Survey on symptoms in patients receiving chemotherapy in an Italian department of oncology: a comparison between period prevalences.

PURPOSE: The purpose of this study is to evaluate the prevalence over time of the measured side effects using a self-assessment questionnaire in normal clinical practice. METHODS: The prevalence of symptoms reported by patients on the questionnaire was evaluated over two 1-year periods: from 1 June 2006 to 31 May 2007 and from 1 July 2013 to 30 June 2014. Descriptive statistics were used to describe population. The 2006-2007 and 2013-2014 datasets were compared with each other using the chi-squared test for equality of proportion, Pearson's chi-squared test, and chi-squared test for trend in proportion. RESULTS: We analyzed 1974 questionnaires from 283 patients in 2006-2007 and 2619 questionnaires from 403 patients in 2013-2014. The most frequently encountered symptom in both periods was fatigue; nausea and constipation decreased in 2013-2014 compared with 2006-2007, while alopecia increased. CONCLUSIONS: Using the self-assessment questionnaire in normal clinical practice has allowed us to carry out an accurate prevalence survey on symptoms in patients receiving chemotherapy that takes into account not only reports of the presence of symptoms but also of their absence. Between 2006-2007 and 2013-2014, there was an increase in patients treated at the Oncological Day Hospital of the Biella Hospital, whose characteristics were comparable in the two periods, except for the type of therapies carried out. Some symptoms were in decline: fatigue, nausea, and constipation.

Normal saline versus heparin solution to lock totally implanted venous access devices: Results from a multicenter randomized trial.

PURPOSE: Our aim was to determine the non-inferiority of normal saline flushing compared to heparin flushing in maintaining the patency of totally implanted venous access devices (TIVADs). METHOD: Four hundred and thirty patients were recruited from 14 Italian centres. Patients were randomized to heparin group or to normal saline group. The primary outcome of the study was TIVAD occlusion. RESULTS: After randomisation, 203 patients were assigned to normal saline group and 212 to heparin group. Median follow up time was 204 days in normal saline group and 294 in the heparin group. We observed 24 withdrawal occlusions (5.78%): 10 in the heparin group and 14 in the normal saline group. One total occlusion was observed in the normal saline group. Taking as reference the arm treated with heparin, the absolute risk difference was 2.67 with the 90% CI including the non - inferiority margin of 4%. No significant difference between hazards of occlusion was found. CONCLUSIONS: This study failed to demonstrate that normal saline flushing is not inferior to heparin flushing, even if a significant difference between the two treatments was not found. The use of heparin is controversial and other prospective trials are necessary in this field. TRIAL REGISTRATION: EudraCT number: 2009-013620-22.