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NCT Number: NCT06852014

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

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.

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Key information

Conditions

Pancreatic Cancer, Adult Cephalic Duodenopancreatectomy Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location status: Recruiting

Location contact

Gabriel Olveira Fuster, MD, PhD

CONTACT

[email protected]

951290343

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Adherence to nutritional treatment

    Time frame: At weeks 6 and 13

    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).

  2. Natural food intake

    Time frame: At weeks 6 and 13

    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%

  3. Tolerance to nutritional treatment

    Time frame: At weeks 6 and 13

    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)

  4. 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

    Aminoacids measured in µmol/L

  5. Change in IL-6 and TNF-alpha RNA expression

    Time frame: At baseline and in weeks 6, 7, and 13

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

Secondary outcomes

  1. Doses of pancreatic enzyme replacement therapy

    Time frame: Only at baseline

    Measured in International Unit per day (IU/day)

  2. Stool characteristics

    Time frame: At baseline and in weeks 6, 7, and 13

    The number and type of stools will be assessed using the Kings Stool Chart, a standardized tool that classifies stool consistency and form to evaluate digestive function alterations.

    • Number of bowel movements: A numerical field to record the daily count.
    • Type of bowel movements: A categorical field with options ranging from 1 to 7, based on the King's Stool Chart.
    • Variability in type: A binary field (0 = No, 1 = Yes) to indicate whether there is variation.

  3. Symptoms of anxiety and depression

    Time frame: At baseline and in weeks 6, 7, and 13

    Measured using the Hospital Anxiety and Depression Scale (HADS), which consists of two subscales: HADS-Anxiety (HADSA) and HADS-Depression (HADSD)

    Interpretation of scores:

    • 0-7: Normal.
    • 8-10: Suggests the presence of mood disorders.
    • ≥11: Indicates a probable mood disorder.

  4. Nutritional status

    Time frame: At baseline and in weeks 6, 7, and 13

    Evaluated using the Subjective Global Assessment (SGA) and Global Leadership Initiative on Malnutrition (GLIM) criteria, both validated tools for classifying malnutrition severity.

    Patients will be categorized as at risk of malnutrition or having moderate or severe malnutrition based on results.

  5. Change in Phase angle (PhA) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Phase angle (PhA) measured in degrees (º)

  6. Change in total body water (TBW) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Total body water (TBW) measured in liters (l)

  7. Change in extracellular water (ECW) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Extracellular water (ECW) measured in liters (l)

  8. Change in intracellular water (ICW) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Intracellular water (ICW) measured in liters (l)

  9. Change in Fat-free mass (FFM) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Fat-free mass (FFM) measured in kilograms (kg) and percentage (%)

  10. Change in Fat mass (FM) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Fat mass (FM) measured in kilograms (kg) and percentage (%)

  11. Change in Body cell mass (BCM) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Body cell mass (BCM) measured in kilograms (kg)

  12. Change in appendicular skeletal muscle mass (ASMM) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Appendicular skeletal muscle mass (ASMM) measured in kilograms (kg)

  13. Change in skeletal muscle index (SMI) (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Skeletal muscle index (SMI) measured in kilogram per square meter (kg/m²)

  14. Change in hydration (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Hydration measured in percentage (%)

  15. Change in resistance (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Resistance measured in ohms (Ω)

  16. Change in reactance (Vectorial Bioimpedance Analysis (BIVA))

    Time frame: At baseline and in weeks 6, 7, and 13

    Reactance measured in ohms (Ω)

  17. Handgrip dynamometry

    Time frame: At baseline and in weeks 6, 7, and 13

    • Device: Jamar hydraulic dynamometer
    • Measurement:

    Mean and maximum grip strength (kg) from three measurements Used to assess sarcopenia

  18. Timed Up and Go (TUG) Test

    Time frame: At baseline and in weeks 6, 7, and 13

    • Measures mobility and physical function
    • Procedure: Time (seconds) taken for the patient to:
    • Rise from a chair
    • Walk a short distance
    • Return to the chair

  19. Change in total fat (Abdominal Ultrasound)

    Time frame: At baseline and in weeks 6, 7, and 13

    Total fat measured in centimeters (cm)

  20. Change in superficial fat (Abdominal Ultrasound)

    Time frame: At baseline and in weeks 6, 7, and 13

    Superficial fat measured in centimeters (cm)

  21. Change in preperitoneal fat (Abdominal Ultrasound)

    Time frame: At baseline and in weeks 6, 7, and 13

    Preperitoneal fat measured in centimeters (cm)

  22. Change in muscle Ultrasound - Area

    Time frame: At baseline and in weeks 6, 7, and 13

    Area measured in square centimeters (cm²)

  23. Change in muscle Ultrasound - Circumference

    Time frame: At baseline and in weeks 6, 7, and 13

    Circumference measured in centimeters (cm)

  24. Change in muscle Ultrasound - X-axis and Y-axis

    Time frame: At baseline and in weeks 6, 7, and 13

    X-axis and Y-axis measured in centimeters (cm)

