Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
NCT06149546 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-07-08
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Control
* 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
- DIETARY_SUPPLEMENT
-
Intervention
* 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
Sponsors & Collaborators
-
Cancer Trials Ireland
lead NETWORK
Principal Investigators
-
Oonagh Griffin, Dr · SVUH/University College Dublin
-
Ray McDermott, Prof · St Vincent's University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2027-11-30
- Completion
- 2028-11-30
Countries
- Ireland
Study Locations
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