Clinical trial NCT06852014: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer, Adult
Cephalic Duodenopancreatectomy
Keywords: Pancreatic cancer
malnutrition
pancreaticoduodenectomy
oral nutritional supplement
gut microbiota
organoids
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomized in a 1:1 ratio
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients who are malnourished or at risk of malnutrition, with a confirmed diagnosis of 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.
* Intervention performed more than 90 days prior to the baseline visit: 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.

Primary outcomes:
measure: Adherence to nutritional treatment
timeFrame: At weeks 6 and 13
measure: Natural food intake
timeFrame: At weeks 6 and 13
measure: Tolerance to nutritional treatment
timeFrame: At weeks 6 and 13
measure: Change in aminoacids: Ala, Glu, Asp, Pro, Phe, Leu/Ile, Val, Tyr, Met, Cit, Arg, Gly, and Orn
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IL-6 and TNF-alpha RNA expression
timeFrame: At baseline and in weeks 6, 7, and 13
Secondary outcomes:
measure: Doses of pancreatic enzyme replacement therapy
timeFrame: Only at baseline
measure: Stool characteristics
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Symptoms of anxiety and depression
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Nutritional status
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Phase angle (PhA) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in total body water (TBW) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in extracellular water (ECW) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in intracellular water (ICW) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Fat-free mass (FFM) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Fat mass (FM) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Body cell mass (BCM) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in appendicular skeletal muscle mass (ASMM) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in skeletal muscle index (SMI) (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in hydration (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in resistance (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in reactance (Vectorial Bioimpedance Analysis (BIVA))
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Handgrip dynamometry
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Timed Up and Go (TUG) Test
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in total fat (Abdominal Ultrasound)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in superficial fat (Abdominal Ultrasound)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in preperitoneal fat (Abdominal Ultrasound)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in muscle Ultrasound - Area
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in muscle Ultrasound - Circumference
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in muscle Ultrasound - X-axis and Y-axis
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in muscle Ultrasound - Adipose tissue of the rectus femoris of the quadriceps
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Glucose
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Cholesterol
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Triglycerides
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Uric acid
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in AST
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in ALT
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in GGT
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in ALP
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in insulin
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in albumin
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in C-reactive protein (CRP)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Intestinal fatty acid-binding protein (I-FABP)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in zonulin
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in musclin
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in galectin-3
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in myostatin
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Total antioxidant capacity (TAC)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Glutathione peroxidase (GSH-Px)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in Superoxide dismutase (SOD)
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in GLP-1
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in GIP
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in PYY
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IFN-gamma
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IL-2
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IL-4
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IL-6
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IL-10
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IL-12p70
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in IL-17A
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in TNF-alpha
timeFrame: At baseline and in weeks 6, 7, and 13
measure: Change in stool calprotectin
timeFrame: At baseline and in weeks 6, 7, and 13
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
Study officials:
affiliation: Hospital Regional Universitario de Málaga, FIMABIS
name: Gabriel Olveira Fuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: