Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.

Launched by HOSPITAL CLINICO UNIVERSITARIO DE SANTIAGO · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Pancreatic Exocrine Replacement Therapy (PERT) on patients with unresectable pancreatic cancer, which means that the cancer cannot be surgically removed. The trial will look at patients who have significant weight loss and have a tumor located in the head of the pancreas, along with a dilated main pancreatic duct. Participants will receive standard cancer treatments along with PERT to see if this combination helps improve their condition over a period of six months.

To be eligible for this study, patients must have been diagnosed with pancreatic cancer that is locally advanced or has spread to other parts of the body. Other key requirements include having a significant weight loss of 5% or more and a life expectancy of at least six months. During the trial, patients will be randomly assigned to either receive PERT along with their usual treatments or to continue with standard care for three months before starting PERT. All participants will also take an acid-reducing medication to help with digestion. It’s important to note that the study is not yet recruiting participants, but it aims to find out whether adding PERT can make a difference in the treatment of this challenging condition.

Gender

ALL

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.