The PRO-ACTIVE trial protocol: a randomized study comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer

Background Swallowing therapy is commonly provided as a treatment to lessen the risk or severity of dysphagia secondary to radiotherapy (RT) for head and neck cancer (HNC); however, best practice is not yet established. This trial will compare the effectiveness of prophylactic (high and low intensity) versus reactive interventions for swallowing in patients with HNC undergoing RT. Methods This multi-site, international randomized clinical trial (RCT) will include 952 adult patients receiving radiotherapy for HNC and who are at high risk for post-RT dysphagia. Participants will be randomized to receive one of three interventions for swallowing during RT: RE-ACTIVE, started promptly if/when dysphagia is identified; PRO-ACTIVE EAT, low intensity prophylactic intervention started before RT commences; or, PRO-ACTIVE EAT+EXERCISE, high intensity prophylactic intervention also started before RT commences. We hypothesize that the PRO-ACTIVE therapies are more effective than late RE-ACTIVE therapy; and, that the more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to the low intensive PRO-ACTIVE (EAT). The primary endpoint of effectiveness is duration of feeding tube dependency one year post radiation therapy, selected as a pragmatic outcome valued equally by diverse stakeholders (e.g., patients, caregivers and clinicians). Secondary outcomes will include objective measures of swallow physiology and function, pneumonia and weight loss, along with various patient-reported swallowing-related outcomes, such as quality of life, symptom burden, and self-efficacy. Discussion Dysphagia is a common and potentially life-threatening chronic toxicity of radiotherapy, and a priority issue for HNC survivors. Yet, the optimal timing and intensity of swallowing therapy provided by a speech-language pathologist is not known. With no clearly preferred strategy, current practice is fraught with substantial variation. The pragmatic PRO-ACTIVE trial aims to specifically address the decisional dilemma of when swallowing therapy should begin (i.e., before or after a swallowing problem develops). The critical impact of this dilemma is heightened by the growing number of young HNC patients in healthcare systems that need to allocate resources most effectively. The results of the PRO-ACTIVE trial will address the global uncertainty regarding best practice for dysphagia management in HNC patients receiving radiotherapy. Trial registration The protocol is registered with the US Patient Centered Outcomes Research Institute, and the PRO-ACTIVE trial was prospectively registered at ClinicalTrials.gov, under the identifier NCT03455608; First posted: Mar 6, 2018; Last verified: Jun 17, 2021. Protocol Version: 1.3 (January 27, 2020).

Prevalence of Dysphagia in Dysphonic Patients with Non-Neoplastic Vocal Fold Lesions

Background Dysphagia is the swallowing difficulties and trouble to move liquids, solids, medications and may be saliva from the mouth down to the stomach and is considered a serious red flag or alarm symptom. Aim of the Work to examine the prevalence of dysphagia on basis of subjective and objective measures in patients with the presenting symptom of dysphonia and diagnosed with non-neoplastic vocal fold lesions to consider the potential benefit of swallowing therapy hand in hand with the chosen management line of voice problem in the treatment of these patients if proved to have high prevalence of dysphagia. Subjects and Methods This study was applied on 50 patients with age ranging from 15-50 years diagnosed as being dysphonic secondary to non-neoplastic vocal fold lesions on objective and clinical measures, attending at the Phoniatric outpatient clinic at El-Demerdash hospital and Ain Shams University Specialized hospital. Results After the application of the A-EAT-10 questionnaire on 50 dysphonic patients who were selected to participate in this study, 12 cases (about 24%) were considered dysphagic with score above 3 and underwent VFSS. Within these 12 patients, Zero percent were found complaining of dysphagia according to VFSS. So there is No Correlation between frequencies of dysphagia by A-EAT-10 and by VFSS. Conclusion The present study showed that non-neoplastic vocal fold lesions are not an etiological factor for dysphagia despite the intricacy in the neuromuscular supply of pharynx and larynx. Diagnosis of Dysphagia can’t be confirmed depending only on subjective screening tools like A-EAT-10.

