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Chapter 4
METHODS
Approval and consent
This study was approved by the medical research ethics committee of the Netherlands Cancer Institute (METC17.1906/N17SSF).Written informed consent was obtained from all patients.
Patient selection
All evaluable, disease-free patients who participated in the previously published RCT comparing preventive rehabilitation with and without the TheraBite Jaw Motion Rehabilitation System during CRT for HNC in the Netherlands Cancer Institute (NKI-AVL) were included in the analysis (6, 10, 17, 23). Initially, 55 patients treated with cisplatin-based CRT between September 2006 and April 2008 with curative intent for stage III-IV cancer of the oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx were included. All patients received 70 Gy of Intensity Modulated RT (IMRT) in 35 fractions over seven weeks with concomitant cisplatin (100 mg/m2) on days 1, 22, and 43. All 55 included patients received preventive exercises (randomized for exercises with or without the TheraBite) which included jaw range of motion and swallowing exercises. They were instructed to perform the exercises daily from the start of treatment up until one year afterwards, as described by van der Molen et al. (6). In summary, the experimental exercises consisted of a stretch exercise (i.e., passive and slow opening of the mouth using the TheraBite) and a strengthening exercise (i.e., swallow with tongue elevated to the palate at 50% of the maximal mouth opening using the Therabite). The standard rehabilitation consisted of five range of motion exercises and three strengthening exercises (i.e., Masako maneuver, effortful swallow and super-supraglottic swallow).
Data collection
The selection of outcomes measures collected in the present study were based on the data collected 6 years after CRT (17). Baseline characteristics included gender, age at start CRT, tumor site, T and N classification (AJCC 7th edition), AJCC stage, and preventive rehabilitation type (with or without TheraBite).
Swallowing related outcomes
The following swallowing outcomes and adverse events that might be related to swallowing impairment were assessed: history of pneumonia since six-year follow-up (according to patient and notes in medical chart), feeding tube dependency, and body weight. Videofluoroscopy was recorded in an upright position in lateral view with 25 frames per second. The subject was asked to swallow 3 and 10 cc thin liquid, 5 cc thick liquid, and a piece of gingerbread coated in Omnipaque consecutively from a spoon (Omnipaque contrast agent, GE Healthcare, Chicago, Illinois, United States). The validated Dynamic Imaging Grade for Toxicity (DIGEST) grading system was used to rate pharyngeal swallowing safety (penetration/aspiration) and efficiency (residue) (see Appendix 1) (24, 25). Videofluoroscopy studies were scored blinded for follow-up moment. The safety grade is assessed by means of the Penetration Aspiration Scale (PAS) over all bolus trials (26). Efficiency is assessed by estimating the maximum percentage of