Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients with Head and Neck Cancer Receiving (Chemo) Radiotherapy. The Redyor Study: Protocol for a Randomized Clinical Trial.

Background: Squamous carcinoma of the head and neck (HNC) has a high incidence in our context. Although therapeutic radiotherapy protocols try to preserve swallowing function and essential speech organs, dysphagia is a frequent symptom in the acute and long-term phases, due to the toxic effects of therapies needed to confront the illness. Some studies have shown prophylactic oropharyngeal exercises to be quite useful in improving swallowing function after completion of chemo-radiation therapy (CRT) protocols; others have focused on their use to prevent or minimize post-CRT swallowing dysfunction. Patients’ quality of life deteriorates greatly during CRT, with a peak of maximum intensity during the days immediately after finishing CRT treatment. Afterwards, function gradually improves, although scope or timeframe remains undetermined. Available evidence suggests that exercise therapy prior to oncological treatment could potentially improve deglutition and quality of life; however, a randomized study is needed to confirm this observation. Design/Methods: The Redyor singe-blind randomized clinical trial is designed to compare the effect of prophylactic oropharyngeal exercises on quality of life, dysphagia, and sustainability to the length of rehabilitative treatment. At enrollment, participants will be randomly assigned to one of two treatment groups. Both groups follow the protocol described here, although one group begins the training 2 weeks before initiating CRT and the other group just after finishing the therapy. Both groups will complete standard swallow therapy for training submental muscles involved and 3 sets of 5 inspiratory and expiratory repetitions using the Orygen Dual® valve, with a progressive weekly increase in workload. Discussion: This ongoing clinical trial, registered in 2016, is based on the hypothesis that undergoing a pre-radiotherapy rehabilitation (pre-habilitation) program will have greater benefits (less decrease in quality of life, less delay in swallowing parameters, and less severe dysphagia) compared to post-CRT rehabilitation. The primary objective is to assess dysphagia severity and evaluate quality of life due to swallowing dysfunction in HNC patients. Secondary objectives are to assess the correlation between a clinical variable and instrumental parameters in this period