Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)

NCT01587534 | Completed Phase 2

• 1 other identifier: NCCCTS-11-570
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators planned a prospective, randomized, placebo controlled trial to test the hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in combination with dietary counseling.

Conditions

Pancreatic Cancer

Keywords

Unresectable Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• the change in body weight at eight weeks after the randomisation

  the percentage change in body weight at eight weeks after the randomisation

  at baseline and 4, 8 week, 24 week

Secondary Outcomes (2)

• Frequency and intensity of abdominal pain daily

  at baseline and 4, 8 week, 24 week

• Frequency of bowel movements per day

  at baseline and 4, 8 week, 24 week

Study Arms (2)

pancreatic enzyme replacement therapy

EXPERIMENTAL

The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.

Drug: Norzyme

Placebo

NO INTERVENTION

The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances.

Interventions

Norzyme DRUG

Patients will be randomized to receive either pancreatic enzyme replacement therapy or placebo. Patients will use two capsules three times daily during main meals and one capsule three times daily during in between snacks. The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.

Also known as: placebo

pancreatic enzyme replacement therapy

Eligibility Criteria

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

You may qualify if:

• Subjects with unresectable pancreatic cancer preferably proven by cytology or histology
• not eligible for surgery because of poor general condition, local unresectability, or advanced disease with metastases
• Age over 18 years old
• Performance status (ECOG scale): 0-2
• Agree to record daily food intake
• Patients should sign a written informed consent before study entry

You may not qualify if:

• Patients will be excluded from the study for any of the following reasons:
• History of major gastrointestinal surgery
• history of chronic gastrointestinal disease (for example, Crohn's disease)
• Diabetes decompensated
• Diabetes mellitus with severe gastroparesis
• presence of pancreatic pseudocysts impeding gastric or duodenal passage
• any use of antacids, mucosal protective agents, H 2 receptor antagonists, or proton pump inhibitors that could not be discontinued
• concomitant medication affecting gastroduodenal motility (e.g. metoclopramide and erythromycin), or interfering with bile secretion (e.g. bile acids)
• Abusive use of alcohol in the three months preceding the study;
• known allergy to pancreatin
• Any major surgery within 4 weeks prior to study treatment
• Pregnant or lactating woman
• Any patients judged by the investigator to be unfit to participate in the study

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Pharmbio Korea Co., Ltd.: collaborator

Study Sites (1)

NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

• Woo SM, Joo J, Kim SY, Park SJ, Han SS, Kim TH, Koh YH, Chung SH, Kim YH, Moon H, Hong EK, Lee WJ. Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial. Pancreatology. 2016 Nov-Dec;16(6):1099-1105. doi: 10.1016/j.pan.2016.09.001. Epub 2016 Sep 4.

  PMID: 27618657 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Sangmyung Woo, M.D

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician, Ceneter for Liver Cancer

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 30, 2012
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

KR (1)