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Trial Title:
Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
NCT ID:
NCT06149546
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Cancer
Multi-modal Nutritional
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Control
Description:
- 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
Arm group label:
Control
Intervention type:
Dietary Supplement
Intervention name:
Intervention
Description:
- 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
Arm group label:
Intervention
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.
Detailed description:
This is a translational, single-site, open-label, randomised, prospective 12-week study.
70 (35 in each arm) patients will be enrolled in the study; The study will examine if a
multi-modal nutritional care package, with or without resistance training delivered
concurrently to neoadjuvant chemotherapy, is effective at preventing loss of muscle
strength during neoadjuvant chemotherapy for pancreatic cancer. There are two arms in
this study: The control group will receive standard dietetic care and be prescribed
standard pancreatic enzyme replacement therapy and oral nutritional supplement drinks
concurrently with their neoadjuvant chemotherapy. The intervention group in comparison to
the control group will have 3 additional dietitian visits and 6 physiotherapist visits
that the control group will not.
Criteria for 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 products due to allergy,
intolerance, religious beliefs, or dietary preferences.
4. 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.
5. Patients with uncontrolled hypertension (BP >180/110 mm Hg) which prohibits
exercise.
6. Patients with muscle wasting disorders, e.g. paraplegia, motor neuron disease,
Duchenne muscular dystrophy, multiple sclerosis.
7. Women who are pregnant or breastfeeding due to differing nutritional needs and
macronutrient metabolism.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Vincent's University Hospital
Address:
City:
Dublin
Zip:
D04 T6F4
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Ray McDermott, Prof
Start date:
May 1, 2024
Completion date:
November 2028
Lead sponsor:
Agency:
Cancer Trials Ireland
Agency class:
Other
Source:
Cancer Trials Ireland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149546
