RecruitingNot ApplicableNCT06149546

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


Sponsor

Cancer Trials Ireland

Enrollment

70 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called the FEED Trial) is studying whether a multi-part nutrition program — including dietary changes, protein supplements, fish oil, and exercise guidance — can help preserve strength and body composition in people with pancreatic cancer who are receiving chemotherapy before surgery (called neoadjuvant chemotherapy). **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with pancreatic ductal adenocarcinoma (a type of pancreatic cancer) - Your treatment team has recommended neoadjuvant chemotherapy (FOLFIRINOX or Gemcitabine/Nab-Paclitaxel) before surgery - You have adequate grip strength and can tolerate a scan to assess body composition **You may NOT be eligible if...** - You cannot eat orally and need tube feeding or IV nutrition - You cannot eat fish or pork (due to allergy, intolerance, religion, or preference), as the study uses these foods - You have a blood clotting disorder or liver cirrhosis where fish oil supplementation would be unsafe - You have uncontrolled high blood pressure (above 180/110 mmHg) that prevents exercise - You have a muscle-wasting neurological condition (e.g., multiple sclerosis, muscular dystrophy) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTControl

* 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_SUPPLEMENTIntervention

* 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


Locations(1)

St Vincent's University Hospital

Dublin, Leinster, Ireland

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NCT06149546


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