Clinical trial · Interventional
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
NCT02985801CI-TRIAL-00050644terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to difficulty in recruiting subjects.
Summary
Brief summary (as posted)
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
Conditions
Conditions (3)
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 |
| Pancreatic Enzyme Abnormality | — | UNRESOLVED | — |
| Pancreatic Insufficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancrelipase | Drug | — | UNRESOLVED |
| Placebo Oral Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Placebo First, then Pancrelipase
- description
- 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).
- interventionNames
- Drug: Pancrelipase
- Drug: Placebo Oral Capsule
- type
- EXPERIMENTAL
- label
- Pancrelipase First, then Placebo
- description
- 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).
- interventionNames
- Drug: Pancrelipase
- Drug: Placebo Oral Capsule
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Common bile duct obstruction resulting in obstructive jaundice * Celiac disease * Crohn's disease * Benign pancreatic conditions * Bowel obstruction * Surgically altered bowel anatomy
References
Publications (19)
- BACKGROUNDHeffernan 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
- BACKGROUNDPerez 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
- BACKGROUNDPartelli 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
- BACKGROUNDSikkens 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
- BACKGROUNDDutta 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
- BACKGROUNDValerio 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
- BACKGROUNDBruno 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.