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

NCT02985801 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 15-008713
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Insufficiency; Pancreatic Cancer; Pancreatic Enzyme Abnormality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Baseline, 4 weeks

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

  Baseline, 10 weeks

• Change in Body Weight Composition

  Baseline, 4 weeks, 10 weeks

Study Arms (2)

Placebo First, then Pancrelipase

EXPERIMENTAL

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).

Drug: Pancrelipase; Drug: Placebo Oral Capsule

Pancrelipase First, then Placebo

EXPERIMENTAL

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).

Drug: Pancrelipase; Drug: Placebo Oral Capsule

Interventions

Pancrelipase DRUG

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

Also known as: Pertzye

Pancrelipase First, then Placebo; Placebo First, then Pancrelipase

Placebo Oral Capsule DRUG

Placebo Oral Capsule

Pancrelipase First, then Placebo; Placebo First, then Pancrelipase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Common bile duct obstruction resulting in obstructive jaundice
• Celiac disease
• Crohn's disease
• Benign pancreatic conditions
• Bowel obstruction
• Surgically altered bowel anatomy

Sponsors & Collaborators

• Massimo Raimondo, M.D.: lead
• Digestive Care, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (19)

• 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. doi: 10.1200/JCO.2002.07.093.

  PMID: 11980994 BACKGROUND

• 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. doi: 10.1002/1097-0142(19830715)52:23.0.co;2-z.

  PMID: 6305473 BACKGROUND

• 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.

  PMID: 22749648 BACKGROUND

• 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.

  PMID: 24717227 BACKGROUND

• 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.

  PMID: 6549746 BACKGROUND

• 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. doi: 10.1177/0148607181005002110.

  PMID: 7195437 BACKGROUND

• 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. doi: 10.1136/gut.42.1.92.

  PMID: 9505892 BACKGROUND

• 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. doi: 10.1111/j.1365-2036.1991.tb00040.x.

  PMID: 1777547 BACKGROUND

• Ghaneh P, Neoptolemos JP. Exocrine pancreatic function following pancreatectomy. Ann N Y Acad Sci. 1999 Jun 30;880:308-18. doi: 10.1111/j.1749-6632.1999.tb09534.x.

  PMID: 10415875 BACKGROUND

• 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.

  PMID: 431121 BACKGROUND

• Graham DY. An enteric-coated pancreatic enzyme preparation that works. Dig Dis Sci. 1979 Dec;24(12):906-9. doi: 10.1007/BF01311943.

  PMID: 510089 BACKGROUND

• 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. doi: 10.3109/00365528609034631.

  PMID: 3633631 BACKGROUND

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

  PMID: 3548109 BACKGROUND

• 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.

  PMID: 2408983 BACKGROUND

• 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. doi: 10.1016/s0022-3476(77)80657-4.

  PMID: 830926 BACKGROUND

• Gullo L, Pezzilli R, Gaiani S. Tolerability and safety of the long-term administration of pancreatic extracts. Pancreas. 1997 Mar;14(2):210-2. doi: 10.1097/00006676-199703000-00018. No abstract available.

  PMID: 9057197 BACKGROUND

• Seiler CM, Izbicki J, Varga-Szabo L, Czako L, Fiok 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.

  PMID: 23383603 BACKGROUND

• 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.

  PMID: 23561971 BACKGROUND

• 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.

  PMID: 21418260 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatic Neoplasms

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Results Point of Contact

• Title: Dr. Massimo Raimondo
• Organization: Mayo Clinic

Raimondo.Massimo@mayo.edu

904-953-6982

Study Officials

• Massimo Raimondo, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, College of Medicine

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 15, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)