Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy

Conditions
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Otitis Media With Effusion, Chronic Otitis Media, Hearing Loss

Intervention / Treatment
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* Device: Otovent®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Otovent®<br>Otovent® is a special designed balloon that is blown up through the nose, also referred to as auto-inflation of the eustachian tube. The patients use the Otovent® 5 times a day. | Device: Otovent®<br>* Otovent® is a special designed balloon that is blown up through the nose, also referred to as auto-inflation of the eustachian tube. The patients use the Otovent® 5 times a day.<br>* Other names: Auto-inflation device;|
| No Intervention: No treatment<br>Observation: No treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perforation of the tympanic membrane. | Otoscopy is used to visualize dry perforations of the tympanic membrane. | 6 months | 
| 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 | 
| Hearing loss | Pure tone audiometry: Patient's hearing loss range in decibels (dB HL) presented in an audiogram. | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck neoplasms, Radiotherapy, Otitis media