Clinical trial · Interventional
Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)
Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer
NCT01587534CI-TRIAL-00017524completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Norzyme | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pancreatic enzyme replacement therapy
- description
- The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.
- interventionNames
- Drug: Norzyme
- type
- NO_INTERVENTION
- label
- Placebo
- description
- The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances.
Primary outcomes (1)
- measure
- the change in body weight at eight weeks after the randomisation
- timeFrame
- at baseline and 4, 8 week, 24 week
- description
- the percentage change in body weight at eight weeks after the randomisation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWoo 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