Pancreatic Cancer Clinical Trial
Official title:
Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial
Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many procedures for diagnostic workup that require fasting periods. In a prospective randomized monocentric study we evaluate the effect of additional parenteral nutrition on weight loss, nutritional status, quality of life and length of hospital stay.
Patients with pancreatic and biliary tract cancer suffer from weight loss, malnutrition and
cachexia. These factors are associated with poor prognosis, reduction in quality of life and
a higher risk of complications during treatment. Moreover, patients undergo fasting periods
during their diagnostic work-up at hospital that worsens malnutrition.
This is a prospective randomized monocentric study to investigate, whether parenteral
nutritional supplementation may have an impact on weight loss, nutritional status, quality
of life and length of hospital stay in patients with tumors of the pancreas or biliary
tract. Patients either receive 1 l Olimel peri 2.5 %® (Baxter Germany GmbH Medication
Delivery, Unterschleißheim, Germany containing 700 kcal, 25.3 g protein, 30.0 g fat and 75.0
g glucose) on fasting days or 1 l of isotonic fluid (E153, Berlin-Chemie AG, Berlin,
Germany) in the control group. A hospital stay of at least three days is required. Patients
are assessed for anthropometric measurements, bioelectrical impedance analysis, quality of
life and length of hospital stay.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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