Prospective study to determine the radiation-related effects on the cochlea and vestibular organ in intracranial and extracranial head and neck tumours

Prospective study to determine the radiation-related effects on the cochlea and vestibular organ in intracranial and extracranial head and neck tumours - VESTIRAD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021027

Enrollment

Registered

2020-03-06

Start date

2020-04-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C32 C11 C14 C13 C10 C12 C07 C08 C09 C00 C01 C02 C03 C04 C05 C06 C30 C31 D33 C76.0

Interventions

Group 1: Patients with head and neck cancer who will receive radiotherapy Group 2: Patients with head and neck cancer who receive additional chemotherapy.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criterion for the study is the indication of primary or adjuvant irradiation in patients with histologically proven malignancy in the head and neck region. Only patients who have reached the age of 18 at the time of study enrolment, have a written and spoken command of the German language and are able to participate in regular tumor follow-ups will be included. Patients with planned combined cisplatin-containing radiochemotherapy will be included as a separate study arm and later compared to patients with radiotherapy alone.

Exclusion criteria

Exclusion criteria: Excluded are all patients with tumor-related affection of the vestibular organ, the inner ear or the brain stem which could influence the vestibular diagnostics, patients who are pre-irradiated in the head and neck area as well as patients with known peripheral-vestibular disorders. These include patients with a history of vestibular neuropathy within the last 6 months as well as patients with a history of vestibular paroxysm, endolymph hydrops (M.Menière) or vestibularis schwannoma.

Design outcomes

Primary

Measure	Time frame
pre- and post-therapeutic hearing threshold, tympanic membrane compliance and vestibular function parameters and - subjective dizziness (DHI-G) and quality of life (EORTC-QLQ-C30)	—

Secondary

Measure	Time frame
Comparison of the above-mentioned parameters between the patient group with combined cisplatin-containing radiochemotherapy and the patient group with radiation alone	—

Countries

Germany

Contacts

Public ContactTill Jakob

Klinik für Hals-, Nasen- und Ohrenheilkunde, Universitätsklinikum Freiburg, Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg, Deutschland

till.jakob@uniklinik-freiburg.de076127042010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026