Clinical trial NCT06149546: Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
Official title: Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Multi-modal Nutritional
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2023-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy
timeFrame: 12 weeks
Secondary outcomes:
measure: Effectiveness of the intervention compared to the control on weight changes
timeFrame: 12 weeks
measure: To compare the effectiveness of the intervention compared to the control on treatment delivery
timeFrame: 6 months
measure: To compare the effectiveness of the intervention compared to the control on treatment delivery
timeFrame: 6 months
measure: To compare the effectiveness of the intervention compared to the control on treatment delivery
timeFrame: 6 months
measure: To compare the effectiveness of the intervention compared to the control on treatment response
timeFrame: 6 months
measure: To compare the effectiveness of the intervention compared to the control on treatment response
timeFrame: 6 months
measure: To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence.
timeFrame: 12 weeks
measure: Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score)
timeFrame: 12 weeks
measure: Change in Timed-up and Go (seconds) between control and intervention cohorts.
timeFrame: 12 weeks
measure: Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
timeFrame: 12 weeks
measure: Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
timeFrame: 12 weeks
measure: Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
timeFrame: 12 weeks
measure: Changes in lumbar skeletal muscle index between control and intervention cohorts.
timeFrame: 6 months
measure: Changes in skeletal muscle between control and intervention cohorts.
timeFrame: 6 months
measure: Changes in skeletal muscle between control and intervention cohorts.
timeFrame: 6 months
measure: Effectiveness of the intervention compared to the control on body composition indices
timeFrame: 6 months
measure: Effectiveness of the intervention compared to the control on body composition indices
timeFrame: 6 months
measure: Effectiveness of the intervention compared to the control on body composition indices
timeFrame: 6 months
measure: Effectiveness of the intervention compared to the control on Overall Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
state: Leinster
Study officials:
affiliation: SVUH/University College Dublin
name: Oonagh Griffin, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's University Hospital
name: Ray McDermott, Prof
role: PRINCIPAL_INVESTIGATOR
References: