Effekten av PERT for PEI ved uoperabel kreft i bukspyttkjertelen. (PERTseverance)
Open Label randomisert, multisenter, kontrollert utprøving av pankreatisk enzymerstatningsterapi (PERT) for pankreatisk eksokrin insuffisiens (PEI) hos pasienter med ikke-opererbar pankreaskreft. PERTsavbruddsforsøket.
- 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: J. Enrique Dominguez-Munoz, PhD, MD
- Telefonnummer: +34981951364
- E-post: juan.enrique.dominguez.munoz@sergas.es
Studiesteder
-
-
-
Milan, Italia, 20132
- Rekruttering
- Istituto di Ricovero e Cura Carattere Scientifico San Raffaele
-
Ta kontakt med:
- MhD
- Telefonnummer: +39 06 660581
- E-post: capurso.gabriele@hsr.it
-
-
-
-
A Coruna
-
Santiago de Compostela, A Coruna, Spania, 15706
- Rekruttering
- University Hospital of Santiago de Compostela
-
Ta kontakt med:
- J. Enrique Dominguez-Munoz, PhD, MD
- Telefonnummer: +34981951364
- E-post: juan.enrique.dominguez.munoz@sergas.es
-
-
Navarre
-
Pamplona, Navarre, Spania, 31008
- Rekruttering
- Hospital Universitario de Navarra
-
Ta kontakt med:
- MhD
- Telefonnummer: 848422222
- E-post: federico.bolado.concejo@navarra.es
-
-
-
-
-
Stockholm, Sverige, 17177
- Har ikke rekruttert ennå
- Karolinska Institutet
-
Ta kontakt med:
- MhD
- Telefonnummer: +46 8 524 800 00
- E-post: matthias.lohr@ki.se
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Experimental arm: Pancreatic Exocrine Replacement Therapy (PERT) treatment during the six months study period. |
|
Annen: 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. |
Control arm: no treatment over 3 months from randomization. PERT from third month untill last visit in sixt month
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in body weight over study period.
Tidsramme: From visit 1 day 1 to visit 4 sixt month.
|
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.
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PEI004/2021
Legemiddel- og utstyrsinformasjon, studiedokumenter
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