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

Massimo Raimondo, M.D.

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Pancreatic Insufficiency; Pancreatic Enzyme Abnormality; Pancreatic Cancer

Treatments: Drug: Pancrelipase; Drug: Placebo Oral Capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02985801

15-008713

Details and patient eligibility

About

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

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

16 participants in 2 patient groups

Placebo First, then Pancrelipase

Experimental group

Description:

Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).

Treatment:

Drug: Placebo Oral Capsule

Drug: Pancrelipase

Pancrelipase First, then Placebo

Experimental group

Description:

Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).

Treatment:

Drug: Placebo Oral Capsule

Drug: Pancrelipase