A Study Looking at Whether a Nutritional Composition Can Help People With Pancreatic Cancer Stay Stronger and Better Tolerate Chemotherapy

Korábbi kezelés

• Patients who received prior treatment for PDAC
• Current alcohol or drug abuse in the opinion of the Investigator
• Participation in any other studies involving investigational or marketed products within 14 days prior to screening and/or during the intervention period

Más betegség

• Clinically significant dysphagia, gastrointestinal obstruction or any other condition preventing adequate oral intake to reasonably comply with the protocol recommendation of taking 2 servings of study product per day in the opinion of the Investigator
• Pancreatic insufficiency uncontrolled by enzyme therapy or uncontrolled metabolic conditions such as diabetes mellitus or phenylketonuria, that may compromise the patient's safe participation in the study, in the opinion of the Investigator
• Known allergy or intolerance to any of the ingredients of the study products

Laborértékek

• Presence of an ileostomy or ileal pouch. Participants with an ileostomy at or near the terminal ileum may be enrolled if, in the opinion of the Investigator, the ileostomy does not affect the absorption of nutrients other than sodium, potassium, and water
• Severe renal dysfunction (estimated Glomerular Filtration Rate (eGFR) <29 mL/min/1.73m2 or albumin: creatinine (ACR)>30) or other clinically significant renal dysfunction in the opinion of the Investigator
• Severe hypercalcemia, i.e. total calcium level corrected for albumin >14.0mg/dL (>3.5mmol/L)

Egyéb

• Patients with metastatic PDAC (i.e. confirmed distant metastases or otherwise confirmed by local practice)
• Life expectancy < 3 months
• Hepatic encephalopathy regardless of etiology, reflecting clinically significant hepatic dysfunction that may interfere with metabolic stability, cognition, or safe participation in the study in the opinion of the Investigator
• Known pregnancy or lactation
• Participant not capable of understanding or not willing to adhere to the study procedures and/or other protocol requirements in the opinion of the Investigator

• Patients with pancreatic ductal adenocarcinoma (PDAC) who are scheduled to be treated with (modified) FOLFIRINOX* chemotherapy (* or NALIRIFOX if that becomes the standard of care during the study per recognized (inter)national guidelines) as first therapy after initial diagnosis of PDAC
• ECOG performance score 0 or 1
• Age 18 years or above
• Written informed consent