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

July 25, 2022 updated by: Jakob Gerlach Christensen, Zealand University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Otovent®
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®
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.
Other Names:
  • Auto-inflation device
No Intervention: No treatment
Observation: No treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of otitis media with effusion (OME)
Time Frame: 6 months

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.
Time Frame: 6 months
Otoscopy is used to visualize dry perforations of the tympanic membrane.
6 months
Chronic suppurative otitis media.
Time Frame: 6 months
Otoscopy is used to visualize recurrent ear discharges or otorrhoea through a tympanic perforation for more than two weeks.
6 months
Hearing loss
Time Frame: 6 months
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.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Jakob Gerlach Christensen, Køge University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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