Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy\xa0(PRESTO trial)

Margot Baudelet,Steven Mariën,Fréderic Duprez,Ann Goeleven,Joost Van Dinther,Leen Van Den Steen,Caroline Vandenbruaene,Isabel Hutsebaut,Hilde Verstraete,Marc Peeters,Olivier M Vanderveken ,Sarah Deschuymer,Daan Nevens,Tom Vauterin,Lisette Van Der Molen,C Van Laer ,Sabine Meersschout,Sandra Nuyts,Pol Specenier,Marc De Bodt,Michiel W M Van Den Brekel ,Gwen Van Nuffelen

doi:10.1186/s13063-020-4171-0

Abstract

BackgroundDysphagia is a common and serious complication after (chemo)radiotherapy (CRT) for head-and-neck cancer (HNC) patients. Prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-treatment swallowing function. However, low adherence rates are a key issue in undermining this positive effect. This current randomized trial will investigate the effect of adherence-improving measures on patients’ swallowing function, adherence and quality of life (QOL).MethodsThis ongoing trial will explore the difference in adherence and swallowing-related outcome variables during and after PSE in HNC patients performing the same therapy schedule, receiving different delivery methods. One hundred and fifty patients treated in various hospitals will be divided into three groups. Group 1 performs PSE at home, group 2 practices at home with continuous counseling through an app and group 3 receives face-to-face therapy by a speech and language pathologist. The exercises consist of tongue-strengthening exercises and chin-tuck against resistance with effortful swallow. The Iowa Oral Performance Instrument and the Swallowing Exercise Aid are used for practicing. Patients are evaluated before, during and after treatment by means of strength measurements, swallowing and QOL questionnaires.DiscussionSince low adherence rates undermine the positive impact of PSE on post-treatment swallowing function, there is need to develop an efficient PSE protocol maximizing adherence rates.Trial registrationISRCTN, ID: ISRCTN98243550. Registered retrospectively on 21 December 2018.

Highlights

Dysphagia is a common and serious complication afterradiotherapy (CRT) for head-and-neck cancer (HNC) patients
An increasing number of studies show that prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-treatment swallowing function, can lead to significantly less muscle atrophy and can improve dysphagia-related quality of life (QOL) in HNC patients treated with CRT [7, 19,20,21,22,23,24]
This study aims to Conduct a prospective randomized trial investigating the effect of specific adherence measures on patients’ actual compliance, wellbeing, muscle strength, swallowing function and QOL during and following CRT

Summary

Introduction

Dysphagia is a common and serious complication after (chemo)radiotherapy (CRT) for head-and-neck cancer (HNC) patients. 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]. An increasing number of studies show that prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-treatment swallowing function, can lead to significantly less muscle atrophy and can improve dysphagia-related QOL in HNC patients treated with CRT [7, 19,20,21,22,23,24]. Shinn et al [25] and Wells and King [30] showed that the etiology can be multifactorial; e.g., forgetting, absence of supervision or the fact that patients do not experience the problem at the start of the exercises

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