Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Clinico Universitario de Santiago
Collaborators:
Beaujon Hospital Complejo Hospitalario de Navarra Karolinska Institutet San Raffaele University Hospital, Italy