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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка 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
• Пищевая добавка 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Regional Universitario de Málaga — Málaga

Идентификаторы

NCT: NCT06852014 · PEP-NUTRIDPC trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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