Pancreatic Cancer study: Intervention
Official title Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
ClinicalTrials.gov ID: NCT06149546
What this study is testing
- What it's testing
- 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.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Dublin, Leinster, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dublin, Leinster, Ireland. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.