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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
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 3, 2016
    Last Updated
    July 25, 2022
    Sponsor
    Zealand University Hospital
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    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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