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

Phase 2TerminatedNCT02985801

Massimo Raimondo, M.D.16 enrolled

Overview

Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pancreatic Insufficiency Pancreatic Cancer Pancreatic Enzyme Abnormality

Interventions

PancrelipaseDRUG

Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units

Placebo Oral CapsuleDRUG

Placebo Oral Capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Change in Body Weight

Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.

Time frame: Baseline, 4 weeks, 10 weeks

Secondary Outcomes

Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks

Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).

Time frame: Baseline, 4 weeks

Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks

Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).

Time frame: Baseline, 10 weeks

Change in Body Weight Composition

Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.

Time frame: Baseline, 4 weeks, 10 weeks

Data from ClinicalTrials.gov

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