C10 C13
Conditions
Interventions
Group 1: Patients in the intervention group receive speech therapy by a speech therapist biweekly for 30 minutes per therapy session. Standard exercises for dysphagia and trismus are applied, whereby
Sponsors
Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients with a histologically proven, locally advanced (=T3 and/or N+) carcinoma of the oro- or hypopharynx without distant metastases; • Indication for a definitive or adjuvant (chemo)radiotherapy with an intended radiation dose between 50 Gy and 70 Gy; • Age = 18 years; • Karnofsky performance status = 70%; • Patient education and written consent for participation in the study
Exclusion criteria
Exclusion criteria: • Considerable neurological or psychiatric diseases including dementia and epilepsy; • Medical condition that impairs successful completion of the study or impedes adequate patient education; • Previous tumor treatment (surgery or irradiation) in the head-and-neck region > 3 months ago; • Impairment of the swallowing function prior to radiotherapy treatment, e.g. after other operative interventions in the head-and-neck region; • Lack of legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bogenhausener Dysphagia Score (BODS) at 3 months after radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| BODS at 6 and 24 months after radiotherapy; Quality of life quantified by EQ-5D-5L, DHI and EORTC H&N 35 questionnaires; Body weight; Maximum mouth opening; Prevalence of percutaneous endoscopic gastrostomy (PEG). | — |
Countries
Germany
Contacts
Public ContactAlexander Rühle
Universitätsklinikum Freiburg, Department für Radiologische Diagnostik und Therapie, Klinik für Strahlenheilkunde
Outcome results
None listed