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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).

Background Human papillomavirus-positive oropharyngeal squamous cell carcinoma is increasing in incidence worldwide. Current treatments are associated with high survival rates but often result in significant long-term toxicities. In particular, long-term dysphagia has a negative impact on patient quality of life and health. The aim of PATHOS is to determine whether reducing the intensity of adjuvant treatment after minimally invasive transoral surgery in this favourable prognosis disease will result in better long-term swallowing function whilst maintaining excellent disease-specific survival outcomes. Methods/Design The study is a multicentre phase II/III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal squamous cell cancer staged T1-T3 N0-N2b with a primary tumour that is resectable via a transoral approach. Following transoral surgery and neck dissection, patients are allocated into three groups based on pathological risk factors for recurrence. Patients in the low-risk pathology group will receive no adjuvant treatment, as in standard practice. Patients in the intermediate-risk pathology group will be randomised to receive either standard dose post-operative radiotherapy (control) or reduced dose radiotherapy. Patients in the high-risk pathology group will be randomised to receive either post-operative chemoradiotherapy (control) or radiotherapy alone. The primary outcome of the phase II study is patient reported swallowing function measured using the MD Anderson Dysphagia Inventory score at 12 months post-treatment. If the phase II study is successful, PATHOS will proceed to a phase III non-inferiority trial with overall survival as the primary endpoint. Discussion PATHOS is a prospective, randomised trial for Human papillomavirus-positive oropharyngeal cancer, which represents a different disease entity compared with other head and neck cancers. The trial aims to demonstrate that long-term dysphagia can be lessened by reducing the intensity of adjuvant treatment without having a negative impact on clinical outcome. The study will standardise transoral surgery and post-operative intensity-modulated radiotherapy protocols in the UK and develop a gold-standard swallowing assessment panel. An associated planned translational research programme, underpinned by tumour specimens and sequential blood collected as part of PATHOS, will facilitate further empirical understanding of this new disease and its response to treatment. Trial registration This study is registered with ClinicalTrials.gov identifier NCT02215265 .

Purpose: To evaluate the therapeutic effect of rehabilitation therapy on radiation-induced dysphagia and trismus in nasopharyngeal carcinoma (NPC) patients after radiotherapy. Patients and Methods: 43 NPC patients after radiotherapy were included. Patients were randomly assigned to either the rehabilitation group or a control group. Both groups were subjected to routine treatment, while the rehabilitation group also received rehabilitation therapy for 3 months. The severity of dysphagia was assessed using the water swallow test, while trismus was evaluated with the LENT/SOMA score and the interincisor distance (IID). The water swallow test, the LENT/SOMA score, as well as IID for both groups before and after treatment were analyzed and compared. Results: After treatment, the rehabilitation group displayed a significant improvement in swallowing function, while the control group did not. The efficacy rate (percentage of patients with excellent or effective results) of rehabilitation group was higher than that of control group (77% vs. 43%), and the difference was statistically significant (ϰ 2 = 5.32, p = 0.02). IID pretreatment and posttreatment did not show much difference in the rehabilitation group, while in the control group IID significantly decreased posttreatment (1.1 ± 0.36 cm vs.1.8 ± 0.56 cm, p = 0.001). Although the mean IID in patients of both groups decreased after the 3 month follow-up, the decrease in the rehabilitation group was less than that of the control group (0.19 ± 0.5 cm vs. 0.69 ± 0.56 cm, p = 0.004 ). The efficacy rate of trismus in the rehabilitation group was significantly higher than that of the control group (64% vs. 28%, ϰ 2 = 5.31, p = 0.02). Conclusions: Rehabilitation training can improve swallow function and slow down the progress of trismus in NPC patients following radiotherapy.

