Checking the feasibility of a new hearing assessment tool(Oto-acoustic Emission) in identifying early and significant amount of hearing loss caused due to Cisplatin (widely used as a chemotherapy drug in cancer patients) chemotherapy in pediatric cancer patients.
- Conditions
- Health Condition 1: C222- HepatoblastomaHealth Condition 2: C40- Malignant neoplasm of bone and articular cartilage of limbsHealth Condition 3: C56- Malignant neoplasm of ovaryHealth Condition 4: C62- Malignant neoplasm of testisHealth Condition 5: C7A- Malignant neuroendocrine tumorsHealth Condition 6: C45- MesotheliomaHealth Condition 7: H838- Other specified diseases of innerear
- Registration Number
- CTRI/2023/03/051221
- 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.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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method