Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099119
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-19
Brief Title:
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer
Sponsor:
Hospital Clinico Universitario de Santiago
Organization:
Hospital Clinico Universitario de Santiago
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERTseverance
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 35000 PhU 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
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 35000 PhU 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None