Health Condition 1: C222- Hepatoblastoma Health Condition 2: C40- Malignant neoplasm of bone and articular cartilage of limbs Health Condition 3: C56- Malignant neoplasm of ovary Health Condition 4: C62- Malignant neoplasm of testis Health Condition 5: C7A- Malignant neuroendocrine tumors Health Condition 6: C45- Mesothelioma Health Condition 7: H838- Other specified diseases of innerear
Conditions
Interventions
Intervention1: Not applicable: Not applicable
Control Intervention1: Not applicable: Not applicable
Sponsors
Tata Research Administrative Council
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 earTimepoint: 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. | — |
Countries
India
Contacts
Public ContactJitesh Prasad Sahoo
Tata Memorial Hospital
Outcome results
None listed