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Open label randomized, multicentre, controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.
EU CTIS ID: 2023-507367-18-00
What this study is testing
As hypothesis, PERT in patients with unresectable pancreatic cancer is associated with weight gain and improved nutritional status, which, in turn, improves the performance status of patients, quality of life and tolerance to chemotherapy. This approach could have therefore a benefit on survival. To test this hypothesis, the primary objective of the study is to evaluate the impact of PERT on body weight in patients with unresectable pancreatic cancer.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients older than 18 years, any gender, fulfilling all the following criteria will be considered for enrolment into the study
- Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer.
- Tumour located in the head of the pancreas
- Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS)
- Significant weight loss (≥5% of the usual body weight, over the last 6 months) at screening
- Life expectancy of at least six months at screening
You likely can't join if
- Hypersensitivity to pancreatin of porcine origin or to any of the excipients
- Unwillingness to participate in the study
- Patients with body weight <46 kg
- Patients with pancreatitis in the acute phase.
- Patients with contraindications to PPI concomitant treatment.
- Inability to comply with the study visits and study protocol, whatever the reason
See the full eligibility criteria
- Patients older than 18 years, any gender, fulfilling all the following criteria will be considered for enrolment into the study
- Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer.
- Tumour located in the head of the pancreas
- Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS)
- Significant weight loss (≥5% of the usual body weight, over the last 6 months) at screening
- Life expectancy of at least six months at screening
- Signed informed consent to the study
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Hypersensitivity to pancreatin of porcine origin or to any of the excipients
- Unwillingness to participate in the study
- Patients with body weight <46 kg
- Patients with pancreatitis in the acute phase.
- Patients with contraindications to PPI concomitant treatment.
- Inability to comply with the study visits and study protocol, whatever the reason
- Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned
- Patients already on PERT
- Prior history of upper gastrointestinal or pancreatic surgery
- Short life expectancy (shorter than 6 months)
- Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy)
- Patients in whom a pancreatic stent has been placed
- Unsolved gastric outlet obstruction
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.