Peptamen 1.6 versus Resource HP/HC for nutrition after cephalic pancreaticoduodenectomy
Effects of Peptamen 1.6 in Malnourished Patients (or in Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Study Mechanistic.
This tests whether Peptamen 1.6, a hydrolysed whey protein oral supplement, helps malnourished or at-risk adults recover better than a standard high-protein/high-calorie formula after cephalic pancreaticoduodenectomy for pancreatic or periampullary cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Málaga, Málaga) |
| Trial ID | NCT06852014 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, crossover trial comparing a peptide-based enteral formula (Peptamen 1.6) with a polymeric high-protein/high-calorie formula (Resource HP/HC) in ambulatory patients who are malnourished or at risk after cephalic pancreaticoduodenectomy. In the in vivo arm, participants receive both formulas in sequence and investigators measure digestive tolerance, amino acid absorption, nutritional status, metabolic and inflammatory markers, and changes in gut microbiota. The in vitro component uses human intestinal organoids to examine how the different formulations affect intestinal permeability and related cellular mechanisms. The trial enrols patients within the immediate postoperative period and excludes those who received neoadjuvant therapy to avoid confounding effects on metabolism and microbiota.
Who should consider this trial
Good fit: Ambulatory adults with pancreatic or periampullary neoplasms who are malnourished or at risk and who underwent cephalic pancreaticoduodenectomy without prior neoadjuvant therapy within three months of surgery are ideal candidates.
Not a fit: Patients who are well-nourished, received preoperative (neoadjuvant) chemotherapy or radiotherapy, or whose surgery was performed more than three months earlier are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could improve postoperative nutritional recovery, reduce inflammatory complications, and enhance tolerance and absorption after pancreatic surgery.
How similar studies have performed: Previous studies of peptide-based enteral formulas have shown improved digestive tolerance in some surgical and pancreatitis populations, but randomized crossover trials specifically in pancreaticoduodenectomy patients with accompanying organoid mechanistic work are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ambulatory patients who are malnourished or at risk of malnutrition, with a confirmed diagnosis of neoplasms of the periampullary region, pancreas, and duodenum, or pancreatic cancer, and who have undergone cephalic pancreaticoduodenectomy (CPD). * No prior neoadjuvant treatment (preoperative chemotherapy or radiotherapy): Patients must not have received neoadjuvant therapy as these treatments can affect metabolism, nutritional status, and gut microbiota, potentially interfering with the objectives of the study's nutritional intervention. Exclusion Criteria: * Refusal to sign informed consent: Informed consent is a mandatory requirement for study participation. Any patient unwilling to participate voluntarily will be excluded. * Patients who underwent surgery more than three months ago will be excluded, as the nutritional intervention must begin in the immediate postoperative period to adequately evaluate its impact on nutritional and metabolic status. * Presence of severe cardiac disease, nephropathy, or other severe comorbidities: Conditions such as severe cardiac disease, renal failure, or comorbidities that could induce malnutrition or impair the patient's ability to tolerate nutritional treatment will be exclusion criteria. These conditions may interfere with assessing the effects of nutritional supplementation in the context of pancreatic cancer treatment. * Diarrhoea associated with antibiotics, laxatives, or osmotically active agents: Diarrhoea caused by medications may alter nutrient absorption and affect tolerance to the nutritional supplement, potentially skewing results attributable solely to the nutritional intervention. * Treatment with other nutritional support: Patients receiving other oral nutritional supplement, enteral or parenteral nutrition will be excluded, as interactions with the studied formula could confound the efficacy results of the study's nutritional intervention. * Pregnancy or possibility of becoming pregnant. * Type 1 or Type 2 diabetes with HbA1c \>8%. * Galactosaemia, fructosaemia, or allergies to components of the nutritional supplement.
Where this trial is running
Málaga, Málaga
- Hospital Regional Universitario de Málaga — Málaga, Málaga, Spain (Recruiting)
Study contacts
- Principal investigator: Gabriel Olveira Fuster, MD, PhD — Hospital Regional Universitario de Málaga, FIMABIS
- Study coordinator: Gabriel Olveira Fuster, MD, PhD
- Email: gabrielm.olveira.sspa@juntadeandalucia.es
- Phone: 951290343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.