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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
NA trial testing Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B in Pancreatic Cancer, Adult in 20 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 29 May 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 September 2026 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B
- Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A
Conditions studied
- Pancreatic Cancer, Adult — all drugs for Pancreatic Cancer, Adult →
- Cephalic Duodenopancreatectomy — all drugs for Cephalic Duodenopancreatectomy →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT06852014
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06852014 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Last refreshed: 2 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06852014.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing