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... Show moreThe 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 TheraBiteA (R) Jaw Motion Rehabilitation System (TM) (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. Show less
Molen, L. van der; Heemsbergen, W.D.; Jong, R. de; Rossum, M.A. van; Smeele, L.E.; Rasch, C.R.N.; Hilgers, F.J.M. 2013
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... Show moreBackground 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. (C) 2013 Elsevier Ireland Ltd. All rights reserved. Show less
Molen, L. van der; Rossum, M.A. van; Jacobi, I.; Son, R.J.J.H. van; Smeele, L.E.; Rasch, C.R.N.; Hilgers, F.J.M. 2012
Objectives. Perceptual judgments and patients' perception of voice and speech after concurrent chemoradiotherapy (CCRT) for advanced head and neck cancer.Study Design. Prospective clinical trial... Show moreObjectives. Perceptual judgments and patients' perception of voice and speech after concurrent chemoradiotherapy (CCRT) for advanced head and neck cancer.Study Design. Prospective clinical trial.Methods. A standard Dutch text and a diadochokinetic task were recorded. Expert listeners rated voice and speech quality (based on Grade, Roughness, Breathiness, Asthenia, and Strain), articulation (overall, [p], [t], [k]), and comparative mean opinion scores of voice and speech at three assessment points calculated. A structured study-specific questionnaire evaluated patients' perception pretreatment (N = 55), at 10-week (N = 49) and 1-year posttreatment (N = 37).Results. At 10 weeks, perceptual voice quality is significantly affected. The parameters overall voice quality (mean, -0.24; P = 0.008), strain (mean, -0.12; P = 0.012), nasality (mean, -0.08; P = 0.009), roughness (mean, -0.22; P = 0.001), and pitch (mean, -0.03; P = 0.041) improved over time but not beyond baseline levels, except for asthenia at 1-year posttreatment (voice is less asthenic than at baseline; mean, +0.20; P = 0.03). Perceptual analyses of articulation showed no significant differences. Patients judge their voice quality as good (score, 18/20) at all assessment points, but at 1-year posttreatment, most of them (70%) judge their "voice not as it used to be.'' In the 1-year versus 10-week posttreatment comparison, the larynx-hypopharynx tumor group was more strained, whereas nonlarynx tumor voices were judged less strained (mean, -0.33 and +0.07, respectively; P = 0.031). Patients' perceived changes in voice and speech quality at 10-week post-versus pretreatment correlate weakly with expert judgments.Conclusion. Overall, perceptual CCRT effects on voice and speech seem to peak at 10-week posttreatment but level off at 1-year posttreatment. However, at that assessment point, most patients still perceive their voice as different from baseline. Show less
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... Show moreBackground 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. (c) 2011 Wiley Periodicals, Inc. Head Neck, 2012 Show less
Retel, V.P.; Molen, L. van der; Hilgers, F.J.M.; Rasch, C.R.N.; L'Ortye, A.A.A.M.H.J.; Steuten, L.M.G.; Harten, W.H. van 2011
Background: Concomitant chemo-radiotherapy (CCRT) has become an indispensable organ, but not always function preserving treatment modality for advanced head and neck cancer. To prevent/limit the... Show moreBackground: Concomitant chemo-radiotherapy (CCRT) has become an indispensable organ, but not always function preserving treatment modality for advanced head and neck cancer. To prevent/limit the functional side effects of CCRT, special exercise programs are increasingly explored. This study presents cost-effectiveness analyses of a preventive (swallowing) exercise program (PREP) compared to usual care (UC) from a health care perspective.Methods: A Markov decision model of PREP versus UC was developed for CCRT in advanced head and neck cancer. Main outcome variables were tube dependency at one-year and number of post-CCRT hospital admission days. Primary outcome was costs per quality adjusted life years (cost/QALY), with an incremental cost-effectiveness ratio (ICER) as outcome parameter. The Expected Value of Perfect Information (EVPI) was calculated to obtain the value of further research.Results: PREP resulted in less tube dependency (3% and 25%, respectively), and in fewer hospital admission days than UC (3.2 and 4.5 days respectively). Total costs for UC amounted to (sic)41,986 and for PREP to (sic)42,271. Quality adjusted life years for UC amounted to 0.68 and for PREP to 0.77. Based on costs per QALY, PREP has a higher probability of being cost-effective as long as the willingness to pay threshold for 1 additional QALY is at least (sic)3,200/QALY. At the prevailing threshold of (sic)20,000/QALY the probability for PREP being cost-effective compared to UC was 83%. The EVPI demonstrated potential value in undertaking additional research to reduce the existing decision uncertainty.Conclusions: Based on current evidence, PREP for CCRT in advanced head and neck cancer has the higher probability of being cost-effective when compared to UC. Moreover, the majority of sensitivity analyses produced ICERs that are well below the prevailing willingness to pay threshold for an additional QALY (range from dominance till (sic)45,906/QALY). Show less
Molen, L. van der; Rossum, M.A. van; Burkhead, L.M.; Smeele, L.E.; Rasch, C.R.N.; Hilgers, F.J.M. 2011
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... Show moreThe 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. Show less
Jacobi, I.; Molen, L. van der; Huiskens, H.; Rossum, M.A. van; Hilgers, F.J.M. 2010
Purpose of this review is to systematically assess the effects on voice and speech of advanced head and neck cancer and its treatment by means of chemoradiotherapy (CRT). The databases Medline,... Show morePurpose of this review is to systematically assess the effects on voice and speech of advanced head and neck cancer and its treatment by means of chemoradiotherapy (CRT). The databases Medline, Embase and Cochrane were searched (1991-2009) for terms head and neck cancer, chemoradiation, voice and speech rehabilitation. Twenty articles met the inclusion criteria, whereof 14 reported on voice outcomes and 10 on speech. Within the selected 20 studies, 18 different tools were used for speech or voice evaluation. Most studies assessed their data by means of patient questionnaires. Four studies presented outcome measures in more than one dimension. Most studies summarised the outcomes of posttreatment data that were assessed at various points in time after treatment. Except for four studies, pre-treatment measurements were lacking. This and the fact that most studies combined the outcomes of patients with radiated laryngeal cancers with outcome data of non-laryngeal cancer patients impedes an interpretation in terms of the effects of radiation versus the effects of the disease itself on voice or speech. Overall, the studies indicated that voice and speech degenerated during CRT, improved again 1-2 months after treatment and exceeded pre-treatment levels after 1 year or longer. However, voice and speech measures do not show normal values before or after treatment. Given the large-ranged posttreatment data, missing baseline assessment and the lacking separation of tumour/radiation sites, there is an urgent need for structured standardised multi-dimensional speech and voice assessment protocols in patients with advanced head and neck cancer treated with CRT. Show less
Hilgers, F.J.M.; Ackerstaff, A.H.; Rossum, M. van; Jacobi, I.; Balm, A.J.M.; Tan, I.B.; Brekel, M.W.M. van den 2010
