Home-based Intensive Treatment of Chronic Radiation Associated Dysphagia in head and neck cancer survivors (HIT-CRAD)

Radiation associated dysphagia (RAD) is one of the most disabling complications in head and neck cancer survivors. Due to the specific nature of RAD including the never-ending cascade of tissue fibrosis and muscle atrophy, treatment of RAD is very challenging and RAD often becomes chronic (C-RAD). Although the need for evidence-based and patient-supported therapy methods for C-RAD is loud and clear and internationally acknowledged, research addressing this issue is scarce, heterogeneous and levels of evidence are low, retarding clinical implementation. This patient-centered study aims to fill in this need by conducting a 3-arms randomized controlled trial. The study design allows to investigate the effect of state-of-the-art and innovative rehabilitation methods in patients with C-RAD, comparing the efficacy and possible detraining effects of mere strengthening exercises (group 1) with a combination of strengthening exercises and functional swallowing therapy (group 2) and non-invasive brain stimulation added to that combination (group 3). In order to limit the additional burden for the patients, therapy sessions take place at home under supervision of a qualified speech language pathologist. Functional oral intake following 8 weeks of therapy is the primary outcome measure. Secondary outcome measures are related to changes in quality of life, muscle strength and swallowing function. Since clinical implementation of a therapy method requires that it is patient-supported. A dummy run will be conducted prior to actual data collection and patient-centered outcome parameters like adherence and patient attitudes and experiences are investigated. It is expected that the study results will facilitate and promote clinical implementation of evidence-based patient-centered care in this challenging population. Hence, a lot of attention will be spent to dissemination of the study and study results to professional caregivers and patients.