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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituto di Ricovero e Cura Carattere Scientifico San Raffaele
  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, Sweden Not yet recruiting

Study contacts

• Study coordinator: J. Enrique Dominguez-Munoz, PhD, MD
• Email: juan.enrique.dominguez.munoz@sergas.es
• Phone: +34981951364

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.