Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJuly 26, 2022
July 1, 2022
6 years
March 3, 2016
July 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Perforation of the tympanic membrane.
6 months
Chronic suppurative otitis media.
6 months
Hearing loss
6 months
Quality of life after treatment of head and neck cancer.
6 months
Study Arms (2)
Otovent®
EXPERIMENTALOtovent® 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.
No treatment
NO INTERVENTIONObservation: No treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jakob Gerlach Christensen
Køge University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 23, 2016
Study Start
April 1, 2016
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
July 26, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share