Hearing Loss Clinical Trial
Official title:
Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
NCT number | NCT02716376 |
Other study ID # | SJ-435 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | April 1, 2022 |
Verified date | July 2022 |
Source | Zealand University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Head and neck cancer patients in Zealand region, Capital region and North Jutland region. - Only patients who received or is going to receive radiotherapy or chemoradiotherapy as curative intended treatment. - The irradiated volume involve the nasopharynx. Exclusion Criteria: - Patients with documented history of otitis media with effusion or chronic otitis media that is not related to the cancer diagnosis. - Performance status > 3. - Surgery in the middle ear, Eustachian tube and surrounding tissue area. (Biopsies during diagnosis is accepted). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of otitis media with effusion (OME) | Impedance audiometry: A tympanometer I used to measure compliance of the tympanic membrane. Results are presented in a type A, B, or C-curve, with pressure in dekaPascal at the x-axis and compliance in decibel (db) at the y-axis. Type B curve indicates otitis media with effusion.
B-curve indicate middle ear effusion (OME). |
6 months | |
Secondary | Perforation of the tympanic membrane. | Otoscopy is used to visualize dry perforations of the tympanic membrane. | 6 months | |
Secondary | Chronic suppurative otitis media. | Otoscopy is used to visualize recurrent ear discharges or otorrhoea through a tympanic perforation for more than two weeks. | 6 months | |
Secondary | Hearing loss | Pure tone audiometry: Patient's hearing loss range in decibels (dB HL) presented in an audiogram. | 6 months | |
Secondary | Quality of life after treatment of head and neck cancer. | European Organization for Research and Treatment of Cancer Quality of Life and Head and Neck Module (EORTC-H&N35) questionnaire. Patient related outcome. | 6 months |
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