Pancreatic enzyme capsules to help digestion and weight in people with unresectable pancreatic head 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.

This trial will test whether adding pancreatin (Creon) capsules to usual care helps digestion, weight, and nutrition in people with unresectable pancreatic head cancer who have significant weight loss and a dilated main pancreatic duct.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Clinico Universitario de Santiago (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Milan, Milan and 3 other locations)
• Trial ID: NCT06099119 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, randomized controlled Phase 4 trial comparing best standard of care (BSC) plus pancreatic enzyme replacement therapy (PERT) versus BSC alone in patients with unresectable locally advanced or metastatic pancreatic cancer located in the head of the pancreas with a dilated main pancreatic duct and ≥5% weight loss. Eligible, consecutive patients who consent will be randomized to receive fixed-dose pancreatin (35,000 Ph.U. capsules, given with main meals) on top of oncologic, diabetic, acid suppression, and nutritional support as appropriate, or to receive BSC without PERT. Treatment and follow-up continue for up to six months to observe effects on digestion, weight, nutrition and related outcomes. The trial is conducted at several European academic centers and uses routine clinical assessments and imaging for eligibility and follow-up.

Who should consider this trial

Good fit: Adults with pathologically confirmed unresectable locally advanced or metastatic pancreatic cancer in the head of the pancreas, a dilated main pancreatic duct on imaging, at least 5% recent weight loss, life expectancy of at least six months, and who are not currently on PERT are ideal candidates.

Not a fit: Patients already taking PERT, those with prior upper GI or pancreatic surgery, pancreatic stents, unresolved gastric outlet obstruction, short life expectancy, or those on second-line chemotherapy are excluded and unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, adding PERT could improve digestion, nutrient absorption and weight stability, which may enhance symptoms and quality of life for these patients.

How similar studies have performed: Pancreatic enzyme replacement is an established therapy for pancreatic exocrine insufficiency and prior clinical experience and nonrandomized studies indicate benefits for weight and symptoms, but randomized data specifically in unresectable pancreatic head cancer are limited.

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.

Where this trial is running

Milan, Milan and 3 other locations

• Istituto di Ricovero e Cura Carattere Scientifico San Raffaele — Milan, Milan, Italy (Recruiting)
• University Hospital of Santiago de Compostela — Santiago de Compostela, A Coruna, Spain (Recruiting)
• Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)
• Karolinska Institutet — Stockholm, Stockholm County, Sweden (Not_yet_recruiting)

Study contacts

• Study coordinator: J. Enrique Dominguez-Munoz, PhD, MD

Conditions Unresectable Pancreatic Cancer