Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

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.

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Key information

Conditions

Intraocular Retinoblastoma Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Distortion product otoacoustic emission measurement (DPOAE)

Diagnostic Test

Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.

Primary outcomes

Estimate the incidence of hearing loss

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Mar 7, 2019
Registry last updated: Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed