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Pancreatic Cancer, AdultNCT06852014

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

A study testing Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B and Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A in people with Pancreatic Cancer, Adult and Cephalic Duodenopancreatectomy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B and Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
29 May 2025to 1 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gabriel Olveira Fuster, MD, PhD contact

951290343

gabrielm.olveira.sspa@juntadeandalucia.es

Spain1 site, 1 recruiting

  • Hospital Regional Universitario de Málaga

    Málaga, Málaga, 29009

    Gabriel Olveira Fuster, MD, PhD, 951290343, gabrielm.olveira.sspa@juntadeandalucia.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read more

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.

Being tested
Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B, Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A
Keywords
Pancreatic cancer, malnutrition, pancreaticoduodenectomy, oral nutritional supplement, gut microbiota, organoids
Medical subject headings
Pancreatic cancer, adult, Pancreatic Neoplasms, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement BDietary 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 ADietary supplement

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

Study groups in NCT06852014
Study groupRoleWhat they receive
EXPERIMENTAL GROUP A (Nutritional supplement order A --> B)ExperimentalNot described
Receives: Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B
EXPERIMENTAL : EXPERIMENTAL GROUP B (Nutritional supplement order B --> A)ExperimentalNot described
Receives: Dietary Supplement: Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At weeks 6 and 13

  2. 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%

    Measured: At weeks 6 and 13

  3. 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)

    Measured: At weeks 6 and 13

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

    Aminoacids measured in µmol/L

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

Secondary outcomes (56)

  1. Doses of pancreatic enzyme replacement therapy

    Measured in International Unit per day (IU/day)

    Measured: Only at baseline

  2. Stool characteristics

    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.

    Measured: At baseline and in weeks 6, 7, and 13

  3. Symptoms of anxiety and depression

    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.

    Measured: At baseline and in weeks 6, 7, and 13

  4. Nutritional status

    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.

    Measured: At baseline and in weeks 6, 7, and 13

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

    Phase angle (PhA) measured in degrees (º)

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

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

    Extracellular water (ECW) measured in liters (l)

    Measured: At baseline and in weeks 6, 7, and 13

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

    Intracellular water (ICW) measured in liters (l)

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

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

    Hydration measured in percentage (%)

    Measured: At baseline and in weeks 6, 7, and 13

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

    Resistance measured in ohms (Ω)

    Measured: At baseline and in weeks 6, 7, and 13

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

    Reactance measured in ohms (Ω)

    Measured: At baseline and in weeks 6, 7, and 13

  17. Handgrip dynamometry

    • Device: Jamar hydraulic dynamometer
    • Measurement:

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

    Measured: At baseline and in weeks 6, 7, and 13

  18. Timed Up and Go (TUG) Test

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

    Measured: At baseline and in weeks 6, 7, and 13

  19. Change in total fat (Abdominal Ultrasound)

    Total fat measured in centimeters (cm)

    Measured: At baseline and in weeks 6, 7, and 13

  20. Change in superficial fat (Abdominal Ultrasound)

    Superficial fat measured in centimeters (cm)

    Measured: At baseline and in weeks 6, 7, and 13

  21. Change in preperitoneal fat (Abdominal Ultrasound)

    Preperitoneal fat measured in centimeters (cm)

    Measured: At baseline and in weeks 6, 7, and 13

  22. Change in muscle Ultrasound - Area

    Area measured in square centimeters (cm²)

    Measured: At baseline and in weeks 6, 7, and 13

  23. Change in muscle Ultrasound - Circumference

    Circumference measured in centimeters (cm)

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

  26. Change in Glucose

    glucose measured in mg/dl

    Measured: At baseline and in weeks 6, 7, and 13

  27. Change in Cholesterol

    Cholesterol measured in mg/dl

    Measured: At baseline and in weeks 6, 7, and 13

  28. Change in Triglycerides

    Triglycerides measured in mg/dl

    Measured: At baseline and in weeks 6, 7, and 13

  29. Change in Uric acid

    Uric acid measured in mg/dl

    Measured: At baseline and in weeks 6, 7, and 13

  30. Change in AST

    AST measured in units per litre (U/L)

