Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716376
Recruitment Status : Unknown
Verified March 2016 by Jakob Gerlach Christensen, Zealand University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jakob Gerlach Christensen, Zealand University Hospital

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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Chronic Otitis Media Hearing Loss Device: Otovent® Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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 Name: Auto-inflation device

No Intervention: No treatment
Observation: No treatment.



Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. Perforation of the tympanic membrane. [ Time Frame: 6 months ]
    Otoscopy is used to visualize dry perforations of the tympanic membrane.

  2. 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.

  3. Hearing loss [ Time Frame: 6 months ]
    Pure tone audiometry: Patient's hearing loss range in decibels (dB HL) presented in an audiogram.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716376


Contacts
Layout table for location contacts
Contact: Jakob Gerlach Christensen +45 29803285 jgch@regionsjaelland.dk
Contact: Preben Homøe, Professor +45 47329609 prho@regionsjaelland.dk

Sponsors and Collaborators
Zealand University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jakob Gerlach Christensen Køge University Hospital
Layout table for additonal information
Responsible Party: Jakob Gerlach Christensen, Resident, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02716376    
Other Study ID Numbers: SJ-435
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jakob Gerlach Christensen, Zealand University Hospital:
Head and neck neoplasms
Radiotherapy
Otitis media
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Hearing Loss
Otitis
Otitis Media
Otitis Media with Effusion
Neoplasms by Site
Neoplasms
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases