Dysphagia, trismus and speech impairment following radiation-based treatment for advanced stage oropharyngeal carcinoma: a one-year prospective evaluation.

OBJECTIVE: The objective was to assess swallowing, mouth opening and speech function during the first year after radiation-based treatment (RT(+)) after introduction of a dedicated preventive rehabilitation program for stage III-IV oropharyngeal carcinoma (OPC). METHODS: Swallowing, mouth opening and speech function were collected before and at six- and twelve-month follow-up after RT(+) for OPC as part of ongoing prospective assessments by speech-language pathologists . RESULTS: Objective and patient-perceived function deteriorated until 6 months and improved until 12 months after treatment, but did not return to baseline levels with 25%, 20% and 58% of the patients with objective dysphagia, trismus and speech problems, respectively. Feeding tube dependency and pneumonia prevalence was low. CONCLUSION: Despite successful implementation, a substantial proportion of patients still experience functional limitations after RT(+) for OPC, suggesting room for improvement of the current rehabilitation program. Pretreatment sarcopenia seems associated with worse functional outcomes and might be a relevant new target for rehabilitation strategies.

MRI Assessment of Swallow Muscle Activation with the Swallow Exercise Aid and with Conventional Exercises in Healthy Volunteers: An Explorative Biomechanical Study.

Swallowing muscle strength exercises are effective in restoring swallowing function. In order to perform the exercises with progressive load, the swallow exercise aid (SEA) was developed. Precise knowledge on which muscles are activated with swallowing exercises, especially with the SEA, is lacking. This knowledge would aid in optimizing the training program to target the relevant swallowing muscles, if necessary. Three healthy volunteers performed the three SEA exercises (chin tuck against resistance, jaw opening against resistance and effortful swallow) and three conventional exercises [conventional effortful swallow (cES), Shaker and Masako] in supine position inside an MRI scanner. Fast muscle functional MRI scans (generating quantitative T2-maps) were made immediately before and after the exercises. Median T2 values at rest and after exercise were compared to identify activated muscles. After the three SEA exercises, the suprahyoid, infrahyoid, sternocleidomastoid, and lateral pterygoid muscles showed significant T2 value increase. After the Shaker, the lateral pterygoid muscles did not show such an increase, but the three other muscle groups did. The cES and Masako caused no significant increase in any of these muscle groups. During conventional (Shaker) exercises, the suprahyoid, infrahyoid, and sternocleidomastoid muscles are activated. During the SEA exercises, the suprahyoid, infrahyoid, sternocleidomastoid, and lateral pterygoid muscles are activated. The findings of this explorative study further support the potential of the SEA to improve swallowing rehabilitation.

A cost-effectiveness analysis of using TheraBite in a preventive exercise program for patients with advanced head and neck cancer treated with concomitant chemo-radiotherapy.

Previous studies have shown that a "Preventive Exercise Program" (PREP) is cost-effective compared to the standard exercise program provided in "Usual Care" (UC) in patients with advanced head and neck cancer. The current paper specifically estimates the cost-effectiveness of the TheraBite jaw rehabilitation device (TB) which is used as part of the PREP, compared to Speech Language Pathology (SLP) sessions as part of UC, and herewith intents to inform reimbursement discussions regarding the TheraBite device. Costs and outcomes [quality-adjusted life-years (QALYs)] of the TB compared to SLP were estimated using a Markov model of advanced head and neck cancer patients. Secondary outcome variables were trismus, feeding substitutes, facial pain, and pneumonia. The incremental cost-effectiveness ratio (ICER) was estimated from a health care perspective of the Netherlands, with a time horizon of 2 years. The total health care costs per patient were estimated to amount to €5,129 for the TB strategy and €6,915 for the SLP strategy. Based on the current data, the TB strategy yielded more quality-adjusted life-years (1.28) compared to the SLP strategy (1.24). Thus, the TB strategy seems more effective (+0.04) and less costly (-€1,786) than the SLP only strategy. At the prevailing threshold of €20,000/QALY the probability for the TB strategy being cost-effective compared to SLP was 70 %. To conclude, analysis of presently available data indicates that TB is expected to be cost-effective compared to SLP in a preventive exercise program for concomitant chemo-radiotherapy for advanced head and neck cancer patients.

Prospective clinical study on long-term swallowing function and voice quality in advanced head and neck cancer patients treated with concurrent chemoradiotherapy and preventive swallowing exercises.

Concurrent chemoradiotherapy (CCRT) for advanced head and neck cancer (HNC) is associated with substantial early and late side effects, most notably regarding swallowing function, but also regarding voice quality and quality of life (QoL). Despite increased awareness/knowledge on acute dysphagia in HNC survivors, long-term (i.e., beyond 5 years) prospectively collected data on objective and subjective treatment-induced functional outcomes (and their impact on QoL) still are scarce. The objective of this study was the assessment of long-term CCRT-induced results on swallowing function and voice quality in advanced HNC patients. The study was conducted as a randomized controlled trial on preventive swallowing rehabilitation (2006-2008) in a tertiary comprehensive HNC center with twenty-two disease-free and evaluable HNC patients as participants. Multidimensional assessment of functional sequels was performed with videofluoroscopy, mouth opening measurements, Functional Oral Intake Scale, acoustic voice parameters, and (study specific, SWAL-QoL, and VHI) questionnaires. Outcome measures at 6 years post-treatment were compared with results at baseline and at 2 years post-treatment. At a mean follow-up of 6.1 years most initial tumor-, and treatment-related problems remained similarly low to those observed after 2 years follow-up, except increased xerostomia (68%) and increased (mild) pain (32%). Acoustic voice analysis showed less voicedness, increased fundamental frequency, and more vocal effort for the tumors located below the hyoid bone (n = 12), without recovery to baseline values. Patients' subjective vocal function (VHI score) was good. Functional swallowing and voice problems at 6 years post-treatment are minimal in this patient cohort, originating from preventive and continued post-treatment rehabilitation programs.

Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer.

The objective of the study was the assessment of the results of a prospective clinical trial with two preventive swallowing rehabilitation programs on the long-term side effects of chemoradiotherapy (CCRT) in advanced head and neck cancer patients. The study cohort consisted of 29 patients, randomized in two exercise groups: a standard (S) group receiving routine swallowing exercises (N = 14), and an experimental (E) group receiving swallowing exercises based on the TheraBite® Jaw Motion Rehabilitation System™ (N = 15). Assessment of functional changes was carried out with multidimensional outcome measures (e.g., videofluoroscopy, study-specific questionnaires) at four time points (pre-treatment, at 10 weeks, 1 year, and 2 years post-treatment). Overall, in the first year post-treatment many initial tumor- and treatment-related problems diminished significantly, except xerostomia (59%). The only additional improvement at 2 years was that the overall weight significantly further increased (p = 0.000), however, without regaining baseline value. In the subgroup analysis according to exercise group, this difference was significant in the E-group only (p = 0.002). The same was the case for the subgroup analysis according to site of disease, with a significant weight gain in the 'below the hyoid bone' group only. This study shows that the overall functional problems at 1 and 2 years post-CCRT are limited. Both rehabilitation programs produce similar results, with a slight but significant benefit for the E-group in weight gain at 2 years, as also seen in the 'below the hyoid bone' group. Both rehabilitation programs applied are feasible and show good compliance despite the burdensome CCRT.

A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects.

The aim of this study was to assess the effect of (preventive) rehabilitation on swallowing and mouth opening after concomitant chemoradiotherapy (CCRT). Forty-nine patients with advanced oral cavity, oropharynx, hypopharynx and larynx, or nasopharynx cancer treated with CCRT were randomized into a standard (S) or an experimental (E) preventive rehabilitation arm. Structured multidimensional assessment (i.e., videofluoroscopy, mouth-opening measurement, structured questionnaires) was performed before and 10 weeks after CCRT. In both S and E arms, feasibility was good (all patients could execute the exercises within a week) and compliance was satisfactory (mean days practiced per week was 4). Nevertheless, mouth opening, oral intake, and weight decreased significantly. Compared to similar CCRT studies at our institute, however, fewer patients were still tube-dependent after CCRT. Furthermore, some functional outcomes seemed less affected than those of studies in the literature that did not incorporate rehabilitation exercises. Patients in the E arm practiced significantly fewer days in total and per week, but they obtained results comparable to the S arm patients. Preventive rehabilitation (regardless of the approach, i.e., experimental or standard) in head and neck cancer patients, despite advanced stage and burdensome treatment, is feasible, and compared with historical controls, it seems helpful in reducing the extent and/or severity of various functional short-term effects of CCRT.

Pretreatment organ function in patients with advanced head and neck cancer: clinical outcome measures and patients' views.

