Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
Primary Purpose
Otitis Media With Effusion, Chronic Otitis Media, Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Otovent®
Sponsored by
About this trial
This is an interventional prevention trial for Otitis Media With Effusion focused on measuring Head and neck neoplasms, Radiotherapy, Otitis media
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Otovent®
No treatment
Arm Description
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.
Observation: No treatment.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Perforation of the tympanic membrane.
Otoscopy is used to visualize dry perforations of the tympanic membrane.
Chronic suppurative otitis media.
Otoscopy is used to visualize recurrent ear discharges or otorrhoea through a tympanic perforation for more than two weeks.
Hearing loss
Pure tone audiometry: Patient's hearing loss range in decibels (dB HL) presented in an audiogram.
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.
Full Information
NCT ID
NCT02716376
First Posted
March 3, 2016
Last Updated
July 25, 2022
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02716376
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion, Chronic Otitis Media, Hearing Loss
Keywords
Head and neck neoplasms, Radiotherapy, Otitis media
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Otovent®
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Observation: No treatment.
Intervention Type
Device
Intervention Name(s)
Otovent®
Other Intervention Name(s)
Auto-inflation device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of otitis media with effusion (OME)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Perforation of the tympanic membrane.
Description
Otoscopy is used to visualize dry perforations of the tympanic membrane.
Time Frame
6 months
Title
Chronic suppurative otitis media.
Description
Otoscopy is used to visualize recurrent ear discharges or otorrhoea through a tympanic perforation for more than two weeks.
Time Frame
6 months
Title
Hearing loss
Description
Pure tone audiometry: Patient's hearing loss range in decibels (dB HL) presented in an audiogram.
Time Frame
6 months
Title
Quality of life after treatment of head and neck cancer.
Description
European Organization for Research and Treatment of Cancer Quality of Life and Head and Neck Module (EORTC-H&N35) questionnaire. Patient related outcome.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Gerlach Christensen
Organizational Affiliation
Køge University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
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