Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.

Официальное название

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.

Обзор

\- 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.

Вмешательства

• Препарат creon 35.000 Ph.U (R)
  Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six months study period.
• Другое Best Standarard of Care
  Control arm: no treatment over 3 months from randomization. PERT from third month untill last visit in sixt month

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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) at screening.
• Life expectancy of at least six months at screening.
• Signed informed consent to the study.

Критерии исключения

• Hypersensitivity to pancreatin of porcine origin or to any of the excipients.
• 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.
• Unwillingness to participate in the study.
• Inability to comply with the study visits and study protocol, whatever the reason.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• University Hospital of Santiago de Compostela — Santiago de Compostela
• Hospital Universitario de Navarra — Pamplona

Италия · 1 центр

• Istituto di Ricovero e Cura Carattere Scientifico San Raffaele — Milan

Швеция · 1 центр

• Karolinska Institutet — Stockholm

Идентификаторы

NCT: NCT06099119 · PEI004/2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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