Checking the effectiveness of a new hearing assessment (Oto-acoustic Emission) in identifying hearing loss caused due to Cisplatin (widely used as part of cancer treatment) in adult cancer patients.
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/12/060500
- Lead Sponsor
- Tata Research Administrative Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the criteria of ototoxic hearing loss with highest agreement between interpretation of PTA and OAE findings between 1.5 to 6 kHZTimepoint: It will be analyzed based on the audiological findings within three months of completion of treatment.
- Secondary Outcome Measures
Name Time Method To check any significant audiological changes in findings of PTA & DPOAE across all time points. <br/ ><br>Timepoint: It will be analyzed based on the findings of the evaluation conducted after two cycles of chemotherapy & follow up evaluation conducted within three months of completion chemotherapy.;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. <br/ ><br>Timepoint: It will be analyzed based on the findings of the evaluation conducted after two cycles of chemotherapy