title: Pre-operative oral nutritional supplementation with dietary advice versus dietary advice alone in weight-losing patients with colorectal cancer: single-blind randomized controlled trial.
abstract: BACKGROUND
  Pre-operative weight loss has been consistently associated with increased post-operative morbidity. The study aims to determine if pre-operative oral nutritional supplements (ONSs) with dietary advice reduce post-operative complications.
  
  
  METHODS
  Single-blinded randomized controlled trial. People with colorectal cancer scheduled for surgery with pre-operative weight loss >1 kg/3-6 months were randomized by using stratified blocks (1:1 ratio) in six hospitals (1 November 2013-28 February 2015). Intervention group was given 250 mL/day ONS (10.1 KJ and 0.096 g protein per mL) and dietary advice. Control group received dietary advice alone. Oral nutritional supplements were administered from diagnosis to the day preceding surgery. Research team was masked to group allocation. Primary outcome was patients with one or more surgical site infection (SSI) or chest infection; secondary outcomes included percentage weight loss, total complications, and body composition measurements. Intention-to-treat analysis was performed with both unadjusted and adjusted analyses. A sample size of 88 was required.
  
  
  RESULTS
  Of 101 participants, (55 ONS, 46 controls) 97 had surgery. In intention-to-treat analysis, there were 21/45 (47%) patients with an infection-either an SSI or chest infection in the control group vs. 17/55 (30%) in the ONS group. The odds ratio of a patient incurring either an SSI or chest infection was 0.532 (P = 0.135 confidence interval 0.232 to 1.218) in the unadjusted analysis and when adjusted for random differences at baseline (age, gender, percentage weight loss, and cancer staging) was 0.341 (P = 0.031, confidence interval 0.128 to 0.909). Pre-operative percentage weight loss at the first time point after randomization was 4.1% [interquartile range (IQR) 1.7-7.0] in ONS group vs. 6.7% (IQR 2.6-10.8) in controls (Mann-Whitney U P = 0.021) and post-operatively was 7.4% (IQR 4.3-10.0) in ONS group vs. 10.2% (IQR 5.1-18.5) in controls (P = 0.016).
  
  
  CONCLUSIONS
  Compared with dietary advice alone, ONS resulted in patients having fewer infections and less weight loss following surgery for colorectal cancer. We have demonstrated that pre-operative oral nutritional supplementation can improve clinical outcome in weight losing patients with colorectal cancer.
authors.affiliation: School of Health Sciences, The University of Manchester, Manchester, UK.|Salford Royal NHS Foundation Trust, Salford, UK.|Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
authors.forename: Sorrel T
authors.initials: ST
authors.lastname: Burden
authors.affiliation: School of Health Sciences, The University of Manchester, Manchester, UK.|Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
authors.forename: Debra J
authors.initials: DJ
authors.lastname: Gibson
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK.|School of Medicine, The University of Manchester, Manchester, UK.|Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Lal
authors.affiliation: Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.|School of Medicine, The University of Manchester, Manchester, UK.|Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
authors.forename: James
authors.initials: J
authors.lastname: Hill
authors.affiliation: School of Health Sciences, The University of Manchester, Manchester, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Pilling
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK.|School of Medicine, The University of Manchester, Manchester, UK.|Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
authors.forename: Mattias
authors.initials: M
authors.lastname: Soop
authors.affiliation: University Hospital South Manchester NHS Foundation Trust, Wythenshawe, UK.|Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
authors.forename: Aswatha
authors.initials: A
authors.lastname: Ramesh
authors.affiliation: School of Health Sciences, The University of Manchester, Manchester, UK.|Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Todd
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000178:diet therapy* / Q000601:surgery; D015897:Comorbidity; D003376:Counseling; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D044623:Nutrition Therapy; D011300:Preoperative Care; D016896:Treatment Outcome; D015431:Weight Loss
keywords: Cancer; Colorectal; Infections; RCT; Supplements; Weight loss