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

Abstract

Background: Dysphagia 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 posttreatment 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). Methods: This 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 chintuck 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. Discussion: Since 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.

Prehabilitation in head and neck cancer patients: A literature review

“…Duration of the treatment block was defined in 15 studies [ 14 – 16 , 21 – 27 , 30 – 32 , 36 , 37 ]. The most common recommendation was the duration of radiotherapy [ 15 , 16 , 21 , 22 , 27 , 30 , 31 , 37 ].…”

“…Only one article [ 37 ] compared prehabilitation using the Shaker versus the Mendelsohn maneuver and found superior results in the Shaker group, including improvements in hyoid bone movement, thyrohyoid shortening, upper esophageal sphincter opening, reduced aspiration score and reduced feeding tube rates. Four articles included in the present review were proposed protocols or feasibility studies reporting no outcomes [ 22 , 26 , 29 , 32 ]. Of the remaining studies that reported on outcomes, 20 studies reported on short term outcomes (12 months or less), while five reported on outcomes beyond 12 months.…”

“…Two articles define the control group as the group of patients that were seen prior to the implementation of a prehabilitation program [ 38 , 40 ]. Two articles had control groups based on the mode of service delivery [ 22 , 32 ]. Three articles had control groups that received exercise based therapy post cancer treatment [ 17 , 26 , 35 ].…”

European white paper: oropharyngeal dysphagia in head and neck cancer

“…Since these reviews, a few randomized clinical trials of swallowing exercise interventions have been published and/or are currently underway each with differing foci. These include a theory-based behavior change approach to swallowing exercise interventions [ 286 ], prophylactic exercises delivered via different methods including home-based, home-based with counseling via an App, face-to-face therapy [ 287 ], and swallowing exercises with respiratory muscle training randomized to two groups of patients; before CRT or immediately after treatment completion [ 288 ].…”

Respiratory‐swallow coordination in a rat model of chemoradiation

“…2 Clinical studies have reported that 50%-60% of patients undergoing CRT for HNC present with significant postintervention dysphagia. 52 While studies have sought to characterize swallowing deficits exhibited post-CRT, an explanation of the dichotomous presence or absence of deficits is not forthcoming. Our study identified a significant increase in postswallow inhale events for rats that underwent CRT.…”