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

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

Swallowing outcomes for patients with oropharyngeal squamous cell carcinoma treated with primary (chemo)radiation therapy receiving either prophylactic gastrostomy or reactive nasogastric tube: A prospective cohort study

“…This was a non‐randomised observational cohort study, potentially introducing a selection bias. A previous randomised controlled study failed to recruit enough patients, and the feasibility of conducting such a study is currently under investigation . We are unable to confirm the degree to which patients in either group maintained oral feeding in spite of tube placement, thus preventing disuse atrophy.…”

Prophylactic versus reactive feeding approach in patients undergoing adjuvant radiation therapy for oral cavity squamous cell carcinoma: A propensity score matched‐pair analysis

“…The TUBE study was a mixed model multicentric study to establish the feasibility of conducting a randomized controlled trial comparing oral feeding plus pre-treatment gastrostomy versus oral feeding plus as required nasogastric tube feeding in patients with HNSCC with a target accrual of 60 patients. 26 The recruitment rate was around 23% (17 out of 75 were recruited) despite being hypothesized that at least 50% of patients approached would be recruited. 27 The investigators recommended organizational and operational measures (research approval process, patient availability, and strong patient preferences) based on a qualitative process evaluation to improve the accrual for such studies in the future.…”

“…Randomized trials addressing the issue of prophylactic versus reactive feeding strategies are challenging to conduct mainly because of patient accrual issues. The TUBE study was a mixed model multicentric study to establish the feasibility of conducting a randomized controlled trial comparing oral feeding plus pre‐treatment gastrostomy versus oral feeding plus as required nasogastric tube feeding in patients with HNSCC with a target accrual of 60 patients 26 . The recruitment rate was around 23% (17 out of 75 were recruited) despite being hypothesized that at least 50% of patients approached would be recruited 27 .…”

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

“…A focus group of GPs will explore preliminary trial findings and discuss implications for primary care management of nasal obstruction. Our analysis of the implementation of study findings will be informed by Normalisation Process Theory (NPT) [48].…”