Respiratory swallowing therapy in patients with radiation associated dysphagia

The effect of respiratory swallowing therapy in patients with radiation associated dysphagia on swallowing function and quality of life

Registry ID
ISRCTN47914607
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Antwerp University Hospital
Enrollment
60
Start date
2025-03-07
Completion date
2028-06-30
Last update
2026-08-17

Conditions

Summary

Dysphagia

Detailed description

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 RES-ST in a period of two weeks. These sessions take place at the patient's home or nursery home and is supervised by one of the researchers. All sessions will consist of at least 100 (food bolus) swallows with the super-supraglottic swallow maneuver (SSGS). These swallows will gradually build up, varying in type of bolus (IDDSI levels) and volume (5-10-15 ml and spontaneous cup swallows). During the swallows, the respiratory inductance plethysmography (RIP) and the speech language therapist provide feedback on the respiratory swallow patterns used. Feedback will start at 100% for each new bolus type and will decrease systemically depending on the skill acquisition to avoid feedback dependency. Besides the 4 sessions, participants will practice daily on their own (two sets of 10 swallows) during the two-week intervention period.

Interventions

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 <3 months or subacute 3–6 months post irradiation) are attributed to cell death and subsequent inflammation; whereas late deeper tissue responses (chronic >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

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

Locations

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