Abstract
BackgroundPancreatic 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/DesignPANUSCO 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).DiscussionThe 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 registrationCurrent Controlled Trials ISRCTN60516908.
Highlights
Pancreatic cancer is an extremely aggressive malignancy
BMC Cancer 2009, 9:412 http://www.biomedcentral.com/1471-2407/9/412 the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause. 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
There are data indicating that parenteral nutrition (PN) has a synergistic effect with chemotherapy and results in better clinical outcome [6,7]
Summary
Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Cachexia is a strong independent predictor of mortality, poor therapeutic response, diminished functional capacity, and reduced QoL. It is defined as the debilitating state of involuntary weight loss, often connected with anorexia, tissue wasting, malnutrition, and inability for natural nutrition intake. The combination of these symptoms is named "cancer anorexia-cachexia syndrome" [4]. The most important phenotypic feature is muscle wasting and functional impairment as a result of increased protein degradation and reduced protein synthesis or both [5] It is a life-threatening and debilitating syndrome for 50% of all cancer subjects [5]. Compared to other solid tumours, the pancreatic cancer has the highest incidence for cancer cachexia (CC), as much as 80% at the time of diagnosis [4]
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