UK Stroke Supplement: 001 – High Scoring Oral Presentation – Swallowing and Nutrition: SWALLOWING THERAPY FOR DYSPHAGIA IN ACUTE AND SUB-ACUTE STROKE (COCHRANE SYSTEMATIC REVIEW)

Introduction Swallowing difficulties (oropharyngeal dysphagia (OD)) are common post-stroke but there is no specific guidance on treatment. We have updated the 2018 Cochrane review of dysphagia interventions to explore whether there is evidence of a significant benefit from OD interventions on swallowing impairment. Methods RCT’s of patients with a new onset of OD after stroke published before January 2021 were included. Results were screened and analysed by two independent researchers. Trials were divided to specific intervention types and data was analysed against 8 outcomes, the primary outcome being swallowing impairment (SI). Results 83 additional trials were analysed producing a review to a total of 129 trials. Three interventions were associated with reductions in outcomes: Acupuncture: SI (SMD −0.94 [95% CI−1.25,−0.63], p < 0.0001); dysphagia (OR 0.41 [95% CI 0.33, 0.49], p < 0.0001); and penetration aspiration scale score (PAS) (MD −0.68 [95% CI −1.17, −0.19], p = 0.006). Behavioural therapy: SI (SMD −0.88 95% CI −1.28, −0.48], p < 0.0001); dysphagia (OR 0.41 [95% CI 0.29, 0.59], p < 0.0001); PAS (MD −0.77 [95% CI −1.11, −0.42], p < 0.0001); and chest infection/pneumonia (OR 0.43 [0.25, 0.74], p = 0.002). Neuromuscular electrical stimulation (NMES): SI (SMD −0.96 95% CI −1.38, −0.54], p < 0.0001) and dysphagia (OR 0.39 [95% CI 0.27, 0.56], p < 0.0001). The limited number of trials precluded comment on other interventions included within the review. Heterogeneity of trials ranged from mild-significant. Conclusions Low-to-moderate quality evidence from small-moderate sized trials suggest that Acupuncture, Behavioural and NMES interventions reduce swallowing impairment after stroke. Large, high-quality trials are needed to test whether specific interventions are effective.

Noninvasive Brain Stimulation for Poststroke Dysphagia: A Meta-Analysis for Randomized Controlled Trials

<b><i>Background:</i></b> Past research has indicated that repetitive transcranial magnetic stimulation (rTMS) on the pharyngeal motor cortex may be beneficial to poststroke dysphagic patients. In addition, some studies have supported that transcranial direct current stimulation (tDCS) over the pharyngeal motor cortex can improve swallowing function in poststroke dysphagia. However, some studies showed that rTMS and tDCS show no effect on poststroke dysphagia. This study aims to make a meta-analysis to investigate the therapy effect of rTMS and tDCS on poststroke dysphagia in randomized controlled trials (RCTs). <b><i>Methods:</i></b> We searched for studies published before March 2021 in databases (PubMed, Web of Science, MEDLINE, EMBASE, and Google Scholar). Meta-analysis was made to compute the results of included studies using STATA 12.0 software. <b><i>Results:</i></b> The present study shows a significant increase in the swallowing function in poststroke dysphagia given rTMS compared to those given sham rTMS (standardized mean difference [SMD] = 1.08, 95% confidence interval [CI] = 0.37–1.80, <i>I</i>² = 81.2%, <i>p</i> &#x3c; 0.001). In addition, the study shows a significant increase in the swallowing function in poststroke dysphagia given tDCS (combined or not combined with conventional swallowing therapy), compared to those given sham tDCS (combined or not combined with conventional swallowing therapy) (SMD = 1.43, 95% CI = 0.73–2.13, <i>I</i>² = 77.6%, <i>p</i> &#x3c; 0.001). <b><i>Conclusions:</i></b> The study demonstrates that rTMS and tDCS over the pharyngeal motor cortex show therapy effects on poststroke dysphagia. Many more large-scale, blinded RCTs are essential to investigate the effect of rTMS and tDCS on poststroke dysphagia.

Usability Testing of a mHealth System for Swallowing Therapy in Patients Following Stroke

Purpose The objective of this study was to evaluate the usability of a mobile health (mHealth) system designed for dysphagia exercise in persons with a history of stroke. Method Five participants with a history of stroke were recruited from a tertiary health center and assessed for their ability to use and interact with the system. After being introduced to the technology, participants were asked to independently complete five tasks, one at a time. Assistance was available when required or requested. Usability was evaluated with respect to effectiveness, efficiency, and user satisfaction when completing the prespecified goals. Results Four men and one woman between the ages of 50 and 83 years ( M = 65.4) completed the usability testing. Time from stroke onset varied from 1 month to 2.5 years. Additional poststroke challenges related to the usability of the mHealth system included reduced range of motion or mobility, vision, and short-term memory difficulties. Independent success (system effectiveness) varied in this user subgroup, and the research clinician or the family member was required to adjust the level and type of support they provided (system efficiency). All participants reported satisfaction with the use of the system. Conclusion Usability of and satisfaction with this mHealth system and others like it can be achieved in individuals who have had a stroke, either as an independent user or as a patient–caregiver dyad.

