Prophylactic Swallowing Therapy During Head-and-Neck Cancer Radiotherapy: Effect of Service-Delivery Mode and Overall Adherence Level on Swallowing Function and Muscle Strength-the PRESTO Trial.

Prophylactic swallowing exercises (PSE) during head-and-neck cancer (HNC) (chemo)radiotherapy (CRT) have a positive effect on swallowing function and muscle strength. Adherence rates to PSE are, however, moderate to low, undermining these effects. PRESTO already showed that the service-delivery mode (SDM), the way the exercises are offered, can influence adherence. The aim of this study was to investigate the effect of SDM on swallowing function and muscle strength during and post-CRT. In addition, the effect of overall adherence (OA), independent of SDM, was also investigated. A total of 148 HNC patients, treated with CRT, were randomly assigned to one of the three SDM's (paper-supported, app-supported, or therapist-supported PSE) and performed a 4-week PSE program. OA was calculated based on the percentage of completed exercises. Patients were divided into OA levels: the OA75+ and OA75- group performed respectively ≥ 75 and < 75% of the exercises. Swallowing function based on Mann Assessment of Swallowing Ability-Cancer (MASA-C), tongue and suprahyoid muscle strength during and up to 3 months after CRT were compared between the SDM's and OA levels. Linear Mixed-effects Models with post hoc pairwise testing and Bonferroni-Holm correction was used. No significant differences were found between the three SDMs. Significant time effects were found: MASA-C scores decreased and muscle strength increased significantly during CRT. By the end of CRT, the OA75+ showed significantly better swallowing function compared to OA75-. Muscle strength gain was significantly higher in the OA75+ group. SDM had no impact on swallowing function and muscle strength; however, significant effects were shown for OA level. Performing a high level of exercise repetitions is essential to benefit from PSE.Trial registration ISRCTN, ISRCTN98243550. Registered December 21, 2018-retrospectively registered, https://www.isrctn.com/ISRCTN98243550?q=gwen%20van%20nuffelen&filters=&sort=&offset=1&totalResults=2&page=1&pageSize=10&searchType=basic-search.

Increasing Adherence to Prophylactic Swallowing Exercises During Head and Neck Radiotherapy: The Multicenter, Randomized Controlled PRESTO-Trial.

BACKGROUND: Prophylactic swallowing exercises (PSE) during radiotherapy can significantly reduce dysphagia after radiotherapy in head and neck cancer (HNC). However, its positive effects are hampered by low adherence rates during the burdensome therapy period. Hence, the main goal of this multicenter randomized controlled trial (RCT) was to investigate the effect of 3 different service-delivery modes on actual patients' adherence. METHODS: A total of 148 oropharyngeal cancer patients treated with primary (chemo)radiotherapy were randomly assigned to a 4 weeks PSE program, either diary-supported (paper group; n = 49), app-supported (app group; n = 49) or therapist-supported (therapist group; n = 50). Participants practiced 5 days/week, daily alternating tongue strengthening exercises with chin tuck against resistance exercises. Adherence was measured as the percentage of completed exercise repetitions per week (%reps). Statistical analysis was performed by means of SPSSv27, using Linear Mixed-effects Models with post hoc pairwise testing and Bonferroni-Holm correction. RESULTS: Adherence and evolution of adherence over time was significantly different between the three groups (p < .001). Adherence rates decreased in all three groups during the 4 training weeks (p < .001). During all 4 weeks, the therapist group achieved the highest adherence rates, whilst the app group showed the lowest adherence rates. CONCLUSIONS: PSE adherence decreased during the first 4 radiotherapy weeks regardless of group, but with a significant difference between groups. The therapist group achieved the highest adherence rates with a rather limited decline, therefore, increasing the face-to-face contact with a speech-language therapist can overcome the well-known problem of low adherence to PSE in this population. TRIAL REGISTRATION: Trial registration: ISRCTN, ISRCTN98243550. Registered December 21, 2018 - retrospectively registered, https://www.isrctn.com/ISRCTN98243550?q=gwen%20van%20nuffelen&filters=&sort=&offset=1&totalResults=2&page=1&pageSize=10&searchType=basic-search .

Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial).

BACKGROUND: Chronic radiation-associated dysphagia (C-RAD) is considered to be one of the most severe functional impairments in head and neck cancer survivors treated with radiation (RT) or chemoradiation (CRT). Given the major impact of these late toxicities on patients' health and quality of life, there is a strong need for evidence-based dysphagia management. Although studies report the benefit of strengthening exercises, transference of changes in muscle strength to changes in swallowing function often remains limited. Therefore, combining isolated strengthening exercises with functional training in patients with C-RAD may lead to greater functional gains. METHODS: This 3-arm multicenter randomized trial aims to compare the efficacy and possible detraining effects of mere strengthening exercises (group 1) with a combination of strengthening exercises and functional swallowing therapy (group 2) and non-invasive brain stimulation added to that combination (group 3) in 105 patients with C-RAD. Patients will be evaluated before and during therapy and 4 weeks after the last therapy session by means of swallowing-related and strength measures and quality of life questionnaires. DISCUSSION: Overall, this innovative RCT is expected to provide new insights into the rehabilitation of C-RAD to optimize post-treatment swallowing function. TRIAL REGISTRATION: International Standard Randomized Controlled Trials Number (ISRCTN) registry ID ISRCTN57028065. Registration was accepted on 15 July 2021.