BACKGROUND: Aim of this study is to thoroughly assess pretreatment organ function in advanced head and neck cancer through various clinical outcome measures and patients' views. METHODS: A comprehensive, multidimensional assessment was used, that included quality of life, swallowing, mouth opening, and weight changes. Fifty-five patients with stage III-IV disease were entered in this study prior to organ preserving (chemoradiation) treatment. RESULTS: All patients showed pretreatment abnormalities or problems, identified by one or more of the outcome measures. Most frequent problems concerned swallowing, pain, and weight loss. Interestingly, clinical outcome measures and patients' perception did no always concur. E.g. videofluoroscopy identified aspiration and laryngeal penetration in 18% of the patients, whereas only 7 patients (13%) perceived this as problematic; only 2 out of 7 patients with objective trismus actually perceived trismus. CONCLUSION: The assessment identified several problems already pre-treatment, in this patient population. A thorough assessment of both clinical measures and patients' views appears to be necessary to gain insight in all (perceived) pre-existing functional and quality of life problems.

Functional outcomes and rehabilitation strategies in patients treated with chemoradiotherapy for advanced head and neck cancer: a systematic review.

Organ preservation with radiotherapy and concomitant chemotherapy has become an accepted treatment modality in advanced head and neck cancer. Unfortunately, organ preservation is not synonymous with function preservation. The aim of this review was to systematically assess the effects of the disease and chemoradiotherapy (CRT) on functions such as swallowing, mouth opening, nutrition, pain and quality of life in patients with head and neck cancer. Another aim was to search for (evidence-based) techniques or strategies known to alleviate or rehabilitate the loss of function(s) associated with CRT. Two databases were searched (time period, January 1997 to August 2007) for the terms head and neck cancer, chemotherapy or cisplatin and radiotherapy, and the functional outcomes swallowing, trismus, nutrition, pain and quality of life or a variation of those words. In total, 15 relevant articles were identified that met the inclusion criteria. The majority of the studies that met the criteria focused on the outcomes swallowing, quality of life, and nutrition. Two studies reported on the outcome pain, but no paper reported on the outcome trismus. Only two papers mentioned rehabilitation options, but specific information was lacking. Further long-term prospective research is essential, not only to determine the function impairment caused by the tumor and CRT, but also to assess the effects of known and newly developed rehabilitation measures. Therefore, in September 2006, the Netherlands Cancer Institute started a randomised clinical trial (RCT): Prevention of trismus, swallowing and speech problems in patients treated with chemoradiotherapy for advanced head and neck cancer. This systematic review was carried out to collect the baseline information for the future outcomes of this RCT.

A thin tracheal silicone washer to solve periprosthetic leakage in laryngectomies: direct results and long-term clinical effects.

OBJECTIVES: Assessment of the immediate results and long-term clinical effects of a thin silicone washer placed behind the tracheal flange of voice prostheses to treat periprosthetic leakage. PATIENTS AND METHODS: Three year retrospective analysis of 32 laryngectomized patients with 107 periprosthetic leakage events (PLEs). Custom-made silicone washers (outer diameter 18 mm, inner diameter 7.5 mm, thickness 0.5 mm) were placed behind the tracheal flange either in combination with prosthesis replacement or later. RESULTS: There was immediate resolution of periprosthetic leakage in 88 PLEs (median, 38 d; mean, 53 d; range, 8-330 d) and in 6 PLEs with the washer still in situ at the date of analysis (median, 75; mean, 97 d; range, 38-240 d). There was no resolution for periprosthetic leakage in 13 PLEs. Thus, in total, 94 of 107 PLEs (88%) were successfully resolved. In 29 of 32 (91%) patients, the washer resolved the problem at least in one PLE successfully. Twelve of 32 patients, including all 3 with washer failures, also required other interventions to ultimately solve the problem. The vast majority of patients (80%) did not consider placement of the washer to be inconvenient. CONCLUSIONS: In consideration of the high success rate and limited inconvenience for patients, this simple thin silicon washer application provides a good first option for the treatment of periprosthetic leakage.

Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors.

BACKGROUND: The efficacy of rehabilitative exercises for chronic dysphagia treatment in head and neck cancer survivors has not been studied extensively and is ambiguous. METHODS: A prospective clinical phase II study using an intensive strength training program was carried out in 17 head and neck cancer survivors with chronic dysphagia. Both swallow and nonswallow exercises were performed for 6-8 weeks with a newly developed tool allowing for progressive muscle overload, including chin tuck, jaw opening, and effortful swallow exercises. Outcome parameters were feasibility, compliance, and parameters for effect. RESULTS: Feasibility in terms of the program completion rate was 88%. Compliance with the exercises was 97%. After the training period, chin tuck, jaw opening, and anterior tongue strength had substantially improved. All but 1 patient reported to benefit from the exercises. CONCLUSION: Feasibility and compliance were high. Some objective and subjective effects of progressive load on muscle strength and swallowing function could be demonstrated.

