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

Official title

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

Overview

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.

Interventions

• Dietary supplement 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
• 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

Primary outcome measures

• Adherence to nutritional treatment [Time frame: At weeks 6 and 13]
• Natural food intake [Time frame: At weeks 6 and 13]
• Tolerance to nutritional treatment [Time frame: At weeks 6 and 13]
• Change in aminoacids: Ala, Glu, Asp, Pro, Phe, Leu/Ile, Val, Tyr, Met, Cit, Arg, Gly, and Orn [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in IL-6 and TNF-alpha RNA expression [Time frame: At baseline and in weeks 6, 7, and 13]

Secondary outcome measures (12)

• Doses of pancreatic enzyme replacement therapy [Time frame: Only at baseline]
• Stool characteristics [Time frame: At baseline and in weeks 6, 7, and 13]
• Symptoms of anxiety and depression [Time frame: At baseline and in weeks 6, 7, and 13]
• Nutritional status [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in Phase angle (PhA) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in total body water (TBW) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in extracellular water (ECW) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in intracellular water (ICW) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in Fat-free mass (FFM) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in Fat mass (FM) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in Body cell mass (BCM) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]
• Change in appendicular skeletal muscle mass (ASMM) (Vectorial Bioimpedance Analysis (BIVA)) [Time frame: At baseline and in weeks 6, 7, and 13]

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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Regional Universitario de Málaga — Málaga

Identifiers

NCT: NCT06852014 · PEP-NUTRIDPC trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