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Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03866460
Collaborator
(none)
50
Enrollment
1
Location
47.8
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma
Actual Study Start Date :
Mar 6, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Hearing evaluation 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Mary Elizabeth Davis, MSN, RN, AOCNS, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03866460
Other Study ID Numbers:
  • 18-529
First Posted:
Mar 7, 2019
Last Update Posted:
Dec 21, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Hearing Status
18-529
Additional relevant MeSH terms:
Retinoblastoma
Hearing Loss
Deafness

Study Results

No Results Posted as of Dec 21, 2021