Biofilm formation on the Provox ActiValve: Composition and ingrowth analyzed by Illumina paired-end RNA sequencing, fluorescence in situ hybridization, and confocal laser scanning microscopy.

BACKGROUND: The most frequent cause of voice prosthesis failure is microbial biofilm formation on the silicone valve, leading to destruction of the material and transprosthetic leakage. The Provox ActiValve valve is made of fluoroplastic, which should be insusceptible to destruction. The purpose of this study was to determine if fluoroplastic is insusceptible to destruction by Candida species. METHODS: Thirty-three dysfunctional Provox ActiValves (collected 2011-2013). Biofilm analysis was performed with Illumina paired-end sequencing (IPES), assessment of biofilm-material interaction with fluorescence in situ hybridization (FISH), and confocal laser scanning microscopy (CLSM). RESULTS: IPES (n = 10) showed that Candida albicans and Candida tropicalis are dominant populations on fluoroplastic and silicone. Microbial diversity is significantly lower on fluoroplastic. Lactobacillus gasseri is the prevalent bacterial strain on most voice prostheses. FISH and CLSM (n = 23): in none of the cases was ingrowth of Candida species present in the fluoroplastic. CONCLUSION: Fluoroplastic material of Provox ActiValve seems insusceptible to destruction by Candida species, which could help improve durability of voice prostheses. © 2015 Wiley Periodicals, Inc. Head Neck 38: E432-E440, 2016.

A new problem-solving indwelling voice prosthesis, eliminating the need for frequent Candida- and "underpressure"-related replacements: Provox ActiValve.

OBJECTIVES: To develop and clinically assess a new prosthesis for voice rehabilitation after total laryngectomy that solves the problem of frequent Candida- and "underpressure"-related replacements. MATERIAL AND METHODS: We designed a voice prosthesis with a new valve mechanism, applying Candida-resistant fluoroplastic (Teflon-like) material for the valve and valve seat and magnets to generate an active closing force, preventing inadvertent opening of the valve during swallowing or deep inhalation. Several prototypes were tested in 13 laryngectomized patients and, subsequently, the final design was assessed in a prospective clinical trial in a cohort of 18 patients with a short device lifetime of their standard indwelling voice prosthesis (mean 30 days). RESULTS: Prototype testing and the long-term clinical trial confirmed that the new valve material remained free of Candida growth and that the use of magnets can prevent inadvertent opening of the valve during swallowing and/or deep inhalation. This resulted in a highly significant increase in device lifetime in the 18 laryngectomized patients in the prospective trial (14-fold increase on average, range 3-39-fold; p < 0.001). Lubrication with special medical-grade fluoridated silicone oil is favorable in patients who experience possible adhesion of the valve to the valve seat. CONCLUSIONS: This new voice prosthesis, the Provox ActiValve, represents a solution for patients who have the problem of requiring very frequent voice prosthesis replacements due to excessive Candida growth and/or inadvertent opening of the valve by swallowing and inhalation-related underpressure in the esophagus.

Dysphagia and trismus after concomitant chemo-Intensity-Modulated Radiation Therapy (chemo-IMRT) in advanced head and neck cancer; dose-effect relationships for swallowing and mastication structures.

BACKGROUND AND PURPOSE: Prospective assessment of dysphagia and trismus in chemo-IMRT head and neck cancer patients in relation to dose-parameters of structures involved in swallowing and mastication. MATERIAL AND METHODS: Assessment of 55 patients before, 10-weeks (N=49) and 1-year post-treatment (N=37). Calculation of dose-volume parameters for swallowing (inferior (IC), middle (MC), and superior constrictors (SC)), and mastication structures (e.g. masseter). Investigation of relationships between dose-parameters and endpoints for swallowing problems (videofluoroscopy-based laryngeal Penetration-Aspiration Scale (PAS), and study-specific structured questionnaire) and limited mouth-opening (measurements and questionnaire), taking into account baseline scores. RESULTS: At 10-weeks, volume of IC receiving ≥60 Gy (V60) and mean dose IC were significant predictors for PAS. One-year post-treatment, reported problems with swallowing solids were significantly related to masseter dose-parameters (mean, V20, V40 and V60) and an inverse relationship (lower dose related to a higher probability) was observed for V60 of the IC. Dose-parameters of masseter and pterygoid muscles were significant predictors of trismus at 10-weeks (mean, V20, and V40). At 1-year, dose-parameters of all mastication structures were strong predictors for subjective mouth-opening problems (mean, max, V20, V40, and V60). CONCLUSIONS: Dose-effect relationships exist for dysphagia and trismus. Therefore treatment plans should be optimized to avoid these side effects.

