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NCT03866460 Clinical Trial

Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

Hearing Loss Clinical Trial

Official title:
Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03866460
Other study ID # 18-529
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 6, 2019
Est. completion date March 2025

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to find out how often hearing loss occurs in patients with retinoblastoma after receiving treatment with intra-arterial carboplatin.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility Inclusion Criteria: - Signed informed consent indicating awareness of the investigational nature of the protocol. - Children with RB aged 3 months and older who are scheduled to receive their first dose of IA carboplatin chemotherapy. - Retinoblastoma is rarely seen in children over 8 years old, however we will not include an upper age range so as not to exclude any possible participants Exclusion Criteria: - Children with known and documented preexisting hearing loss.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Distortion product otoacoustic emission measurement (DPOAE)
Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Estimate the incidence of hearing loss will be defined as a >10 db loss from baseline in any frequency, based on the lower threshold of the American Speech and Hearing Associations (ASHA) hearing change criteria. For children unable to cooperate for an audiogram, the DPOAE will be the primary measurement. 1 year
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