title: A feasibility study incorporating a pilot randomised controlled trial of oral feeding plus pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemoradiation for head and neck cancer (TUBE trial): study protocol.
abstract: BACKGROUND
  There are 7000 new cases of head and neck squamous cell cancers (HNSCC) treated by the NHS each year. Stage III and IV HNSCC can be treated non-surgically by radio therapy (RT) or chemoradiation therapy (CRT). CRT can affect eating and drinking through a range of side effects with 90 % of patients undergoing this treatment requiring nutritional support via gastrostomy (G) or nasogastric (NG) tube feeding. Long-term dysphagia following CRT is a primary concern for patients. The effect of enteral feeding routes on swallowing function is not well understood, and the two feeding methods have, to date, not been compared to assess which leads to a better patient outcome. The purpose of this study is to explore the feasibility of conducting a randomised controlled trial (RCT) comparing these two options with particular emphasis on patient willingness to be randomised and clinician willingness to approach eligible patients.
  
  
  METHODS
  This is a mixed methods multicentre study to establish the feasibility of a randomised controlled trial comparing oral feeding plus pre-treatment gastrostomy versus oral feeding plus as required nasogastric tube feeding in patients with HNSCC. A total of 60 participants will be randomised to the two arms of the study (1:1 ratio). The primary outcome of feasibility is a composite of recruitment (willingness to randomise and be randomised) and retention. A qualitative process evaluation investigating patient, family and friends and staff experiences of trial participation will also be conducted alongside an economic modelling exercise to synthesise available evidence and provide estimates of cost-effectiveness and value of information. Participants will be assessed at baseline (pre-randomisation), during CRT weekly, 3 months and 6 months.
  
  
  CONCLUSIONS
  Clinicians are in equipoise over the enteral feeding options for patients being treated with CRT. Swallowing outcomes have been identified as a top priority for patients following treatment and this trial would inform a future larger scale RCT in this area to inform best practice.
  
  
  BACKGROUND
  ISRCTN48569216.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK ; University of Manchester, Manchester, UK.
authors.forename: Vinidh
authors.initials: V
authors.lastname: Paleri
authors.affiliation: University of Manchester, Manchester, UK.
authors.forename: Joshua
authors.initials: J
authors.lastname: Wood
authors.affiliation: City Hospitals Sunderland NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Patterson
authors.affiliation: Clinical Trials and Biostatistics, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Deborah D
authors.initials: DD
authors.lastname: Stocken
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Cole
authors.affiliation: Health Economics, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Luke
authors.initials: L
authors.lastname: Vale
authors.affiliation: University of Manchester, Manchester, UK.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Franks
authors.affiliation: Guy's & St Thomas' NHS Foundation Trust, London, UK.
authors.forename: Teresa
authors.initials: T
authors.lastname: Guerrero-Urbano
authors.affiliation: Guy's & St Thomas' NHS Foundation Trust, London, UK.
authors.forename: Rachael
authors.initials: R
authors.lastname: Donnelly
authors.affiliation: Restorative Dentistry, Newcastle Dental Hospital, Newcastle upon Tyne, UK.
authors.forename: Stewart
authors.initials: S
authors.lastname: Barclay
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Rapley
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Nikki
authors.initials: N
authors.lastname: Rousseau
keywords: Chemoradiation therapy; Gastrostomy; Head and neck cancer; Nasogastric tube; Swallow outcome