Feasibility of Oto-acoustic Emission assessment in identification of ototoxic hearing loss in adult individuals with cancer receiving Cisplatin based Chemo-radiotherapy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To establish the criteria of ototoxic hearing loss with highest agreement between interpretation of PTA and OAE findings between 1.5 to 6 kHZ
Study Overview
Brief Summary
Cisplatin is a medicine that is being administered as part several chemotherapy protocols for many types of cancer in adult patients and often causes a permanent hearing loss. This side effect is referred as ototoxicity and it may negatively affect the patients post-treatment quality of life. In recent years, there has been considerable debate on adopting different test tools for timely of identification hearing loss caused by cancer and its treatment that will facilitate effective management of ototoxic hearing loss.
Pure-tone Audiometry (PTA) is a routinely used test to identify overall hearing loss and Oto-acoustic Emission (OAE) is an objective test usually done to check the integrity of the inner ear. We can identify ototoxic hearing loss based on PTA findings. Though, PTA has been the gold standard test tool for ototoxicity assessment in adult cancer patients, OAE is thought to be more sensitive than PTA to identify subtle inner ear changes happening in ototoxic treatments. However, it is less often used in cancer patients due to lack of research evidence.
Hence, We propose to evaluate the effectiveness of OAE assessment in identifying the presence of ototoxic hearing loss in adult cancer patients receiving Cisplatin based chemotherapy by comparing with Pure-tone Audiometry (PTA) findings during the course chemotherapy.
PTA and OAE findings will be obtained before, during and after the administration of Cisplatin based chemotherapy in eligible adult cancer patients according to the proposed inclusion/ exclusion criteria. These findings will be subjected to statistical analysis for agreement to check feasibility of OAE assessment in timely identification of ototoxic hearing loss.
The potential outcome of the study may have several clinical applications and usefulness as follows.
1-To understand and characterize the ototoxic hearing loss and its course from audiological point of view which may help us to identify patients earlier if feasible and also counsel them regarding the long term effects.
2-To establish a relationship among audiological indicators of ototoxicity over time and to design the audiological monitoring protocol accordingly in order to prevent and manage ototoxic hearing loss effectively.
3-To design ototoxicity monitoring protocol by using OAE for difficult-to-test population, who may not provide reliable responses in subjective hearing evaluations like Pure-tone Audiometry.
4-To decide upon well-informed treatment decision and counseling
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Following are the inclusion criteria for enrollment of the study participants.
- •1-Head-neck cancer patients who are planned to receive Cisplatin-based definitive or adjuvant chemo-radiotherapy 2-Head-neck cancer patients who are able to provide consistent and reliable responses in conventional pure-tone audiometry.
- •3-Head-neck cancer patients who have not received any known ototoxic cancer treatment before.
- •4-Head-neck cancer patients without any known cognitive or psychological problems.
Exclusion Criteria
- •Following ear-wise exclusion criteria at the time of enrollment will be taken for the study.
- •1-Ears of Head-neck cancer patients with air Conduction Hearing thresholds >50dBHL at any of the octave-band test frequencies between 0.5 to 8 KHz. 2-Ears of Head-neck cancer patients with Distortion Product Oto-acoustic Emission (DPOAE)Signal to Noise Ratio (SNR) level < 6 dBSPL and/ or absolute DPOAE amplitude < -10dBSPL at any two test frequencies between 1.5 to 6KHz 3-Ears of Head-neck cancer patients with presence of any Conductive hearing loss at baseline or at end-of-treatment evaluation.
- •4-Ears of Head-neck cancer patients with a history of previous ear surgery 5-Ears of Head-neck cancer patients with any known pre-treatment hearing loss documented in baseline audiogram.
Outcomes
Primary Outcomes
To establish the criteria of ototoxic hearing loss with highest agreement between interpretation of PTA and OAE findings between 1.5 to 6 kHZ
Time Frame: It will be analyzed based on the audiological findings within three months of completion of treatment.
Secondary Outcomes
- To check any significant audiological changes in findings of PTA & DPOAE across all time points.
- To check the agreement between interpretation of PTA & DPOAE findings based on the newly set criteria of defining auditory abnormality at all other time points.
Investigators
jitesh prasad sahoo
Tata Memorial Hospital