Clinical trial · Interventional
Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
NCT02716376CI-TRIAL-00059892completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Otitis Media | — | UNRESOLVED | — |
| Hearing Loss | — | UNRESOLVED | — |
| Otitis Media With Effusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Otovent® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Otovent®
- 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.
- interventionNames
- Device: Otovent®
- type
- NO_INTERVENTION
- label
- No treatment
- description
- Observation: No treatment.
Primary outcomes (1)
- measure
- Incidence of otitis media with effusion (OME)
- timeFrame
- 6 months
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.