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Recruiting NCT06149546

NCT06149546 Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)

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Clinical Trial Summary
NCT ID NCT06149546
Status Recruiting
Phase
Sponsor Cancer Trials Ireland
Condition Pancreatic Cancer
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2024-05-01
Primary Completion 2027-11

Trial Parameters

Condition Pancreatic Cancer
Sponsor Cancer Trials Ireland
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-05-01
Completion 2027-11
Interventions
ControlIntervention

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Brief Summary

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

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 p

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