Background Radiation-induced dysphagia is common in patients with head and neck cancer (HNC). Available evidence suggests that exercise therapy prior to oncological treatment could potentially improve deglutition and quality of life; however, a randomized clinical trial is needed to confirm this observation. Methods/design The Redyor study is a single-blind randomized clinical trial designed to compare the effect of prophylactic oropharyngeal exercises on quality of life and dysphagia of 52 patients with HNC referred to the Radiotherapy Department. The intervention will consist of respiratory muscle training (3 times/day, 5 days/week, 21 weeks) added to the standard swallow therapy. All patients will perform the same exercise intervention, but at different times: before chemoradiotherapy (CRT; early intervention group) or immediately after completing CRT (late intervention group). The main outcome will be change in dysphagia severity assessed with the Penetration-Aspiration Scale in videofluoroscopy study; quality of life will be assessed with the EORTC-QLQ-C30 and its Head and Neck Cancer Module (QLQ-H&N35) at 3, 6, and 12 months after completing CRT. 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 main objective is to assess dysphagia severity in HNC patients; and secondly, to evaluate changes in dysphagia-related quality of life, and to determine the correlation between a clinical variable and instrumental parameters during this period. Trial registration NCT0209009911 . Electronic supplementary material The online version of this article (10.1186/s13063-019-3587-x) contains supplementary material, which is available to authorized users.

Methods. Measurements were taken with the Exradin A20 (Standard Imaging) ionisation chamber, and the ‘homemade’ MARM phantom was made with the 3D Ultimaker 2+ printer using PLA material. The material used for validation was ABS Medical from Smart Materials 3D. The irradiation was undertaken with a 192Ir source by means of Varian’s GammaMed Plus iX HDR equipment. EBT3 films were used to run additional tests. We compared different measurements for PLA, ABS Medical, and water. Additional validation methods, described in the bibliography, were also compared. Results. The measurements with the ionisation chamber that we obtained using the MARM phantom with PLA and ABS within the clinically relevant range (0.5–1.5 cm) differ with respect to the measures in the water reference, by 2.3% and 0.94%, respectively. Discussion. The literature describes highly heterogeneous validation methods, complicating the performance of systematic reviews and comparisons between materials. Thus, creating a phantom represents a single effort that will quickly pay off. This system enables comparisons, ensuring that geometric conditions remain stable—something that is not always possible with radiochromic films. The use of a calibrated ionisation chamber in the corresponding energy range, combined with the ‘homemade’ MARM phantom applied according to the proposed methodology, allows a differentiation between the attenuation of the material itself and the drop in the dose due to distance. Conclusion. The validation method for 3D printing materials, using an ionisation chamber and the MARM PLA phantom, represents an accessible, standardisable solution for manufacturing brachytherapy applicators.

Objective/Hypothesis: The 10-item Eating-Assessment Tool (EAT-10) is a dysphagia screening test. In HNC patients, screening and diagnosis of dysphagia are not well-established. To determine the metrological properties of the EAT-10 compared with videofluoroscopy in non-surgical HNC-patients and to assess the relationship between EAT-10 scores and patients’ self-reported symptoms. Study Design: Prospective cohort study. Methods: Forty-six HNC-patients recently diagnosed and referred to chemoradiotherapy (CRT). Main outcome was evidence of dysphagia according to EAT-10 score, self-perception on a Visual Analog Scale (VAS) of impaired swallowing, severity on the Penetration-Aspiration Scale (PAS), and the Functional Oral Intake Scale (FOIS). Patients were assessed at baseline, before-CRT, after-CRT, and at 3-month follow-up. Results: A strong baseline correlation between EAT-10, VAS, and FOIS was observed. All 3 values decreased in weeks 6 to 9 after CRT initiation; a poor correlation of EAT-10 with VAS was observed at 3-month follow-up. A receiver operating characteristic curve determined new cut-off points (sensitivity/specificity) for safe swallowing: baseline 3 (86%, 77%); post-CRT, 15 (62.5%, 80%); and 3-month follow-up, 4 (83%, 75%). Conclusions: New safe-swallow EAT-10-points are suggested for this population during screening and the oncological follow-up. A poor correlation between EAT10-score and patient self-reported symptoms was observed at the end-RT and at 3-month follow-up, highlighting the need for an objective evaluation instrument.

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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

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

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codeletion may not be sufficient criteria to omit RT as a treatment option. These results suggest that RT should continue to be offered as a treatment option for patients with anaplastic oligodendroglial tumors.