Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
NCT ID: NCT06099119
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-02-20
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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experimental arm
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.
creon 35.000 Ph.U (R)
Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six months study period.
control arm
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.
Best Standarard of Care
Control arm: no treatment over 3 months from randomization. PERT from third month untill last visit in sixt month
Interventions
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creon 35.000 Ph.U (R)
Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six months study period.
Best Standarard of Care
Control arm: no treatment over 3 months from randomization. PERT from third month untill last visit in sixt month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Tumour located in the head of the pancreas.
3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS).
4. Significant weight loss (≥5% of the usual body weight) at screening.
5. Life expectancy of at least six months at screening.
6. Signed informed consent to the study.
Exclusion Criteria
2. Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned.
3. Patients already on PERT.
4. Prior history of upper gastrointestinal or pancreatic surgery.
5. Short life expectancy (shorter than 6 months).
6. Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy).
7. Patients in whom a pancreatic stent has been placed.
8. Unsolved gastric outlet obstruction.
9. Unwillingness to participate in the study.
10. Inability to comply with the study visits and study protocol, whatever the reason.
18 Years
ALL
No
Sponsors
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Complejo Hospitalario de Navarra
OTHER
Karolinska Institutet
OTHER
San Raffaele University Hospital, Italy
OTHER
Beaujon Hospital
OTHER
Hospital Clinico Universitario de Santiago
OTHER
Responsible Party
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J. Enrique Domínguez-Muñoz
Prof. PhD. MD.
Locations
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Istituto di Ricovero e Cura Carattere Scientifico San Raffaele
Milan, Milan, Italy
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Karolinska Institutet
Stockholm, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PEI004/2021
Identifier Type: -
Identifier Source: org_study_id
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