Dysphagia Signs and Symptoms
Conditions
Interventions
Patients will be randomized to one of two treatment arms, each following a different timeline. Irrespective of their group, all participants will receive the same intervention, namely 4 sessions of RE
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of radiation-associated dysphagia following head and neck cancer. Based on a deviant result on the Penetration-Aspiration Scale (PAS score > 1) (Rosenbek et al., 1996) 2. = 6 months post cancer treatment. Based on the knowledge that radiation toxicities are clinically classified into acute, subacute, or chronic. Early mucosal injuries (acute 6 months post irradiation) are attributed to damage to the vasculature and/or surrounding connective tissue. Often acute injuries are transient and resolve within a few months after treatment. In order to study the effect of this specific treatment, it’s important to include only patients without possible spontaneous recovery as described in the acute phase <6 months (King et al., 2016) 3. Previous swallowing rehabilitation including strength training is allowed, but not simultaneously
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 07/04/2026: 1. Severe frailty: =level 7 @ the Clinical Frailty Scale (Rockwood et al., 2005) 2. Cognitive or language impairments interfering with the therapy/assessments within RES-ST 3. No resection(s) of any structure of the laryngeal vestibule (vocal folds, arytenoids, epiglottis) _____ Previous key exclusion criteria: 1. Severe frailty: =level 7 @ the Clinical Frailty Scale (Rockwood et al., 2005) 2. Cognitive or language impairments interfering with the therapy/assessments within RES-ST 3. Major surgery in the head and neck
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PAS (Penetration-Aspiration Scale) score at baseline and after RES-ST | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures, measured at baseline (T0), two weeks after baseline (T1) and four weeks after baseline (T2): 1. Swallowing function, measured with the Modified Barium Swallow Impairment Profile (MBSImP) and the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). 2. Patient reported outcome with the Eating Assessment Tool (EAT-10). 3. Respiratory outcome measures: percentage of pathological respiratory swallow patterns and the percentage of normal respiratory swallow patterns. 4. Quality of life, based on the results of the Dysphagia Handicap Index (DHI), the M.d. Anderson Dysphagia Inventory (MDADI) and the Dutch version of the Performance Status Scale for Head and Neck Cancer (D-PSS-HN). Tertiary/exploratory endpoint: Data on the following confounders will be collected at baseline: 1. Patient characteristics: age, gender, duration of RAD, frailty (Clinical Frailty Scale), COPD-status (GOLD-criteria). COPD-stage will be determined at the pneumology department. The occurrence of (aspiration) pneumonias before, during and after RES-ST treatment. 2. Disease characteristics: tumor size (TNM-classification), HPV-status and feeding mode (enteral vs oral), gathered through medical records of the patient. The functional oral intake will be questioned by means of the Functional Oral Intake Scale (FOIS) and the Food Intake Level Scale (FILS). The clinical swallow function will be described with the Mann Assessment of Swallowing Ability Scale for Cancer patients (MASA-C). 3. Therapy characteristics: chemotherapy, fractionation, bilateral neck irradiation, duration, time post treatment, all gatherd through medical records of the patient. Data on the following confounders will be collected after two weeks of RES-ST: 1. Attitudes about exercising, based on the results on the Attitudes On Exercise questionnaire 2. Level of patient activation, based on the results on American short form Patient Activation Measure (PAM-13 | — |
Countries
Belgium
Contacts
Public ContactCharlotte Schellen
Outcome results
None listed