Patients with dysphagia following head and neck cancer or neurodegenerative diseases. Cancer Head and neck cancer
Conditions
Interventions
At enrollment, 45 head and neck cancer patients, whose dysphagia is primarily related to reduced tongue strength, are randomly assigned to a training schedule of 100% (group 1), 80% (group 2), or 60%
Sponsors
Antwerp University Hospital (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Head and neck cancer patients previously treated with chemoradiotherapy 2. Men and women older than 18, without cognitive, language, motor, hearing or visual deficits that could interfere with the correct execution of the training. 3. Chronic dysphagia (i.e. present for at least 1 month and no earlier than 6 months after the last day of radiation treatment), primarily related to reduced tongue strength 4. Score 1 or higher for the BRACS-items ‘base of tongue’ and/or ‘valleculae’ at baseline judged by an experienced clinician
Exclusion criteria
Exclusion criteria: 1. History of major oral or head and neck surgery and neurological disorders with an impact on oral function and/or swallowing (amongst others stroke, traumatic brain injury, Parkinson’s disease, Amyotrophic Lateral Sclerosis). 2. Concurrent oral motor exercises or swallowing maneuvers to improve swallowing are not allowed during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tongue strength measurements: Maximum Isometric Pressures (expressed as kPa) anterior and posterior. The primary measures are evaluated prior to (max 1 week in advance), during (after 4 weeks of therapy), after 8 weeks of therapy and 4 and 8 weeks post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Swallowing function: the swallowing function will be evaluated using a comprehensive fiber optic endoscopic evaluation of swallowing (FEES) examination, the - Mann Assessment of Swallowing Ability-Cancer (MASA-C), the Functional Oral Intake Scale (FOIS), and a self-evaluation. For the latter a 100 mm visual analogue scale is used with the ends defined as 'I can’t swallow' (0) and 'I don’t have any swallowing difficulties’ (100) respectively. Both the FEES and MASA-C are conducted with 4 different bolus types: 5 and 10 ml of thin liquid, and 5 and 10 ml of yoghurt. Each bolus type is administered 3 times. Outcome measures for FEES are the Penetration-Aspiration-Scale, the Carnaby- Video Fluoroscopic Examination (C-VFE) scales for dysphagia and aspiration, the Pooling-score and the Boston Residue and Clearance Scale (BRACS). 2. Quality of Life: swallowing-related quality of life will be surveyed by means of the Dutch Swallowing Quality-of-Life Questionnaire (DSWAL-QoL) and the Dysphagia Handicap Index. The secondary outcome measures are evaluated prior to (max 1 week in advance), during (after 4 weeks of therapy), after 8 weeks of therapy and 4 and 8 weeks post treatment. | — |
Countries
Belgium
Outcome results
None listed