title: A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study.
abstract: BACKGROUND
  Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients.
  
  
  METHODS
  Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control). Intervention comprised overnight feeding, providing 50 % of energy and protein requirements, in addition to usual oral intake. Primary outcome measures were recruitment and retention rates at six weeks and six months. Nutritional intake, nutritional parameters, quality of life and healthcare costs were also collected. Interviews were conducted with a sample of participants, to ascertain patient and carer experiences.
  
  
  RESULTS
  Fifty-four of 112 (48 %) eligible patients participated in the study over the 20 months. Study retention at six weeks was 41/54 patients (76 %) and at six months was 36/54 (67 %). At six weeks, participants in the control group had lost on average 3.9 kg more than participants in the intervention group (95 % confidence interval [CI] 1.6 to 6.2). These differences remained evident at three months (mean difference 2.5 kg, 95 % CI -0.5 to 5.6) and at six months (mean difference 2.5 kg, 95 % CI -1.2 to 6.1). The mean values observed in the intervention group for mid arm circumference, mid arm muscle circumference, triceps skin fold thickness and right hand grip strength were greater than for the control group at all post hospital discharge time points. The economic evaluation suggested that it was feasible to collect resource use and EQ-5D data for a full cost-effectiveness analysis. Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial: 1) a positive experience, 2) the reasons for taking part, and 3) uncertainty of the study process.
  
  
  CONCLUSIONS
  This study demonstrated that home enteral feeding by jejunostomy was feasible, safe and acceptable to patients and their carers. Whether home enteral feeding as 'usual practice' is a cost-effective therapy would require confirmation in an appropriately powered, multi-centre study.
  
  
  BACKGROUND
  UK Clinical Research Network ID 12447 (main trial, first registered 30 May 2012); UK Clinical Research Network ID 13361 (qualitative substudy, first registered 30 May 2012); ClinicalTrials.gov NCT01870817 (first registered 28 May 2013).
authors.affiliation: Department of Surgery, University Hospitals of Leicester NHS Trust, Level 6 Balmoral Building, Leicester, UK. djb57@le.ac.uk.
authors.forename: David J
authors.initials: DJ
authors.lastname: Bowrey
authors.affiliation: Department of Surgery, University Hospitals of Leicester NHS Trust, Level 6 Balmoral Building, Leicester, UK. melanie.baker@uhl-tr.nhs.uk.
authors.forename: Melanie
authors.initials: M
authors.lastname: Baker
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK. vanessa.halliday@sheffield.ac.uk.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Halliday
authors.affiliation: Department of Cancer Studies, University of Leicester, Leicester, UK. at107@le.ac.uk.
authors.forename: Anne L
authors.initials: AL
authors.lastname: Thomas
authors.affiliation: Department of Health Economics, University of Warwick, Coventry, UK. r.jacob@warwick.ac.uk.
authors.forename: Ruth
authors.initials: R
authors.lastname: Pulikottil-Jacob
authors.affiliation: Department of Health Sciences, University of Leicester, Leicester, UK. kls27@le.ac.uk.
authors.forename: Karen
authors.initials: K
authors.lastname: Smith
authors.affiliation: Leicester Clinical Trials Unit, University of Leicester, Leicester, UK. tm221@le.ac.uk.
authors.forename: Tom
authors.initials: T
authors.lastname: Morris
authors.affiliation: Leicester Clinical Trials Unit, University of Leicester, Leicester, UK. ar346@le.ac.uk.|Current affiliation: Department of Mathematical Statistics and Actuarial Science, University of the Free State, Bloemfontein, South Africa. ar346@le.ac.uk.
authors.forename: Arne
authors.initials: A
authors.lastname: Ring
mesh_terms: D000368:Aged; D017028:Caregivers; D003362:Cost-Benefit Analysis; D004739:England; D004750:Enteral Nutrition / Q000009:adverse effects / Q000191:economics / Q000379:methods; D004938:Esophageal Neoplasms / Q000191:economics / Q000473:pathology / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects / Q000191:economics / Q000534:rehabilitation*; D004943:Esophagogastric Junction / Q000473:pathology / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects / Q000191:economics / Q000534:rehabilitation*; D017048:Health Care Costs; D018575:Home Care Services, Hospital-Based / Q000191:economics; D006801:Humans; D007582:Jejunostomy; D008297:Male; D008875:Middle Aged; D015596:Nutrition Assessment; D009752:Nutritional Status; D017060:Patient Satisfaction; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000191:economics / Q000473:pathology / Q000601:surgery*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome