PERTseverance: Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.

• Sponsor: Hospital Clinico Universitario de Santiago (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06099119
• Collaborator: Complejo Hospitalario de Navarra (Other), Karolinska Institutet (Other), San Raffaele University Hospital, Italy (Other), Beaujon Hospital (Other)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 19

Study Details

Study Description

Brief Summary

• This will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. Pancreatic Exocrine Replacement Therapy (PERT) in these patients will be given on top of other required therapies (best standard of care, BSC), including oncologic therapies, diabetes mellitus therapies and acid suppressants and nutritional support as appropriate. The duration of the study will be up to six months.

Consecutive patients meeting inclusion criteria and none of the exclusion criteria will be evaluated for the study. Those patients signing the informed consent for study participation will be randomized to one of the following two arms:

• The experimental arm will receive the best standard of care (BSC) and PERT (capsules containing pancreatin 35,000 Ph.U.) at a fixed dose of 3 capsules with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months.

• The control arm will receive the BSC over 3 months, followed by a further 3-month open uncontrolled phase of BSC + PERT at the dose mentioned above.

All patients will receive in addition a proton pump inhibitor (PPI) bid (any PPI at standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, rabeprazole 20 mg, esomeprazole 40 mg) while on PERT, 20-30 minutes before breakfast and dinner.

To make the two arms comparable, patients will be stratified in two groups (locally advanced and metastatic pancreatic cancer) for randomization using computer generated random numbers.

Condition or Disease	Intervention/Treatment	Phase
Unresectable Pancreatic Cancer	Drug: creon 35.000 Ph.U (R); Other: Best Standarard of Care	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Label Randomized, Multicentre, Controlled Trial of Pancreatic Enzyme Replacement Therapy (PERT) for Pancreatic Exocrine Insufficiency (PEI) in Patients With Unresectable Pancreatic Cancer. The PERTseverance Trial.
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental arm Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months post randomization.	Drug: creon 35.000 Ph.U (R); Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six months study period.
Other: control arm Creon 35.000 Ph.U (R) at a fixed dose of 3 capsules orally with main meals (breakfast, lunch and dinner) and 2 capsules with snacks during the last 3 months post randomization.	Other: Best Standarard of Care; Control arm: no treatment over 3 months from randomization. PERT from third month untill last visit in sixt month; Other Names: creon 35.000 Ph.U (R)

Outcome Measures

Primary Outcome Measures

1. Change in body weight over study period. [From visit 1 day 1 to visit 4 sixt month.]

   ƍ between visit 4 (sixt month) and visit 1 (day 1) in the patient's weight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer.

2. Tumour located in the head of the pancreas.

3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS).

4. Significant weight loss (≥5% of the usual body weight) at screening.

5. Life expectancy of at least six months at screening.

6. Signed informed consent to the study.

Exclusion Criteria:

1. Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

2. Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned.

3. Patients already on PERT.

4. Prior history of upper gastrointestinal or pancreatic surgery.

5. Short life expectancy (shorter than 6 months).

6. Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy).

7. Patients in whom a pancreatic stent has been placed.

8. Unsolved gastric outlet obstruction.

9. Unwillingness to participate in the study.

10. Inability to comply with the study visits and study protocol, whatever the reason.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Clinico Universitario de Santiago
• Complejo Hospitalario de Navarra
• Karolinska Institutet
• San Raffaele University Hospital, Italy
• Beaujon Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: J. Enrique Domínguez-Muñoz, Prof. PhD. MD., Hospital Clinico Universitario de Santiago
• ClinicalTrials.gov Identifier: NCT06099119
• Other Study ID Numbers: PEI004/2021
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Pancrelipase

Study Results

No Results Posted as of Oct 25, 2023