Objectives: We sought to describe the findings of modified barium swallow study after chemoradiation in patients with head and neck cancer and to correlate these findings with clinical variables, including gastrostomy tube dependence and clinical pneumonia. Methods: We retrospectively reviewed 49 patients at a tertiary care center who underwent modified barium swallow study for dysphagia after chemoradiation. Results: Patients with nonlaryngeal lesions had increased cricopharyngeal impairment (27.8% versus 0.0%; p = .04). Patients who underwent concomitant chemotherapy had increased epiglottic changes relative to those who had radiotherapy alone (66.7% versus 30.8%; p = .05). Clinical pneumonia developed in 31.9% of the patients, and 79.6% required gastrostomy tube placement for a mean duration of 18.1 months. Conclusions: Chemoradiation effects deglutition at multiple levels. A large percentage of patients will develop pneumonia and feeding tube dependence. This study is among the largest to correlate the results of modified barium swallow studies to clinical variables in this patient population. This study highlights the significant incidence of gastrostomy tube dependence and pneumonia in these patients.

GOAL OF THE WORK: Oral mucositis (OM) is a functionally destructive complication of aggressive head and neck cancer therapy, often resulting in intense pain, an inability to eat and drink and secondary malnutrition and dehydration. The barrier-forming properties of Gelclair have shown promise in relieving such symptoms. The aim of this randomised-controlled trial was to evaluate the efficacy of Gelclair, as compared to standard therapy, as a means of short-term symptom control for patients suffering from radiotherapy-induced OM. Twenty patients, with radiotherapy-induced OM seen in two oncology centres in Devon, were randomised to either standard therapy (Sucralfate and Mucaine) or Gelclair and assessed over 24 h. Both treatments were taken four times during the 24-h period, 30 min before meals. No significant difference was found between the Gelclair and standard therapy arms in terms of general pain (F = 1.512, df = 1, 17, ns). There did appear to be a trend towards pain improvement initially after the use of Gelclair, but this did not last for the full 24-h assessment period. There was no significant reduction in pain on speaking (F = 0.261, df = 1, 17, ns) nor an improvement in capacity to eat and drink, although the effects of standard therapy did appear to last longer than the Gelclair. This study indicates that Gelclair is no more effective than current standard practice in relieving the pain associated with radiotherapy-induced OM. Nevertheless, observations from this preliminary study warrant further investigation, with a view to shaping the way forward for head and neck cancer practice on a national level.

Emerging research suggests that preventative swallowing rehabilitation, undertaken before or during (chemo)radiotherapy ([C]RT), can significantly improve early swallowing outcomes for head and neck cancer (HNC) patients. However, these treatment protocols are highly variable. Determining specific physiological swallowing parameters that are most likely to be impacted post-(C)RT would assist in refining clear targets for preventative rehabilitation. Therefore, this systematic review (1) examined the frequency and prevalence of physiological swallowing deficits observed post-(C)RT for HNC, and (2) determined the patterns of prevalence of these key physiological deficits over time post-treatment. Online databases were searched for relevant papers published between January 1998 and March 2013. A total of 153 papers were identified and appraised for methodological quality and suitability based on exclusionary criteria. Ultimately, 19 publications met the study’s inclusion criteria. Collation of reported prevalence of physiological swallowing deficits revealed reduced laryngeal excursion, base-of-tongue (BOT) dysfunction, reduced pharyngeal contraction, and impaired epiglottic movement as most frequently reported. BOT dysfunction and impaired epiglottic movement showed a collective prevalence of over 75 % in the majority of patient cohorts, whilst reduced laryngeal elevation and pharyngeal contraction had a prevalence of over 50 %. Subanalysis suggested a trend that the prevalence of these key deficits is dynamic although persistent over time. These findings can be used by clinicians to inform preventative intervention and support the use of specific, evidence-based therapy tasks explicitly selected to target the highly prevalent deficits post-(C)RT for HNC.