A multicenter, prospective, clinical trial evaluating a novel adhesive baseplate (Provox StabiliBase) for peristomal attachment of postlaryngectomy pulmonary and voice rehabilitation devices.

OBJECTIVES/HYPOTHESIS: Assessment of a novel adhesive baseplate (Provox StabiliBase) for heat and moisture exchanger (HME) and/or automatic speaking valve (ASV) application. STUDY DESIGN: Prospective, clinical, multicenter trial. METHODS: This was a trial in laryngectomized patients comparing their usual adhesive with the trial adhesive. Primary outcome measure was overall patient preference; additional outcome parameters possibly explaining patients' preferences were 1) patient tolerance and preference with respect to daily handling of the adhesive; 2) adhesive lifespan, and 3) voice and speech with the adhesives. Study specific questionnaires, visual analog scales, patients' diaries, and stoma assessments were used for data collection. RESULTS: In total, 58 of the 65 laryngectomized individuals entered in the study completed the trial. Patients' overall preference for the new device was high (76%; P < .001). Significantly better performance was found for the trial adhesive with respect to ease of application (P = .034), fit (P < .001), and air leakage through the adhesive (P < .001). Comfort and stoma depth correlated weakly (r = 0.297; P = .024; deeper stoma-more comfort with StabiliBase). The adhesive lifespan with HME is significantly increased (1.7 times and 15.7 hours-plus airtight use; P < .001). This longer lifespan coincided with somewhat increased dirtying of the adhesive (P = .02). There were no serious adverse events. CONCLUSIONS: The StabiliBase adhesive for peristomal attachment of HMEs and/or ASVs was preferred by 76% of study participants and showed a promising prolonged lifespan. This new device further increases the options for stoma attachment in laryngectomized individuals, and subsequently the availability of optimal voice and pulmonary rehabilitation for a larger proportion of patients.

Five-year quality of life results of the randomized clinical phase III (RADPLAT) trial, comparing concomitant intra-arterial versus intravenous chemoradiotherapy in locally advanced head and neck cancer.

BACKGROUND: The purpose of this investigation was to present 5-years of quality-of-life (QOL) results of a multicenter randomized phase III trial, assessing intra-arterial (IA) versus standard intravenous (IV) chemoradiation for inoperable stage IV head and neck cancer. METHODS: Evaluation of 71 patients through European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module (EORTC QLQ-C30) and Head and Neck Module (QLQ-H&N35), and trial-specific questionnaires. Treatment consisted of standard radiotherapy with 4 weekly IA or 3 weekly IV cisplatin infusions. RESULTS: No significant differences in treatment-related QOL problems between 1 and 5 years posttreatment were observed, except for "dry mouth" (gradually improving; p = .004). Survivors have lower fatigue levels (p = .04), better voice (p = 0.3), and swallowing (p = .03) than patients who could not complete all subsequent follow-up questionnaires. CONCLUSIONS: Most treatment-related QOL issues deteriorate during treatment, improve in the first year, and then remain stable, except xerostomia, improving up to the 5-year assessment point. Survivors show more positive scores for fatigue, voice, and swallowing. QOL issues at 1 year, thus, for most already represent those after 5-year follow-up.

Heat and moisture exchange capacity of the upper respiratory tract and the effect of tracheotomy breathing on endotracheal climate.

BACKGROUND: The aim of this study was to assess the heat and moisture exchange (HME) capacity of the upper respiratory tract and the effect of tracheotomy breathing on endotracheal climate in patients with head and neck cancer. METHODS: We plotted the subglottic temperature and humidity measurements in 10 patients with head and neck cancer with a temporary precautionary tracheotomy during successive 10-minute periods of nose, mouth, and tracheotomy breathing in a randomized sequence. RESULTS: End-inspiratory temperatures of nose, mouth, and tracheotomy breathing were 31.1, 31.3, and 28.3°C, respectively. End-inspiratory humidity measurements of nose, mouth, and tracheotomy breathing were 29.3, 28.6, and 21.1 mgH2O/L, respectively. There was a trend toward lower end-inspiratory humidity in patients with radiotherapy or with large surgery-induced oropharyngeal mucosal defects, whereas temperatures were similar. CONCLUSION: This study gives objective information about the HME capacity of the upper respiratory tract in patients with head and neck cancer with precautionary tracheotomy, and thus provides target values for HMEs for laryngectomized and tracheotomized patients.