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NCT06852014

Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study

Recruiting now NA Last updated 2 September 2025
What this trial tests

NA trial testing Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B in Pancreatic Cancer, Adult in 20 participants. Currently enrolling.

Timeline
29 May 2025
Primary endpoint
1 June 2026
1 September 2026

Quick facts

Lead sponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment20
Start date29 May 2025
Primary completion1 June 2026
Estimated completion1 September 2026
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer, Adult or Cephalic Duodenopancreatectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Unlocking the Potential of Bioactive Compounds in Pancreatic Cancer Therapy: A Promising Frontier.
    Brugiapaglia S, Spagnolo F, Curcio C. · · 2025 · cited 1× · PMID 40427617 · DOI 10.3390/biom15050725
  2. Pancreatic Cancer in the Holobiont and Therapeutic Targets: A Review.
    Terry C, Hall LA, Halle-Smith J, Edwards LA, et al · · 2026 · PMID 42122957 · DOI 10.3390/jcm15093225
  3. Harnessing induced pluripotent stem cells and organoids for disease modeling and precision medicine.
    Lee CJ, Nam Y, Rim YA, Ju JH. · · 2026 · PMID 41656303 · DOI 10.1186/s13287-026-04906-9
  4. Strategic modulation of the gastrointestinal microbiome to enhance pancreatic cancer immunotherapy.
    Jagwani S, Musumeci L, Flores L, Mackenzie GG, et al · · 2025 · PMID 41203044 · DOI 10.1016/j.drudis.2025.104528

Verify or expand the search:

Other recruiting trials for Pancreatic Cancer, Adult

Currently open trials in the same condition.

Other Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing