title: Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer.
abstract: 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.
authors.affiliation: Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands, l.vd.molen@nki.nl.
authors.forename: Lisette
authors.initials: L
authors.lastname: van der Molen
authors.forename: Maya A
authors.initials: MA
authors.lastname: van Rossum
authors.forename: Coen R N
authors.initials: CR
authors.lastname: Rasch
authors.forename: Ludi E
authors.initials: LE
authors.lastname: Smeele
authors.forename: Frans J M
authors.initials: FJ
authors.lastname: Hilgers
mesh_terms: D000328:Adult; D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage; D003680:Deglutition Disorders / Q000175:diagnosis / Q000517:prevention & control* / Q000534:rehabilitation*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010039:Otorhinolaryngologic Neoplasms / Q000473:pathology / Q000628:therapy*; D011446:Prospective Studies; D050397:Radiotherapy, Intensity-Modulated; D011795:Surveys and Questionnaires; D014741:Video Recording
chemical_list: D002945:Cisplatin
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