NCT06099119 Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
| NCT ID | NCT06099119 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital Clinico Universitario de Santiago |
| Condition | Unresectable Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-02-20 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
\- 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.
Eligibility Criteria
Inclusion Criteria: 1. Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer. 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: 1. Hypersensitivity to pancreatin of porcine origin or to any of the excipients. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06099119 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unresectable Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06099119 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06099119 currently recruiting?
Yes, NCT06099119 is actively recruiting participants. Contact the research team at juan.enrique.dominguez.munoz@sergas.es for enrollment information.
Where is the NCT06099119 trial being conducted?
This trial is being conducted at Milan, Italy, Santiago de Compostela, Spain, Pamplona, Spain, Stockholm, Sweden.
Who is sponsoring the NCT06099119 clinical trial?
NCT06099119 is sponsored by Hospital Clinico Universitario de Santiago. The trial plans to enroll 100 participants.
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