Successful treatment of dysphagia in a COVID-19 survivor

<p class="abstract">This study was aimed<strong> </strong>document a successful case of dysphagia management after coronavirus disease 2019 (COVID-19) infection. COVID-19 is highly infectious disease and causes 75 million infection and 1.66 million deaths worldwide. Clinical features of COVID-19 including respiratory compromise, microvascular thrombosis and neurologic dysfunction as well as well as prolonged intensive care unit (ICU) care in severe cases yield patients particularly susceptible to mild to severe swallowing impairment which can persist for months or years after ICU discharge. A 52 years old female was diagnosed with severe pharyngo-oesophageal dysphagia after COVID-19 infection and was advised for swallowing therapy. The swallowing therapy was given thrice a week for 45 minutes including Masako, Shaker’s and modified Shaker’s exercise along with effortful swallow, Mendelsohn maneuvers and super-supraglottic swallow. After 2 weeks of swallowing therapy patient started taking semisolid food orally and maintain normal SpO₂level during feeding. This study concluded early intervention is the key to boost faster recovery and helped to improve patient’s quality of life.<strong> </strong>Swallowing manuvers and exercises were very effective for the management of dysphagia secondary to COVID-19 infection. This can be generalized and efficacy can be determined with large group of patients having swallowing difficulty after COVID-19 infection.</p>

Impact of nasogastric tube feeding on swallowing function in patients with dysphagia: a pilot study

During dysphagia treatment, direct oral swallowing therapy is applied to some patients temporarily fed via nasogastric tube. However, the risk of aspiration in oral swallowing while nasogastric tube in situ may be disregarded in a standard videofluoroscopic swallowing study performed without a nasogastric tube. To evaluate the diagnostic significance of nasogastric tube in situ videofluoroscopic swallowing study of nectar and pureed diet compared to the standard videofluoroscopic swallowing study without nasogastric tube. Videofluoroscopic swallowing study records of dysphagia patients conducted between June and August 2017 in a university hospital were collected for review. Rosenbek’s penetration-aspiration scale, diagnostic criteria of aspiration were used to define aspiration. videofluoroscopic dysphagia scale for videofluoroscopic swallowing study with or without nasogastric tube were compared for nectar and pureed diet swallowing. Patients had various duration of nasogastric tube feeding. Paired T-test comparing the videofluoroscopic dysphagia scales for videofluoroscopic swallowing study with or without nasogastric tube revealed significant aggravation of swallowing dysfunction in nectar drinking while nasogastric tube in situ. This aggravation was noted in 19% (n=4) of patients who suffered from stroke regardless of nasogastric tube duration. Nasogastric tube in situ videofluoroscopic swallowing study, at least of nectar drinking could be beneficial in selecting a safe candidate for direct oral swallowing therapy in conjunction with the conventional nasogastric tube removed videofluoroscopic swallowing study.

Adherence to Home-Based Swallowing Therapy Using a Mobile System in Head and Neck Cancer Survivors

Purpose A large knowledge gap related to dysphagia treatment adherence was identified by a recent systematic review: Few existing studies report on adherence, and current adherence tracking relies heavily on patient self-report. This study aimed to report weekly adherence and dysphagia-specific quality of life following home-based swallowing therapy in head and neck cancer (HNC). Method This was a quasi-experimental pretest–posttest design. Patients who were at least 3 months post–HNC treatment were enrolled in swallowing therapy using a mobile health (mHealth) swallowing system equipped with surface electromyography (sEMG) biofeedback. Participants completed a home dysphagia exercise program across 6 weeks, with a target of 72 swallows per day split between three different exercise types. Adherence was calculated as percent trials completed of trials prescribed. The M. D. Anderson Dysphagia Inventory (MDADI) was administered before and after therapy. Results Twenty participants (75% male), with an average age of 61.9 years ( SD = 8.5), completed the study. The majority had surgery ± adjuvant (chemo)radiation therapy for oral (10%), oropharyngeal (80%), or other (10%) cancers. Using an intention-to-treat analysis, adherence to the exercise regimen remained high from 84% in Week 1 to 72% in Week 6. Radiation therapy, time since cancer treatment, medical difficulties, and technical difficulties were all found to be predictive of poorer adherence at Week 6. A statistically significant improvement was found for composite, emotional, and physical MDADI subscales. Conclusions When using an mHealth system with sEMG biofeedback, adherence rates to home-based swallowing exercise remained at or above 72% over a 6-week treatment period. Dysphagia-specific quality of life improved following this 6-week treatment program.