Actively Recruiting
Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study
Led by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Updated on 2025-09-02
20
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Malnutrition is a common challenge in patients with pancreatic cancer undergoing cephalic pancreaticoduodenectomy (CPD), impacting postoperative recovery and overall prognosis. Nutritional support plays a crucial role in optimising metabolic, inflammatory, and digestive outcomes. This randomised, double-blind, crossover clinical trial aims to evaluate the effects of Peptamen 1.6, a hydrolysed whey protein-based enteral formula, compared to Resource HP/HC, a high-protein and high-calorie polymeric formula, in malnourished or at-risk patients with pancreatic cancer undergoing PD. The study comprises both in vivo and in vitro analyses. The in vivo component will assess the impact of Peptamen 1.6 on digestive tolerance, amino acid absorption, nutritional status, metabolic profile, inflammatory markers, and gut microbiota composition. The in vitro component will utilise human intestinal organoid models to explore how enteral nutrition formulations influence intestinal permeability and metabolism, with a focus on microbiota interactions. Primary outcomes include improvements in metabolic status, assessed through serum biomarkers (albumin, immune markers, intestinal permeability, and myosin profile), inflammatory status via peripheral blood mononuclear cells (PBMCs), and microbiota shifts in faecal samples. Additionally, adherence to treatment, digestive tolerance, and changes in body composition will be monitored using bioelectrical impedance, dynamometry, and functional mobility tests. By elucidating the mechanisms through which different enteral nutrition strategies influence clinical, physiological, and molecular parameters, this study aims to enhance personalised nutritional interventions for patients with pancreatic cancer. The findings could contribute to optimising nutritional support strategies, ultimately improving patient outcomes following CPD.
CONDITIONS
Official Title
Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ambulatory patients malnourished or at risk of malnutrition with confirmed neoplasms of the periampullary region, pancreas, or duodenum, or pancreatic cancer
- Patients who have undergone cephalic pancreaticoduodenectomy (CPD)
- No prior neoadjuvant chemotherapy or radiotherapy treatment
You will not qualify if you...
- Refusal to sign informed consent
- Surgery performed more than three months ago
- Severe cardiac disease, nephropathy, or other severe comorbidities
- Diarrhoea caused by antibiotics, laxatives, or osmotically active agents
- Receiving other oral nutritional supplements, enteral or parenteral nutrition
- Pregnancy or possibility of becoming pregnant
- Type 1 or Type 2 diabetes with HbA1c greater than 8%
- Galactosaemia, fructosaemia, or allergies to components of the nutritional supplement
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain, 29009
Actively Recruiting
Research Team
G
Gabriel Olveira Fuster, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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