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临床试验/NCT02716376
NCT02716376已完成不适用

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

Zealand University Hospital0 个研究点目标入组 30 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Incidence of otitis media with effusion (OME)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients with documented history of otitis media with effusion or chronic otitis media that is not related to the cancer diagnosis.
  • Performance status >
  • Surgery in the middle ear, Eustachian tube and surrounding tissue area. (Biopsies during diagnosis is accepted).

结局指标

主要结局

Incidence of otitis media with effusion (OME)

时间窗: 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).

次要结局

  • Chronic suppurative otitis media.(6 months)
  • Hearing loss(6 months)
  • Perforation of the tympanic membrane.(6 months)
  • Quality of life after treatment of head and neck cancer.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jakob Gerlach Christensen

Resident

Zealand University Hospital

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