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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?
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Onkologische Schwerpunktpraxis und Tagesklinik
Bad Soden, Germany
Krankenhaus Nordwest Frankfurt
Frankfurt am Main, Germany
University Hospital of Heidelberg / National Center for Tumordiseases
Heidelberg, Germany
Asklepios Klinik Weißenfels
Weißenfels, Germany
Start Date
March 1, 2010
Primary Completion Date
August 1, 2014
Completion Date
September 1, 2014
Last Updated
September 25, 2014
32
ACTUAL participants
SMOF Kabiven
DRUG
Lead Sponsor
National Center for Tumor Diseases, Heidelberg
Collaborators
NCT05053971
NCT04550494
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