    Measured: At baseline and in weeks 6, 7, and 13

  31. Change in ALT

    ALT measured in units per litre (U/L)

    Measured: At baseline and in weeks 6, 7, and 13

  32. Change in GGT

    GGT measured in units per litre (U/L)

    Measured: At baseline and in weeks 6, 7, and 13

  33. Change in ALP

    ALP measured in units per litre (U/L)

    Measured: At baseline and in weeks 6, 7, and 13

  34. Change in insulin

    Insulin measured in units per mililitre (U/mL)

    Measured: At baseline and in weeks 6, 7, and 13

  35. Change in albumin

    Albumin measured in grams per liter (g/l)

    Measured: At baseline and in weeks 6, 7, and 13

  36. Change in C-reactive protein (CRP)

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

    Measured: At baseline and in weeks 6, 7, and 13

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

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

    Measured: At baseline and in weeks 6, 7, and 13

  38. Change in zonulin

    Zonulin measured in micrograms per milliliter (μg/mL)

    Measured: At baseline and in weeks 6, 7, and 13

  39. Change in musclin

    Musclin measured in nanograms per milliliter (ng/mL)

    Measured: At baseline and in weeks 6, 7, and 13

  40. Change in galectin-3

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

    Measured: At baseline and in weeks 6, 7, and 13

  41. Change in myostatin

    Myostatin measured in nanograms per milliliter (ng/mL)

    Measured: At baseline and in weeks 6, 7, and 13

  42. Change in Total antioxidant capacity (TAC)

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

    Measured: At baseline and in weeks 6, 7, and 13

  43. Change in Glutathione peroxidase (GSH-Px)

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

    Measured: At baseline and in weeks 6, 7, and 13

  44. Change in Superoxide dismutase (SOD)

    Superoxide dismutase (SOD) measured in inhibition rate %

    Measured: At baseline and in weeks 6, 7, and 13

  45. Change in GLP-1

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

    Measured: At baseline and in weeks 6, 7, and 13

  46. Change in GIP

    GIP measured in picograms per milliliter (pg/mL)

    Measured: At baseline and in weeks 6, 7, and 13

  47. Change in PYY

    PYY measured in picograms per milliliter (pg/mL)

    Measured: At baseline and in weeks 6, 7, and 13

  48. Change in IFN-gamma

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

    Measured: At baseline and in weeks 6, 7, and 13

  49. Change in IL-2

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

    Measured: At baseline and in weeks 6, 7, and 13

  50. Change in IL-4

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

    Measured: At baseline and in weeks 6, 7, and 13

  51. Change in IL-6

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

    Measured: At baseline and in weeks 6, 7, and 13

  52. Change in IL-10

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

    Measured: At baseline and in weeks 6, 7, and 13

  53. Change in IL-12p70

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

    Measured: At baseline and in weeks 6, 7, and 13

  54. Change in IL-17A

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

    Measured: At baseline and in weeks 6, 7, and 13

  55. Change in TNF-alpha

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

    Measured: At baseline and in weeks 6, 7, and 13

  56. Change in stool calprotectin

    Calprotectin measured in micrograms per gram (µg/g)

    Measured: At baseline and in weeks 6, 7, and 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start29 May 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Patients will be randomized in a 1:1 ratio
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06852014
Sponsor's protocol ID
PEP-NUTRIDPC trial
Status last verified
Aug 2025
First submitted
13 Feb 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not necessary to reach the objectives of the project

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B and Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A in people with Pancreatic Cancer, Adult and Cephalic Duodenopancreatectomy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriel Olveira Fuster, MD, PhD (951290343, gabrielm.olveira.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to nutritional treatment (time frame: At weeks 6 and 13). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06852014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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