Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

Completed

• Conditions: Hearing Loss; Intraocular Retinoblastoma
• Interventions: Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)

• Registration Number: NCT03866460
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Status Verified: 2024-11
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Children with known and documented preexisting hearing loss.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hearing evaluation DPOAE	Distortion product otoacoustic emission measurement (DPOAE)	Post IA hearing evaluation will be allowed up until 9 months after IA completion (or roughly one year from initiation of treatment). After completion of standard treatment for RB that included IA carboplatin.

Primary Outcome Measures

Name	Time	Method
Estimate the incidence of hearing loss	1 year	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States