Pancreatic CancerFEEDNCT06149546
Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
A study testing Intervention in people with Pancreatic Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 1 May 2024to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are unable to consume oral diet and require prolonged enteral and/or parenteral nutritional support.
- Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent.
- Patients who can/will not consume fish and pork products due to allergy, intolerance, religious beliefs, or dietary preferences.
- 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.
- Patients with uncontrolled hypertension (BP >180/110 mm Hg) which prohibits exercise.
- Patients with muscle wasting disorders, e.g. paraplegia, motor neuron disease, Duchenne muscular dystrophy, multiple sclerosis.
- Women who are pregnant or breastfeeding due to differing nutritional needs and macronutrient metabolism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
St Vincent's University Hospital
Dublin, Leinster, D04 T6F4
Ray McDermott, Prof
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Control, Intervention
- Keywords
- Pancreatic Cancer, Multi-modal Nutritional
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
- 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
InterventionDietary supplement
- 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
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | * 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 Receives: Dietary Supplement: Control |
| Intervention | Experimental | * 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 Receives: Dietary Supplement: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy
To compare the effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (Percentage change in handgrip strength as determined by handgrip dynamometry) during chemotherapy with an intensive multi-modal nutrition and physiotherapist delivered intervention (1:1 randomisation).
Measured: 12 weeks
Secondary outcomes (19)
Effectiveness of the intervention compared to the control on weight changes
To compare the effectiveness of a multi-modal nutrition-led intervention on weight changes (kg and %) versus the control.
Measured: 12 weeks
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on the occurrence of dose limiting toxicity (NCI CTCAE grading V5).
Measured: 6 months
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on the need for dose reduction due to weight loss.
Measured: 6 months
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on unplanned hospital admissions (frequency, duration (days), reason).
Measured: 6 months
To compare the effectiveness of the intervention compared to the control on treatment response
Treatment response will be assessed by Resectability Status per National Cancer Control Network (NCCN)
Measured: 6 months
To compare the effectiveness of the intervention compared to the control on treatment response
Treatment response will be assessed by Radiographic Classification of Borderline Resectable Pancreatic Cancer
Measured: 6 months
To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence.
Patient acceptance/adherence is defined as attendance at dietetic and physiotherapy appointments, dose of ONS and PERT delivered vs prescribed, step target achievement, exercise program adherence and progress.
Measured: 12 weeks
Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score)
To compare the effectiveness of a multi-modal nutrition-led intervention on patient health-related quality of life (change in European Organisation for Research and Treatment of Cancer - Core Quality of Life questionnaire (EORTC QLQ-C30) function or symptom score) versus the control.
The core EORTC QLQ C30 questionnaire has five functioning subscale scores and nine symptoms subscale scores.
Minimum value = 0; Max value = 100 Function Scales: Higher numbers mean better function Symptom Scale: Higher numbers mean more symptoms
Measured: 12 weeks
Change in Timed-up and Go (seconds) between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on function (change in Timed-up and Go (seconds)) versus the control.
Measured: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Changes in C-reactive Protein (CRP) will be measured between control and intervention cohorts.
Measured: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Changes in Tumour Necrosis Factor-alpha (TNF-α) will be measured between control and intervention cohorts.
Measured: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Changes in Interleukin-6 (IL-6) will be measured between control and intervention cohorts.
Measured: 12 weeks
Changes in lumbar skeletal muscle index between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar skeletal muscle index (cm²/m²) via diagnostic and restaging CT scans.
Measured: 6 months
Changes in skeletal muscle between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on skeletal muscle (area in cm²) via diagnostic and restaging CT scans
Measured: 6 months
Changes in skeletal muscle between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on skeletal muscle (mass in kg) via diagnostic and restaging CT scans
Measured: 6 months
Effectiveness of the intervention compared to the control on body composition indices
To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar adipose tissue (area in cm²) via diagnostic and restaging CT scans.
Measured: 6 months
Effectiveness of the intervention compared to the control on body composition indices
To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar adipose tissue (mass in kg) via diagnostic and restaging CT scans.
Measured: 6 months
Effectiveness of the intervention compared to the control on body composition indices
To compare the effectiveness of a multi-modal nutrition-led intervention on body composition indices: assessment of muscle attenuation (Hounsfield Units (HU)) via diagnostic and restaging CT scans.
Measured: 6 months
Effectiveness of the intervention compared to the control on Overall Survival
Overall survival rate at 6 months following the first day of chemotherapy and median overall survival time.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 May 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Oonagh Griffin, Dr, Principal investigator, SVUH/University College DublinRay McDermott, Prof, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149546
- Sponsor's protocol ID
- CTRIAL-IE 20-26
- Acronym
- FEED
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudo-anonymised data will be shared with research partner University College of Dublin for performance of the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
- ClinicalTrials.gov ID
- NCT06149546
- Acronym / sponsor ID
- FEED / CTRIAL-IE 20-26
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Multi-modal Nutritional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 1 May 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | 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 |
| Intervention | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients who are unable to consume oral diet and require prolonged enteral and/or parenteral nutritional support.
- Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent.
- Patients who can/will not consume fish and pork products due to allergy, intolerance, religious beliefs, or dietary preferences.
- 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.
- Patients with uncontrolled hypertension (BP >180/110 mm Hg) which prohibits exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control |
| 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 | Dietary supplement | Intervention |
Primary outcome
Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy
Time frame: 12 weeks
To compare the effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (Percentage change in handgrip strength as determined by handgrip dynamometry) during chemotherapy with an intensive multi-modal nutrition and physiotherapist delivered intervention (1:1 randomisation).
19 secondary outcomes
Effectiveness of the intervention compared to the control on weight changes
Time frame: 12 weeks
To compare the effectiveness of the intervention compared to the control on treatment delivery
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment delivery
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment delivery
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment response
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment response
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence.
Time frame: 12 weeks
Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score)
Time frame: 12 weeks
Change in Timed-up and Go (seconds) between control and intervention cohorts.
Time frame: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Time frame: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Time frame: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Time frame: 12 weeks
Changes in lumbar skeletal muscle index between control and intervention cohorts.
Time frame: 6 months
Changes in skeletal muscle between control and intervention cohorts.
Time frame: 6 months
Changes in skeletal muscle between control and intervention cohorts.
Time frame: 6 months
Effectiveness of the intervention compared to the control on body composition indices
Time frame: 6 months
Effectiveness of the intervention compared to the control on body composition indices
Time frame: 6 months
Effectiveness of the intervention compared to the control on body composition indices
Time frame: 6 months
Effectiveness of the intervention compared to the control on Overall Survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes. Pseudo-anonymised data will be shared with research partner University College of Dublin for performance of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oonagh Griffin, Dr principal investigator
SVUH/University College Dublin
Ray McDermott, Prof principal investigator
St Vincent's University Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Pancreatic Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Trials Ireland (+35316677211, info@cancertrials.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.