Study protocol, PANUSCO, pancreatic adenocarcinoma
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
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.
Trial registration: Current Controlled Trials ISRCTN60516908.
Type of Publication:
Journal article published