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.
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 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.
Parallel
Control
Dietary supplement* High protein, high energy diet * Fish oil supplement (ProSure®) * Pancreatic Enzymes (Creon®) * A daily individualised step target (10% above your own baseline) * Four scheduled appointments with a dietitian
Intervention
Dietary supplement* High protein, high energy diet * Fish oil supplement (ProSure®) * Pancreatic Enzymes (Creon®) * A daily individualised step target (10% above your own baseline) * Seven scheduled appointments with a dietitian * Six scheduled appointments with a physiotherapist
Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy
To compare the effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (Percentage change in handgrip strength as determined by handgrip dynamometry) during chemotherapy with an intensive multi-modal nutrition and physiotherapist delivered intervention (1:1 randomisation).
Effectiveness of the intervention compared to the control on weight changes
To compare the effectiveness of a multi-modal nutrition-led intervention on weight changes (kg and %) versus the control.
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on the occurrence of dose limiting toxicity (NCI CTCAE grading V5).
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on the need for dose reduction due to weight loss.
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on unplanned hospital admissions (frequency, duration (days), reason).
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