NCT00458887

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
• Phase: —
• Study type: Observational
• Enrollment: 301 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ototoxicity
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
PROCEDURE	management of therapy complications	Undergo hearing tests

Timeline

• Start date: 2007-05-01
• Primary completion: 2015-01-01
• Completion: 2017-02-28
• First posted: 2007-04-11
• Last updated: 2017-03-13

Locations

81 sites across 3 countries: United States, Australia, Canada