PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

• Status: Terminated
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massimo Raimondo, M.D.
• Collaborator: Digestive Care, Inc.
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Patients 18-80 years

• Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis)

• On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study

• Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool

Exclusion Criteria:

• Common bile duct obstruction resulting in obstructive jaundice

• Celiac disease

• Crohn's disease

• Benign pancreatic conditions

• Bowel obstruction

• Surgically altered bowel anatomy