Ototoxicity
Conditions
Interventions
Group 1: 10 radiochemotherapy patients, with targeted one-sided protection of the inner ear, with good recruitment and acceptance by the patients Extension by a further 20 patients to a total of 30 pa
Sponsors
Univ. HNO-Klinik Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with resected squamous cell or adenocarcinoma of the ENT area who receive adjuvant cisplatin-containing radiochemotherapy with radiotherapy of the bilateral cervical lymphatic drainage pathways Life expectancy > 1 year CT or MRI of the head and neck area and complete staging (at least ENT examination, panendoscopy, whole-body CT) Signed declaration of consent Sufficient language comprehension to understand the patient information, the declaration of consent and the cooperation during the examinations (except language test). In the case of non-native speakers, it should be noted if, in the opinion of the examiner, the language test is not sufficiently usable. These patients can be included in the study after consultation with the study management.
Exclusion criteria
Exclusion criteria: Pre-existing moderate or profound hearing loss, average hearing loss (4PTA 0.5 - 4 kHz) > 50 dB HL Conductive hearing loss or a conductive component (combined hearing loss) of 4PTA 0.5 - 4kHz > 15 dB Pathological tympanogram with a negative tympanic pressure of less than -65 daPa Known genetic diseases that may be associated with hearing loss Known systemic, neurological or otological diseases, such as chronic otitis media meso- and epitympanalis, otosclerosis, acoustic neuroma, recurrent sudden deafness, chronic decompensated tinnitus auris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of the temporal course of hearing damage, taking into account the different cochlear radiation doses caused by combined cisplatin-containing radiochemotherapy, with hearing tests before, during and after completion of therapy (2 years after the end of therapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Relation of post-therapeutic ototoxicity and quality of life, communication skills and psychosocial activities of patients both during therapy and especially in the long-term course. Establishment of pulsed DPOAE as an innovative, objective and non-invasive testing method for the early quantitative and qualitative assessment of ototoxicity. | — |
Countries
Germany
Contacts
Public ContactKatharina Bader
Univ. HNO-Klinik Tübingen
Outcome results
None listed