Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

Study Overview
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Brief Summary
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RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may improve the ability to plan cancer treatment and may help patients live more comfortably. PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with cisplatin.

Detailed Description
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OBJECTIVES: Determine the optimal criteria for determination of ototoxicity in younger cancer patients treated with cisplatin. Determine the feasibility of including ultrahigh frequency and evoked otoacoustic emission testing as adjunctive measures of ototoxicity. Determine the feasibility and necessity of central review of audiometry data. OUTLINE: This is a multicenter, prospective, cohort study. Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin. Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests before the transplantation and 4 weeks after transplantation. PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.

Official Title
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A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy

Conditions
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Ototoxicity, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer Treatment does not need to be on a COG therapeutic study Planning to enroll on clinical trial ACCL0431 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior cisplatin

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary/Correlative (ototoxicity assessment)<br>Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) for management of therapy complications before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin. Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests for management of therapy complications before the transplantation and 4 weeks after transplantation. | Procedure: management of therapy complications<br>* Undergo hearing tests<br>* Other names: complications of therapy, management of;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria |  | Length of study | 
| Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing |  | Length of study | 
| Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations) |  | Length of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ototoxicity, unspecified childhood solid tumor, protocol specific