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2024-02-20
2026-06
2026-12
100
NCT06099119
Hospital Clinico Universitario de Santiago
Hospital Clinico Universitario de Santiago
INTERVENTIONAL
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
- 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-19 | N/A | 2025-06-03 |
2023-10-19 | N/A | 2025-06-06 |
2023-10-25 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/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)
|
| 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in body weight over study period. | ƍ between visit 4 (sixt month) and visit 1 (day 1) in the patient's weight | From visit 1 day 1 to visit 4 sixt month. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: J. Enrique Dominguez-Munoz, PhD, MD Phone Number: +34981951364 Email: juan.enrique.dominguez.munoz@sergas.es |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
