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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02985801
• Other study ID #: 15-008713
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 2016
• Est. completion date: April 2019

Study information

• Verified date: February 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Cancer
• Pancreatic Enzyme Abnormality
• Pancreatic Insufficiency
• Pancreatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Massimo Raimondo, M.D.	Digestive Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (19)

Bruno MJ, Haverkort EB, Tijssen GP, Tytgat GN, van Leeuwen DJ. Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region. Gut. 1998 Jan;42(1):92-6. — View Citation

Delchier JC, Vidon N, Saint-Marc Girardin MF, Soule JC, Moulin C, Huchet B, Zylberberg P. Fate of orally ingested enzymes in pancreatic insufficiency: comparison of two pancreatic enzyme preparations. Aliment Pharmacol Ther. 1991 Aug;5(4):365-78. — View Citation

DiMagno EP, Malagelada JR, Go VL. The relationships between pancreatic ductal obstruction and pancreatic secretion in man. Mayo Clin Proc. 1979 Mar;54(3):157-62. — View Citation

Dutta SK, Rubin J, Harvey J. Comparative evaluation of the therapeutic efficacy of a pH-sensitive enteric coated pancreatic enzyme preparation with conventional pancreatic enzyme therapy in the treatment of exocrine pancreatic insufficiency. Gastroenterology. 1983 Mar;84(3):476-82. — View Citation

Ghaneh P, Neoptolemos JP. Exocrine pancreatic function following pancreatectomy. Ann N Y Acad Sci. 1999 Jun 30;880:308-18. Review. — View Citation

Graham DY. An enteric-coated pancreatic enzyme preparation that works. Dig Dis Sci. 1979 Dec;24(12):906-9. — View Citation

Gubergrits N, Malecka-Panas E, Lehman GA, Vasileva G, Shen Y, Sander-Struckmeier S, Caras S, Whitcomb DC. A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery. Aliment Pharmacol Ther. 2011 May;33(10):1152-61. doi: 10.1111/j.1365-2036.2011.04631.x. Epub 2011 Mar 21. — View Citation

Gullo L, Pezzilli R, Gaiani S. Tolerability and safety of the long-term administration of pancreatic extracts. Pancreas. 1997 Mar;14(2):210-2. — View Citation

Halgreen H, Pedersen NT, Worning H. Symptomatic effect of pancreatic enzyme therapy in patients with chronic pancreatitis. Scand J Gastroenterol. 1986 Jan;21(1):104-8. — View Citation

Heffernan N, Cella D, Webster K, Odom L, Martone M, Passik S, Bookbinder M, Fong Y, Jarnagin W, Blumgart L. Measuring health-related quality of life in patients with hepatobiliary cancers: the functional assessment of cancer therapy-hepatobiliary questionnaire. J Clin Oncol. 2002 May 1;20(9):2229-39. — View Citation

Lankisch PG, Lembcke B, Göke B, Creutzfeldt W. Therapy of pancreatogenic steatorrhoea: does acid protection of pancreatic enzymes offer any advantage? Z Gastroenterol. 1986 Dec;24(12):753-7. — View Citation

Nouisa-Arvanitakis S, Stapleton FB, Linshaw MA, Kennedy J. Therapeutic approach to pancreatic extract-induced hyperuricosuria in cystic fibrosis. J Pediatr. 1977 Feb;90(2):302-5. — View Citation

Partelli S, Frulloni L, Minniti C, Bassi C, Barugola G, D'Onofrio M, Crippa S, Falconi M. Faecal elastase-1 is an independent predictor of survival in advanced pancreatic cancer. Dig Liver Dis. 2012 Nov;44(11):945-51. doi: 10.1016/j.dld.2012.05.017. Epub 2012 Jun 28. — View Citation

Perez MM, Newcomer AD, Moertel CG, Go VL, Dimagno EP. Assessment of weight loss, food intake, fat metabolism, malabsorption, and treatment of pancreatic insufficiency in pancreatic cancer. Cancer. 1983 Jul 15;52(2):346-52. — View Citation

Ramesh H, Reddy N, Bhatia S, Rajkumar JS, Bapaye A, Kini D, Kalla M, Thorat V. A 51-week, open-label clinical trial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis. Pancreatology. 2013 Mar-Apr;13(2):133-9. doi: 10.1016/j.pan.2013.01.009. Epub 2013 Feb 5. — View Citation

Schneider MU, Knoll-Ruzicka ML, Domschke S, Heptner G, Domschke W. Pancreatic enzyme replacement therapy: comparative effects of conventional and enteric-coated microspheric pancreatin and acid-stable fungal enzyme preparations on steatorrhoea in chronic pancreatitis. Hepatogastroenterology. 1985 Apr;32(2):97-102. — View Citation

Seiler CM, Izbicki J, Varga-Szabó L, Czakó L, Fiók J, Sperti C, Lerch MM, Pezzilli R, Vasileva G, Pap A, Varga M, Friess H. Randomised clinical trial: a 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension. Aliment Pharmacol Ther. 2013 Apr;37(7):691-702. doi: 10.1111/apt.12236. Epub 2013 Feb 5. — View Citation

Sikkens EC, Cahen DL, de Wit J, Looman CW, van Eijck C, Bruno MJ. A prospective assessment of the natural course of the exocrine pancreatic function in patients with a pancreatic head tumor. J Clin Gastroenterol. 2014 May-Jun;48(5):e43-6. doi: 10.1097/MCG.0b013e31829f56e7. — View Citation

Valerio D, Whyte EH, Schlamm HT, Ruggiero JA, Blackburn GL. Clinical effectiveness of a pancreatic enzyme supplement. JPEN J Parenter Enteral Nutr. 1981 Mar-Apr;5(2):110-4. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.	Baseline, 4 weeks, 10 weeks
Secondary	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).	Baseline, 4 weeks
Secondary	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).	Baseline, 10 weeks
Secondary	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.	Baseline, 4 weeks, 10 weeks

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