跳至主要内容
临床试验/CTRI/2014/08/004940
CTRI/2014/08/004940已完成不适用

STUDY TO ASSESS HEARING LOSS IN PATIENTS RECEIVING CHEMORADIOTHERAPY IN ADJUVANT SETTING FOR HEAD AND NECK MALIGNANCY

FATHER MULLER MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
HEARING LOSS IN DECIBELS ACHIEVED BY PURE TONE AUDIOMETRY

研究概览

简要总结

Head andneck cancers in India account for 30% of all cancers. In India, 60 to 80 % ofpatients present with advanced disease as compared to 40% in developedcountries.Chemoradiotherapy (CTRT) is the most common modalityof treatment for advanced head and neck cancers.

Radiation induced sensorineuralhearing loss (SNHL) is an important side effect as the temporal bone is oftenincluded in the field of radiation.It is usually high frequencySNHL that occurs either during or 6-24 months after therapy and may progress tocomplete deafness. The widely used chemotherapeutic drug, cisplatin, is alsoknown to cause ototoxicity, thus adding to the SNHL.

This hearing impairment can causesignificant disability in these patients especially in cases of binauralhearing loss, hence this should be kept in mind during the pre- radiotherapycounseling and post-radiotherapy follow-up of these patients. Manyof the previous reports were based on studies that were either retrospective orinvolved a limited number of patients. The aim of this study is the qualitativeand quantitative assessment of hearing loss in patients receiving CTRT inadjuvant settings for head and neck malignancy.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •INDIVIDUALS SUFFERING FROM HEAD AND NECK MALIGNANCIES RECEIVING CHEMO-RADIATION FOR THE SAME WITH TEMPORAL BONE IN THE RADIATION FIELD.
  • •INDIVIDUALS WILLING FOR TIMED AUDIOLOGICAL ASSESSMENT.

排除标准

  • •INDIVIDUALS ALREADY SUFFERING FROM PROFOUND HEARING LOSS AND RECEIVING NEOADJUVANT CHEMORADIOTHERAPY.

结局指标

主要结局

HEARING LOSS IN DECIBELS ACHIEVED BY PURE TONE AUDIOMETRY

时间窗: PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP

次要结局

  • DEGREE OF SEVERITY AND TYPE OF HEARING LOSS(PRE THERAPY, 3 WEEKS AFTER INITIATING THERAPY, AT THE COMPLETION OF THERAPY, 3 MONTHS FOLLOW UP)

研究者

发起方
FATHER MULLER MEDICAL COLLEGE
申办方类型
Private medical college

研究点 (1)

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