Pancreatic Cancer Clinical Trial
Official title:
Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).
Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion,
early metastasis, and marked cachexia. Subjects are afflicted with a variety of
disconcerting symptoms, including profound cachexia and deterioration in performance status,
even when their tumour burden is low. Therefore, one of the most important therapeutic
targets is the improvement of quality of life. Supplementation with parenteral nutrition
improves Quality of Life in subjects with advanced cancer cachexia. The European Society of
Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not
reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is
recommended for pancreatic adenocarcinoma, but often asked for.
Within this clinical trial, we evaluate if parenteral nutrition in combination with
chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality
of life?
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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