NCT06099119RecruitingPhase 4
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
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.
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
\- 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. 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Oct 2023
- Start date
- 20 Feb 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Diseases
- Pancreatic cancer
- NCT number
- NCT06099119
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 20 Feb 2024 to the primary completion date, Jun 2027
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Hypersensitivity to pancreatin of porcine origin or to any of the excipients.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| University Hospital of Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Istituto di Ricovero e Cura Carattere Scientifico San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Karolinska Institutet Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.