Towards a patient supported, well-tolerated and evidence-based home-based treatment program to improve quality of life and swallowing function in head and neck cancer survivors with chronic radiation-associated dysphagia treated with chemoradiotherapy: a multicentre randomised controlled trial
Chronic radiation-associated dysphagia in head and neck cancer survivors
Participants will be stratified into groups using Qminim. Selected minimization factors are the centre, time between completion of RT or CRT and beginning the swallowing therapy program and the highest score on the Functional Oral Intake Scale (FOIS). The assignment is done automatically in real-time based on these criteria. Researchers of each centre have access to the program but do not have any precognition of the randomization. The duration, frequency and location of the treatment programs are the same in each group. All subjects will practice four times a week for 8 weeks. The therapy will take place at home under the supervision of a qualified speech-language pathologist. The exercise program differs according to the group. Group 1: 8 weeks strength training Group 2: 4 weeks strength training and 4 weeks functional swallowing therapy combined with Sham HD-tDCS Group 3: 4 weeks strength training and 4 weeks functional swallowing therapy combined with real HD-tDCS Patients referred to group 1 will receive evidence-based exercises targeting the main muscle groups involved in swallowing i.e. muscles involved in tongue strength, pharyngeal contraction, laryngeal elevation and upper oesophagal sphincter opening. Tongue strengthening exercises (TSE) will be alternated with chin tucks against resistance (CTAR) and expiratory muscle strength training (EMST). Tongue-strengthening exercises consist of 120 tongue presses and are divided into 12 sets of 10 repetitions with a 30-s rest between sets. Each CTAR session includes 150 repetitions divided into 30 sets of 5 repetitions. Every fifth repetition subjects are asked to push the chin bar towards the chest bar and swallow as hard as they can to practice an effortful swallow. The EMST session involves 25 targeted exhalations, performed in 5 sets of 5 repetitions with a 30-s rest between sets. The program uses existing therapeutic devices offering the possibility to practice with visual feedback and a certain intensity.
1. Patients with a history of head and neck cancer treated with radiotherapy or chemoradiotherapy 2. Diagnosis of C-RAD, present for at least 3 months, based on the EAT-10 (score ≥3) and/or FOIS (max level 6 out of 7) 3. Eligible tumour sites: oral cavity, oropharynx, larynx, hypopharynx and nasopharynx 4. At least 6 months post-treatment
1. History of major surgery within the head and neck region 2. Recurrent carcinoma in the head and neck region 3. Neurological history that might adversely affect cognition, muscle strength in the head and neck region or swallowing function 4. Dysphagia prior to CRT 5. Intensive swallowing therapy (> once per week) in the last 6 months 6. Complete dependency on tube feeding during more than 1 year 7. Severe frailty or worse following the Clinical Frailty Scale (CFS) (≥7) 8. Related to HD-tDCS: presence of implanted metal or electronic medical devices in the brain or other sites in the body (e.g. deep brain stimulator, cochlear Implant, pacemaker) except for dental implants, history of migraine, epilepsy, brain damage (stroke) or head trauma followed by impairment or consciousness, skin problems (e.g. dermatitis, psoriasis) and use of medication that interferes with non-invasive brain stimulation