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NCT06149546 | RECRUITING | Pancreatic Cancer

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

Cancer Trials Ireland

Brief 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.

Condition or disease

Pancreatic Cancer

Intervention/treatment

Control

Intervention

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
Actual Study Start Date : 2024-05-01
Estimated Primary Completion Date : 2027-11
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)

Location Details

NCT06149546

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Locations

RECRUITING

Ireland, Leinster

St Vincent's University Hospital

Dublin, Leinster, Ireland, D04 T6F4