TY  - JOUR
U1  - Zeitschriftenartikel, wissenschaftlich - begutachtet (reviewed)
A1  - Märten, Angela
A1  - Wente, Moritz N.
A1  - Ose, Jennifer
A1  - Büchler, Markus W.
A1  - Rötzer, Ingeborg
A1  - Decker-Baumann, Christiane
A1  - Karapanagiotou-Schenkel, Irini
A1  - Harig, Sabine
A1  - Schmidt, Jan
A1  - Jäger, Dirk
T1  - An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2ndor higher line chemotherapy regarding clinical benefit - PANUSCO
JF  - BMC Cancer
N2  - Background: Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Recent data indicate that the outcome of oncological patients suffering from cancer cachexia could be improved by parenteral nutrition and that parenteral nutrition results in an improvement of quality of life and in prolonged survival.

Currently, there is no recommendation of routine use of parenteral nutrition. Furthermore, there is no clear recommendation for 2nd line therapy (or higher) for pancreatic adenocarcinoma but often asked for.

Methods/Design: PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC). In the experimental group BSNC will be expanded with parenteral nutrition (PN). In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff.

A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS), defined as the time from randomization till time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score) or withdrawal due to fulfilling the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause (whichever occurs first).

Discussion: The aim of this clinical trial is to evaluate whether parenteral nutrition in combination with defined 2nd line or higher chemotherapy has an impact on quality of life for patients suffering from pancreatic adenocarcinoma.
KW  - Parenteral Nutrition
KW  - Folinic Acid
KW  - Cancer Cachexia
KW  - Data Safety Monitoring Board
KW  - Oxaliplatin
KW  - Parenterale Ernährung
KW  - Folinsäure
KW  - Kachexie
Y1  - 2009
UN  - https://nbn-resolving.org/urn:nbn:de:bsz:960-opus4-31747
SN  - 1471-2407
SS  - 1471-2407
U6  - https://doi.org/10.25968/opus-3174
DO  - https://doi.org/10.25968/opus-3174
VL  - 9
SP  - 8
S1  - 8
PB  - Springer Nature
ER  -