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

NCT06852014 | Recruiting

• 1 other identifier: PEP-NUTRIDPC trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreatic cancer; malnutrition; pancreaticoduodenectomy; oral nutritional supplement; gut microbiota; organoids

Outcome Measures

Primary Outcomes (5)

• Adherence to nutritional treatment

  Categorized based on the average daily consumption compared to the prescribed volume (200 ml per bottle): * Full content (200 ml/bottle) * 2/3 content (150 ml/bottle) * 1/2 content (100 ml/bottle) * 1/4 content (50 ml/bottle) Patients will self-report their average daily consumption (ml/day).

  At weeks 6 and 13

• Natural food intake

  Patients will report their food intake over the previous week, categorized into quartiles (%) relative to: * Pre-illness consumption * Perceived normal intake for patients without supplementation * ALL -100% * 3/4 - 75% * HALF - 50% * ¼ - 25% * NONE - 0%

  At weeks 6 and 13

• Tolerance to nutritional treatment

  Evaluated based on the frequency of gastrointestinal symptoms (e.g., nausea, vomiting, reflux, abdominal pain, flatulence, satiety, constipation, and stomach heaviness) within two hours of supplement consumption. Symptoms classified as: * Never * Rarely * Sometimes * Frequently * Always Bivariate analysis will classify tolerance as: * Good (no symptoms) * Poor (presence of any gastrointestinal symptoms)

  At weeks 6 and 13

• Change in aminoacids: Ala, Glu, Asp, Pro, Phe, Leu/Ile, Val, Tyr, Met, Cit, Arg, Gly, and Orn

  Aminoacids measured in µmol/L

  At baseline and in weeks 6, 7, and 13

• Change in IL-6 and TNF-alpha RNA expression

  IL-6 and TNF-alpha measured from Peripheral blood mononuclear cell (PBMC)

  At baseline and in weeks 6, 7, and 13

Secondary Outcomes (56)

• Doses of pancreatic enzyme replacement therapy

  Only at baseline

• Stool characteristics

  At baseline and in weeks 6, 7, and 13

• Symptoms of anxiety and depression

  At baseline and in weeks 6, 7, and 13

• Nutritional status

  At baseline and in weeks 6, 7, and 13

• Change in Phase angle (PhA) (Vectorial Bioimpedance Analysis (BIVA))

  At baseline and in weeks 6, 7, and 13

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, Málaga, 29009, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatic cancer, adult; Pancreatic Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Gabriel Olveira Fuster, MD, PhD

  Hospital Regional Universitario de Málaga, FIMABIS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Olveira Fuster, MD, PhD

CONTACT

951290343; gabrielm.olveira.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will take Peptamen 1,6 and Resource HP/HC de forma secuencial pero con un orden predeterminado as assigned at randomization . For this purpose, identical formats will be used and neither the participant nor the researcher will know their content.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 28, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)