Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
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.
Unspecified Childhood Solid Tumor, Protocol Specific
Procedure: management of therapy complications
|Official Title:||A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy|
- Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
- Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
- Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
|Study Start Date:||May 2007|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- 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.