Effects of parenteral nutrition + best supportive nutritional care vs. best supportive nutritional care alone on quality of life in patients with pancreatic cancer-a secondary analysis of PANUSCO.

PURPOSE: Parenteral nutrition (PN) can be an effective treatment to improve the nutritional status of patients with pancreatic cancer, but the effects of PN on quality of life (QoL) are still understudied. Therefore, we aimed at investigating whether the best supportive nutritional care (BSNC) in combination with PN at home compared to BSNC alone changed QoL in patients with advanced pancreatic cancer undergoing chemotherapy over a period of 7 weeks. METHODS: n = 12 patients in the PANUSCO study received nutritional counseling only (control group (CG)) and n = 9 patients were also given supportive PN (intervention group (IG)). The primary endpoint was the change of QoL (EORTC-QLQ-C30 and QLQ-PAN26) over 7 weeks between the groups. RESULTS: There was a significant worsening in social functioning in IG (p = 0.031) and a significant difference between groups in change of social functioning (p = 0.020). In all other domains of QoL, there was no significant difference between groups. Within groups, there was a significant improvement in the domain weight loss in IG (p = 0.031), showing that patients were less worried about their weight being too low. Furthermore, there was a significant difference in the change of BW over time between groups (p < 0.001) with IG showing an increase (p = 0.004) and CG showing no change (p = 0.578). CONCLUSION: The administration of PN had in one of five domains negative consequences on QoL. The decision to administer PN should always be made individually and together with the patient, and the impact on QoL should be included in the decision to administer PN.

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 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO.

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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60516908.