Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00458887

Enrollment

301

Registered

2007-04-11

Start date

2007-05-31

Completion date

2017-02-28

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ototoxicity, Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

ototoxicity, unspecified childhood solid tumor, protocol specific

Brief summary

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

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.

Interventions

PROCEDUREmanagement of therapy complications

Undergo hearing tests

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Countries

Australia, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026