Skip to content

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.

Feasibility of Oto-acoustic Emission assessment in identification of ototoxic hearing loss in adult individuals with cancer receiving Cisplatin based Chemo-radiotherapy. - Nil

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/12/060500
Enrollment
80
Registered
2023-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Control Intervention1: NIL: NIL

Sponsors

Tata Research Administrative Council
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To check any significant audiological changes in findings of PTA & DPOAE across all time points. 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. Timepoint: It will be analyzed based on the findings of the evaluation conducted after two cycles of chemotherapy

Countries

India

Contacts

Public Contactjitesh prasad sahoo

Tata Memorial Hospital

jitesh.aslp@gmail.com9437491391

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026