Abstract
BackgroundThere 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/designThis 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.DiscussionClinicians 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.Trial registration ISRCTN48569216
Highlights
There are 7000 new cases of head and neck squamous cell cancers (HNSCC) treated by the NHS each year
Clinicians are in equipoise over the enteral feeding options for patients being treated with chemoradiation therapy (CRT)
The TUBE study feasibility phase is a necessary prelude to a full trial of these complex interventions, to assess (i) whether an adequate proportion of eligible patients can be recruited into the study and (ii) whether an adequate proportion of patients comply with the trial protocol including outcome measure completion, according to both quantitative and qualitative data
Summary
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. Over 7000 new head and neck squamous cell cancers (HNSCC) are treated by the NHS every year. Advanced (stages III and IV) HNSCC are treated non-surgically by radiation therapy (RT), or chemoradiation therapy (CRT). In CRT, chemotherapy is delivered concurrently with RT, potentiating tumour kill and toxicity, profoundly affecting eating and drinking by causing a range of side effects: loss of taste, dry mouth, pain, loss of appetite and impaired swallow mechanism. Nutritional support can be delivered through a pre-treatment gastrostomy (G) tube or nasogastric (NG) tube feeds
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