Diseases and Abnormalities at or Before Birth

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Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

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Pancreatic Neoplasms

Exocrine Pancreatic Insufficiency

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

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Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

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).

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).

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

Placebo Oral Capsule

Massimo Raimondo, MD

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.

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

Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

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

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).

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).

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

Digestive Care, Inc.

Massimo Raimondo, M.D.

Professor, College of Medicine

Subjects who received placebo oral capsule in either the first or last 4 weeks of the study

Placebo

Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study

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).

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

Placebo Oral Capsule: Placebo Oral Capsule

Placebo First, Then Pancrelipase

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).

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

Placebo Oral Capsule: Placebo Oral Capsule

Pancrelipase First, Then Placebo

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Massimo Raimondo

Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer	NCT02985801	Pancreatic Insu... Pancreatic Canc... Pancreatic Enzy...	Pancrelipase Placebo Oral Ca...	18 Years - 80 Years	Mayo Clinic
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer	NCT02985801	Pancreatic Insu... Pancreatic Canc... Pancreatic Enzy...	Pancrelipase Placebo Oral Ca...	18 Years - 80 Years	Mayo Clinic
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer	NCT02985801	Pancreatic Insu... Pancreatic Canc... Pancreatic Enzy...	Pancrelipase Placebo Oral Ca...	18 Years - 80 Years	Mayo Clinic

Spots Global Cancer Trial Database for pancreatic enzyme abnormality