible. Participants can expect several visits with healthcare professionals to help them manage their nutrition and strength during chemotherapy. This trial is currently recruiting, so there are opportunities for eligible patients to get involved.

Gender

ALL

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.