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

NCT ID: NCT06852014

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-29
• Study Completion Date: 2026-09-01

Brief Summary

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

Pancreatic Cancer, Adult; Cephalic Duodenopancreatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EXPERIMENTAL GROUP A (Nutritional supplement order A --> B)

Group Type: EXPERIMENTAL

Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B

Intervention Type: DIETARY_SUPPLEMENT

Intervention group will receive a nutritional formula A and, after 1-week washout period, will receive a nutritional formula B

EXPERIMENTAL : EXPERIMENTAL GROUP B (Nutritional supplement order B --> A)

Group Type: EXPERIMENTAL

Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A

Intervention Type: DIETARY_SUPPLEMENT

Intervention group will receive a nutritional formula B and, after 1-week washout period, will receive a nutritional formula A

Interventions

Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B

Intervention group will receive a nutritional formula A and, after 1-week washout period, will receive a nutritional formula B

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A

Intervention group will receive a nutritional formula B and, after 1-week washout period, will receive a nutritional formula A

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Olveira Fuster, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional Universitario de Málaga, FIMABIS

Locations

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Gabriel Olveira Fuster, MD, PhD

Role: CONTACT

gabrielm.olveira.sspa@juntadeandalucia.es

951290343

Facility Contacts

Gabriel Olveira Fuster, MD, PhD

Role: primary

gabrielm.olveira.sspa@juntadeandalucia.es

951290343

Other Identifiers

PEP-NUTRIDPC trial

Identifier Type: -

Identifier Source: org_study_id