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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborator: Pharmbio Korea Co., Ltd.

Criteria

Inclusion Criteria:

• To be eligible for inclusion, each patient must fulfill each of the following criteria:

1. Subjects with unresectable pancreatic cancer preferably proven by cytology or histology

2. not eligible for surgery because of poor general condition, local unresectability, or advanced disease with metastases

3. Age over 18 years old

4. Performance status (ECOG scale): 0-2

5. Agree to record daily food intake

6. Patients should sign a written informed consent before study entry

Exclusion Criteria:

• Patients will be excluded from the study for any of the following reasons:

1. History of major gastrointestinal surgery

2. history of chronic gastrointestinal disease (for example, Crohn's disease)

3. Diabetes decompensated

4. Diabetes mellitus with severe gastroparesis

5. presence of pancreatic pseudocysts impeding gastric or duodenal passage

6. any use of antacids, mucosal protective agents, H 2 receptor antagonists, or proton pump inhibitors that could not be discontinued

7. concomitant medication affecting gastroduodenal motility (e.g. metoclopramide and erythromycin), or interfering with bile secretion (e.g. bile acids)

8. Abusive use of alcohol in the three months preceding the study;

9. known allergy to pancreatin

10. Any major surgery within 4 weeks prior to study treatment

11. Pregnant or lactating woman

12. Any patients judged by the investigator to be unfit to participate in the study