Feasibility of Oto-acoustic Emission assessment in identification of early and significant ototoxic hearing loss in pediatric cancer patients receiving Cisplatin based Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To test the agreement between PTA and OAE findings in identifying early and significant ototoxic hearing loss in pediatric cancer patients by comparing the results after every two cycles of cisplatin containing chemotherapy, at the end of the treatment and at six of completing treatment.
研究概览
简要总结
Cisplatin is amedicine that is being administered as part several chemotherapy protocols formany types of cancer in pediatric patients and often causes a permanent hearingloss. This side effect is refered as ototoxicity and it may significantlyaffect the child’s communication, social and academic skills sometimes up to adisabling degree. In recent years, there has been considerable debate onadopting different test tools for timely identification hearing loss caused bycancer and its treatment that will facilitate effective management of ototoxichearing loss.
Pure-toneAudiometry (PTA) is a routinely used test to identify overall hearing loss andOto-acoustic Emission (OAE) is an objective test, usually done to check the integrity of the inner ear. Wecan identify early and significant ototoxic hearing loss according to grades ofhearing loss based on PTA findings.Though, PTA has been the gold standard testtool for ototoxicity assessment in pediatric patients, OAE has been proved tobe more sensitive than PTA to identify subtle inner ear changes happening inototoxic treatments. But,it is less often used in pediatric cancer patients dueto lack of research evidence.
Hence, Wepropose to evaluate the effectiveness of OAE assessment in identifying thepresence of early and significant ototoxic hearing loss in pediatric cancerpatients receiving Cisplatin based chemotherapy by comparing with Pure-toneAudiometry (PTA) findings during the course chemotherapy.
PTA and OAEfindings will be obtained before, during and after the administration ofCisplatin based chemotherapy in eligible pediatric cancer patients according tothe proposed inclusion/ exclusion criteria. These findings will be subjected tostatistical analysis for agreement in order to check feasibility of OAEassessment in timely identification of severity of ototoxic hearing loss.
The potentialoutcome of the study may have following several clinical applications andusefulness
•Understand andcharacterize the ototoxic hearing loss and its course from audiological pointof view
•Effective designof the audiological monitoring protocol
•Effective Use of OAEfor very young children and difficult-to-test population
•Assist in well-informed treatment decision andcounseling.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Following are the inclusion criteria for enrollment of the study participants.
- •1.Pediatric cancer patients who are planned to receive Cisplatin based chemotherapy 2.Pediatric cancer patients who must be within the age range of 3-17 years 3.Pediatric cancer patients who must be able to provide consistent and reliable responses in conventional pure-tone audiometry 4.Pediatric cancer patients who must present with normal OAE findings at all the test frequencies; i.e. I.
- •For TEAOE, SNR equal to or greater than 6dBSPLand TEOAE level equal to or greater than 0 dBSPL at all the test frequencies with a minimum overall reproducibility rate of 80%; II.
- •For DPOAE, SNR equal to or greater than 6 dBSPL and DPOAE level equal to or greater than 0 dBSPL with a minimum DP reliability rate of 98%based on DP tolerance level ±2 at all the test frequencies.
排除标准
- •Following ear-wise exclusion criteria at the time of enrollment will be taken for the study.
- •1.Pediatric cancer patients with any middle ear pathology or previous ear surgery 2.Pediatric cancer patients with any known pre-treatment hearing loss documented in baseline audiogram.
- •3.Pediatric cancer patients with any known cognitive or psychological problems 4.Pediatric cancer patients with any known ototoxic cancer treatment before.
- •5.Pediatric cancer patients who are planned for cranial radiation therapy.
结局指标
主要结局
To test the agreement between PTA and OAE findings in identifying early and significant ototoxic hearing loss in pediatric cancer patients by comparing the results after every two cycles of cisplatin containing chemotherapy, at the end of the treatment and at six of completing treatment.
时间窗: PTA and OAE will be assessed: | After every two cycles of cisplatin containing chemotherapy, at the end of the treatment and at six months of completing treatment.
次要结局
- To compare the time to reach significant ototoxic hearing loss according to the adopted criteria for each assessment tool (i.e. PTA with grading and OAE) for each ear(It will be analyzed based on the findings of following timepoints. They are at baseline, after every two cycles of Cisplatin based chemotherapy, at the end of the chemotherapy and at six months of completion of chemotherapy.)