Clinical trial NCT02716376: Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
Official title: Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media With Effusion
Chronic Otitis Media
Hearing Loss
Keywords: Head and neck neoplasms
Radiotherapy
Otitis media
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Middle ear complications and TD are common following RT to the Head \& Neck, where the radiation field involves the ET and ME. These are due to mucositis and swelling in the surrounding pharyngeal tissue and on the long-term fibrosis. The ET is a small channel from the middle ear to the upper part of the pharynx. It is normally closed but briefly opens while swallowing or yawning. The ME pressure then equalizes and optimize sound conduction to the inner ear. If the function of the ET is impaired it can lead to negative pressure and effusion. This causes pain, tinnitus, otitis media with effusion (OME), chronic otitis media (COM) and hearing loss. Last can be none reversible. Almost everyone experience middle ear morbidity short after RT, but on the long-term up to 20 % have chronic otitis media and TD with significant hearing impairment and the need for hearing aid. Conventional treatment with insertion of ventilation tubes in to the tympanic membrane is not recommended for radiation-induced ME problems.

Methods and materials: The investigators will by randomized controlled trials examine the effect of auto-inflation of the ET on ME morbidity with a custom-made balloon called Otovent®. Examination of the ear is conducted by otoscopy, pure tone and impedance audiometry and questionnaires.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of otitis media with effusion (OME)
timeFrame: 6 months
Secondary outcomes:
measure: Perforation of the tympanic membrane.
timeFrame: 6 months
measure: Chronic suppurative otitis media.
timeFrame: 6 months
measure: Hearing loss
timeFrame: 6 months
measure: Quality of life after treatment of head and neck cancer.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Køge University Hospital
name: Jakob Gerlach Christensen
role: PRINCIPAL_INVESTIGATOR
References: