HEaring impairment After Radiotherapy in patients with OroPharyngeal Squamous Cell Carcinoma

HEaring impairment After Radiotherapy in patients with OroPharyngeal Squamous Cell Carcinoma - HEAR-OPSCC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040654

Enrollment

300

Registered

2026-06-16

Start date

2026-06-03

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C10

Interventions

Group 1: (Control group) Patients with laryngeal cancer who are not receiving radiotherapy as part of their treatment undergo audiological tests to assess changes in hearing independent of radiation e

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Diagnosis of oropharyngeal carcinoma (OPSCC) -Radiotherapy as part of the treatment -Adequate hearing function prior to the start of treatment

Exclusion criteria

Exclusion criteria: -Pre-existing severe hearing loss -Previous radiotherapy to the head and neck region -Concomitant medical conditions or medications that affect hearing -Patients are unable to participate in audiological procedures

Design outcomes

Primary

Measure	Time frame
Hearing loss (HL), measured as the average hearing threshold (PTA4: Pure Tone Average across four frequencies: 0.5, 1, 2 and 4 kHz), in patients with oropharyngeal cancer prior to radiotherapy vs. 12-month follow-up (after completion of treatment).	—

Secondary

Measure	Time frame
-Changes in hearing thresholds across different frequency ranges (high- and low-frequency audiometry). -Function of the eardrum and middle ear, assessed by tympanometry. -Hair cell function, measured using otoacoustic emissions (OAE). - Speech intelligibility, assessed using the Freiburg Monosyllable Test at 55 and 65 dB. - Comparison of audiological parameters between irradiated OPSCC patients and the control group (patients with laryngeal cancer without radiotherapy). - Calculated effective radiation dose to the inner ear and its correlation with audiological changes. - Temporal progression of hearing function at the assessment time points prior to therapy, 6–8 weeks, 6 months and 12 months after completion of radiotherapy. - Identification of dose thresholds at which significant hearing loss occurs. - Influence of other covariates such as age, gender, concomitant chemotherapy and pre-existing conditions on hearing function.	—

Measure

Time frame

-Changes in hearing thresholds across different frequency ranges (high- and low-frequency audiometry). -Function of the eardrum and middle ear, assessed by tympanometry. -Hair cell function, measured using otoacoustic emissions (OAE). - Speech intelligibility, assessed using the Freiburg Monosyllable Test at 55 and 65 dB. - Comparison of audiological parameters between irradiated OPSCC patients and the control group (patients with laryngeal cancer without radiotherapy). - Calculated effective radiation dose to the inner ear and its correlation with audiological changes. - Temporal progression of hearing function at the assessment time points prior to therapy, 6–8 weeks, 6 months and 12 months after completion of radiotherapy. - Identification of dose thresholds at which significant hearing loss occurs. - Influence of other covariates such as age, gender, concomitant chemotherapy and pre-existing conditions on hearing function.

—

Countries

Germany

Contacts

Public ContactNicholas Bevis

Klinik für Hals-, Nasen- und Ohrenheilkunde, Universitätsmedizin

nicholas.bevis@med.uni-goettingen.de0551-39 64229

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026