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

Phase 2 Completed 67 enrolled National Cancer Center, Korea Pharmbio Korea Co., Ltd. · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2011-10
Primary completion: 2014-12
Completion: 2014-12

Outcome

Missed primary endpoint

paper PERT did not reduce weight loss in patients with unresectable pancreatic cancer. PMID 27618657 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Norzyme	Protein / enzyme biologic	457.7 mg	Oral