Chronic radiation-associated dysphagia in head and neck cancer survivors Signs and Symptoms Dysphagia
Conditions
Interventions
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 highes
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional oral intake based on scores from the Functional Oral Intake Scale (FOIS) measured after 8 weeks of training | — |
Secondary
| Measure | Time frame |
|---|---|
| All participants will be assessed using the scales described above at baseline, weekly during therapy, after 4 and 8 weeks of therapy and 4 weeks after the last therapy session: 1. Swallowing function measured using: 1.1. Mann Assessment of Swallowing Ability-Cancer score (MASA-C) 1.2. Food Intake Level Scale (FILS) 1.3. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) 1.3.1. Penetration Aspiration Scale (PAS) 1.3.2. Pooling Score (P-score) 1.3.3. Dynamic Imaging Grade of Swallowing Toxicity score (DIGEST-score) 1.3.4. International Dysphagia Diet Functional Diet Scale (IDDSI FDS) 1.4. Eating Assessment Tool (EAT-10) 1.5. Self-perception of swallowing ability, assessed using a visual analogue scale ranging from ‘I can’t swallow’ (0 mm) to ‘I don’t have any swallowing difficulties’ (100 mm) 1.6. Short Nutritional Assessment Questionnaire (SNAQ) 2. Quality of life measured using the Dysphagia Handicap Index (DHI) 3. Muscle strength measured using: 3.1. Maximum isometric tongue pressures (best out of three trials; kPa) measured using the Iowa Oral Performance Instrument (IOPI) 3.2. Maximum muscle strength of the suprahyoid muscles measured using a dynamometer 3.3. Maximal Expiratory Pressure (MEP) measured using a spirometer (best out of three trials) 3.4. Total performed number of exercises per week, based on daily therapist registration 4. Reasons for adherence/non-adherence measured using: 4.1. Recorded after each session through three standardised questions: 4.1.1. How much difficulty patients had completing the session (no difficulties/significant difficulties) 4.1.2. What factors made therapy difficult (e.g. fatigue, feelings of depression/anxiety, pain etc) 4.1.3. Any other important message (free text) 4.2. The work-alliance questionnaire (WAV-12, NL) Data on the following possible confounders will be collected: 1. Patient and situational characteristics: age, gender, educational level, social status, personality traits using the NEO Five-Factor Inventor | — |
Countries
Belgium
Contacts
Public ContactGwen Van Nuffelen
Outcome results
None listed