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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 have adequate upper limb dexterity to allow assessment of hand grip strength.

Locations
Other Locations
Ireland
St Vincent's University Hospital
RECRUITING
Dublin
Contact Information
Primary
Cancer Trials Ireland
info@cancertrials.ie
+35316677211
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2028-11
Participants
Target number of participants: 70
Treatments
Experimental: 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
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Cancer Trials Ireland

This content was sourced from clinicaltrials.gov

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