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Taking people in SpainPhase 4

Tests enzyme capsules for digestive problems in people with unresectable pancreatic cancer

Tests enzyme capsules added to standard care in adults with unresectable pancreatic cancer.

Key facts

Who runs it
Hospital Clinico Universitario de Santiago
Where
Pamplona and Santiago de Compostela, SpainSee the 2 sitesAlso in 2 other countries, 2 sites
Trial code
Registry title
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
Status
Recruiting
Phase
Phase 4
People taking part
100 people, planned
Started
20 Feb 2024
Expected to end
Dec 2027
Type of study
Interventional, 2 groups
Treatments tested
  • creon 35.000 Ph.U (R)
  • Best Standarard of Care
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pancreatic cancer that cannot be removed by surgery, with the tumour in the head of the pancreas and clear weight loss. It tests enzyme capsules (PERT) added to usual care.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Pancreatic cancer confirmed by tissue tests that cannot be removed by surgery, locally advanced or metastatic. Tumour in the head of the pancreas, with a widened main pancreatic duct seen on CT scan, MRI and/or EUS.
Earlier treatment
People cannot join if they are already taking PERT, had first-line chemotherapy that failed, are on or planned for neoadjuvant therapy, or had upper gastrointestinal or pancreatic surgery.

Main reasons for not taking part

  • Allergy to pancreatin from pigs or its other ingredients
  • Already taking PERT
  • Second-line or later chemotherapy
  • A stent placed in the pancreas
  • Gastric outlet obstruction that is not resolved

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer
  • Tumour located in the head of the pancreas
  • Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS)
  • Significant weight loss (≥5% of the usual body weight) at screening
  • Life expectancy of at least six months at screening
  • Signed informed consent to the study

Who cannot take part

  • Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned
  • Prior history of upper gastrointestinal or pancreatic surgery
  • Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy)
  • Hypersensitivity to pancreatin of porcine origin or to any of the excipients
  • Patients already on PERT
  • Short life expectancy (shorter than 6 months)
  • Patients in whom a pancreatic stent has been placed
  • Unsolved gastric outlet obstruction
  • Unwillingness to participate in the study
  • Inability to comply with the study visits and study protocol, whatever the reason

Where in Spain

Also in 2 other countries, 2 sites

  • Hospital Universitario de NavarraPamplona, SpainContact: MhDTaking people
  • University Hospital of Santiago de CompostelaSantiago de Compostela, SpainContact: J. Enrique Dominguez-Munoz, PhD, MDTaking people

About the trial

What the trial wants to find out

- This will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. Pancreatic Exocrine Replacement Therapy (PERT) in these patients will be given on top of other required therapies (best standard of care, BSC), including oncologic therapies, diabetes mellitus therapies and acid suppressants and nutritional support as appropriate. The duration of the study will be up to six months.

Read full original descriptionShow less

Consecutive patients meeting inclusion criteria and none of the exclusion criteria will be evaluated for the study. Those patients signing the informed consent for study participation will be randomized to one of the following two arms:

* The experimental arm will receive the best standard of care (BSC) and PERT (capsules containing pancreatin 35,000 Ph.U.) at a fixed dose of 3 capsules with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months. * The control arm will receive the BSC over 3 months, followed by a further 3-month open uncontrolled phase of BSC + PERT at the dose mentioned above.

All patients will receive in addition a proton pump inhibitor (PPI) bid (any PPI at standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, rabeprazole 20 mg, esomeprazole 40 mg) while on PERT, 20-30 minutes before breakfast and dinner.

To make the two arms comparable, patients will be stratified in two groups (locally advanced and metastatic pancreatic cancer) for randomization using computer generated random numbers.

The 2 groups in the trial

  • experimental armTreatment being tested

    Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months post randomization.

    Treatment: creon 35.000 Ph.U (R)

  • control armOther group

    Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks during the last 3 months post randomization.

    Treatment: Best Standarard of Care

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Open Label Randomized, Multicentre, Controlled Trial of Pancreatic Enzyme Replacement Therapy (PERT) for Pancreatic Exocrine Insufficiency (PEI) in Patients With Unresectable Pancreatic Cancer. The PERTseverance Trial.
Plain-language title
Tests enzyme capsules for digestive problems in people with unresectable pancreatic cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 September 2026