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

Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme
replacement therapy in weight loss and quality of life.

Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal
elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of
pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic
ultrasound (EUS).

Patients with PEI (FE1 <200) receive Pertzye or placebo in a cross-over fashion, each for 4
weeks.

Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time
of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of
Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin
B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).

Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the
Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas
cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.

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