Frequency of Aspirating Gastric Tubes for Patients Receiving Enteral Nutrition in the ICU: A Randomised Controlled Trial

Background: Enteral nutrition (EN) tolerance is often monitored by aspirating stomach contents by syringe at prescribed intervals. No studies have been conducted to assess the most appropriate time interval for aspirating gastric tubes. We compared gastric tube aspirations every 4 hours (usual care) with a variable regimen (up to every 8 hours aspirations).Methods: This randomized controlled trial (RCT) enrolled patients who stayed in the intensive care unit (ICU) for >48 hours, had a gastric tube, and were likely to receive EN for 3 or more days. Patients were randomized (computer-generated randomization) to either the control (every 4 hours) or intervention group (variable regimen). The primary outcome was number of gastric tube aspirations per day from randomization until EN was ceased or up to 2 weeks postrandomization.Results: Following Institutional Ethics Committee approval, 357 patients were recruited (control group, n = 179; intervention group, n = 178). No differences were found in age, sex, worst APACHE II score, or time to start of EN. In the intention-to-treat analysis, the intervention group had fewer tube aspirations per day (3.4 versus 5.4 in the control group, P < .001). Vomiting/regurgitation was increased in the intervention group (2.1% versus 3.6%, P = .02). There were no other differences in complications.Conclusion: This is the first RCT to examine the frequency of gastric tube aspirations. The frequency of gastric tube aspirations was reduced in the variable-regimen group with no increase in risk to the patient. Reducing the frequency of aspirations saves nursing time, decreases risk of contamination of feeding circuit, and minimizes risk of body fluid exposure

Capecitabine in combination with docetaxel and mitomycin C in patients with pre-treated tumours: results of an extended phase-I trial

Preclinical data suggest that the anti-tumour activity of capecitabine is enhanced by taxanes and mitomycin C through up-regulation of thymidine phosphorylase (TP). Here, we studied safety and efficacy of the combination of capecitabine with docetaxel and mitomycin C. Two dose levels (DL) were investigated: capecitabine 1000 mg m−2 b.i.d. on days 1–14, docetaxel 40 mg m−2 i.v. day 1, mitomycin C 4 or 6 mg m−2 i.v. day 1 (DL I or II). Cycles were repeated every 3 weeks. The primary aim was to determine the dose-limiting toxicities (DLT) during the first two treatment cycles and the maximum tolerated dose (MTD). A total of 46 patients (pts) refractory to standard therapies were enrolled, of whom the majority had gastrointestinal tumours (n=40). 14 pts had received ⩾3 lines of prior chemotherapy. At DL I, one out of six pts experienced DLT. At DL II, two out of six pts had DLT (mucositis grade 3). Thus, DL I was determined as MTD. Among a total of 37 pts treated on DL I the following toxicities were observed during cycles 1 and 2 (number of patients with grade 1/2/3/4 toxicity; NCI-CTC v. 3.0): anaemia 10/8/3/0, leucocytopenia 4/11/1/2, thrombocytopenia 0/1/2/0, diarrhoea 8/1/2/0, stomatitis/mucositis 3/3/1/0, nausea/vomiting 10/2/0/0, and hand-foot skin reaction 5/1/1/0. Of 30 pts who received at least two treatment cycles nine achieved complete or partial remissions, six pts achieved minor remissions, and seven pts had stable disease (tumour control rate 73%). Of note, four out of 10 patients with pancreatic cancer had partial remissions. In conclusion, capecitabine can safely be combined with docetaxel (40 mg m−2) and mitomycin C (4 mg m−2). The established regimen was well tolerated and the preliminary efficacy data in this heavily pre-treated patients population appears to be promising

Epidermal Growth Factor Receptor and K-RAS status in two cohorts of squamous cell carcinomas

With the availability of effective anti-EGFR therapies for various solid malignancies, such as non-cell small lung cancer, colorectal cancer and squamous cell carcinoma of the head and neck, the knowledge of EGFR and K-RAS status becomes clinically important. The aim of this study was to analyse EGFR expression, EGFR gene copy number and EGFR and K-RAS mutations in two cohorts of squamous cell carcinomas, specifically anal canal and tonsil carcinomas.Journal ArticleMulticenter StudyResearch Support, Non-U.S. Gov'tSCOPUS: ar.jinfo:eu-repo/semantics/publishe