  25. Change in muscle Ultrasound - Adipose tissue of the rectus femoris of the quadriceps

    Time frame: At baseline and in weeks 6, 7, and 13

    Adipose tissue of the rectus femoris of the quadriceps measured in centimeters (cm)

  26. Change in Glucose

    Time frame: At baseline and in weeks 6, 7, and 13

    glucose measured in mg/dl

  27. Change in Cholesterol

    Time frame: At baseline and in weeks 6, 7, and 13

    Cholesterol measured in mg/dl

  28. Change in Triglycerides

    Time frame: At baseline and in weeks 6, 7, and 13

    Triglycerides measured in mg/dl

  29. Change in Uric acid

    Time frame: At baseline and in weeks 6, 7, and 13

    Uric acid measured in mg/dl

  30. Change in AST

    Time frame: At baseline and in weeks 6, 7, and 13

    AST measured in units per litre (U/L)

  31. Change in ALT

    Time frame: At baseline and in weeks 6, 7, and 13

    ALT measured in units per litre (U/L)

  32. Change in GGT

    Time frame: At baseline and in weeks 6, 7, and 13

    GGT measured in units per litre (U/L)

  33. Change in ALP

    Time frame: At baseline and in weeks 6, 7, and 13

    ALP measured in units per litre (U/L)

  34. Change in insulin

    Time frame: At baseline and in weeks 6, 7, and 13

    Insulin measured in units per mililitre (U/mL)

  35. Change in albumin

    Time frame: At baseline and in weeks 6, 7, and 13

    Albumin measured in grams per liter (g/l)

  36. Change in C-reactive protein (CRP)

    Time frame: At baseline and in weeks 6, 7, and 13

    C-reactive protein (CRP) measured in milligrams per liter (mg/L)

  37. Change in Intestinal fatty acid-binding protein (I-FABP)

    Time frame: At baseline and in weeks 6, 7, and 13

    Intestinal fatty acid-binding protein (I-FABP) measured in picograms per milliliter (pg/mL)

  38. Change in zonulin

    Time frame: At baseline and in weeks 6, 7, and 13

    Zonulin measured in micrograms per milliliter (μg/mL)

  39. Change in musclin

    Time frame: At baseline and in weeks 6, 7, and 13

    Musclin measured in nanograms per milliliter (ng/mL)

  40. Change in galectin-3

    Time frame: At baseline and in weeks 6, 7, and 13

    Galectin-3 measured in nanograms per milliliter (ng/mL)

  41. Change in myostatin

    Time frame: At baseline and in weeks 6, 7, and 13

    Myostatin measured in nanograms per milliliter (ng/mL)

  42. Change in Total antioxidant capacity (TAC)

    Time frame: At baseline and in weeks 6, 7, and 13

    Total antioxidant capacity (TAC) measured in nanomoles per microliter (nmol/μL)

  43. Change in Glutathione peroxidase (GSH-Px)

    Time frame: At baseline and in weeks 6, 7, and 13

    Glutathione peroxidase (GSH-Px) measured in milliunits per milliliter (mU/mL)

  44. Change in Superoxide dismutase (SOD)

    Time frame: At baseline and in weeks 6, 7, and 13

    Superoxide dismutase (SOD) measured in inhibition rate %

  45. Change in GLP-1

    Time frame: At baseline and in weeks 6, 7, and 13

    GLP-1 measured in picograms per milliliter (pg/mL)

  46. Change in GIP

    Time frame: At baseline and in weeks 6, 7, and 13

    GIP measured in picograms per milliliter (pg/mL)

  47. Change in PYY

    Time frame: At baseline and in weeks 6, 7, and 13

    PYY measured in picograms per milliliter (pg/mL)

  48. Change in IFN-gamma

    Time frame: At baseline and in weeks 6, 7, and 13

    IFN-gamma measured in picograms per milliliter (pg/mL)

  49. Change in IL-2

    Time frame: At baseline and in weeks 6, 7, and 13

    IL-2 measured in picograms per milliliter (pg/mL)

  50. Change in IL-4

    Time frame: At baseline and in weeks 6, 7, and 13

    IL-4 measured in picograms per milliliter (pg/mL)

  51. Change in IL-6

    Time frame: At baseline and in weeks 6, 7, and 13

    IL-6 measured in picograms per milliliter (pg/mL)

  52. Change in IL-10

    Time frame: At baseline and in weeks 6, 7, and 13

    IL-10 measured in picograms per milliliter (pg/mL)

  53. Change in IL-12p70

    Time frame: At baseline and in weeks 6, 7, and 13

    IL-12p70 measured in picograms per milliliter (pg/mL)

  54. Change in IL-17A

    Time frame: At baseline and in weeks 6, 7, and 13

    IL-17A measured in picograms per milliliter (pg/mL)

  55. Change in TNF-alpha

    Time frame: At baseline and in weeks 6, 7, and 13

    TNF-alpha measured in picograms per milliliter (pg/mL)

  56. Change in stool calprotectin

    Time frame: At baseline and in weeks 6, 7, and 13

    Calprotectin measured in micrograms per gram (µg/g)

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Olveira Fuster, MD, PhD

CONTACT

[email protected]

951290343

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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