Purpose Chemoradiotherapy (CRT) for head and neck cancer (HNC) often causes dysphagia. The risk of dysphagia increases during CRT tends to become more severe after finishing CRT, and persists for a few weeks thereafter. Thus, understanding the changes in swallowing physiology during and immediately after CRT is essential. This study aimed to clarify the changes in the swallowing response during and early after CRT and identify associated factors. Methods This retrospective study enrolled 107 patients with HNC who underwent CRT. We measured pharyngeal delay time (PDT) and laryngeal elevation delay time (LEDT) as indicators of the timing of the swallowing response at three time points: at CRT initiation (baseline), at 40-Gy irradiation during CRT (mid-CRT) and within 2 weeks following the completion of CRT (early post-CRT) as primary outcomes; and subgroup analyses based on clinical parameters, such as tumor sites, T stage, N stage, and opioid use at 40-Gy irradiation as secondary outcomes. Results Both PDT and LEDT were significantly prolonged between baseline and mid-CRT (PDT: p  = 0.003, LEDT: p  = 0.002) and between baseline and early post-CRT (PDT, p  = 0.001; LEDT, p  < 0.001). N2c/N3 and opioid use at 40-Gy irradiation showed prolonged PDT and LEDT at mid-CRT and early post-CRT. Conclusion PDT and LEDT were prolonged at mid-CRT irradiation and further extended at early post-CRT. Additionally, N2c/N3 involvement, which typically necessitates bilateral neck irradiation fields and opioid use at mid-CRT, may constitute as risk factors for a delayed swallowing response.

Background The radiation dose to dysphagia and aspiration-related structures (DARS) for patients undergoing transoral robotic surgery (TORS) and post-operative radiation therapy (PORT) for primary oropharyngeal carcinoma is unknown. Methods This prospective study measured swallowing using the MD Anderson Dysphagia Inventory at baseline and then 12-months after PORT. Dosimetric parameters were collected. Results 19 patients were recruited between 2017 and 2019. Worse swallow function at 12-months after PORT was associated with dose-parameters to the oesophageal inlet muscle, superior pharyngeal constrictor muscle and cervical oesophagus. Mean dose, V50Gy, and V60Gy to the base of tongue and pharyngeal constrictors was significantly lower in those receiving PORT to the neck alone. Conclusion Dose to DARS was lower in patients who received PORT to the neck alone. In patients treated with TORS and PORT, poorer swallowing outcomes at 12 months post-treatment were associated with increased dose to oesophageal inlet muscle, superior constrictor muscle, and cervical oesophagus.

Purpose The study aims to describe patients’ experiences of swallowing difficulties following (chemo)radiotherapy for head and neck cancer and to explore any changes over time. Methods A purposive sample of patients with swallowing difficulties was selected at a range of time points, from 3 to 18 months following treatment. Ethnographic observations of 12 patients were conducted in their own homes, over a mealtime situation. Nine new patients were interviewed about changes to their eating and drinking from pre- to post-treatment. Thematic analysis was used to code and analyse the data. Results Patients’ reports of swallowing function were divided into four time zones: pre-treatment, during radiotherapy, early (0–3 months) and late (6–18 months) time points following treatment. The majority reported minimal problems at diagnosis, but marked impairment during and after radiotherapy, without a return to pre-treatment functioning. The focus was on severe physical side effects and changes to food preparation during radiotherapy and in the early phase of recovery. By 6 months, side effects began to subside, but swallowing was still difficult, leading to major changes to family life, socialisation and lifestyle. Conclusions Swallowing problems after (chemo)radiotherapy are multi-faceted and highly individualised and restrict lives in the long term. Swallowing ability may improve in time, but does not appear to return to pre-treatment function. Further work is required to find ways of being able to best support patients living with this long-term condition.

Patients treated with chemoradiation for head and neck cancer often report difficulty with swallowing and are frequently diagnosed with dysphagia. The extent to which patient awareness of dysphagia corresponds to observed physiologic changes in swallowing is unclear. The purpose of this study was to determine how both patient awareness of swallowing function and swallowing physiology individually change following chemoradiation and then to clarify the relationship between them. Twenty-one patients with head and neck cancer treated with chemoradiation were assessed before and after treatment and matched with twenty-one control subjects. The modified barium swallow test was utilized to examine swallowing physiology. Each subject was also given a series of items regarding awareness of specific dysphagia symptoms. Results showed decreased swallow efficiencies, higher percentages of residue, and more occurrences of penetration and aspiration following chemoradiation. Patients also had significantly higher ratings for 4 of the 12 items (“dry mouth,” “food sticking in my mouth,” “need water to help food go down,” and “change in sense of taste”). Only one strong and significant correlation was found between ratings for “I have difficulty swallowing” and swallow efficiency values. Based on these findings, it appears that patients sense a general difficulty with swallowing but have less awareness of specific symptoms of dysphagia.