Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT06099119
Recruiting Phase 4

Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.

NCT06099119 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Clinico Universitario de Santiago
Phase
Phase 4
Started
2024-02-20
Last updated
2026-09-21

Condition(s) studied

Unresectable Pancreatic Cancer

Investigational drug(s) / intervention(s)

creon 35.000 Ph.U (R)Best Standarard of Care

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in body weight over study period. — From visit 1 day 1 to visit 4 sixt month.
    ƍ between visit 4 (sixt month) and visit 1 (day 1) in the patient's weight

Trial sites (4)

FacilityCityRegionStatus
Istituto di Ricovero e Cura Carattere Scientifico San Raffaele Milan Italy Recruiting
University Hospital of Santiago de Compostela Santiago de Compostela A Coruna Recruiting
Hospital Universitario de Navarra Pamplona Navarre Recruiting
Karolinska Institutet Stockholm Sweden Not Yet Recruiting

More Hospital Clinico Universitario de Santiago trials in Spain

Personalized Treatment of Refractory BPPV Recruiting
Effectiveness of Health Education as a Nursing Intervention in Improving Quality of Life and Reducing Symptoms of Anxiety and Depression in Ostomy Patients Following Digestive Surgery: A Quasi-Experimental Study. Enrolling by invitation
Flexible Tip Bougie vs Tube With Stylet for Intubation With Videolaryngoscopy. Recruiting
Cardio-Oncology Rehabilitation Care Process Recruiting
Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06099119 on ClinicalTrials.gov ↗ ← All trials in Spain