Improving swallowing outcomes in patients with head and neck cancer using a theory-based pretreatment swallowing intervention package: protocol for a randomised feasibility study

Abstract

IntroductionThe incidence of head and neck cancer (HNC) in the UK is rising, with an average of 31 people diagnosed daily. Patients affected by HNC suffer significant short-term and long-term post-treatment morbidity as a result of dysphagia, which affects daily functioning and quality of life (QOL). Pretreatment swallowing exercises may provide additional benefit over standard rehabilitation in managing dysphagia after primary HNC treatments, but uncertainty about their effectiveness persists. This study was preceded by an intervention development phase to produce an optimised swallowing intervention package (SIP). The aim of the current study is to assess the feasibility of this new intervention and research processes within a National Health Service (NHS) setting.Method and analysisA two-arm non-blinded randomised controlled feasibility study will be carried out at one tertiary referral NHS centre providing specialist services in HNC. Patients newly diagnosed with stage III and IV disease undergoing planned surgery and/or chemoradiation treatments will be eligible. The SIP will be delivered pre treatment, and a range of swallowing-related and QOL measures will be collected at baseline, 1, 3 and 6 months post-treatment. Outcomes will test the feasibility of a future randomised controlled trial (RCT), detailing rate of recruitment and patient acceptance to participation and randomisation. Salient information relating to protocol implementation will be collated and study material such as the case report form will be tested. A range of candidate outcome measures will be examined for suitability in a larger RCT.Ethics and disseminationEthical approval was obtained from an NHS Research Ethics Committee. Findings will be published open access in a peer-reviewed journal, and presented at relevant conferences and research meetings.Trial registration numberISRCTN40215425; Pre-results.

Very late xerostomia, dysphagia, and neck fibrosis after head and neck radiotherapy

“…23 Nilsen et al found that HNC survivors who were more than 6 years from treatment completion, reported an increase in swallowing dysfunction. 40,52,53 Preventive as well as curative swallowing therapy programs, both during and after radiotherapy, have been shown to result in better swallowing function. Studies assessing the impact of late dysphagia on QOL remain, however, scarce; novel prospective trials in this area still need to be undertaken.…”

“…Nevertheless, it is known that the consequences of dysphagia, for example, malnutrition, dehydration, and aspiration pneumonia, have a negative impact on daily functioning and QOL and can be life-threatening. 40,52,53 Preventive as well as curative swallowing therapy programs, both during and after radiotherapy, have been shown to result in better swallowing function. 50,51,[54][55][56][57] We, therefore, initiated two prospective trials, one investigating the effect of tongue strengthening exercises on long-term dysphagia in patients with HNC (ISRCTN14447678), the other assessing the effect of three different prophylactic swallowing programs on post-treatment swallowing function as well as determining the adherence to these programs in patients undergoing primary CRT for oropharyngeal squamous cell carcinoma (ISRCTN98243550).…”

SIP SMART: A parallel group randomised feasibility trial of a tailored pre-treatment Swallowing Intervention Package compared with usual care for patients with head and neck cancer

“…A full protocol of this study has been published (12). In summary, this was a two-arm parallel group non-blinded randomised controlled feasibility trial allocated in a 1:1 ratio.…”

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)

“…Fifty to 60% of the HNC patients undergoing CRT may experience significant post-treatment dysphagia involving both muscle weakness and incoordination/timing issues [6][7][8]. The medical consequences (e.g., feeding-tube dependency, malnutrition, aspiration pneumonia) have a major negative impact on daily functioning and health-related quality of life (QOL) and can even be life-threatening [9][10][11][12][13][14][15]. These consequences and the high prevalence of swallowing disorders in HNC patients stress the importance of prevention, monitoring and management of this problem [16].…”