van Nuffelen 2014.

Trial name or title	Tongue strengthening exercises in head and neck cancer patients: does level of resistance matter?
Methods	Single‐centre interventional RCT
Participants	Participant 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 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: 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 manoeuvres to improve swallowing are not allowed during the study period Sample size: 45 (15 per group)
Interventions	Tongue strengthening exercises The effect of tongue strengthening exercises will depend upon the level of resistance
Outcomes	Primary outcome measures: 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 at 4 and 8 weeks post‐treatment Secondary outcome measures: 1. Swallowing function: the swallowing function will be evaluated using a comprehensive fibre‐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 yogurt. Each bolus type is administered 3 times. Outcome measures for FEES are the Penetration‐Aspiration Scale, the Carnaby‐Videofluoroscopic 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 (DHI) 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 at 4 and 8 weeks post‐treatment
Starting date	March 2014 End date: December 2016
Contact information	Prof Gwen Van Nuffelen Wilrijkstraat 10 Edegem (Antwerp) 2650 Belgium gwen.van.nuffelen@uza.be
Notes	Hospitals Protocol/serial number: NKR_2014_01 Single‐centre interventional RCT Recruiting

BRACS: Boston Residue and Clearance Scale (BRACS)
 ECOG: Eastern Cooperative Oncology Group
 FACT: Functional Assessment of Cancer Therapy
 MDADI: MD Anderson Dysphagia Inventory
 N/A: not applicable
 PSS‐H&N: Performance Status Scale for Head and Neck
 QOL: quality of life
 RCT: randomised controlled trial
 VFSS: videofluoroscopic swallowing study